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Adverse events of auricular therapy: a systematic review.

1. Introduction

Being one of the most popular complementary therapeutic approaches, auricular therapy (AT) is defined as "a health care modality whereby the external surface of the ear, or auricle, is stimulated to alleviate pathological conditions in other parts of the body" [1]. The earliest record of AT can trace back to 500 to 300 B.C. in ancient China, where the Yellow Emperor's Inner Canon (Huangdi Neijing) described that the ear is not isolated but intimately connected with the five viscera and the six bowels [2]. The modern system of AT was developed by the French neurologist Paul Nogier in the late 1950s, and it is recognized that the outer ear has a somatotopic arrangement with an inverted fetus pattern and each internal organ is corresponding to a sensitive point located in the auricle [3]. AT could produce a therapeutic effect for treating various types of disorders by stimulating the particular acupoint which corresponds to the targeted part of the body or organ [4]. Various modalities are adopted in AT practice including auricular acupuncture, acupressure, moxibustion, injection, and auricular bloodletting therapy.

The WHO recognizes AT as a microacupuncture system that can produce a positive impact on regulating the whole body function [5], and its therapeutic effect has been investigated in a wide range of health problems in both oriental and western countries. Clinical trials and systematic reviews have shown that AT can be a promising modality in relieving preoperative anxiety [6], psychosomatic disorders [7], and various types of pain [8], managing hypertension [9] and cocaine dependence [10], and controlling obesity [11]. The wide use of AT in clinical practice requires continual safety evaluation. It is said that the popularity of AT is partially attributed to its convenience and safety, and in some oriental countries, AT is usually conducted by healthcare professionals only with AT short-term training or even by unqualified practitioners without any experience in performing AT [12]. However, this kind of intervention is not entirely risk-free, where adverse events, such as chest tightness, dizziness, perichondritis, and nausea, are also reported in the literature [13]; meanwhile, when applying AT to special populations such as pregnant women and immunocompromised patients, unwanted miscarriage and infection could have occurred [13].

The ear possesses abundant capillaries which make it highly vulnerable to skin inflammations and other infections [13]. To minimize potential harms caused by AT, practitioners need to strictly follow standardized procedures of AT administration as well as fully understand the potential adverse events associated with it. It is important to assess the safety of AT in clinical practice. Unfortunately, different from other traditional therapies such as body acupuncture, moxibustion, and cupping, whose safety is well analyzed in surveys and/or systematic reviews [14-17], clinical evidence on the safety of AT has not been clearly established to date. Despite the increasing number of studies in recent years reporting harm data associated with AT, their results have not been systematically summarized. Up to now, there is no systematic review to evaluate the adverse events associated with AT. Therefore, the aim of this study was to evaluate the type and frequency of AT-related adverse events, to identify any avoidable adverse events associated with nonstandardized AT procedures, and to provide recommendations for future research and practice in this area.

2. Methods

A study protocol accompanied with a data extraction form was formulated and critically reviewed by two experts who were familiar with AT and systematic reviews before the initiation of the study.

2.1. Definition of Adverse Events. In this study, an adverse event was defined as "an undesirable experience associated with the use of a medical product in a patient" according to the US Food and Drug Administration 18]. A serious adverse event was defined when the event led to serious outcomes such as death, hospitalization, disability, and permanent damage or as being life-threatening [18].

2.2. Inclusion and Exclusion Criteria. Case reports, case series, prospective and retrospective surveys, and all types of clinical trials (randomized controlled trials, nonrandomized controlled clinical trials, or other uncontrolled clinical trials) reporting adverse events associated with AT in human subjects were included. Animal research, in vitro studies, and review papers were excluded. Types of AT could be auricular acupuncture, auricular electroacupuncture, auricular acupressure, auricular moxibustion, auricular injection, or auricular bloodletting therapy.

2.3. Data Sources and Searching Strategies. Relevant studies were retrieved from three sources: electronic database, manual search, and reference lists search for final included studies. Electronic search was conducted in 13 databases (from inception to May 8,2014) including PubMed, EMBase, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, PsycINFO, Allied and Complementary Medicine (AMED), Thomson Reuters Web of Science, Science Direct, Foreign Medical Journal Service (FMJS), China National Knowledge Infrastructure (CNKI), WanFang Data, Chinese Scientific Journal Database (CQVIP), and Chinese Biomedical Literature Database (CBM). No language restriction was applied for electronic search. Meanwhile, seven Chinese core journals on complementary medicine (Journal of Integrative Medicine, Chinese Acupuncture & Moxibustion, China Journal of Traditional Chinese Medicine and Pharmacy, Journal of Traditional Chinese Medicine, Chinese Journal of Basic Medicine in Traditional Chinese Medicine, Chinese Journal of Integrated Traditional and Western Medicine, Journal of Beijing University of Traditional Chinese Medicine, and Journal of Nanjing University of Traditional Chinese Medicine, issues within the latest three years) were manually retrieved for further relevant articles. Reference lists of the included papers were also checked to identify any potential eligible studies. All searches were conducted by two reviewers (Tan JY and Wang T) independently. Mesh terms, keywords, and free words such as "auriculotherapy," "acupuncture, ear," "adverse event*," "side effect*," "adverse effect*," "adverse health care event," "safe*," and "risk*" were used in the searching strategies. Table 3 presents three main search strategies for this review.

2.4. Study Selection and Data Extraction. Study characteristics and outcome data of each included article were extracted using the data extraction form, which included (1) first author, year of publication, study design, and setting; (2) participant characteristics (age, gender, sample size, diagnostic criteria, and reason for AT); (3) AT protocol (type of AT, practitioner, selected acupoints, type of AT equipment, and treatment duration); and (4) AT-related adverse events (type of adverse event, frequency, outcome, and causality). Study selection and data extraction were conducted by two reviewers independently, and disagreement was resolved through discussion.

2.5. Outcome Assessment. Type and frequency of AT-related adverse events were the main outcomes of this study. The likelihood of causality and quality of adverse events reporting were also judgedbytwo reviewers and checked by two experts specialized in AT and acupuncture.

For adverse events reported in case reports or case series, the likelihood of causality was judged by the WHOUppsala Monitoring Centre (UMC) System for Standardized Case Causality Assessment [19]. The likelihood was classified into six grades including the following: (1) certain: a plausible time relationship that adverse events clearly occurred after receiving AT and disappeared after withdrawal, and these events could not be explained by other health problems or interventions; (2) probable/likely: a reasonable time relationship that the onset of symptoms was most likely related to AT and that was unlikely attributed to other health problems or interventions; (3) possible: a reasonable time relationship that the onset of symptoms was most likely related to AT but that could also be explained by other health problems or interventions, and the information on AT withdrawal was lacking or unclear; (4) unlikely: there was an improbable time relationship between AT and the adverse event; (5) conditional/unclassified: event occurred but more data were essential for a proper causality assessment; and (6) unassessable/unclassifiable: an adverse event was suggested by a report but cannot be judged due to insufficient or contradictory information [19].

For clinical trials, the quality of adverse events reporting was assessed using the CONSORT for Harms Data Recommendations [20, 21]. Seven items were employed for assessment [17,20,21]: (1) report of data on harms in the title or abstract; (2) report of AT-related harms in the introduction section; (3) prespecification of potential adverse events of AT (clinical and/or laboratory); (4) specification of approach for collecting harm-related information; (5) description of plans for presenting and analyzing adverse events of AT; (6) description of participant withdrawals due to adverse events of AT; and (7) report of the particular denominators for analyses on AT-related harms. The quality of each item was judged as "adequate," "partially adequate" "inadequate" or "not reported" accordingly [17]. It was rated as "adequate" if an item was properly described in detail in the article or in the study protocol; "partially adequate" was given if an item was properly described but only in a brief format; when an item failed to be properly described, the quality was judged as "inadequate"; and "not reported" meant an item was not described [17].

3. Results

3.1. Characteristics of Analyzed Studies. Electronic and manual searches yielded 8015 records. After checking by reference management software, 1187 duplicated records were removed, and another 6495 were further excluded after browsing the titles and abstracts. Full text of the remaining 333 records was retrieved for eligibility assessment, and 290 articles were finally excluded because they were reviews (n = 28), were study protocols (n = 5), were conference abstracts (n = 22), and were non-AT interventions (n = 34), and the adverse events were not reported (n = 201). Therefore, 43 studies [22-64] were identified for final analysis. The flow chart of study selection is presented in Figure 1.

The analyzed studies included 32 randomized controlled trials, five uncontrolled clinical trials, four case reports, and two nonrandomized controlled trials, with a total of 3396 participants receiving AT treatment. Six studies were from the United States, five from Taiwan, four from Germany, three from Hong Kong, two from Australia, two from Austria, two from the United Kingdom, 15 from China, and one each from Malaysia, Canada, Sweden, and Spain. Four AT modalities were utilized including auricular acupuncture in 18 studies [26-43], auricular acupressure in 21 studies [22-25,44-60], auricular electroacupuncture in three studies [61-63], and auricular bloodletting therapy in one study [64]. AT was applied to deal with a variety of health problems such as drug dependence, smoking cessation, pain, constipation, insomnia, and obesity.

The clinical effectiveness of AT was descriptively summarized from the included 34 controlled clinical trials (randomized or nonrandomized) [26-32, 34-42, 44-50, 52-56, 58-63], as the data synthesis was not available due to the significant clinical heterogeneity in the types of disease, AT protocols, and intervention durations among analyzed trials. Twenty-three studies reported significantly positive effect of AT for the primary and/or secondary outcomes between groups, while eight studies only detected favorable changes within the AT groups. Of the controlled clinical trials that employed auricular acupuncture, 93.8% (15/16) stated positive outcomes of AT between or within groups, whereas it was 93.3% (14/15) in studies using auricular acupressure, respectively. Two out of three trials on auricular electroacupuncture showed clinical effectiveness of AT. The majority (30 studies) described the person who administered AT including acupuncturist, TCM practitioner, physician, psychiatrist, therapist, and nurse. The selection of acupoints for treatment was based on the targeted health problem but shenmen was the most commonly referred acupoint which was used in 35 studies for treating various types of disorders.

3.2. Case Reports. Table 1 presents AT-related adverse events reported in case reports. Four cases were located and the reported adverse events were dizziness in one case [22], somnolence in two cases [23, 24], and abdominal pain in one case [25]. No serious adverse events were identified. All cases were treated with auricular acupressure using vaccaria seeds, whereas only two [22, 23] specified the practitioner who administered AT (a physician).

In Ye's report [22], a 48-year-old woman with constipation experienced dizziness five minutes after receiving auricular acupressure. The symptom gradually disappeared after removing the taped seeds. In two other reports [23, 24], two men (one was 41-year-old with lumbar muscle strain, and another was 43-year-old with dilated cardiomyopathy) reported drowsiness and somnolence at the 12th and 15th day, respectively, during the AT treatment. Their symptoms disappeared immediately after removing the taped seeds and reoccurred when seeds were taped again. Adverse events described in these three cases were assessed as probably/likely related to AT. In Ma's report [25], a 58-year-old woman with chronic diarrhea suffered from abdominal pain 30 minutes after receiving auricular acupressure, and the symptom disappeared immediately after removing the taped seeds. The author described it as a rare event caused by AT and the causality was assessed as possible.

