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Fuke Qianjin Combined with Antibiotic Therapy for Pelvic Inflammatory Disease: A Systematic Review and Meta-Analysis.

1. Introduction

1.1. Background. PID is a spectrum of inflammatory disorders of the upper female genital tract, including endometritis, salpingitis, tubo-ovarian abscess, and pelvic peritonitis [1]. Without timely and thorough treatment PID can cause a series of sequelae including chronic pelvic pain, pelvic adhesion, and infertility [2]. A population-based nested controlled study, which included 18,276 women with a new diagnosis of infertility and 73,104 matched controls, showed PID were associated with an increased risk of infertility in women aged <40 years [3]. Reproductive tract infection, especially N. gonorrhoeae and C. trachomatis [4], and uterine cavity operation are the most common causes of PID. The age is mainly concentrated from 25 to 35, and more than 1% of sexually mature females are estimated to be suffering from PID [5]. In developing countries, the incidence of PID among women of childbearing age is 40% [6]. It is the most common gynecological cause for hospital admission in America, and in England, even though the incidence is decreasing, 1.1% of young women attending primary care services are diagnosed with PID [7-9]. Although there is a reduction in the rate of hospitalisation in developed countries, PID is still the most common gynecological disease, and over 1% of young women are diagnosed with PID when attending primary care services [7].

As the guideline of the US Centers for Disease Control and Prevention (CDC) suggests, the treatment of PID is ordinarily with broad-spectrum antibiotics [10]. However, due to the inappropriate and irrational use of antibiotics, there are problems of drug-resistant bacteria, reduced drug sensitivity, and some side effects. Traditional Chinese medicine (TCM) has a long-standing history, with exact efficacy and obvious advantages in treating gynecological diseases. The evidence suggests that Chinese patent medicine combined with antibiotics in the treatment of PID has a remarkable curative effect, improves the clinical symptoms effectively, and reduces the relapse rate notably [11]. Fuke Qianjin tablets/capsules (FKQJ) are a pure traditional Chinese medicine, used in the treatment of PID. The principal constituents of FKQJ are Philippine flemingia root, Cherokee rose root, Andrographis paniculata Nees (APN), Leatherleaf mahonia, Zanthoxylum dissitum Hemsl, Angelica sinensis, Lignum millettiae, and Codonopsis pilosula. The main therapeutic effects of FKQJ are clearing heat and dehumidifying and benefiting qi and stasis. APN, one of FKQJ's main components, has been reported to have antioxidant [12] and immunomodulatory effects [13], and likewise it showed a potent anti-inflammatory effect on pathogen-induced PID in rats [14]. Although there was a meta-analysis about the treatment of PID with FKQJ combined with antibiotics and some with TCM, the optimal treatment strategy and the safety were still controversial. And more than ten related RCTs have been published in the past two years. Therefore, this systematic review and meta-analysis of RCTs about FKQJ combined with antibiotics for the treatment of PID were conducted to conclude a comprehensive assessment of FKQJ as an adjunctive therapy of PID.

2. Method

21. Study Registration. The registration number of this systematic review on PROSPERO is CRD42019131527.

2.2. Search Strategy. We searched the Cochrane Central Register of Controlled Trials, PubMed, Embase, Medline, and four Chinese databases-the China National Knowledge Infrastructure Database (CNKI), the Wanfang Database, the China Science and Technology Journal Database (VIP), and the Chinese Biology Medicine (CBM)--to make a collection of the RCTs about FKQJ combined with antibiotic therapy from 1990 to December 2019. And we also searched clinical trials in progress from the NIH Clinical Trials, the International Clinical Trials, and the Chinese Clinical Register. The language was limited to Chinese and English. We used the following search terms ((pelvic inflammatory disease OR PID OR endometritis OR salpingitis) AND (fukeqianjin OR fuke qianjin OR Chinese patent medicine) NOT sequelae NOT chronic). The titles and abstracts of all literature were reviewed and investigated to eliminate repetitive or irrelevant articles.

2.3. Eligibility Criteria and Study Selection. Two reviewers evaluated potentially relevant RCTs independently by reading the whole article based on the inclusion criteria. Disagreements about inclusion and exclusion were resolved by consensus or consulting the third reviewer. The following inclusion criteria were the eligibility criteria for the study selection.

2.31. Types of Studies. Data from RCTs and quasi-randomized trials were sought electronically. The RCTs comparing FKQJ combined with antibiotic therapy for PID were included.

2.3.2. Types of Participants. They are patients of childbearing age diagnosed with acute PID by clinical symptoms or auxiliary examinations based on the criteria of guidelines and teaching materials. Patients who are systemically unwell, with presence of a tubo-ovarian abscess, who are pregnant, undergoing surgery, or after salpingography were excluded.

2.3.3. Types of Interventions. We limited antibiotics without any dosage form restriction for the control group, which were all recommended by the 2015 US CDC guidelines for PID [10]. And we did not limit the dosage forms of FKQJ as orally ingested product (such as capsules and tablets).

2.3.4. Types of Outcome Measures. Primary outcomes were the rate of markedly effective and adverse events. Secondary outcomes were the symptom improvement of leucorrhea, the improvement of lower abdominal pain, the recurrent rate at half year, recurrent rate, and the time of abdominal pain disappearance.

