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Adverse events from complementary therapies: an update from the natural therapies workforce survey part 2.

Introduction

Part 1 of this article (JATMS 21(2): 86-91) presented the results of a survey of complementary medicine practitioners who reported on adverse events that they suspected were associated with their practices. Part 2 compares the results of this survey with previous surveys and concludes with recommendations for practitioners.

Discussion

Only 8% of survey respondents reported an adverse event during the previous 12 months. Of those, the most frequently reported events were mild and short-lived. Most reported events were digestive (36%), integumentary (26%), and neurological (19%). From a discipline perspective, most (19%) adverse events were reportedly associated with ingestive medicine (19%), followed by registered professions (acupuncture and traditional Chinese medicine, chiropractic and osteopathy) (13%). The relatively low level of reported adverse events does not support the frequencies reported in previous surveys. Bensoussan et al.'s survey (1) concluded that the number of adverse events an acupuncturist, naturopath or western herbal medicine practitioner would encounter in their practice life was significant. In Hale's two earlier studies respondents also reported higher frequencies than those found in the present study, although the types of events reported were similar (2,3). In Hale's survey of remedial therapists in 20022, 60.5% of respondents reported observing one adverse event in their practice lifetime: 34.4% were skin reactions, 31-2% were categorised as headache/dizziness/nausea/digestive disturbance, and muscular soreness accounted for 15.1%. Similarly, in Hale's survey of acupuncturists, naturopaths and western herbal medicine practitioners (3) 37.9% reported a range of adverse events including sleepiness, insomnia, light-headedness and digestive conditions (e g. stomach upsets, cramps, nausea and diarrhoea) and 25% reported skin reactions. The discrepancy between the frequencies reported in Hale's two surveys and those in the present one may be related to the time period involved in each. In the present study, respondents were asked about adverse events in the past 12 months, whereas in Hale's surveys practitioners were asked for observed events during their whole practice lifetime. Discrepancies may also have arisen from the populations surveyed. The present study canvassed all complementary medicine practitioners, whereas earlier ones targeted different combinations of discipline groups.

In our study 9.8% of adverse events reportedly required medical consultation. Again this rate is lower than that reported in Hale's surveys (15.6% of naturopaths, herbalists and acupuncturists, and 17.2% of remedial therapist reported adverse events requiring consultation with a medical practitioner). In our survey, only 2.8% of adverse events were reported to the Therapeutic Goods Administration. This figure is similar to that reported in Bensoussan's 2004 survey (1). One third of respondents (33%) to Bensoussan's survey of acupuncturists, naturopaths and western herbal medicine practitioners reported adverse reactions: 1% to the Therapeutic Goods Administration, 4% to the Australian Drug Reactions Advisory Committee and the remainder to the manufacturer, supplier or professional association.

The current study reported that digestive reactions including diarrhoea, nausea, vomiting and gut reactions were the most common adverse events in patients who consumed herbal medicine (63%) and nutritional medicine (58%) products. The previous workforce survey published by Bensoussan et al. (1) excluded mild gastrointestinal effects from the data analysis of adverse reactions. The higher risk of digestive adverse events reported in the present study is an important finding since it has implications for clinical practice and the compliance of a client to treatment. Therefore, reducing the risk of adverse events of the gastrointestinal tract needs to be taken into account when prescribing herbal and nutritional medicines. The digestive adverse reactions experienced by patients can be due to a number of reasons:

1. Herbal constituents increasing the risk of adverse digestive reactions (e.g. saponins and anthraquinones)

2. Side-effects of treatment and the individual's responses (pharmacogenetics) to the herbal or nutritional product (4)

3. Possible herb-drug interactions (which have been explored extensively by Hu et al. (5)

While the current study did not record the herbs that reportedly contributed to gastrointestinal disturbances, there are a number of common herbs that are known to contribute to digestive adverse reactions, including herbs that contain high levels of saponins (6). These include Horse Chestnut (Aesculus hippocastanum), Butcher's Broom (Ruscus aculeatus), Gymnema (Gymnema sylvestre), Tribulus (Tribulus terrestris) and Liquorice (Glycyrrhiza glabra) (4). It should be noted that Liquorice has a demulcent action and possesses healing qualities for mucosa membrane of the intestine. The high percentage of adverse reactions to herbal medicines and gastrointestinal complaints may be explained in part by side effects of certain herbs that cause irritation to the gastrointestinal tract. A comprehensive list of herbs that can cause gastrointestinal side effects is provided in Table 1.