3.3. Clinical Studies

3.3.1. Quality of Adverse Events Reporting. Table 2 presents AT-related adverse events reported in clinical trials. For the quality of adverse events reporting, the overall results were not optimal. Twenty studies adequately or partially adequately described adverse events in the title and/or abstract (51.3%), whereas there were only nine studies appropriately describing safety issues of AT in the introduction (23.1%). AT-related adverse events were seldom prespecified (17.9%), and 16 studies properly described approaches for adverse events data collection such as investigator observation, questionnaire, or self-report (41.0%). Only six studies properly described plans for presenting and analyzing adverse events (15.4%). Twelve studies adequately or partially adequately reported whether there were any subjects that withdrew due to adverse events of AT (30.8%), and 13 studies appropriately described the denominators for analyzing adverse events (33.3%).

3.3.2. Auricular Acupuncture-Related Adverse Events. Auricular acupuncture-related adverse events were reported in 18 clinical studies [26-43] with a total of 1753 participants receiving AT (Table 2). Duration of treatment varied among studies and 10 studies offered AT for more than three weeks. The most frequently reported adverse events were tenderness or pain at the needling site, dizziness, discomfort at the needling site, local bleeding, nausea, headache, and inflammation at insertion. Most of these events were transient, minor, and tolerable.

Eleven studies reported 134 cases complaining of local pain and tenderness at the needling site. AT was performed by acupuncturist in eight studies [27, 31, 32, 34-36, 38, 39], by psychiatrist and nurse in two studies [37, 41], and by physiotherapist in one study [28]. Forty-three cases withdrew due to pain but the majority could tolerate AT and completed the treatment. Two studies [32, 35] did not take any measures to decrease adverse events and symptoms gradually declined, and one study [41] stopped AT temporarily or reduced treatment frequencies to deal with local pain.

Twenty-five cases in eight studies reported minor bleeding at insertion. AT was administered by an acupuncturist in five studies [27, 35, 38, 40, 42], by psychiatrist and nurse in two studies [37, 41], and by physiotherapist in one study [28]. Bleeding often happened during inserting and/or withdrawing the needle and stopped soon without any treatment.

Seven studies [27, 29, 30, 35, 36, 42, 43] reported 51 cases experiencing dizziness after receiving auricular acupuncture; one study was conducted by a TCM practitioner [43] and one by an investigator with acupuncture diploma [29], while all others were carried out by acupuncturists. One study [35] took no action for dizziness and the symptom gradually disappeared, and three studies [36,42,43] reported that dizziness disappeared after removing the auricular stimulation, and only one case withdrew due to dizziness.

Minor nausea was reported in five studies (22 cases). AT was provided by an acupuncturist in four studies [27, 35, 36, 42] and by a TCM practitioner in one [43]. Three studies [36, 42, 43] stated that nausea subsided after withdrawing the ear stimulation, one study [35] did not take any action, and the symptom gradually declined, whereas one study [27] failed to report the outcome. Two studies [27, 38] (AT performed by acupuncturist) reported 18 cases developing minor headache after AT, one did not report the outcome [27], and another stated that headache was resolved afterwards [38].

Two studies reported two cases experiencing minor inflammation (swelling or redness) around the needling site. AT was administered by an acupuncturist [31] and a physiotherapist [28], respectively. One study [28] stated that the subject who complained of swelling concealed a history of rheumatoid arthritis, which belonged to one of the exclusion criteria of that study. Twenty-seven cases in two studies [26, 29] reported discomfort or a strange feeling at insertion and one case withdrew. Only one study [35] reported minor infection around the needling site in one case and the condition gradually improved.

In addition, there were some other adverse events reported in a single study, including slight fever (19 cases) and dry mouth (15 cases), which focused on methadone maintenance treatment (MMT) for drug-dependent persons [27]. Transient exacerbation of vasomotor symptoms (2 cases) was found in one study which focused on the vasomotor symptoms associated with luteinizing hormone releasing hormone agonist treatment in prostate cancer patients [33]. Upper limb numbness was mentioned in one study [43] and it was resolved immediately after removing stimulation of acupoint "sympathetic."

3.3.3. Auricular Acupressure-Related Adverse Events. Auricular acupressure-related adverse events were reported in 17 clinical trials [44-60] (Table 2). A total of 1266 participants were treated with auricular acupressure (true or sham intervention) and the majority employed vaccaria seeds and/or magnetic pellets performing acupressure. More than half of the studies provided AT for no less than two weeks. The commonly reported adverse events were local skin irritation, discomfort, tenderness or pain at the taped site, and dizziness, and most of them were also mild, short-term, and well tolerated.

Thirteen studies [45, 47-50, 53-60] reported 63 cases suffering from local skin irritation with itchiness, allergy, or redness after receiving auricular acupressure. Only half of the studies specified the professional conducting AT, which include acupuncturist in two studies [53, 60], TCM practitioner in two studies [50, 58], therapist in one study [48], and nurse in the other one [54]. Skin irritation was mostly attributed to the adhesive tapes. However, there was one study [57] reporting several subjects who were allergic to magnetic pellets. Seven cases withdrew due to skin irritation, and five cases changed adhesive tape to desensitization material and treatment continued, and those subjects who were allergic to magnetic pellets switched to vaccaria seeds and symptoms disappeared. Itchiness spontaneously subsided in 25 cases, and three cases recovered after treatment, while others tolerated well these symptoms and continued to complete treatment.

Three studies [51-53] reported tenderness or pain at the taped site (16 cases), and only two [51, 53] specified the AT practitioner (acupuncturist). No subjects withdrew, but one study [52] reported five cases experiencing obvious ear pain when receiving AT for the first time, and symptoms were relieved after reducing the pressing frequency and intensity of the taped seeds.

Two studies [46, 53] reported mild to moderate discomfort at the taped site (35 cases). Apart from one case that withdrew, others tolerated well the discomfort. Another two articles [45, 46] reported three cases experiencing minor dizziness during AT treatment and one subject withdrew. In one study [54] in which AT was administered by a nurse (the author did not declare whether the nurse had received any training in AT), ear skin breakdown was recorded in one subject, and the skin recovered two days later after using entoiodine. One study [44] reported pressure ulcers in the pinna in 18 subjects after receiving auricular acupressure and all ulcers healed within 10 days after removing the tapes.

3.3.4. Auricular Electroacupuncture-Related Adverse Events. Three articles [61-63] reported adverse events of auricular electroacupuncture (Table 2), which included 203 participants treated with true or sham AT. Treatment duration ranged from five to six weeks. Two studies described AT practitioners including a doctor with acupuncture experience in one [63] and nurse in another [62]. Reported adverse events included discomfort and pain at insertion and local skin irritation. All reactions were mild and tolerable.

Two studies [62, 63] mentioned two cases complaining of discomfort at the needling site but the outcome was not reported. One study [61] reported mild ear skin irritation in eight cases, and the author explained it was induced by the adhesive patch of the P-stim or placebo device. Skin irritations were resolved immediately after AT. One study [63] found one case experiencing pain at the needling site but no outcome was reported.

3.3.5. Auricular Bloodletting Therapy-Related Adverse Events. There was only one study [64] using auricular bloodletting therapy and 170 subjects were included. Two cases reported minor infection at the needling site but the outcome was not described.

4. Discussion

Our findings provide preliminary evidence that AT is a relatively safe approach in routine practice. The most frequently reported adverse events were mainly confined to short-term, mild, and tolerable reactions such as local discomfort, transient tenderness and pain, local skin irritation, minor bleeding, and dizziness. Some of them are potentially avoidable, and no serious adverse events were detected. However, the clinical practice of AT still needs caution because some adverse events like dizziness, somnolence, and infection could also result in serious negative outcomes. Meanwhile, the quality of adverse events reporting should be improved in future research and related guidelines such as the Guidelines for Case Reports of Adverse Events Related to Acupuncture [65], and the CONSORT for Harms Data Recommendations [20] should be followed.

Complementary therapeutic approaches such as body acupuncture, moxibustion, cupping, and AT have been widely used in dealing with a variety of disorders. Apart from the increasing emphasis on their therapeutic effects, safety of these interventions also received wide attention. The safety of body acupuncture has been well summarized in the literature and a number of serious adverse events have been identified including pneumothorax, hepatitis, staphylococcus infection, and central nervous system injuries [14]. Adverse events of moxibustion were also systematically analyzed and some rare but dangerous events, for instance, burns, cellulitis, ecchymoma, and hepatitis C, were reported [14, 16]. In a recent systematic review [17], cupping-related adverse events reported in South Korea were investigated, and anemia, herpes viral infections, and skin lacerations were identified. In our findings, no serious adverse events of AT were reported and the reactions were mostly transient, mild, and tolerable. Based on our findings, the safety of AT seems superior to other traditional therapies such as body acupuncture, moxibustion, and cupping.

Various adverse events were identified in studies using auricular acupuncture, of which dizziness was one of the most commonly reported symptoms. Similar reports can also be found in body acupuncture [66-68], which viewed dizziness as mild symptoms of acupuncture-related fainting. This maybe because of transient hypotension, as acupuncture stimulation through the peripheral vagus nerve reflex could dilate the peripheral blood vessels and reduce venous return [68, 69]. As a result, decreasing in the brain blood supply induces transient hypotension and causes symptoms such as dizziness and weakness [68, 69]. Dizziness was often seen in people who received AT for the first time, especially for those who felt anxious or nervous before treatment and for those with extremely weak condition or with hypoglycemia [12]. Although dizziness is generally mild and can spontaneously subside, potential risks associated with it still need caution, especially when applying AT in community or in clinical settings. Most clients there would leave the clinic immediately after finishing AT, and if dizziness occurs afterwards, accidental falls might happen. AT practitioners should pay attention to this issue, particularly for those elderly patients with osteoporosis.

As an invasive approach, auricular acupuncture may also lead to some infections. But from our findings, only one case was found with minor infection at insertion, and no serious infections such as chondritis, cellulitis, and hepatitis were detected. This finding is inconsistent with Norheim's study [70] which indicated that auricular chondritis was a commonly reported infection in patients receiving acupuncture on the ear. The infected cases came from the literature published 20-30 years ago, and the author concluded that the hygienic problem, such as insufficient needle skin disinfection, partially contributed to these infections [70]. Unqualified sterilization and disinfection for either skin or needle equipment may be one of the crucial risk factors for acupuncture-related infections at that time. In our analyzed studies, the needles used in AT were generally sterilized and disposable, and the ear skin was mostly reported well disinfected. The gradually improved awareness of strict hygienic procedures during AT could be one of the reasons for the low incidence of infection identified in our review. However, practitioners also need to prudently use this approach on clients with poor wound-healing capacity, such as patients with diabetes mellitus, extremely weak status, or immunocompromised disorders [13], as potentially local damage could result in some nonhealing wounds or even systemic infections. Considering these circumstances, other noninvasive AT modalities such as auricular acupressure could be adopted instead.