2.4. Assessment of Risk of Bias. Two reviewers independently evaluated the risk of bias for the included studies using the Cochrane Collaboration's tool for evaluating the risk of bias [15], consensus, or consulting with the third author if necessary. This tool supports the consideration of sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other sources of bias. We assessed the risk of bias in each source as low risk of bias, high risk of bias, and unclear risk of bias and contacted the study's authors to request for missing information by using open-ended questions if necessary.

2.5. Data Extraction and Management. The authors independently extracted the data from the included studies by a standardised Excel form. We collected the following data: author, year, country, sample size, age, the dosage of FKQJ, the dosage, and regimen of antibiotics. We checked the data for erratum, retraction, fraud, and inconsistencies. If a study had more than two intervention arms, we included or combined only those that met the predefined inclusion criteria.

2.6. Statistical Analysis. We extracted both dichotomous and continuous data. For dichotomous data, the number of events in each group was used to calculate risk ratios (RR), with all outcomes presenting 95% confidence intervals (CI).

For continuous data, we calculate the mean difference (MD), with all outcomes presenting 95% confidence intervals (CI). Subgroup analysis was examined according to the route of antibiotic administration and the length of therapy. Heterogeneity between trials and subgroups of trials with different regimens of antibiotics was calculated using chi-square statistic and analysed with the [I.sup.2] statistics. If the substantial heterogeneity ([I.sup.2] 50% or higher) was identified, we used a random-effects analysis. For each outcome with more than ten studies, the publication bias was examined by the funnel plot.

3. Results

3.1. Description of Studies

3.1.1. Results of the Search. The search and selection process of this review was described based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline [16] in Figure 1. We searched the CENTRAL, PubMed, Embase, Medline, CNKI, the Wanfang Database, VIP, and CBM and provided a total of 847 references. After eliminating the duplicate literature, 343 records remained. Of these, 224 records were discarded as clearly irrelevant and we considered 119 full-text studies. After full-text review, 23 articles met our inclusion criteria, and we excluded 96 studies. The most common reason for exclusion was that these studies were with small sample size or included nonchildbearing age women (43 studies). Other common reasons for exclusion were as follows: the therapeutic regimen did not meet the inclusion criteria (11 studies), studies without detailed information (4 studies), or nonrandomized studies (29 studies) (Figure 1). Finally, 23 RCTs (2527 women) were identified for inclusion in the review (Table 1).

4. Risk of Bias in Included Studies

We assessed the risk of bias of the 23 included trials in Figures 2 and 3. Ten trials mentioned the way of generating the allocation sequences. Ten trials [17-19, 24, 25, 27-29, 32, 37] used the random number table, and Meng [20] used a computer random number generator. All included trials did not mention blinding of participants and personnel or the blinding of outcome assessment, which makes the risk of performance and detection bias unclear. The publication bias was assessed through the funnel plot for comparison when there were 10 or more studies in the same analysis.

5. Synthesis of Results

We analysed the outcomes in five subgroups based on the different regimens of antibiotics class comparison:

(i) Regimen A containing FKQJ combined with nitroimidazoles versus nitroimidazoles

(ii) Regimen B containing FKQJ combined with clindamycin versus clindamycin

(iii) Regimen C containing FKQJ combined with quinolones versus quinolones

(iv) Regimen D containing FKQJ combined with cephalosporin plus nitroimidazoles versus cephalosporin plus nitroimidazoles

(v) Regimen E containing FKQJ combined with cephalosporin plus doxycycline versus cephalosporin plus doxycycline

5.1. Primary Outcomes

5.1.1. Markedly Effective Rate. The calculation of markedly effective rate is the sum number of cured cases and effective cases divided by the total number of cases. All inclusion studies with a total of 2527 patients reported the markedly effective rate in results. With the heterogeneity for this analysis, a random-effect model was conducted to estimate pooled effect size. Meanwhile, based on the different antibiotics regimens, subgroup analysis was performed. The results indicated that FKQJ combined with antibiotics improved the effective rate compared with antibiotics alone (P < 0.00001) (RR = 1.38, 95% CI 1.27 to 1.49, [I.sup.2] = 42%) (Figure 4). The subgroup analysis indicated difference (P = 0.03). The asymmetrical funnel plot observed potential publication bias (Figure 5).

Because of the high heterogeneity, a sensitivity analysis was performed. When we removed the trial, Zhang [33], in sensitivity analyses of the markedly effective rate, there was an impact on the random-effects pooled efficacy difference (P = 0.07) (RR = 1.35, 95% CI 1.26 to 1.46, [I.sup.2] = 33%) and the subgroup analysis suggested no difference (P = 0.09).

5.1.2. Adverse Events. Two studies [25, 26] mentioned adverse events. Wang et al. [26] reported no adverse events, and Shen [25] reported adverse events and provided data in results. The FKQJ combined with antibiotics group [5.13%, (2/39)] did not increase the rate of adverse events compared with antibiotics alone group [5.13%, (2/39)]. The adverse reactions were slight nausea, vomiting, or dizziness, and all adverse reactions can be alleviated or eliminated after symptomatic treatment.

5.2. Secondary Outcomes

5.2.1. Disappearance Time of Lower Abdominal Pain. Three studies [25, 26, 38] reported the disappearance time of lower abdominal pain in results. The FKQJ combined with antibiotics group significantly shortened the length of lower abdominal pain disappearance (P < 0.00001) (MD = -1.11, 95% CI -1.39 to -0.84, [I.sup.2] = 38%) (Figure 6).