A number of studies have highlighted herb-drug interaction in a range of different herbs and drug classes (7,8). The mechanisms of actions are difficult to determine because of the multiple constituents of herbs. Most herb-drug interactions are concerned with blood coagulation/clotting, drug metabolism and the central nervous system (9). Herb-drug interactions can occur via pharmacokinetic and pharmacodynamic actions. There have been a number of herb-drug interactions found to cause gastrointestinal symptoms, including:

* Kava (Piper methysticum) interacts with medications such as antispasmodics (Mebeverine), anticholinergics (Dicyclomine and Porpantheline) and antimotility agents, resulting in gastrointestinal upsets (9)

* Golden seal (Hydrastis canadensis) interacts with laxatives and can oppose their diarrhoeal effects leading to further constipation and gastrointestinal upsets (10)

* Turmeric (Curcuma Longa) may interact with a range of drugs (including Cimetidine, Famotidine, Ranitidine, Esomeprazole, Omeprazole and Lansoprazole) that are used to decrease stomach acid, so opposing this reduction could increase acid content, leading to a range of digestive symptoms such as acid reflux, heartburn and gastrointestinal upsets (11)

The number of adverse events attributed to manual therapy by practitioners in our study was low: 4.1%, representing 61 out of 1475 physical therapists who responded to this section of the survey. Of the 55 responses that could be directly attributed solely to physical medicine (some respondents had also used nutritional supplements and other treatment adjuncts), (16) were described as muscle soreness and increased pain, (12) as skin rashes, six as headaches, three as bruising, three as dizziness, three as flu-like symptoms, three as emotional releases, three as increase in symptoms, and the remainder as isolated cases of symptoms like stiffness and nausea. The very small number of reported adverse events is consistent with the findings of a systematic review (12) that found low risk of major adverse reactions to manual therapy, although about 50% of patients reported minor to moderate adverse reactions. Most were short-lived, occurring within 24 hours of treatment and resolving within 72 hours, and minor (e g. muscle soreness). Similarly, a Scandinavian study reported that adverse reactions were common and transient following manual therapy (13).

[ILLUSTRATION OMITTED]

In this study, the most common adverse reactions were muscle soreness, increased pain and stiffness. Fifty-one percent of patients who received at least three treatments experienced at least one adverse reaction after one or more visits. The discrepancy between the reported incidence of adverse events following manual therapy may reflect the difference between patient and practitioner responses. It is possible that practitioners under-report out of ignorance of patients' reactions, especially minor ones, or reluctance to report adverse events.

High risk does exist in manual therapy, particularly associated with spinal manipulation of the upper cervical spine (14). However, such manipulation is beyond the scope of remedial massage and other non-registered physical therapists in Australia (15). Spinal manipulation is 'the rapid application of a force whether by manual or mechanical means to any part of a person's body that affects a joint or segment of the vertebral column' (16). Risk is also associated with non-thrust techniques, like proprioceptive neuromuscular facilitation (PNF), myofascial release, and passive joint articulation that are within the scope of all physical therapists in Australia. Non-manipulative and other forms of physical therapy have not been subjected to the same degree of study, so no informed judgment can be made regarding their risk factors. Techniques such as strain-counterstrain, muscle energy technique, and functional technique can involve sustained positioning that may place an unacceptable load on vascular tissues (17). Blood flow studies demonstrate significant flow changes during gentle passive positioning of the cervical spine (18, 19) The upper cervical spine is believed to carry a greater risk because of the tortuous course of the vertebral artery between C2 and the occiput. Most blood flow studies have concentrated on the C1/C2 and cervical anatomical area (18,19,20).

Acupuncture has been reported to be associated with quite serious adverse reactions, including pneumothorax, cardiac tamponade, spinal cord injury and viral hepatitis (21-25). The frequency of such serious adverse events (including death, organ trauma or hospital administration) is low (0.024%) 25. The frequency of adverse reactions to acupuncture as a percentage of the total number of adverse reactions reported in this study was 6.5%.