It is worth noting that there were several rare adverse events reported in one trial in which the intervention group received AT plus MMT while the control group received MMT only [27]. The author claimed that dry mouth and slight fever were AT-related adverse events. However, dry mouth is a general side effect of methadone [71], and sometimes fever is considered as one of the opioid withdrawal symptoms during the induction phase of MMT 72]. Unfortunately, the author did not measure methadone treatment-related side effects; therefore, comparison of reported adverse events between groups and causality assessment became impossible. It is difficult for us to distinguish whether these symptoms are caused by AT because the time relationship between symptom onset and the administration of AT was not reported, and the information on dechallenge and/or rechallenge was lacking.

Comparing with auricular acupuncture, auricular acupressure is noninvasive and much easier to access. In addition to qualified AT practitioners, auricular acupressure is also widely conducted by other healthcare professionals or even unqualified persons [12]. In our analyzed studies, auricular acupressure was administered by acupuncturists, TCM practitioners, physicians, therapists, and registered nurses; however, more than half (52.4%) of the studies employing auricular acupressure failed to specify the person who performed AT, which made us unable to analyze whether there were any potentially avoidable adverse events caused by unqualified practitioners. In terms of the risk-benefit balance, either auricular acupuncture or auricular acupressure showed positive effects in managing a variety of health problems in our analyzed studies. However, for the adverse events, cases of local pain and dizziness were much less in auricular acupressure studies compared with those identified in studies on auricular acupuncture, and there were no bleeding and infection reports related to auricular acupressure. According to our findings, it seems that auricular acupressure is superior to other invasive AT approaches regarding its safety and convenience.

Adverse skin reactions, such as itchiness, redness, or allergy, were the most frequently reported adverse events in auricular acupressure, and the majority were associated with the adhesive tape used for taping acupressure seeds, while there were also some rare reports that skin irritation was caused by allergy to magnetic pellets. Despite the frequent complaints on skin irritations, these symptoms could be easily handled by changing adhesive tapes to desensitization textures or changing magnetic pellets to plant seeds. Dizziness was also reported in auricular acupressure, but the frequency was much lower than that reported in auricular acupuncture. In one case report [22], the author analyzed that dizziness might be due to the continual stimulation of the sympathetic nerve fibers wrapped around the vasa labyrinthi which could narrow blood vessels and reduce labyrinth's blood supply and, hence, lead to transient loss of orientation. This indicated that dizziness might be partially managed by reducing the frequency and intensity of acupressure.

Two case reports mentioned somnolence or drowsiness caused by auricular acupressure; the author in one study explained that it might be because of the long-term manipulation of the taped seeds inhibiting the normal functions of the autonomic nerve [23]. These kinds of symptoms were also reported in body acupuncture treatment [66,73], and the activation of central 5-hydroxytryptamine (5-HT) pathways from the raphe nuclei may partially be involved in the onset of drowsiness after receiving acupoint stimulation, where stimulation of the raphe nuclei and the 5-HT secretion could contribute to the symptoms of fatigue, tiredness, and drowsiness [74, 75]. AT practitioners should attach importance to these reactions as somnolence or drowsiness could lead to some dangerous outcomes such as drowsiness-related motor vehicle crash. It is noteworthy that one study [44] reported 18 cases of pressure ulcers. Auricular acupressure in this study was administered by doctors and nurses who had received training in AT. Pressure ulcers were possibly caused by the long treatment duration and continual pressure. Participants in this study received weekly AT consecutively for 8 weeks; auricular implants were kept for seven days during each treatment and participants were asked to press them three times daily. No rest period was mentioned between each treatment and the continual stimulated auricle skin might have not had enough time to heal.

AT-related harms in auricular electroacupuncture and bloodletting therapy were all transient and mild. However, this review cannot ascertain the safety of these two modalities because only four studies with a limited sample size were included for analysis, and the methodological quality of adverse events reporting was unsatisfactory.

Several limitations were identified in our analyzed articles, which could affect the strength of the evidence concluded from our findings. Participant sample sizes included in this review were relatively small, and one-third of the analyzed studies failed to specify the practitioner conducting AT. Quality of adverse events reporting in included clinical trials was generally unsatisfactory, the majority did not prespecify AT-related adverse events, more than half failed to report approaches for collecting and analyzing adverse events, time relationship between the onset of symptoms and the administration of AT was not clearly described, and one-third failed to report outcomes of adverse events, all of which made it difficult to evaluate the causality of adverse events reported in clinical trials. Also, it is noted that several types of needles were utilized in studies on auricular acupuncture, and some adverse events may be associated with the variations on the length and thickness of particular AT needle, depth of insertion, and the frequency and intensity of manual pressing on the needled area. However, the information was described insufficiently in the analyzed studies, which inhibited us to judge whether there were any adverse events associated with particular types of AT equipment and procedure. Meanwhile, certain information such as the particular AT practitioner, patient's medical history, details of AT procedure and equipment, and the adverse events outcome also failed to be reported clearly in the included case reports. Moreover, there was a possibility that AT-related adverse events were underreported because during the process of the literature sorting we found a great number of papers not including adverse events as the study outcome. In addition, case reports on AT-related adverse events were rare in the published literature which made us unable to access any new or previously unrecognized harms associated with AT.

This review itself also has some limitations. Although we have made efforts to retrieve all the relevant literature, the included studies were only English and Chinese articles, and language bias may occur. Meanwhile, as there is no specific tool for the causality assessment of adverse events reported in acupuncture (including AT) studies, we employed the tool developed by the WHO-UMC in this review; however, this tool is particularly designed for adverse drug reactions and some items might not be sensitive enough for evaluating acupuncture or AT-related adverse events. Furthermore, the originally designed outcome on the frequency of AT-related adverse events was finally not calculated, as the majority of the included literature only reported the absolute number of cases complaining of adverse events.

5. Implications for Future Research and Practice

This study has some implications for future research and practice. Firstly, invasive AT approaches such as auricular acupuncture (manual or electric), and bloodletting therapy, should be applied by qualified practitioners. Even for the one administering noninvasive AT like auricular acupressure, receiving AT training from a qualified practitioner before application is essential because nonstandardized practice could create more unintended harms to patients. Secondly, the patients' condition needs to be well assessed before applying AT. Practitioners should identify beforehand if any clients are allergic to steel needles, adhesive tapes, magnetic pellets, or other AT materials. For weakened or elderly patients undergoing AT, semireclining position should be adopted to prevent potential harm induced by dizziness, and invasive AT should be applied with caution on patients with poor wound-healing capacity. Thirdly, the importance of patients' education should be emphasized, and the informed consent should be provided before AT. Patients need to be well informed about the potential risks associated with adverse events such as dizziness, somnolence, and drowsiness. Working at heights or driving should be avoided if patients are undergoing AT treatment. Fourthly, treatment duration and pressure intensity of AT need to be reasonably arranged. Patients should avoid putting excessive pressure on the implanted needles or taped seeds, and de qi sensation (a subjective feeling of numbness, pressure sensation, heaviness, soreness, or distension) could be adopted as an indicator of stopping pressure. For those receiving long-term AT treatment, a reasonable rest period between each treatment course should be provided. Moreover, for future case reports on AT-related adverse events, more details on the qualification of the practitioner, the targeted auricular acupoints, the AT equipment, the instruction on manual press, the position of the patient during AT, and the outcome of adverse events should be fully reported, and related guideline such as the Guidelines for Case Reports of Adverse Events Related to Acupuncture could be considered [65]. Lastly, prospective or retrospective surveys on AT-related adverse events are needed in future research to gather practitioner-reported and/or patient-reported outcomes. Future clinical trials on AT should include safety assessment as an important outcome measure, and related international guidelines such as the CONSORT for Harms Data Recommendations [20] should be followed to report and analyze AT-related adverse events.

Disclosure

This systematic review did not receive any grants from any funding agencies.

Conflict of Interests

The authors declare that there is no conflict of interests regarding the publication of this paper.

Authors' Contribution

Jing-Yu Tan undertook the study design, completed the literature searching and data extraction and analysis, and drafted and revised this paper. Alexander Molassiotis undertook the study design and critically revised this paper. Tao Wang completed the literature searching and data extraction. Lorna K. P Suen undertook the study design and revised this paper.

http://dx.doi.org/10.1155/2014/506758

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Jing-Yu Tan, (1) Alexander Molassiotis, (1) Tao Wang, (2) and Lorna K. P. Suen (1)

(1) School of Nursing, The Hong Kong Polytechnic University, HungHom, Kowloon, Hong Kong

(2) The Second Affiliated People's Hospital, Fujian University of Traditional Chinese Medicine, No. 13 Hudong Road, Gulou District, Fuzhou 350003, China

Correspondence should be addressed to Lorna K. P. Suen; lorna.suen@polyu.edu.hk

Received 24 June 2014; Revised 26 August 2014; Accepted 27 August 2014; Published 10 November 2014

Academic Editor: Byung-Cheul Shin

Table 1: Adverse events associated with auricular therapy
reported in case reports.