5.2.2. Improvement of Lower Abdominal Pain. Two trials [22, 23] mentioned the improvement of lower abdominal pain. The analyses showed the experimental group had a higher symptom improvement rate (P < 0.00001) (RR = 1.35, 95% CI 1.19 to 1.55, [I.sup.2] = 0) (Figure 7).

5.2.3. Recurrent Rate. The recurrence rate in half a year was reported in three trials [18, 19, 33]. The implementation of adjuvant FKQJ reduced the recurrent rate compared with antibiotics alone (P = 0.0006) (RR = 0.27, 95% CI 0.13 to 0.56, [I.sup.2] = 0%) (Figure 8).

5.2.4. Improvement of Leucorrhea. Only one trial [23] reported the improvement rate of leucorrhea. The FKQJ group had a greater improvement of leucorrhea [90.63%, 58/64] than the control group [65.63%, 42/64]

6. Discussion

This study systematically reviewed the efficacy and safety of FKQJ combined with antibiotics in the treatment of PID on the basis of existing literature and data. There was only one meta-analysis [40] of adjuvant FKQJ for PID in 2016. That meta-analysis only included sixteen trials of FKQJ combined with antibiotics in the treatment of endometritis from 2010 to 2016. However, that study focused on outcomes related to efficacy, such as the thickness of the endometrium, the occurrence rate of the normal menstrual cycle, and total effective rate, and safety-related outcomes were not available. Furthermore, more than 20 articles have been published in the past two years. Comparing with the previous study, this study investigated not only the efficacy but also the safety evaluation.

Chinese material medicine is an integral part of TCM, with thousands of years of clinical application history. Chinese patent medicines mainly come from ancient classical prescriptions and current clinical effective prescriptions. As recommended in the Chinese Guidelines for PID, Chinese material medicine and Chinese patent medicine were conventionally used in the treatment of PID [41]. To standardise the application of Chinese patent medicine in the treatment of PID, the Chinese Association of Chinese Medicine (CACM) promulgated the Clinical Practice Guideline on Traditional Chinese Medicine Alone or Combined with Antibiotics for Patients with Pelvic Inflammatory Disease in 2017. A metabolomics study revealed that FKQJ had the efficacy of potential therapeutic to multiple pathogens induced PID by reducing inflammation and improving metabolic disorders [42]. Although the adjuvant treatment of PID with traditional Chinese medicine has clinical efficacy, its mechanism and safety are also worthy of attention.

This meta-analysis of twenty-three studies involved 2527 participants showing that FKQJ combined with antibiotics had advantages over antibiotics alone in improving the markedly effective rate. Auxiliary use of proprietary Chinese medicines did not lead to adverse events. We seemingly found the marked efficacy of FKQJ combined with antibiotics for PID had a certain correlation with the difference of antibiotics regimen.

However, because of the less information about the pathogen culture in participants, it is difficult to analyse which regimen is better. The results showed that the clinical recurrence rate tends to decrease. We considered that FKQJ combined with antibiotics could reduce the clinical recurrence rate of PID according to the existing evidence. However, this conclusion needed more high-quality and substantial study sample evidence to support in the future. We consider the natural pregnancy rate as an outcome in the protocol, but after abstraction there was no data on the rate of fertility. Therefore, it is necessary to extend the follow-up time in future clinical research.

Nevertheless, our meta-analysis exhibited several limitations. Firstly, the quality of evidence was low in some comparisons because of the unclear or high risk of bias. The heterogeneity of most subgroups was acceptable, yet within some subgroups it remained high (e.g., difference of the treatment courses). Secondly, the FKQJ formulae included in this study were mainly Chinese herbal compound capsules and tablets, and the dosages, the forms, and manufacturer information were various. Although we judged the rationality of FKQJ use in each trial according to the medicine instructions, to our minds, there still was heterogeneity in interventions between the included studies. Furthermore, the regimens and administrations of antibiotics varied greatly across trials. According to the guideline, the parenteral regimens appeared to have similar efficacy to oral regimens in women with PID. Therefore, the types of antibiotics provide the basis for ultimate subgroup analysis. Fourthly, the funnel plot is not symmetrical, and there may be publication bias. Additionally, only one trial of 78 participants provided data about adverse events, and all RCTs did not report the rate of fertility after treatment. Due to the inadequate sample size and data, it is shown that few trials were contributing to some outcomes.

7. Conclusions

FKQJ combine with antibiotics therapy have effects on improving the markedly effective rate and reducing the recurrence rate. This therapy appears to improve lower abdominal pain and curtail the relief time in patients after treatment. Antibiotics plus Chinese patent medicine did not increase the incidence of adverse events. However, due to the poor methodological quality and the high heterogeneity of some included trials, our conclusions should be carefully interpreted. To assess the pregnancy rate and safety evaluation after the standardised treatment, future trials based on high-quality evidence should perform a longer period of follow-up for 12 months or more to conduct the convincing conclusions in the future.

https://doi.org/10.1155/2020/5372839

Data Availability

All relevant data are within the manuscript and its Supplementary Materials.

Conflicts of Interest

The authors declare that they have no conflicts of interest.