This result is similar to the frequencies reported in other studies (6.7-15%) that have been classified as mild and transient acupuncture-related adverse reactions (26). Neurological adverse reactions were the most frequent in the current study (n=7, 50%), followed by skin (n=5, 36%) and pain reactions (n=1, 7%). The neurological adverse events from this study have been reported in other studies, with symptoms including tiredness and dizziness (22). Localised pain is another adverse reaction to acupuncture commonly reported in the literature (26). One respondent in the current study reported pain but did not provide detail about its type.

A limitation of this study is its response rate (22.4%). However, the 3177 usable responses that were received corresponded with the key demographic data (i.e. age, gender and primary discipline) of the total membership of the Australian Traditional Medicine Society (11219). This study is based on survey data collected from practitioners of complementary medicine. It is possible that respondents were reluctant to report adverse events that occurred in their practices, although the anonymity of responses was designed to overcome this. The findings of this study need to be confirmed with data from other sources, including patient reports.

Conclusion

Only 8% of survey respondents reported an adverse event to treatment during the previous 12 months. Most were mild and short-lived. Most reported events were digestive (36%), integumentary (26%), and neurological (19%). Most (19%) adverse reactions were to ingestive medicine (19%), followed by registered professions (acupuncture and traditional Chinese medicine, chiropractic and osteopathy) (13%). Although 21 (9.8%) reported events requiring referral to a medical practitioner, only six (2.8%) were reported to the Therapeutic Goods Administration. Further education of CAM practitioners is required about their reporting obligations and to reduce the risk of adverse events, particularly of the gastrointestinal tract when prescribing herbal and nutritional medicines.

Harris TA | Australian Institute of Applied Science, Stones Corner, Queensland

Grace S | Southern Cross University, Lismore, NSW

Eddey S | Health Schools Australia

REFERENCES

(1.) Bensoussan A, Myers S, Wu S, O'Connor K. Naturopathic and Western herbal medicine practice in Australia-a workforce survey. Complementary Therapies in Medicine. 2004 Mar; 12(1):17-27.

(2.) Hale A. 2002 National Survey of Remedial Therapists. Journal of the Australian Traditional Medicine Society. 2003; 9(3):119-24.

(3.) Hale A. 2002 Survey of ATMS: acupuncturists, herbalists and naturopaths. Journal of the Australian Traditional Medicine Society. 2002 Dec; 8(4):143-9.

(4.) Bone K, Mills S. Principles and practice of phytotherapy. 2nd ed. St Louis, MO: Saunders Elsevier; 2013.

(5.) Hu Z, Yang X, Ho PC, Chan SY, Heng PW, Chen E, et al. Herb-drug interactions: a literature review. Drugs. 2005; 65(9):1239-82.

(6.) Price KR, Johnson IT, Fenwick GR, Malinow MR. The chemistry and biological significance of saponins in foods and feeding stuffs Critical Reviews in Food Science and Nutrition. 1987; 26 (1):135.

(7.) Miller LG. Herbal medicinals: selected clinical considerations focusing on known or potential drug-herb interactions. Archive of Internal Medicine. 1998; 158(20):2200-11.

(8.) Fasinu PS, Bouic PJ, Rosenkranz B. An overview of the evidence and mechanisms of herb-drug interactions. Frontiers in Pharmacology. 2012; 3(69):1-19.

(9.) Hechtman L. Clinical Naturopathic Medicine. St Louis, MO: Saunders Elsevier; 2012.

(10.) Frawley J. The Gastrointestinal System. In: Hetchman L, editor. Clinical Naturopathic Medicine Chatswood, NSW: Churchill Livingstone; 2012. p. 166-7.

(11.) Ehrlich S. Possible interactions with turmeric. 2015 [cited 2015 August 1]; Available from: http://stvhs.adam.com/content.aspx?product id=107&pid=33&gid=000932.

(12.) Carnes D, Mars T, Mullinger B, Froud R, Underwood M. Adverse events and manual therapy: A systematic review. Manual Therapy. 2009; 15:355-63.

(13.) Paanalahti K, Holm L, Nordin M, Asker M, Lyander J, Skillgate E. Adverse events after manual therapy among patients seeking care for neck and/or back pain: A randomized controlled trial. BMC Musculoskeletal Disorders. 2014; 15:77-87.

(14.) Vick D, McKay C, Zengerle C. The safety of manipulative treatment: review of the literature from 1925 to 1993. Journal of the American Osteopathic Association. 1996; 96:113-5.