Study and setting      Age (gender)   Reason for AT

Ye, 2014 [22],         48 (female)    Constipation
Chinese PLA General
Hospital, Beijing,
China

Yu and Xie,            41 (male)      Lumbar muscle
2010 [23],                            strain
Teda Hospital,
Tianjin, China

Huo et al.,            43 (male)      Dilated
2000 [24], Chinese                    cardiomyopathy
PLA 546 Hospital,
Xinjiang, China

Ma, 1992 [25],         58 (female)    Chronic
Ningyang TCM                          diarrhea
Hospital, Shandong,
China

Study and setting      Type of AT                  Practitioner
                       (method and duration)

Ye, 2014 [22],         Method: auricular           Physician
Chinese PLA General    acupressure using
Hospital, Beijing,     auricular plaster with
China                  vaccaria seeds Duration:
                       not reported

Yu and Xie,            Method: auricular           Physician
2010 [23],             acupressure using
Teda Hospital,         auricular plaster with
Tianjin, China         vaccaria seeds Duration:
                       three days per treatment,
                       4 treatments in total
                       (12 days)

Huo et al.,            Method: auricular           Not reported
2000 [24], Chinese     acupressure using
PLA 546 Hospital,      auricular plaster with
Xinjiang, China        vaccaria seeds Duration:
                       three days per treatment,
                       5 treatments in total
                       (15 days)

Ma, 1992 [25],         Method: auricular           Not reported
Ningyang TCM           acupressure using
Hospital, Shandong,    auricular plaster with
China                  vaccaria seeds Duration:
                       30 minutes

Study and setting      Selected acupoints          AEs and severity

Ye, 2014 [22],         Shenmen, kidney, liver,     Event(s): dizziness
Chinese PLA General    spleen, stomach, temple,    Severity:
Hospital, Beijing,     subcortex, forehead,        not reported
China                  occiput

Yu and Xie,            Heart, liver, spleen,       Event(s): somnolence
2010 [23],             occiput, shenmen,           Severity:
Teda Hospital,         sympathetic                 not reported
Tianjin, China

Huo et al.,            Heart, liver, lung,         Event(s): somnolence
2000 [24], Chinese     shenmen, spleen,            Severity:
PLA 546 Hospital,      sympathetic, occiput        not reported
Xinjiang, China

Ma, 1992 [25],         Large intestine,            Event(s): abdominal
Ningyang TCM           small intestine, shenmen,   pain Severity:
Hospital, Shandong,    liver, sympathetic,         severe
China                  spleen

Study and setting      Outcomes               Causality *

Ye, 2014 [22],         Recovery after         Probable/likely
Chinese PLA General    removing taped seeds
Hospital, Beijing,
China

Yu and Xie,            Recovery after         Probable/likely
2010 [23],             removing taped seeds
Teda Hospital,
Tianjin, China

Huo et al.,            Recovery after         Probable/likely
2000 [24], Chinese     removing taped seeds
PLA 546 Hospital,
Xinjiang, China

Ma, 1992 [25],         Recovery after         Possible
Ningyang TCM           removing taped seeds
Hospital, Shandong,
China

AT: auricular therapy, AE: adverse event, PLA: Peoples Liberation
Army, and TCM: traditional Chinese medicine.

* The WHO-Uppsala Monitoring Centre (UMC) System for Standardized
Case Causality Assessment: certain-a plausible time relationship
that adverse events clearly occurred after receiving AT and
disappeared after withdrawal, and these events could not be
explained by other health problems or interventions;
probable/likely-a reasonable time relationship that the onset of
symptoms was most likely related to AT and that was unlikely
attributed to other health problems or interventions; possible-a
reasonable time relationship that the onset of symptoms was most
likely related to AT but that could also be explained by other
health problems or interventions, and the information at withdrawal
was lacking or unclear; unlikely-there was an improbable time
relationship between AT and the adverse event;
conditional/unclassified-event occurred but more data were
essential for a proper causality assessment;
unassessable/unclassifiable-an adverse event was suggested by a
report but cannot be judged due to insufficient or contradictory
information.

Table 2: Adverse events associated with auricular therapy reported
in clinical trials.

Study                  Reason              Intervention
                       for AT and          (details of AT)
                       practitioner        and control

                                           Studies on auricular
                                           acupuncture

                                           Intervention
                                           (true AT):
Prisco et al.,                             (i) Method: auricular
2013 [26]              R: PTSD-related     acupuncture with spring
RCT (N = 35)           insomnia            handle needles
Department of          P: physician        (0.16 x 15 mm)
Veterans Affairs                           (ii) Duration: two
Medical Center,                            treatments weekly (45
Washington DC, USA                         minutes per treatment)
                                           for 8 weeks Control 1
                                           (sham AT): auricular
                                           acupuncture at
                                           nonacupuncture points
                                           Control 2: waiting-list
                                           control

                                           Intervention (MMT + AT):
Lua and Talib, 2013                        (i) Method: auricular
[27] RCT (N = 97)                          acupuncture
Three Methadone        R: drug             (needles: 0.25 x
Maintenance            dependence          12.55 mm)
Treatment (MMT)        P: acupuncturist    (ii) Duration: three
Centers, Terengganu,                       treatments weekly
Malaysia                                   (30 minutes per
                                           treatment) for 8 weeks
                                           Control: MMT only

                                           Intervention
                                           (exercise + AT):
Hunter et al., 2012                        (i) Method: auricular
[28] RCT (N = 52)      R: chronic          acupuncture with Seirin
Primary Care & A       low back pain       Pyonex ear needles
University             P:                  (1.80 x 0.26 mm)
Population,            physiotherapist     (ii) Duration: one
Northern Ireland,                          treatment (48 hours)
UK                                         weekly for 6 weeks
                                           Control: exercise only

                                           Intervention (true AT):
                                           (i) Method: auricular
Michalek-Sauberer      R: state anxiety    acupuncture (needles:
et al., 2012 [29]      before dental       0.2 x 15 mm)
RCT (N = 182)          treatment           (ii) Duration: twenty
Outpatient Clinic,     P: investigator     minutes until the start
Medical University     with a diploma      of dental treatment
of Vienna, Vienna,     of acupuncture      Control 1 (sham AT):
Austria                                    auricular acupuncture
                                           at nonspecific points
                                           Control 2: no
                                           intervention

                                           Intervention (true AT):
                                           (i) Method: auricular
                                           acupuncture (needles:
Lien et al.,           R: obesity          2 mm tip and 10 mm
2012 [30]              P: acupuncturist    annular-shaped body)
RCT (N = 90)                               (ii) Duration: three
Taipei City                                treatments weekly
Hospital, Taiwan                           for 4 weeks
                                           Control 1: auricular
                                           stimulation using
                                           magnetic pellets
                                           Control 2 (sham AT):
                                           needles with the tips
                                           removed

                                           Intervention (true AT):
                                           (i) Method: auricular
Hsu et al" 2009 [31]   R; obesity          acupuncture (needles:
RCT (N = 60)           P: acupuncturist    2 mm tip and 10 mm
Taipei Hospital,                           annular-shaped body) (ii)
Taiwan                                     Duration: two treatments
                                           weekly (3 days per
                                           treatment) for 6 weeks
                                           Control (sham AT):
                                           needles with the tips
                                           removed

Wang et al., 2009      R: pregnant women   Intervention (true AT):
[32] RCT (N = 159)     with low back       (i) Method: auricular
Yale-New Have          pain and            acupuncture with Seirin
Hospital, New          posterior pelvic    Pyonex ear needles
Haven, USA             pain                (ii) Duration: one week
                       P: acupuncturist    Control 1 (sham AT):
                                           auricular acupuncture at
                                           nonspecific points
                                           Control 2: no treatment

Harding et al.,        R: hot flushes      Intervention (AT): (i)
2008 [33] Non-RCT      in prostate         Method: auricular
(N = 60) James Cook    cancer patients     acupuncture with 0.20 g
University Hospital,   with LHRH agonist   sterile single-use
Middlesbrough, UK      treatment           needles
                       P: not reported     (ii) Duration: weekly
                                           treatment (40 minutes)
                                           for 10 weeks Control:
                                           not applicable

Courbasson et al.,     R: women with       Intervention (AT + usual
2007 [34] Non-RCT      concurrent          treatment):
(N = 305) The Jean     substance use       (i) Method: auricular
Tweed Centre,          problems and        acupuncture (details not
Toronto, Ontario,      anxiety and         described)
Canada                 depressive          (ii) Duration: three
                       symptoms            treatments weekly
                       P: acupuncturist    (45 minutes per
                                           treatment) (length of
                                           treatment not mentioned)
                                           Control: usual treatment

Wu et al., 2007 [35]   R: smoking          Intervention (true AT):
RCT (?? = 131)         cessation           (i) Method: auricular
Smoking Cessation      P: acupuncturist    acupuncture with 36
Clinics, Taipei                            gauge 0.5 inch ear-
Veterans General                           piercing needles
Hospital, Taiwan                           (ii) Duration: weekly
                                           treatment for 8 weeks
                                           Control (sham AT):
                                           auricular acupuncture at
                                           nonspecific points

                                           Intervention
Usichenko et al.,                          (true AT + analgesia):
2007 [36]                                  (i) Method: auricular
RCT (N = 120)                              acupuncture with
Ambulatory             R: postoperative    indwelling steel needles
Orthopedic Surgery     pain                (0.22 x 1.5 mm)
Center of the Ernst    P: acupuncturist    (ii) Duration: inserted
Moritz Arndt                               before surgery and kept
University,                                until the following
Greifswald, Germany                        morning Control
                                           (sham AT + analgesia):
                                           auricular acupuncture
                                           at nonacupuncture points

                                           Intervention
Kunz et al., 2007                          (AT + usual treatment):
[37] RCT (N = 109)     R: alcohol          (i) Method: auricular
Clinic of              withdrawal          acupuncture with
Psychiatry and         P: psychiatrists    stainless-steel
Psychotherapy          or mental-health    acupuncture needles
Bethel, Bielefeld,     nurses              (0.2 x 0.15 mm)
Germany                                    (ii) Duration: daily
                                           treatment (45 minutes)
                                           for 5 consecutive days
                                           Control: aromatherapy +
                                           usual treatment

                                           Intervention
                                           (true AT + analgesia):
Usichenko et al.,                          (i) Method: auricular
2005 [38] RCT                              acupuncture with
(N = 61) Department    R: postoperative    permanent press steel
of Anesthesiology      pain                needles (0.22 x 1.5 mm)
and Orthopedic         P: acupuncturist    (ii) Duration: inserted
Surgery, University                        the evening before
of Greifswald,                             surgery and kept for
Germany                                    3 days after surgery
                                           Control (sham AT +
                                           analgesia): auricular
                                           acupuncture at
                                           nonacupuncture points

                                           Intervention (true AT):
                                           (i) Method: auricular
Berman et al.,         R: drug use         acupuncture with
2004 [39]              problem,            stainless-steel
RCT (N = 158)          psychological       disposable needles
Two Medium-Security    symptoms, and       (0.22 x 0.13 mm)
Institutions           physical            (ii) Duration: a total
(Jails), Sweden        discomfort in       of 14 treatments
                       prison inmates      (40 minutes per
                       P: acupuncturist    treatment) for 4 weeks
                                           Control (sham AT):
                                           auricular acupuncture at
                                           nonspecific points

                                           Intervention 1
                       R: smoking          (true acupuncture +
Bier et al., 2002      cessation and       education):
[40] RCT (N = 141)     cigarette           (i) Method: auricular
Arizona, USA           consumption         acupuncture with 36
                       P: acupuncturist    gauge 0.5 inch needles
                                           (ii) Duration: five
                                           treatments weekly
                                           (30 minutes per
                                           treatment) for 4 weeks
                                           Intervention 2
                                           (true acupuncture)
                                           Control (sham
                                           acupuncture + education):
                                           auricular acupuncture at
                                           nonacupuncture points

                                           Intervention
Gurevich et al.,       R: substance-       (receiving AT for 5 or
1996 [41] Non-RCT      abuse problem       more times):
(N = 77) North Shore   P: psychiatrist     (i) Method: auricular
University Hospital    and nurses          acupuncture with sterile
at Glen Cove, USA                          disposable needles
                                           (ii) Duration: daily
                                           treatment (20-40 minutes)
                                           Control: receiving AT
                                           for 4 or fewer times