Authors' Contributions

Yu Chen and Mei Luo were responsible for conceptualization of the study. Li Huang and Caimmiao Yin were responsible for data curation. Yu Chen and Mei Luo performed the formal analysis. Caimmiao Yin, Li Huang, and Yang Wu performed the investigation. Yu Chen and Mei Luo were responsible for the methodology. Shaobin Wei performed project administration. Yu Chen and Yang Wu developed the software. Shaobin Wei supervised the study. Shaobin Wei validated the results. Yu Chen, Li Huang, and Yang Wu wrote the original draft. Yu Chen and Shaobin Wei reviewed and edited the manuscript.

Supplementary Materials

S1-PRISMA Checklist.pdf: it contains the PRISMA checklist. (Supplementary Materials)

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Yu Chen, (1) Shaobin Wei [ID], (1) Li Huang, (1) Mei Luo, (2) Yang Wu, (1) and Caimmiao Yin (1)

(1) Department of Gynecology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu 610072, Sichuan, China

(2) Department of Gynecology, Hospital of Chongqing Institute of Traditional Chinese Medicine, Chongqing 400011, China

Correspondence should be addressed to Shaobin Wei; weishaobin5620@163.com

Received 26 February 2020; Revised 23 April 2020; Accepted 10 June 2020; Published 21 July 2020

Guest Editor: Lei Xu

Caption: FIGURE 1: Flow diagram of the literature search process based on the PRISMA guideline. PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses; CNKI: China National Knowledge Infrastructure Database; VIP: the China Science and Technology Journal Database; CBM: Chinese Biology Medicine (CBM); RCT: randomized controlled trials.

Caption: FIGURE 2: Risk of bias.

Caption: FIGURE 5: Funnel plot--markedly effective; FKQJ, Fuke Qianjin.
TABLE 1: Characteristics of included studies.

First author/year     Age (M [+ or -] SD)        Study setting/
                         (years) Total            study period
                          sample size

Li 2014 [17]         E: 37.7 [+ or -] 3.8,    RCT; 2009.02-2012.10
                     C: 38.2 [+ or -] 3.4;
                          72 (36/36)
Zhang 2018 [18]     E: 30.18 [+ or -] 2.02,   RCT; 2016.01-2017.02
                    C: 30.26 [+ or -] 2.19;
                          104 (52/52)
Du 2017 [19]        E: 30.42 [+ or -] 2.44,   RCT; 2016.04-2016.12
                    C: 30.71 [+ or -] 2.78;
                          160 (80/80)
Meng 2018 [20]       E: 30.5 [+ or -] 2.5,    RCT; 2017.05-2018.05
                     C: 30.7 [+ or -] 2.6;
                          84 (42/42)
Chang 2016 [21]     E: 27.34 [+ or -] 2.13,   RCT; 2014.02-2015.10
                    C: 27.15 [+ or -] 2.25;
                          80 (40/40)
Fan 2016 [22]        32.57 [+ or -] 3.11;     RCT; 2014.01-2015.12
                          180 (90/90)
Liu 2017 [23]        E: 32.4 [+ or -] 2.6,    RCT; 2015.10-2017.01
                     C: 33.7 [+ or -] 2.9;
                          128 (64/64)
Guo 2015 [24]        E: 32.5 [+ or -] 3.6,    RCT; 2012.02-2014.02
                     C: 32.7 [+ or -] 3.5;
                          156 (78/78)
Shen 2018 [25]      E: 30.57 [+ or -] 2.12,   RCT; 2015.01-2017.10
                    C: 30.24 [+ or -] 2.13;
                          78 (39/39)
Wang 2018 [26]       E: 31.2 [+ or -] 3.4,    RCT; 2016.04-2017.12
                     C: 32.4 [+ or -] 3.0;
                          102 (51/51)
Lou 2017 [27]        E: 32.7 [+ or -] 4.7,    RCT; 2013.01-2016.01
                     C: 32.1 [+ or -] 4.3;
                          89 (45/ 44)
Chen 2017 [28]      E: 30.05 [+ or -] 4.55,   RCT; 2015.06-2017.05
                    C: 29.51 [+ or -] 4.53;
                          60 (30/30)
Liu 2019 [29]         E: 30-45,C: 32-47;      RCT; 2018.03-2019.03
                          78 (39/39)

Zheng 2019 [30]     E: 31.42 [+ or -] 0.14,   RCT; 2016.05-2018.06
                    C: 30.14 [+ or -] 1.15;
                          80 (40/40)
Lin, 2019 [31]       E: 32.5 [+ or -] 3.1,    RCT; 2016.05-2018.05
                     C: 31.2 [+ or -] 4.5;
                          60 (30/ 30)
Zhang 2019 [32]     E: 29.5 [+ or -] 1.2,     RCT; 2017.05-2018.05
                     C: 28.7 [+ or -] 2.1;
                          68(34/ 34)
Zhang 2017 [33]     E: 30.42 [+ or -] 2.65,   RCT; 2014.01-2015.12
                    C: 30.12 [+ or -] 2.61;
                          90 (45/45)
Yuan, 2015 [34]     E: 31.58 [+ or -] 4.85,   RCT; 2013.05-2015.05
                    C: 31.65 [+ or -] 4.88;
                          150 (75/75)
Chen 2019 [35]      E: 5.14 [+ or -] 2.75,    RCT; 2016.07-2018.07
                    C: 35.36 [+ or -] 2.74;
                          100 (50/50)
Yuan 2012 [36]       E: 34.4 [+ or -] 1.8,    RCT; 2012.06-2014.06
                     C: 34.6 [+ or -] 1.7;
                          80(40/ 40)
He 2017 [37]        E: 33.24 [+ or -] 1.39,   RCT; 2013.08-2016.02
                    C: 33.11 [+ or -] 2.42;
                          120 (60/60)
Lei 2019 [38]        E: 37.5 [+ or -] 3.7,    RCT; 2016.06-2018.06
                     C: 36.8 [+ or -] 3.9;
                          60 (30/ 30)
Deng 2019 [39]       E: 37.5 [+ or -] 1.9,    RCT; 2013.03-2015.02
                     C: 36.7 [+ or -] 2.0;
                         348 (174/174)