(15.) New South Wales Government. Health Practitioner Regulation National Law (NSW) 2010 [cited 2015 January 4]; Available from: http://www.austlii.edu.au/au/legis/nsw/ consol_act/hprn1460/.

(16.) New South Wales Government. Public Health Act 1991 No 10. 2012 [cited 2015 January 4]; Available from: http://www. legislation.nsw.gov.au/viewtop/inforce/ act+10+1991+FIRST+0+N/

(17.) Gibbson P, Thean P. Manipulative of the spine, thorax, and pelvis An osteopathic perspective. Edinburgh: Churhill Livingstone; 2000.

(18.) Kerry R, Taylor A, Mitchell J, Brew J, Kiely R, Robertson G, et al. Cervical Arterial Dysfunction and Manipulative Therapy2007: Available from: macpweb.org/home/index. php?m=file&f=395.

(19.) Arnold C, Bourassa T, Longer T, G. S. Doppler studies evaluating the effect of a physical therapy screening protocol on vertebral artery blood flow. Manual Therapy. 2004; 9:13-21.

(20.) Magarey ME, Rebbeck T, Coughlan B, Grimmer K, Rivett DA, Refshauge K. Pre-manipulative testing of the cervical spine review, revision and new clinical guidelines. Manual Therapy. 2004; 9(2):95-108.

(21.) Norheim AJ. Adverse effects of acupuncture: a study of the literature for the years 1981-1994. Journal of Alternative and Complementary Medicine 1996; 2:291-7.

(22.) Peuker ET, White A, Ernst E, Pera F, Filler TJ. Traumatic complications of acupuncture. Therapists need to know human anatomy. Archives of Family Medicine 1999; 8:553-8.

(23.) Yamashita H, Tsukayama H, White AR, Tanno Y, Sugishita C, Ernst E. Systematic review of adverse events following acupuncture: the Japanese literature. Complementary Therapies in Medicine. 2001; 9:98-104.

(24.) Ernst E, Sherman KJ. Is acupuncture a risk factor for hepatitis? Systematic review of epidemiological studies. Journal of Gastroenterology and Hepatology. 2003; 18:1231-6.

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Table 1: Herbs that produce gastrointestinal side effects

                                                 Gastric
Herb                                            Irritation   Diarrhoea

Andrographis (Andrographis paniculata)
Bacopa (Bacopa monnieri) **
Barberry (Berberis vulgaris)                     [check]
Black Haw (Viburnum prunifolium) *
Buchu (Agathosma betulina)                       [check]
Cats claw (Uncaria tomentosa)                                [check]
Devils's Claw (Harpagophytum procumbens)
Euphorbia (Euphorbia hirta)
False Unicorn (Chamaelirium luteum) *
Fenugreek (Trigonella foenum-graecum)
Feverfew (Tanacetum parthenium)
Gentian (Gentiana lutea)
Golden seal (Hydrastis canadensis)
Greater Celandine (Chelidonium majus)                         [check]
Gymnema (Gymnema sylvestre) **                   [check]
Horsechestnut (Aesculus hippocastanum)           [check]
Jamaica Dogwood (Piscidia erythrina)
Lavender (Lavandula officinalis)
Nettle Root (Urtica dioica)
Olive Leaf (Olea Europaea)
Pleurisy Root (Asclepias tuberosa)                            [check]
Rehmannia (Rehmannia glutinosa) *                             [check]
Sarsaparilla (Smilax ornata)                     [check]
Saw Palmetto (Serenoa serrulata)
Schisandra (Schisandra chinensis)
Siberian ginseng (Eleutherococcus senticosus)    [check]
St. John's wort (Hypericum Perforatum)
Tylophora (Tylophora indica)
Uva Ursi (Arctostaphylos uva-ursi)
Wild yam (Dioscorea villosa) **                  [check]