                                           Intervention
                                           (true AT + support
Washburn et al.,       R: heroin           service):
1993 [42]              addiction           (i) Method: auricular
RCT (N = 100)          P: acupuncturist    acupuncture with
The Bayview-Hunters                        single-use disposable
Point Foundation,                          needles
San Francisco, USA                         (ii) Duration:
                                           twenty-one days
                                           (20-45 minutes per
                                           treatment) Control
                                           (sham AT + support
                                           service): auricular
                                           acupuncture at
                                           nonacupuncture points

                                           Intervention (AT):
Zhang and Fan, 1986                        (i) Method: auricular
[43] Non-RCT                               acupuncture for main
(N = 179) TCM          R: cholecys-        points and auricular
Academy of Shanxi      tolithiasis         acupressure for adjunct
Province, China        P: TCM              points (details were
                       practitioner        not described)
                                           (ii) Duration: not
                                           reported Control:
                                           not applicable

                                           Studies on auricular
                                           acupressure

                                           Intervention (true AT):
                                           (i) Method: auricular
Vas et al, 2014        R: chronic          acupressure using
[44] RCT (N = 265)     nonspecific         auricular plaster with
Ten Primary            spinal pain         vaccaria seeds
Healthcare Centres,    P: doctors and      (ii) Duration: weekly
Seville, Spain         nurses with         treatment (seeds kept
                       AT training         for 7 days) for 8 weeks
                                           Control (placebo AT):
                                           auricular acupressure
                                           using auricular plaster
                                           with inactive black
                                           plastic discs

                                           Intervention (true AT):
                                           (i) Method: auricular
Li et al, 2014 [45]                        acupressure using
RCT (N = 99)           R: constipation     auricular plaster with
Elderly Residential    P: not reported     magnetic pellets
Care Home,                                 (ii) Duration: ten days
Hong Kong                                  Control 1 (placebo AT):
                                           auricular acupressure
                                           using auricular plaster
                                           with vaccaria seeds
                                           Control 2 (usual care):
                                           auricular acupressure
                                           using auricular plaster
                                           only

                                           Intervention (true AT):
                                           (i) Method: auricular
                                           acupressure with stain
Zhang et al., 2013     R: smoking          less-steel press-pellet
[46] RCT (N = 43)      cessation           tapes
RMIT University,       P: acupuncturist    (ii) Duration: weekly
Australia                                  treatment for 8 weeks
                                           Control (sham AT):
                                           auricular acupressure
                                           at nonspecific points

                                           Intervention (AT +
                                           intravenous analgesia):
Kong, 2012 [47]        R: postoperative    (i) Method: auricular
RCT (N = 60)           pain                acupressure using
Foshan Hospital of     P: not reported     auricular plaster with
TCM, Foshan,                               vaccaria seeds
China                                      (ii) Duration: one
                                           treatment (5 hours after
                                           surgery), seeds kept
                                           for 3 days
                                           Control: intravenous
                                           analgesia only

                                           Intervention (true AT +
Yeh et al., 2012       R: chemotherapy-    standard care):
[48] RCT (N = 10)      induced nausea      (i) Method: auricular
A Large Childrens      and vomiting        acupressure using
Hospital, Taiwan       P: therapist        auricular plaster with
                                           plant seeds
                                           (ii) Duration: one
                                           treatment, seeds
                                           kept for 7 days
                                           Control (sham AT +
                                           standard care): auricular
                                           acupressure at
                                           nonspecific points

                                           Intervention (true AT):
                                           (i) Method: auricular
Li et al., 2012 [49]                       acupressure using
RCT (N = 39)                               auricular plaster with
Elderly Residential    R: constipation     magnetic pellets
Care Home,             P: not reported     (ii) Duration: three
Hong Kong                                  weeks
                                           Control (placebo AT):
                                           auricular acupressure
                                           using auricular plaster
                                           with vaccaria seeds

                                           Intervention (AT):
                                           (i) Method: auricular
Jin et al., 2012                           acupressure using
[50] RCT (N = 80)                          auricular plaster with
Cangnan TCM            R: severe           magnetic pellets
Hospital of            insomnia            (ii) Duration: one
Zhejiang Province,     P: TCM              treatment, seeds kept
Cangnan, China         practitioner        for 7 days
                                           Control: standardized
                                           medication

                                           Intervention (AT):
                                           (i) Method: auricular
Kung et al., 2011      R: women with       acupressure using
[51] Non-RCT           postmenopausal      auricular plaster with
(N = 45) Taipei        insomnia            magnetic pellets
Veterans General       P: acupuncturist    (ii) Duration: daily
Hospital, Taiwan                           treatment (every night
                                           before sleep) for
                                           4 weeks
                                           Control: not applicable

                                           Intervention
Xia et al., 2011                           (AT + Chinese medicine
[52] RCT (N = 60)                          plaster):
Baoan Hospital         R: low back pain    (i) Method: auricular
Affiliated to          caused by lumbar    acupressure using
South Medical          strain              auricular plaster with
University,            P: not reported     vaccaria seeds
Shenzhen, China                            (ii) Duration: two
                                           treatments weekly for
                                           2 weeks
                                           Control: Chinese medicine
                                           plaster only

                                           Intervention (true AT):
                                           (i) Method: auricular
Xue et al., 2011                           acupressure using
[53]                   R: persistent       auricular plaster with
RCT (N = 63)           allergic            stain less-steel pellets
Two Metropolitan       rhinitis            (ii) Duration: eight
RMIT Campus in         P: acupuncturist    weeks
Melbourne,                                 Control (sham AT):
Australia                                  auricular acupressure
                                           at nonspecific points

                                           Intervention
Ji et al., 2010 [54]                       (AT + usual care):
RCT (N = 73)           R: functional       (i) Method: auricular
Shuguang Hospital      constipation        acupressure using
Affiliated to          P: nurse            auricular plaster with
Shanghai University                        Liu Shen Wan
of TCM, Shanghai,                          (for excess syndrome) or
China                                      magnetic pellets
                                           (for deficiency syndrome)
                                           (ii) Duration: one month
                                           Control: usual care

                                           Intervention
                                           (true AT + hand
Wing et al., 2010                          acupressure):
[55] RCT (N = 70)                          (i) Method: auricular
Outpatient Clinics     R: smoking          acupressure using
and The Community,     cessation           auricular plaster with
Hong Kong              P: not reported     hard beads
                                           (ii) Duration: three
                                           weeks
                                           Control (sham AT + sham
                                           hand acupressure):
                                           auricular acupressure at
                                           nonmeridian points

Sun, 2010 [56]                             Intervention
RCT (N = 173)          R: insomnia         (AT + psychological
Department of TCM,     P: not reported     support):
Xuzhou First                               (i) Method: auricular
Hospital of Jiangsu                        acupressure using
Province, Xuzhou,                          auricular plaster with
China                                      vaccaria seeds
                                           (ii) Duration: twenty
                                           days Control: AT only

                                           Intervention (AT):
                                           (i) Method: auricular
Peng, 2009 [57]                            acupressure using
Non-RCT (N = 30)                           auricular plaster with
Hanguang Hospital      R: neurasthenia     magnetic pellets
of Handan City,        P: not reported     (ii) Duration: three
Handan, China                              days per treatment,
                                           20 treatments in total
                                           (60 days)
                                           Control: not applicable

Chen et al., 2009                          Intervention (AT):
[58] RCT (N = 180)     R: vascular         (i) Method: auricular
TCM Hospital of        dementia            acupressure using
Hainan Province,       P: TCM              auricular plaster with
Haikou, China          practitioner        vaccaria seeds
                                           (ii) Duration: daily
                                           treatment for 12 weeks
                                           Control: standardized
                                           medication

Wang et al.,                               Intervention (AT):
2007 [59]                                  (i) Method: auricular
RCT (N = 198)          R: myopia           acupressure using
Peoples Hospital of    P: not reported     auricular plaster with
Baoshan City,                              vaccaria seeds
Baoshan, China                             (ii) Duration: four
                                           weeks for one treatment
                                           Control: standardized
                                           medication

Ding et al., 2006                          Intervention (AT +
[60]                                       Neiguan acupressure):
RCT (N = 200)          R: motion           (i) Method: auricular
TCM Hospital of        sickness            acupressure using
Hebei Province,        P: acupuncturist    auricular plaster with
Shijiazhuang, China                        magnetic pellets
                                           (ii) Duration:
                                           not reported
                                           Control: standardized
                                           medication

                                           Studies on auricullar
                                           electroacupuncture

Schukro et al.,                            Intervention (AT + diet
2013 [61]                                  based on TCM):
RCT (N = 56)                               (i) Method: auricular
Department of          R: obesity          acupuncture with
Special Anesthesia     in female           electrical stimulation
and Pain Management    patients            using P-stim
at the Medical         P: not reported     electroacupuncture device
University of                              (needle: 27 gauge,
Vienna, Vienna,                            3 mm length)
Austria                                    (ii) Duration: 4-day
                                           treatment per week for
                                           6 weeks
                                           Control (placebo AT +
                                           diet based on TCM):
                                           auricular acupuncture
                                           with a P-stim dummy

                                           Intervention (AT):
                                           (i) Method: auricular
Fritz et al.,                              acupuncture with the
2013 [62]                                  Stim Flex 400A
RCT (N = 125)          R: smoking          Transcutaneous Electrical
St. Louis Veterans     cessation           Nerve Stimulation Unit
Affairs Medical        P: registered       (active, 80 Hz)
Center, USA            nurse               (ii) Duration: weekly
                                           treatment (20 minutes
                                           per treatment) for
                                           5 consecutive weeks
                                           Control (sham AT):
                                           auricular acupuncture
                                           with the Stim Flex 400A
                                           Transcutaneous Electrical
                                           Nerve Stimulation Unit
                                           (inactive, 0 Hz)

Bernateck et al.,                          Intervention (AT):
2008 [63]                                  (i) Method: auricular
RCT (N = 44)                               acupuncture with
Outpatient Clinic      R: rheumatoid       electrical stimulation
of the Department      arthritis           using P-stim device
of Rheumatology,       P: doctor with      (needle: 27 gauge,
Hannover               profound            3 mm length)
Medical School,        acupuncture         (ii) Duration: weekly
Hannover, Germany      experience          treatment (48 hours per
                                           treatment) for 6 weeks
                                           Control: autogenic
                                           training

                                           Studies on auricular
                                           bloodletting therapy

Yuan and Qiao,                             Intervention (AT):
1998 [64] Non-RCT      R: acute            (i) Method: auricular
(N = 170) Chinese      tonsillitis         bloodletting therapy
PLA 34260 Hospital,    P: not reported     with three-edged needle
Xiangfan, China                            (ii) Duration: not
                                           applicable
                                           Control: not applicable

Study                  Selected acupoints      AEs
                                               (number of Cases)
                                               of AT and outcome