First author/year      Experimental group          Control group

Li 2014 [17]              FKQJ tablet             Nitroimidazoles
                     (6 tablets, tid, po),        (metronidazole,
                      nitroimidazoles (iv)        0.5 g, bid, iv)
Zhang 2018 [18]           FKQJ tablet             Nitroimidazoles
                     (6 tablets, tid, po),        (metronidazole,
                      nitroimidazoles (iv)         15 mg, qd, iv)
Du 2017 [19]              FKQJ tablet             Nitroimidazoles
                     (6 tablets, tid, po),        (metronidazole,
                      nitroimidazoles (iv)         15 mg, qd, iv)
Meng 2018 [20]            FKQJ tablet             Nitroimidazoles
                     (6 tablets, tid, po),        (metronidazole,
                      nitroimidazoles (iv)         15 mg, qd, iv)
Chang 2016 [21]           FKQJ tablet             Nitroimidazoles
                     (3 tablets, tid, po),         (metronidazole
                      nitroimidazoles (po)       tablet, 2 tablets,
                                                      tid, po)
Fan 2016 [22]             FKQJ tablet             Nitroimidazoles
                     (6 tablets, tid, po),        (metronidazole,
                      nitroimidazoles (iv)        0.5 g, q8h, iv)
Liu 2017 [23]             FKQJ tablet             Nitroimidazoles
                     (6 tablets, tid, po),         (metronidazole
                      nitroimidazoles (po)       tablet, 2 tablets,
                                                      tid, po)
Guo 2015 [24]             FKQJ tablet             Nitroimidazoles
                     (6 tablets, tid, po),        (metronidazole,
                      nitroimidazoles (iv)         15 mg, qd, iv)
Shen 2018 [25]           FKQJ capsules            Nitroimidazoles
                     (2 capsules, bid, po),        (metronidazole
                      nitroimidazoles (po)       tablet, 2 tablets,
                                                      tid, po)
Wang 2018 [26]            FKQJ tablet             Nitroimidazoles
                     (2 tablets, bid, po),         (metronidazole
                      nitroimidazoles (po)       tablet, 2 tablets,
                                                      tid, po)
Lou 2017 [27]             FKQJ tablet             Nitroimidazoles
                     (6 tablets, tid, po),         (metronidazole
                      nitroimidazoles (po)       tablet, 2 tablets,
                                                      tid, po)
Chen 2017 [28]            FKQJ tablet             Nitroimidazoles
                     (6 tablets, tid, po),        (metronidazole,
                      nitroimidazoles (iv)         15 mg, qd, iv)
Liu 2019 [29]             FKQJ tablet             Nitroimidazoles
                     (6 tablets, tid, po),        (metronidazole,
                      nitroimidazoles (iv)        0.5 g, q8d, iv)
Zheng 2019 [30]           FKQJ tablet             Nitroimidazoles
                     (6 tablets, tid, po),         (metronidazole
                     nitroimidazoles t (po)      tablet, 2 tablets,
                                                      tid, po)
Lin, 2019 [31]            FKQJ tablet             Nitroimidazoles
                     (6 tablets, tid, po),         (metronidazole
                       nitroimidazoles t         tablet, 2 tablets,
                         (po, 2 weeks)           tid, po, 2 weeks)
Zhang 2019 [32]           FKQJ tablet             Nitroimidazoles
                     (6 tablets, tid, po),        (metronidazole,
                      nitroimidazoles (iv)        0.5 g, q8h, iv)
Zhang 2017 [33]           FKQJ capsule              Clindamycin
                     (2 capsule, tid, po),      (clindamycin, 0.6 g,
                    clindamycin (iv, 1 week)      bid, iv, 1 week)
Yuan, 2015 [34]           FKQJ tablet               Clindamycin
                     (2 tablets, tid, po),          (clindamycin
                        clindamycin (iv)             phosphate,
                                                  1.5 g, tid, iv)
Chen 2019 [35]            FKQJ capsule             Cephalosporin
                     (2 capsules, tid, po),      (cefuroxime axetil
                      cephalosporin (po) +      tablet, 0.75-1.5 g,
                      nitroimidazoles (po)           tid, po) +
                                                  nitroimidazoles
                                                (tinidazole tablets,
                                                  0.5 g, bid, po)
Yuan 2012 [36]            FKQJ capsule             Cephalosporin
                     (2 capsules, tid, po);     (ceftriaxone sodium,
                      cephalosporin (iv) +        2 g, bid, iv) +
                      nitroimidazoles (iv)        nitroimidazoles
                                                  (metronidazole,
                                                  500 mg, bid, iv)
He 2017 [37]              FKQJ tablet                Quinolones
                     (6 tablets, tid, po),     (levofloxacin tablet,
                        quinolones (po)        200 tablets, tid, po)
Lei 2019 [38]             FKQJ capsule               Quinolones
                     (2 capsules, tid, po);    (levofloxacin tablet,
                        quinolones (po)           200 mg, bid, po)
Deng 2019 [39]            FKQJ tablet              Cephalosporin
                     (6 tablets, tid, po),        (cefoxitin, 2 g,
                      cephalosporin (im) +     q6h, im) + doxycycline
                        doxycycline (po)         (100 mg, bid, po)