Herb                                            Vomiting   Constipation

Andrographis (Andrographis paniculata)          [check]
Bacopa (Bacopa monnieri) **
Barberry (Berberis vulgaris)
Black Haw (Viburnum prunifolium) *              [check]
Buchu (Agathosma betulina)
Cats claw (Uncaria tomentosa)
Devils's Claw (Harpagophytum procumbens)
Euphorbia (Euphorbia hirta)                     [check]
False Unicorn (Chamaelirium luteum) *           [check]
Fenugreek (Trigonella foenum-graecum)
Feverfew (Tanacetum parthenium)
Gentian (Gentiana lutea)
Golden seal (Hydrastis canadensis)
Greater Celandine (Chelidonium majus)
Gymnema (Gymnema sylvestre) **
Horsechestnut (Aesculus hippocastanum)
Jamaica Dogwood (Piscidia erythrina)            [check]
Lavender (Lavandula officinalis)
Nettle Root (Urtica dioica)
Olive Leaf (Olea Europaea)
Pleurisy Root (Asclepias tuberosa)              [check]
Rehmannia (Rehmannia glutinosa) *
Sarsaparilla (Smilax ornata)
Saw Palmetto (Serenoa serrulata)
Schisandra (Schisandra chinensis)
Siberian ginseng (Eleutherococcus senticosus)
St. John's wort (Hypericum Perforatum)
Tylophora (Tylophora indica)                    [check]
Uva Ursi (Arctostaphylos uva-ursi)              [check]      [check]
Wild yam (Dioscorea villosa) **

Herb                                            Nausea     Pain

Andrographis (Andrographis paniculata)
Bacopa (Bacopa monnieri) **
Barberry (Berberis vulgaris)                    [check]
Black Haw (Viburnum prunifolium) *              [check]
Buchu (Agathosma betulina)
Cats claw (Uncaria tomentosa)
Devils's Claw (Harpagophytum procumbens)
Euphorbia (Euphorbia hirta)                     [check]
False Unicorn (Chamaelirium luteum) *           [check]
Fenugreek (Trigonella foenum-graecum)
Feverfew (Tanacetum parthenium)                           [check]
Gentian (Gentiana lutea)                        [check]
Golden seal (Hydrastis canadensis)
Greater Celandine (Chelidonium majus)           [check]
Gymnema (Gymnema sylvestre) **
Horsechestnut (Aesculus hippocastanum)          [check]
Jamaica Dogwood (Piscidia erythrina)            [check]
Lavender (Lavandula officinalis)                          [check]
Nettle Root (Urtica dioica)
Olive Leaf (Olea Europaea)
Pleurisy Root (Asclepias tuberosa)
Rehmannia (Rehmannia glutinosa) *
Sarsaparilla (Smilax ornata)
Saw Palmetto (Serenoa serrulata)                [check]
Schisandra (Schisandra chinensis)               [check]
Siberian ginseng (Eleutherococcus senticosus)
St. John's wort (Hypericum Perforatum)
Tylophora (Tylophora indica)                    [check]
Uva Ursi (Arctostaphylos uva-ursi)              [check]
Wild yam (Dioscorea villosa) **

Herb                                             Upset    Discomfort

Andrographis (Andrographis paniculata)                     [check]
Bacopa (Bacopa monnieri) **                     [check]
Barberry (Berberis vulgaris)
Black Haw (Viburnum prunifolium) *
Buchu (Agathosma betulina)
Cats claw (Uncaria tomentosa)
Devils's Claw (Harpagophytum procumbens)                   [check]
Euphorbia (Euphorbia hirta)
False Unicorn (Chamaelirium luteum) *
Fenugreek (Trigonella foenum-graecum)           [check]
Feverfew (Tanacetum parthenium)
Gentian (Gentiana lutea)
Golden seal (Hydrastis canadensis)
Greater Celandine (Chelidonium majus)                      [check]
Gymnema (Gymnema sylvestre) **
Horsechestnut (Aesculus hippocastanum)
Jamaica Dogwood (Piscidia erythrina)
Lavender (Lavandula officinalis)
Nettle Root (Urtica dioica)                                [check]
Olive Leaf (Olea Europaea)                      [check]
Pleurisy Root (Asclepias tuberosa)
Rehmannia (Rehmannia glutinosa) *
Sarsaparilla (Smilax ornata)
Saw Palmetto (Serenoa serrulata)
Schisandra (Schisandra chinensis)
Siberian ginseng (Eleutherococcus senticosus)
St. John's wort (Hypericum Perforatum)          [check]
Tylophora (Tylophora indica)
Uva Ursi (Arctostaphylos uva-ursi)
Wild yam (Dioscorea villosa) **
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Author:Harris, T.A.; Grace, S.; Eddey, S.
Publication:Journal of the Australian Traditional-Medicine Society
Article Type:Survey
Geographic Code:8AUST
Date:Sep 1, 2015
Words:2982
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