                       True AT: shenmen,
Prisco et al.,         liver, kidney,
2013 [26]              sympathetic,            Uncomfortable at
RCT (N = 35)           hippocampus Sham        the needling site
Department of          AT: nonacupuncture      (n = 1)
Veterans Affairs       points located on       Outcome: withdrawal
Medical Center,        the helix of the
Washington DC, USA     ear

                                               Light headache
Lua and Talib, 2013                            (ft = 17) Slight
[27] RCT (N = 97)                              bleeding (n = 14)
Three Methadone        Shenmen,                Tingling sensations
Maintenance            sympathetic, kidney,    (n = 19) Pain
Treatment (MMT)        liver, lung             (ft = 17) and nausea
Centers, Terengganu,                           (ft = 19) Drowsiness
Malaysia                                       (ft = 11) and
                                               dizziness (n = 19)
                                               Dry mouth (ft = 15)
                                               and slight fever
                                               (ft = 19) Outcome:
                                               not reported

                                               Pain and redness
                                               (not reported)
Hunter et al., 2012                            Minor bleeding
[28] RCT (N = 52)      Shenmen, lumbar         (not reported)
Primary Care & A       spine, cushion          Swelling around the
University                                     needling site
Population,                                    (n = 1)# Outcome:
Northern Ireland,                              (i) NR (for pain,
UK                                             redness, and
                                               bleeding)
                                               (ii) Recovery
                                               (for swelling)

Michalek-Sauberer      True AT:
et al., 2012 [29]      relaxation,             Warmth or a strange
RCT (N = 182)          tranquilizer,           feeling at the
Outpatient Clinic,     master cerebral         treated ear or
Medical University     Sham AT: tonsil,        dizziness (ft = 26)
of Vienna, Vienna,     finger, shoulder        Outcome:
Austria                                        not reported

Lien et al.,           Shenmen, stomach,       Dizziness (ft = 1)
2012 [30]              hunger, endocrine       Outcome: withdrawal
RCT (N = 90)
Taipei City
Hospital, Taiwan

                                               Minor inflammation
Hsu et al" 2009 [31]   Shenmen, stomach,       at the needling
RCT (N = 60)           hunger, endocrine       site (n = 1) Mild
Taipei Hospital,                               tenderness at the
Taiwan                                         needling site
                                               (n = 9) Outcome:
                                               not reported

Wang et al., 2009      True AT: shenmen,
[32] RCT (N = 159)     kidney, analgesia
Yale-New Have          Sham AT: shoulder,      Transient ear
Hospital, New          wrist, extra-           tenderness (n = 4)
Haven, USA             auricular point         Outcome: resolved
                                               spontaneously

Harding et al.,
2008 [33] Non-RCT                              Transient
(N = 60) James Cook    Shenmen, liver,         exacerbation of
University Hospital,   lung, autonomic,        vasomotor symptoms
Middlesbrough, UK      kidney                  (n = 2) Outcome:
                                               resolved
                                               spontaneously
                                               (lasted only
                                               seconds)

Courbasson et al.,
2007 [34] Non-RCT
(N = 305) The Jean                             Experiencing pain
Tweed Centre,          Not reported            from needles
Toronto, Ontario,                              (not reported)
Canada                                         Outcome:
                                               not reported

Wu et al., 2007 [35]                           Hematoma (n = 1)
RCT (?? = 131)         True AT: shenmen,       Feeling of residual
Smoking Cessation      lung, mouth,            needling (n = 24)
Clinics, Taipei        sympathetic             Tenderness sensation
Veterans General       Sham AT: eye, elbow,    (n = 50) Minor
Hospital, Taiwan       shoulder, knee          bleeding (n = 3)
                                               Minor infection
                                               (n = 1) Nausea
                                               (n = 2) and
                                               dizziness (n = 4)
                                               Outcome: gradually
                                               declined

                                               Dizziness and
Usichenko et al.,      True AT: shenmen,       nausea (n = 1)
2007 [36]              lung, knee joint        Pain at insertion
RCT (N = 120)          points located          and sleep
Ambulatory             on the helix            disturbance (n = 1)
Orthopedic Surgery                             Outcome:
Center of the Ernst                            (i) Disappeared
Moritz Arndt                                   after withdrawal of
University,                                    the needles
Greifswald, Germany                            (for dizziness
                                               and nausea)
                                               (ii) Not reported
                                               (for pain and sleep
                                               disturbance)

Kunz et al., 2007
[37] RCT (N = 109)     Shenmen,                Pain and mild
Clinic of              sympathetic, kidney,    bleeding (n = 6)
Psychiatry and         liver, lung             Outcome: not
Psychotherapy                                  reported
Bethel, Bielefeld,
Germany

                                               Pain at the
                                               needling site
                                               (n = 3) Minor
Usichenko et al.,      True AT: shenmen,       bleeding at the
2005 [38] RCT          lung, thalamus,         needling site
(N = 61) Department    hip joint               (n = 2) Headache
of Anesthesiology      Sham AT:                (n = 1)
and Orthopedic         nonacupuncture          Hip pain after
Surgery, University    points on the           needle withdrawal
of Greifswald,         auricular helix         (n = 2) Outcome:
Germany                                        (i) One withdrew,
                                               not reported for
                                               another 2 (for pain)
                                               (ii) Recovery after
                                               treatment
                                               (for bleeding)
                                               (iii) Recovery
                                               after surgery
                                               (for headache) (iv)
                                               Not reported
                                               (for hip pain)

Berman et al.,         True AT: shenmen,       Pain at insertion
2004 [39]              lung, liver, kidney,    (n = 44)
RCT (N = 158)          sympathetic             Outcome: forty-two
Two Medium-Security    Sham AT: nonspecific    dropped out and 2
Institutions           points on the           completed treatment
(Jails), Sweden        auricular helix         even though they
                                               found it painful

                       True AT: shenmen,       Infrequent minor
Bier et al., 2002      lung, liver, kidney,    bleeding upon
[40] RCT (N = 141)     sympathetic             needle removal
Arizona, USA           Sham AT:                (not reported)
                       nonacupuncture          Outcome: not
                       points located          reported
                       within 5 mm of the
                       true points

                                               Minor local
Gurevich et al.,                               bleeding
1996 [41] Non-RCT                              (not reported)
(N = 77) North Shore   Shenmen, lung,          Local pain
University Hospital    liver, kidney,          (not reported)
at Glen Cove, USA      sympathetic             Outcome:
                                               (i) Treatment was
                                               not required
                                               (for bleeding)
                                               (ii) Stopped AT
                                               temporarily or had
                                               less frequent
                                               treatments
                                               (for local pain)

                       True AT: shenmen,       Slight bleeding at
Washburn et al.,       lung,                   insertion
1993 [42]              Sham AT:                (not reported)
RCT (N = 100)          nonacupuncture          Mild nausea and
The Bayview-Hunters    points located          dizziness
Point Foundation,      close to the true       (not reported)
San Francisco, USA     points                  Outcome: relief
                                               when the needles
                                               were removed

Zhang and Fan, 1986
[43] Non-RCT           Liver, gallbladder,     Dizziness, upper
(N = 179) TCM          stomach, duodenum,      limb numbness, and
Academy of Shanxi      shenmen,                minor nausea
Province, China        sympathetic, lung       (not reported)
                                               Outcome:
                                               disappeared after
                                               removing stimulation
                                               on acupoint
                                               "sympathetic"

                       Studies on auricular
                       acupressure

                                               Pressure ulcers in
                       Main acupoints:         the pinna (n = 18)
Vas et al, 2014        shenmen, thalamus       Worsened symptoms
[44] RCT (N = 265)     Adjunct acupoints:      (n = 8) Outcome:
Ten Primary            not reported            (i) Healed within
Healthcare Centres,                            10 days of removal
Seville, Spain                                 (for pressure
                                               ulcers)
                                               (ii) Not reported
                                               (for worsened
                                               symptoms)

                                               Minor local
                       Large intestine,        itchiness (n = 27)
Li et al, 2014 [45]    rectum, San Jiao,       Minor dizziness
RCT (N = 99)           spleen, lung,           (n = 2) Outcome:
Elderly Residential    sympathetic,            (i) Spontaneously
Care Home,             subcortex               subsided after AT
Hong Kong                                      (25) and 2 withdrew
                                               (for itchiness)
                                               (ii) Spontaneously
                                               subsided after AT
                                               (1) and 1 withdrew
                                               (for dizziness)

                                               Mild to moderate
                                               local discomfort
                       True AT: shenmen,       (n = 5)
Zhang et al., 2013     lung, mouth, extra,     Slight headache and
[46] RCT (N = 43)      liver                   dizziness (n = 1)
RMIT University,       Sham AT: helix 2,       Outcome:
Australia              shoulder, clavicle,     (i) All AEs were
                       occiput, tooth          resolved without
                                               any medical
                                               intervention
                                               (for both)
                                               (ii) One subject
                                               withdrew
                                               (for ear discomfort)

Kong, 2012 [47]
RCT (N = 60)           Shenmen, liver,         Mild skin
Foshan Hospital of     kidney, heel,           irritation (n = 2)
TCM, Foshan,           lesser occipital        Outcome: no obvious
China                  nerve, great            discomfort and
                       auricular nerve         AT continued

Yeh et al., 2012       True AT: Shenmen,
[48] RCT (N = 10)      sympathetic,            Local itchiness
A Large Childrens      cardia, stomach,        (n = 3)
Hospital, Taiwan       digestive subcortex     Outcome: continued
                       Sham AT: external       to complete the
                       knee point, vision,     study
                       shoulder joint, eye

Li et al., 2012 [49]
RCT (N = 39)           Large intestine,        Mild, tolerable,
Elderly Residential    rectum, San Jiao,       and short-term
Care Home,             spleen, lung,           itchiness of the
Hong Kong              sympathetic,            ears (n = 7)
                       subcortex               Outcomes:
                                               not reported

                       Main acupoints:
                       shenmen, occiput,
Jin et al., 2012       subcortex,              Local redness at
[50] RCT (N = 80)      sympathetic             the taped site
Cangnan TCM            Adjunct acupoints:      (n = 2)
Hospital of            (based on TCM           Outcome: recovery
Zhejiang Province,     syndrome) heart,        after treatment
Cangnan, China         spleen, kidney,
                       liver, stomach

Kung et al., 2011
[51] Non-RCT
(N = 45) Taipei        Shenmen, kidney,        Sensation of
Veterans General       heart, brainstem,       auricular
Hospital, Taiwan       subcortex               tenderness (n = 2)
                                               Outcome:
                                               not reported

Xia et al., 2011                               Obvious pain at the
[52] RCT (N = 60)                              taped site when
Baoan Hospital         Ashi point, kidney,     receiving AT for the
Affiliated to          liver, lumbosacral      first time (n = 5)
South Medical          vertebrae, shenmen,     Outcome: completed
University,            subcortex               the study
Shenzhen, China                                by reducing
                                               pressing frequency
                                               and intensity