First author/year     Course     Outcomes

Li 2014 [17]         2 weeks        (1)

Zhang 2018 [18]      6 weeks      (1)(5)
Du 2017 [19]         6 weeks      (1)(5)
Meng 2018 [20]       6 weeks        (1)
Chang 2016 [21]      6 weeks        (1)
Fan 2016 [22]        2 weeks      (1)(3)
Liu 2017 [23]        2 weeks      (1)(3)
Guo 2015 [24]        6 weeks        (1)
Shen 2018 [25]       2 weeks     (1)(2)(3)
Wang 2018 [26]       2 weeks     (1)(2)(4)
Lou 2017 [27]        6 weeks        (1)
Chen 2017 [28]       8 weeks        (1)
Liu 2019 [29]        4 weeks        (1)
Zheng 2019 [30]      6 weeks        (1)
Lin, 2019 [31]       6 weeks;       (1)
                    antibiotic
                     2 weeks
Zhang 2019 [32]      4 weeks        (1)
Zhang 2017 [33]      2 weeks;     (1)(5)
                    antibiotic
                      1 week
Yuan, 2015 [34]      6 weeks        (1)
Chen 2019 [35]       2 weeks        (1)
Yuan 2012 [36]       2 weeks        (1)
He 2017 [37]         3 weeks        (1)
Lei 2019 [38]        2 weeks      (1)(4)
Deng 2019 [39]       45 days        (1)

Outcomes: (1) markedly effective rate; (2) adverse event;
(3) improvement of lower abdominal pain; 0 time of abdominal pain
disappearance; and (5) recurrence rate. Both the tablets and
capsules of FKQJ are produced by Zhuzhou Qianjin Pharmaceutical
Company Limited; State Drugs Administration (SDA) License Number
(GUOYAOZHUNZI): Z43020027 (tablet), Z20020024 (capsule). M, mean;
SD, standard deviation; RCT, randomized controlled trial;
FKQJ, Fuke Qianjin; E, experimental group; C, control group; qd,
once a day; bid, twice a day; tid, three times a day; q 6h, e
very 6 hours; q 8h, every 8 hours; po, peros; im, intramuscular;
iv, intravenous intravenously.

FIGURE 3: Summary risk of bias graph. Note. "+": low risk of
bias; "?": unclear risk of bias.

                  Zheng, 2019   ZhangHH, 2018   Zhang, 2019

Random sequence        ?              +              +
  generation
  (selection
  bias)
Allocation             ?              ?              ?
  concealment
  (selection
  bias)
Blinding of            ?              ?              ?
  participants
  and personnel
  (performance
  bias)
Blinding of            ?              ?              ?
  outcome
  assessment
  (detection
  bias)
Incomplete             +              +              +
  outcome data
  (attrition
  bias)
Selective              +              +              +
  reporting
  (reporting
  bias)
Other bias             ?              ?              +

                  Zhang, 2017   Yuan, 2015   Yuan, 2012   Wang, 2018

Random sequence        ?            ?            ?            ?
  generation
  (selection
  bias)
Allocation             ?            ?            ?            ?
  concealment
  (selection
  bias)
Blinding of            ?            ?            ?            ?
  participants
  and personnel
  (performance
  bias)
Blinding of            ?            ?            ?            ?
  outcome
  assessment
  (detection
  bias)
Incomplete             +            +            +            +
  outcome data
  (attrition
  bias)
Selective              +            +            +            +
  reporting
  (reporting
  bias)
Other bias             ?            ?            ?            ?

                  Shen, 2018   Meng, 2018   Lou, 2017   Liu, 2019

Random sequence       +            +            +           +
  generation
  (selection
  bias)
Allocation            ?            ?            ?           ?
  concealment
  (selection
  bias)
Blinding of           ?            ?            ?           ?
  participants
  and personnel
  (performance
  bias)
Blinding of           ?            ?            ?           ?
  outcome
  assessment
  (detection
  bias)
Incomplete            +            +            +           +
  outcome data
  (attrition
  bias)
Selective             +            +            +           +
  reporting
  (reporting
  bias)
Other bias            ?            ?            +           +

                  Liu, 2017   Lin, 2019   Li, 2014   Lei, 2019

Random sequence       ?           ?          +           ?
  generation
  (selection
  bias)
Allocation            ?           ?          ?           ?
  concealment
  (selection
  bias)
Blinding of           ?           ?          ?           ?
  participants
  and personnel
  (performance
  bias)
Blinding of           ?           ?          ?           ?
  outcome
  assessment
  (detection
  bias)
Incomplete            +           +          +           +
  outcome data
  (attrition
  bias)
Selective             +           +          +           +
  reporting
  (reporting
  bias)
Other bias            ?           ?          +           ?