                       True AT: shenmen,       Mild to moderate
Xue et al., 2011       internal nose, lung,    local and short-term
[53]                   wind stream             discomfort (n = 30)
RCT (N = 63)           Sham AT: adrenal        Sore ear (n = 9)
Two Metropolitan       gland, helix 2,         Ear itch (n = 7)
RMIT Campus in         shoulder, clavicle,     Outcome: well
Melbourne,             occiput, teeth          tolerated
Australia

                       Main acupoints:
Ji et al., 2010 [54]   large intestine,        Mild redness and
RCT (N = 73)           small intestine,        skin breakdown at
Shuguang Hospital      rectum Adjunct          the taped site
Affiliated to          acupoints: Lung,        (n = 1) Outcome:
Shanghai University    San Jiao, stomach       recovery two days
of TCM, Shanghai,      (for excess             later after using
China                  syndrome), spleen,      entoiodine
                       kidney, endocrine
                       (for deficiency
                       syndrome)

                       True AT: shenmen,
Wing et al., 2010      lung, month, brain      Skin irritation
[55] RCT (N = 70)      Non meridian points:    (allergy) at the
Outpatient Clinics     away from those         site of the adhesive
and The Community,     selected for the        tapes (n = 3)
Hong Kong              treatment group         Outcome: withdrawal

                       Main acupoints:
Sun, 2010 [56]         shenmen,                Skin irritation
RCT (N = 173)          sympathetic,            (allergy) at the
Department of TCM,     endocrine, heart,       site of the adhesive
Xuzhou First           subcortex Adjunct       tapes (n = 5)
Hospital of Jiangsu    acupoints: liver,       Outcome: changed to
Province, Xuzhou,      stomach, spleen,        desensitization
China                  kidney, pancreas        tapes and treatment
                       and gallbladder,        continued
                       heart of dorsal
                       surface

                       Main acupoints:
                       shenmen, subcortex,     Skin allergy and
Peng, 2009 [57]        endocrine, anterior     itchiness of the
Non-RCT (N = 30)       ear lobe                ear (not reported)
Hanguang Hospital      Adjunct acupoints:      Outcome: symptom
of Handan City,        (based on TCM           disappeared after
Handan, China          syndrome) liver,        changing magnetic
                       gallbladder,            pellets to vaccaria
                       San Jiao, stomach,      seeds
                       lung, heart

Chen et al., 2009
[58] RCT (N = 180)                             Severe skin allergy
TCM Hospital of        Shenmen, brain,         and itchiness at
Hainan Province,       kidney, occiput         the taped site
Haikou, China                                  (n = 2)
                                               Outcome: withdrawal

Wang et al.,
2007 [59]                                      Skin allergy and
RCT (N = 198)          Apex of ear, kidney,    local redness at
Peoples Hospital of    liver, eye, eye 2,      the taped site
Baoshan City,          spleen,                 (n = 2)
Baoshan, China                                 Outcome:
                                               not reported

Ding et al., 2006
[60]
RCT (N = 200)          Stomach, occiput,       Itchiness at the
TCM Hospital of        shenmen, sympathetic    taped site (n = 2)
Hebei Province,                                Outcome:
Shijiazhuang, China                            not reported

                       Studies on auricullar
                       electroacupuncture

Schukro et al.,
2013 [61]                                      mild skin
RCT (N = 56)                                   irritations behind
Department of                                  the ear caused by
Special Anesthesia     Hunger, stomach,        the adhesive patch
and Pain Management    colon                   of the P-stim/
at the Medical                                 placebo device
University of                                  (n = 8) Outcome:
Vienna, Vienna,                                resolved
Austria                                        immediately after
                                               the end of
                                               application

Fritz et al.,
2013 [62]                                      Auricle discomfort
RCT (N = 125)          Lung, shenmen,          without redness or
St. Louis Veterans     nicotine, point zero,   swelling (n = 1)
Affairs Medical        palate                  Outcome:
Center, USA                                    not reported

Bernateck et al.,
2008 [63]
RCT (N = 44)
Outpatient Clinic      Shenmen, cushion,       Pain and discomfort
of the Department      an individual point     at the needling
of Rheumatology,       depending on the        site (n = 1)
Hannover               main pain spots         Outcome:
Medical School,                                not reported
Hannover, Germany

                       Studies on auricular
                       bloodletting therapy

Yuan and Qiao,
1998 [64] Non-RCT                              Minor infection at
(N = 170) Chinese      Helix 6 (Ashi point)    the needling site
PLA 34260 Hospital,                            (n = 2)
Xiangfan, China                                Outcome:
                                               not reported

Study                  Quality of
                       AEs Reporting *

                       (1) Not reported
Prisco et al.,         (2) Not reported
2013 [26]              (3) Not reported
RCT (N = 35)           (4) Not reported
Department of          (5) Not reported
Veterans Affairs       (6) Adequate
Medical Center,        (7) Not reported
Washington DC, USA

                       (1) Adequate
Lua and Talib, 2013    (2) Adequate
[27] RCT (N = 97)      (3) Not reported
Three Methadone        (4) Adequate
Maintenance            (5) Adequate
Treatment (MMT)        (6) Inadequate
Centers, Terengganu,   (7) Adequate
Malaysia

                       (1) Adequate
                       (2) Not reported
Hunter et al., 2012    (3) Not reported
[28] RCT (N = 52)      (4) Not reported
Primary Care & A       (5) Not reported
University             (6) Inadequate
Population,            (7) Partially adequate
Northern Ireland,
UK
                       (1) Not reported
                       (2) Not reported
Michalek-Sauberer      (3) Not reported
et al., 2012 [29]      (4) Not reported
RCT (N = 182)          (5) Not reported
Outpatient Clinic,     (6) Not reported
Medical University     (7) Not reported
of Vienna, Vienna,
Austria

                       (1) Adequate
                       (2) Partially adequate
Lien et al.,           (3) Not reported
2012 [30]              (4) Not reported
RCT (N = 90)           (5) Not reported
Taipei City            (6) Adequate
Hospital, Taiwan       (7) Not reported

                       (1) Adequate
                       (2) Not reported
Hsu et al" 2009 [31]   (3) Not reported
RCT (N = 60)           (4) Not reported
Taipei Hospital,       (5) Not reported
Taiwan                 (6) Adequate
                       (7) Not reported

Wang et al., 2009      (1) Not reported
[32] RCT (N = 159)     (2) Not reported
Yale-New Have          (3) Adequate
Hospital, New          (4) Adequate
Haven, USA             (5) Not reported
                       (6) Not reported
                       (7) Partially adequate

Harding et al.,        (1) Adequate
2008 [33] Non-RCT      (2) Not reported
(N = 60) James Cook    (3) Not reported
University Hospital,   (4) Not reported
Middlesbrough, UK      (5) Not reported
                       (6) Adequate
                       (7) Partially adequate

Courbasson et al.,     (1) Not reported
2007 [34] Non-RCT      (2) Inadequate
(N = 305) The Jean     (3) Not reported
Tweed Centre,          (4) Partially adequate
Toronto, Ontario,      (5) Not reported
Canada                 (6) Inadequate
                       (7) Not reported

Wu et al., 2007 [35]   (1) Adequate
RCT (?? = 131)         (2) Not reported
Smoking Cessation      (3) Adequate
Clinics, Taipei        (4) Adequate
Veterans General       (5) Adequate
Hospital, Taiwan       (6) Inadequate
                       (7) Adequate

                       (1) Not reported
Usichenko et al.,      (2) Not reported
2007 [36]              (3) Not reported
RCT (N = 120)          (5) Partially adequate
Ambulatory             (7) Adequate
Orthopedic Surgery
Center of the Ernst
Moritz Arndt
University,
Greifswald, Germany

                       (1) Not reported
Kunz et al., 2007      (2) Not reported
[37] RCT (N = 109)     (3) Not reported
Clinic of              (4) Adequate
Psychiatry and         (5) Partially adequate
Psychotherapy          (6) Inadequate
Bethel, Bielefeld,     (7) Adequate
Germany

                       (1) Not reported
                       (2) Not reported
Usichenko et al.,      (3) Not reported
2005 [38] RCT          (4) Not reported
(N = 61) Department    (5) Inadequate
of Anesthesiology      (6) Adequate
and Orthopedic         (7) Inadequate
Surgery, University
of Greifswald,
Germany

                       (1) Adequate
                       (2) Adequate
Berman et al.,         (3) Adequate
2004 [39]              (4) Adequate
RCT (N = 158)          (5) Partially adequate
Two Medium-Security    (6) Inadequate
Institutions           (7) Adequate
(Jails), Sweden

                       (1) Not reported
                       (2) Not reported
Bier et al., 2002      (3) Not reported
[40] RCT (N = 141)     (4) Adequate
Arizona, USA           (5) Not reported
                       (6) Inadequate
                       (7) Not reported

                       (1) Partially adequate
Gurevich et al.,       (2) Inadequate
1996 [41] Non-RCT      (3) Partially adequate
(N = 77) North Shore   (4) Not reported
University Hospital    (5) Not reported
at Glen Cove, USA      (6) Partially adequate
                       (7) Not reported

                       (1) Not reported
                       (2) Inadequate
Washburn et al.,       (3) Partially adequate
1993 [42]              (4) Not reported
RCT (N = 100)          (5) Not reported
The Bayview-Hunters    (6) Inadequate
Point Foundation,      (7) Not reported
San Francisco, USA

                       (1) Not reported
Zhang and Fan, 1986    (2) Not reported
[43] Non-RCT           (3) Not reported
(N = 179) TCM          (4) Not reported
Academy of Shanxi      (5) Not reported
Province, China        (6) Inadequate
                       (7) Not reported

Vas et al, 2014        (1) Adequate
[44] RCT (N = 265)     (2) Adequate
Ten Primary            (3) Not reported
Healthcare Centres,    (4) Adequate
Seville, Spain         (5) Inadequate
                       (6) Inadequate
                       (7) Partially adequate

                       (1) Partially adequate
                       (2) Partially adequate
Li et al, 2014 [45]    (3) Adequate
RCT (N = 99)           (4) Not reported
Elderly Residential    (5) Inadequate
Care Home,             (6) Adequate
Hong Kong              (7) Partially adequate

                       (1) Adequate
                       (2) Adequate
                       (3) Not reported
Zhang et al., 2013     (4) Adequate
[46] RCT (N = 43)      (5) Inadequate
RMIT University,       (6) Adequate
Australia              (7) Partially adequate

                       (1) Adequate
                       (2) Partially adequate
Kong, 2012 [47]        (3) Not reported
RCT (N = 60)           (4) Adequate
Foshan Hospital of     (5) Partially adequate
TCM, Foshan,           (6) Inadequate
China                  (7) Inadequate

                       (1) Not reported
Yeh et al., 2012       (2) Not reported
[48] RCT (N = 10)      (3) Not reported
A Large Childrens      (4) Not reported
Hospital, Taiwan       (5) Not reported
                       (6) Inadequate
                       (7) Not reported