                  He, 2017   Guo, 2015   Fan, 2016   Du, 2017

Random sequence      +           +           ?          +
  generation
  (selection
  bias)
Allocation           ?           ?           ?          ?
  concealment
  (selection
  bias)
Blinding of          ?           ?           ?          ?
  participants
  and personnel
  (performance
  bias)
Blinding of          ?           ?           ?          ?
  outcome
  assessment
  (detection
  bias)
Incomplete           +           +           +          +
  outcome data
  (attrition
  bias)
Selective            +           +           +          +
  reporting
  (reporting
  bias)
Other bias           +           +           ?          +

                  Deng, 2019  Chen, 2019  Chen, 2017  Chang, 2016

Random sequence       ?           ?           +            ?
  generation
  (selection
  bias)
Allocation            ?           ?           ?            ?
  concealment
  (selection
  bias)
Blinding of           ?           ?           ?            ?
  participants
  and personnel
  (performance
  bias)
Blinding of           ?           ?           ?            ?
  outcome
  assessment
  (detection
  bias)
Incomplete            +           +           +            +
  outcome data
  (attrition
  bias)
Selective             +           +           +            +
  reporting
  (reporting
  bias)
Other bias            ?           +           ?            ?

FIGURE 4: Forest plot--markedly effective rate; FKQJ, Fuke Qianjin.

Study or subgroup     Antibiotics      Antibiotics

                     Events   Total   Events   Total

1.1.1 FKQJ & nitroimidazoles vs. nitroimidazoles
  Chang, 2016          27      40       15      40
  Chen, 2017           24      30       18      30
  Du, 2017             38      80       22      80
  Fan, 2016            51      90       39      90
  Guo, 2015            43      78       20      78
  Li, 2014             18      36       10      36
  Lin, 2019            28      30       23      30
  Liu, 2017            56      64       38      64
  Liu, 2019            21      39       15      39
  Lou, 2017            26      45       15      44
  Meng, 2018           29      42       24      42
  Shen, 2018           20      39       14      39
  Wang, 2018           39      51       35      51
  Zhang, 2019          19      34       13      34
  ZhangHH, 2018        43      52       24      52
  Zheng, 2019          38      40       27      40
Subtotal (95% CI)              790              789
Total events          520              352
Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 17.19,
  df = 15 (P = 0.31); [I.sup.2] = 13%
Test for overall effect: Z = 7.63 (P < 0.00001)
1.1.2 FKQJ & clindamycin vs. clindamycin
  Yuan, 2015           34      75       22      75
  Zhang, 2017          31      45       14      45
Subtotal (95% CI)              75               75
Total events           34               22
Heterogeneity: not applicable
Test for overall effect: Z = 1.98 (P = 0.05)
1.1.3 FKQJ & quinolones vs. quinolones
  He, 2017             50      60       40      60
  Lei, 2019            28      30       21      30
Subtotal (95% CI)              90               90
Total events           78               61
Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 0.15,
  df = 1 (P = 0.70); [I.sup.2] = 0%
Test for overall effect: Z = 3.01 (P = 0.003)
1.1.4 FKQJ & clindamycin plus nitroimidazoles vs.
  clindamycin plus nitroimidazoles
  Chen, 2019           48      50       40      50
  Yuan, 2012           15      40       11      40
Subtotal (95% CI)              90               90
Total events           63               51
Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 0.23,
  df = 1 (P = 0.63); [I.sup.2] = 0%
Test for overall effect: Z = 2.54 (P = 0.01)
1.1.5 FKQJ & clindamycin plus doxycycline vs. clindamycin
  plus doxycycline
  Deng, 2019          170      174     140      174
Subtotal (95% CI)              174              174
Total events          170              140
Heterogeneity: not applicable
Test for overall effect: Z = 4.96 (P < 0.00001)
Total (95% CI)                1219             1218
Total events          865              626

Heterogeneity: [tau.sup.2] = 0.01; [chi.sup.2] = 31.38,
  df = 21 (P = 0.07); [I.sup.2] = 33%
Test for overall effect: Z = 8.01 (P < 0.00001)
Test for subgroup differences: [chi.sup.2] = 8.04,
  df = 4 (P = 0.09); [I.sup.2] = 50.3%

Study or subgroup    Weight (%)       Risk ratio
                                   M-H, random, 95%

1.1.1 FKQJ & nitroimidazoles vs. nitroimidazoles
  Chang, 2016           2.3       1.80 [1.14, 2.83]
  Chen, 2017            3.7       1.33 [0.95, 1.88]
  Du, 2017              2.6       1.73 [1.13, 2.64]
  Fan, 2016             4.5       1.31 [0.97, 1.76]
  Guo, 2015             2.5       2.15 [1.40, 3.30]
  Li, 2014              1.3       1.80 [0.97, 3.35]
  Lin, 2019             6.8       1.22 [0.98, 1.52]
  Liu, 2017             6.7       1.47 [1.18, 1.84]
  Liu, 2019             2.0       1.40 [0.86, 2.29]
  Lou, 2017             2.1       1.69 [1.05, 2.74]
  Meng, 2018            3.9       1.21 [0.87, 1.68]
  Shen, 2018            1.8       1.43 [0.85, 2.40]
  Wang, 2018            6.1       1.11 [0.88, 1.42]
  Zhang, 2019           1.8       1.46 [0.87, 2.46]
  ZhangHH, 2018         4.1       1.79 [1.30, 2.46]
  Zheng, 2019           6.6       1.41 [1.12, 1.77]
Subtotal (95% CI)       58.8      1.42 [1.30, 1.55]
Total events
Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 17.19,
  df = 15 (P = 0.31); [I.sup.2] = 13%
Test for overall effect: Z = 7.63 (P < 0.00001)
1.1.2 FKQJ & clindamycin vs. clindamycin
  Yuan, 2015            2.5       1.55 [1.01, 2.38]
  Zhang, 2017                       Not estimable
Subtotal (95% CI)       2.5       1.55 [1.01, 2.38]
Total events
Heterogeneity: not applicable
Test for overall effect: Z = 1.98 (P = 0.05)
1.1.3 FKQJ & quinolones vs. quinolones
  He, 2017              7.1       1.25 [1.01, 1.54]
  Lei, 2019             5.7       1.33 [1.04, 1.72]
Subtotal (95% CI)       12.8      1.28 [1.09, 1.51]
Total events
Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 0.15,
  df = 1 (P = 0.70); [I.sup.2] = 0%
Test for overall effect: Z = 3.01 (P = 0.003)
1.1.4 FKQJ & clindamycin plus nitroimidazoles vs.
  clindamycin plus nitroimidazoles
  Chen, 2019            10.1      1.20 [1.03, 1.39]
  Yuan, 2012            1.2       1.36 [0.72, 2.59]
Subtotal (95% CI)       11.3      1.21 [1.04, 1.40]
Total events
Heterogeneity: [tau.sup.2] = 0.00; [chi.sup.2] = 0.23,
  df = 1 (P = 0.63); [I.sup.2] = 0%
Test for overall effect: Z = 2.54 (P = 0.01)
1.1.5 FKQJ & clindamycin plus doxycycline vs. clindamycin
  plus doxycycline
  Deng, 2019            14.6      1.21 [1.12, 1.31]
Subtotal (95% CI)       14.6      1.21 [1.12, 1.31]
Total events
Heterogeneity: not applicable
Test for overall effect: Z = 4.96 (P < 0.00001)
Total (95% CI)         100.0      1.35 [1.26, 1.46]
Total events

Heterogeneity: [tau.sup.2] = 0.01; [chi.sup.2] = 31.38,
  df = 21 (P = 0.07); [I.sup.2] = 33%
Test for overall effect: Z = 8.01 (P < 0.00001)
Test for subgroup differences: [chi.sup.2] = 8.04,
  df = 4 (P = 0.09); [I.sup.2] = 50.3%

FIGURE 6: Forest plot--time of lower abdominal pain
disappearance; FKQJ, Fuke Qianjin.

Study or subgroup        FKQJ and            Antibiotics
                        antibiotics

                    Mean    SD    Total   Mean    SD    Total

Lei, 2019            3     1.4     30     5.3    1.6     30
Shen, 2018          4.12   0.15    39     5.26   1.91    39
Wang, 2018          6.24   2.04    51     8.52   1.96    51
Total (95% CI)                     120                   120

Study or subgroup   Weight (%)   Std. mean difference
                                   IV, fixed, 95% CI

Lei, 2019              22.4      -1.51 [-2.09, -0.93]
Shen, 2018             34.9      -0.83 [-1.30, -0.37]
Wang, 2018             42.7      -1.13 [-1.55, -0.71]
Total (95% CI)        100.0      -1.11 [-1.39, -0.84]

Heterogeneity: [chi.sup.2] = 3.22, df = 2 (P = 0.20); [I.sup.2] = 38%
Test for overall effect: Z = 7.96 (P < 0.00001)

FIGURE 7: Forest plot--improvement of lower abdominal
pain. FKQJ, Fuke Qianjin.

Study or subgroup     FKQJ and        Antibiotics
                     antibiotics

                    Events   Total   Events   Total

Fan, 2016             67      76       48      74
Liu, 2017             58      64       43      64
Total (95% CI)                140              138
Total events         125               91

Study or subgroup   Weight (%)       Risk ratio
                                 M-H, fixed, 95% CI

Fan, 2016              53.1      1.36 [1.13, 1.64]
Liu, 2017              46.9      1.35 [1.12, 1.63]
Total (95% CI)        100.0      1.35 [1.19, 1.55]
Total events

Heterogeneity: [chi.sup.2] = 0.00, df = 1 (P = 0.96); [I.sup.2] = 0%
Test for overall effect: Z = 4.47 (P < 0.00001)

FIGURE 8: Forest plot--comparison for recurrent rate.
FKQJ, Fuke Qianjin.

Study or subgroup         FKQJ and         Antibiotics
                          antibiotics

                    Events   Total   Events   Total

Du, 2017              2       80       12      80
Zhang, 2017           3       45       8       45
ZhangHH, 2018         3       52       10      52
Total (95% CI)                177              177
Total events          8                30

Study or subgroup   Weight (%)       Risk ratio
                                 M-H, fixed, 95% CI

Du, 2017               40.0      0.17 [0.04, 0.72]
Zhang, 2017            26.7      0.38 [0.11, 1.32]
ZhangHH, 2018          33.3      0.30 [0.09, 1.03]
Total (95% CI)        100.0      0.27 [0.13, 0.56]
Total events

Heterogeneity: [chi.sup.2] = 0.71, df = 2 (P = 0.70); [I.sup.2] = 0%
Test for overall effect: Z = 3.45 (P = 0.0006)
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Title Annotation:Research Article
Author:Chen, Yu; Wei, Shaobin; Huang, Li; Luo, Mei; Wu, Yang; Yin, Caimmiao
Publication:Evidence - Based Complementary and Alternative Medicine
Geographic Code:9CHIN
Date:Aug 31, 2020
Words:7110
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