                       (1) Not reported
                       (2) Not reported
Li et al., 2012 [49]   (3) Not reported
RCT (N = 39)           (4) Partially adequate
Elderly Residential    (5) Not reported
Care Home,             (6) Inadequate
Hong Kong              (7) Not reported

                       (1) Inadequate
                       (2) Not reported
Jin et al., 2012       (3) Not reported
[50] RCT (N = 80)      (4) Adequate
Cangnan TCM            (5) Not reported
Hospital of            (6) Inadequate
Zhejiang Province,     (7) Not reported
Cangnan, China

                       (1) Not reported
                       (2) Not reported
Kung et al., 2011      (3) Not reported
[51] Non-RCT           (4) Not reported
(N = 45) Taipei        (5) Not reported
Veterans General       (6) Inadequate
Hospital, Taiwan       (7) Not reported

                       (1) Adequate
Xia et al., 2011       (2) Not reported
[52] RCT (N = 60)      (3) Partially adequate
Baoan Hospital         (4) Partially adequate
Affiliated to          (5) Not reported
South Medical          (6) Inadequate
University,            (7) Not reported
Shenzhen, China

                       (1) Not reported
                       (2) Not reported
Xue et al., 2011       (3) Not reported
[53]                   (4) Partially adequate
RCT (N = 63)           (5) Not reported
Two Metropolitan       (6) Inadequate
RMIT Campus in         (7) Inadequate
Melbourne,
Australia

                       (1) Adequate
Ji et al., 2010 [54]   (2) Not reported
RCT (N = 73)           (3) Not reported
Shuguang Hospital      (4) Adequate
Affiliated to          (5) Not reported
Shanghai University    (6) Inadequate
of TCM, Shanghai,      (7) Not reported
China

                       (1) Adequate
                       (2) Partially adequate
Wing et al., 2010      (3) Not reported
[55] RCT (N = 70)      (4) Not reported
Outpatient Clinics     (5) Not reported
and The Community,     (6) Adequate
Hong Kong              (7) Partially adequate

                       (1) Not reported
Sun, 2010 [56]         (2) Not reported
RCT (N = 173)          (3) Not reported
Department of TCM,     (4) Not reported
Xuzhou First           (5) Not reported
Hospital of Jiangsu    (6) Inadequate
Province, Xuzhou,      (7) Not reported
China

                       (1) Not reported
                       (2) Not reported
Peng, 2009 [57]        (3) Not reported
Non-RCT (N = 30)       (4) Not reported
Hanguang Hospital      (5) Not reported
of Handan City,        (6) Inadequate
Handan, China          (7) Not reported

                       (1) Adequate
Chen et al., 2009      (2) Partially adequate
[58] RCT (N = 180)     (3) Not reported
TCM Hospital of        (4) Inadequate
Hainan Province,       (5) Not reported
Haikou, China          (6) Adequate
                       (7) Not reported

                       (1) Adequate
Wang et al.,           (2) Not reported
2007 [59]              (3) Not reported
RCT (N = 198)          (4) Not reported
Peoples Hospital of    (5) Not reported
Baoshan City,          (6) Inadequate
Baoshan, China         (7) Not reported

                       (1) Adequate
Ding et al., 2006      (2) Not reported
[60]                   (3) Not reported
RCT (N = 200)          (4) Not reported
TCM Hospital of        (5) Not reported
Hebei Province,        (6) Inadequate
Shijiazhuang, China    (7) Not reported

Schukro et al.,        (1) Adequate
2013 [61]              (2) Not reported
RCT (N = 56)           (3) Not reported
Department of          (4) Not reported
Special Anesthesia     (5) Not reported
and Pain Management    (6) Inadequate
at the Medical         (7) Not reported
University of
Vienna, Vienna,
Austria

                       (1) Adequate
Fritz et al.,          (2) Not reported
2013 [62]              (3) Not reported
RCT (N = 125)          (4) Partially adequate
St. Louis Veterans     (5) Not reported
Affairs Medical        (6) Partially adequate
Center, USA            (7) Partially adequate

Bernateck et al.,      (1) Not reported
2008 [63]              (2) Not reported
RCT (N = 44)           (3) Not reported
Outpatient Clinic      (4) Not reported
of the Department      (5) Not reported
of Rheumatology,       (6) Inadequate
Hannover               (7) Not reported
Medical School,
Hannover, Germany

                       (1) Not reported
Yuan and Qiao,         (2) Not reported
1998 [64] Non-RCT      (3) Not reported
(N = 170) Chinese      (4) Not reported
PLA 34260 Hospital,    (5) Not reported
Xiangfan, China        (6) Inadequate
                       (7) Not reported

AT: auricular therapy, AE: adverse event, RCT: randomized
controlled trial, R: reason for AT, PTSD: posttraumatic stress
disorder, P: practitioner, LHRH: luteinizing hormone releasing
hormone, and TCM: traditional Chinese medicine.

* The CONSORT Recommendation for AEs: (1) report of data
on harms in the title or abstract, (2) report of AT-related harms
in the introduction section, (3) prespecification of potential
adverse events of AT (clinical and/or laboratory), (4)
specification of approach for collecting harms-related
information, (5) description of plans for presenting and
analyzing adverse events of AT, (6) description of participant
withdrawals due to adverse events of AT, and (7) report of the
particular denominators for analyses on AT-related harms.
Quality grades for each item: adequate-item was properly
described in detail in the article or in the study protocol;
partially adequate-item was properly described but only
in a brief format; inadequate-item failed to be properly
described; not reported-item was not described.

#Happened in one participant who did not disclose a history
of rheumatoid arthritis (one of the exclusion criteria
for that study).

Table 3: Selected searching strategies for the systematic review.

      Searching strategies
ID    PubMed                                                Records

#1    "auriculotherapy"[MeSH Terms] OR "acupuncture,          264
      ear"[MeSH Terms]

#2    ((((((((((((((((((auriculotherap* [Title/              35299
      Abstract]) OR (acupunctur* [Title/Abstract] AND
      ear* [Title/Abstract])) OR (acupunctur*
      [Title/Abstract] AND auricu* [Title/Abstract]))
      OR (acupressur* [Title/Abstract] AND ear*
      [Title/Abstract])) OR (acupressur* [Title/
      Abstract] AND auricu* [Title/Abstract])) OR
      (auricu* [Title/Abstract] AND poin* [Title/
      Abstract])) OR (ear[Title/Abstract] AND poin*
      [Title/Abstract])) OR (auricu* [Title/Abstract]
      AND acupoin* [Title/Abstract])) OR (ear[Title/
      Abstract] AND acupoin* [Title/Abstract])) OR
      (auricu* [Title/Abstract] AND plaster*
      [Title/Abstract])) OR (massag* [Title/Abstract]
      AND ear* [Title/Abstract])) OR (ear[Title/Abstract]
      AND plaster* [Title/Abstract])) OR (massag*
      [Title/Abstract] AND auricu* [Title/Abstract]))
      OR (magne* [Title/Abstract] AND ear* [Title/
      Abstract])) OR (magne* [Title/Abstract] AND
      auricu* [Title/Abstract])) OR otopoin* [Title/
      Abstract]) OR vaccaria* [Title/Abstract]) OR
      erxue[Title/Abstract]

#3    #1 OR #2                                               35338

#4    (((((("adverse event* "[Title/Abstract])              1608414
      OR "adverse effect* "[Title/Abstract]) OR
      "adverse reaction* "[Title/Abstract]) OR "side
      effect* "[Title/Abstract]) OR "complication*"
      [Title/Abstract]) OR "safe*"[Title/Abstract])
      OR "risk* "[Title/Abstract]

#5    #3 AND #4                                               4284

      EMBase

#1    auriculotherap* :ab,ti OR (ear NEAR/3                   9599
      acupunctur*):ab,ti OR (auricu* NEAR/3
      acupunctur*):ab,ti OR (ear NEAR/3 acupressur*):
      ab,ti OR (auricu*NEAR/3 acupressur*):ab,ti OR
      (auricu* NEAR/3 poin*):ab,ti OR 'auricular
      plaster':ab,ti OR (ear NEAR/3 plaster*):ab,ti
      OR (ear NEAR/3 poin*):ab,ti OR (auricu* NEAR/3
      acupoint*):ab,ti OR (ear NEAR/3 acupoint*):ab,ti
      OR otopoin*:ab,ti OR (vaccaria* NEAR/15 ear*):
      ab,ti OR (vaccaria* NEAR/15 auricu*):ab,ti OR
      (massag* NEAR/3 auricu*):ab,ti OR (massag* NEAR/3
      ear*):ab,ti OR (cowherb NEAR/15 ear*):ab,ti OR
      (cowherb NEAR/15 auricu*):ab,ti OR (magne* NEAR/15
      ear*):ab,ti OR (magne* NEAR/15 auricu*):ab,ti
      OR erxue*:ab,ti

#2    (adverse NEAR/3 event*):ab,ti OR (adverse NEAR/3      3092250
      effect*):ab,ti OR (adverse NEAR/3 reaction*):ab,ti
      OR (side NEAR/3 effect*):ab,ti OR complication*:
      ab,ti OR safe*:ab,ti OR risk*:ab,ti

#3    #1 AND #2                                               1688

      CENTRAL

#1    MeSH descriptor: [Auriculotherapy] explode              126
      all trees

#2    MeSH descriptor: [Acupuncture, Ear]                     120
      explode all trees

#3    auriculotherap* or (ear near/3 acupunctur*) or          864
      (auricu* near/3 acupunctur*) or (ear near/3
      acupressur*) or (auricu* near/3 acupressur*) or
      (auricu* near/3 poin*) or (ear near/3 poin*) or
      (ear near/3 plaster*) or (auricu* near/3 plaster*)
      or (auricu* near/3 acupoint*) or (ear near/3
      acupoint*) or otopoint* or (vaccaria* near/15 ear)
      or (vaccaria* near/15 auricu*) or (cowherb near/15
      ear*) or (cowherb near/15 auricu*) or (magne*
      near/15 ear*) or (magne* near/15 auricu*) or
      (massag* near/3 ear*) or (massag* near/3 auricu*)
      or erxue*:ti,ab,kw (Word variations have
      been searched)

#4    #1 OR #2 OR #3                                          864

#5    complication* or (adverse near/3 event*) or            240648
      (adverse near/3 effect*) or (adverse near/3
      reaction*) or (side near/3 effect*) or safe*
      or risk*: ti,ab,kw (Word variations have been
      searched)

#6    #4 AND #5                                               182

#7    #6 in Trials                                            158
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Article Details
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Author:Tan, Jing-Yu; Molassiotis, Alexander; Wang, Tao; Suen, Lorna K.P.
Publication:Evidence - Based Complementary and Alternative Medicine
Article Type:Report
Date:Jan 1, 2014
Words:14748
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