# Evaluating the Efficacy and Adverse Effects of Clearing Heat and Removing Dampness Method of Traditional Chinese Medicine by Comparison with Western Medicine in Patients with Gout

Authors: Nan Xiao; Hao Chen; Shi-Yong He; Chong-Xiang Xue; Hua Sui; Jing Chen; Jia-Lin Qu; Li-Na Liang; Lin Zhang
Journal: Evidence-Based Complementary and Alternative Medicine
 (2018)

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## Abstract

Objective.In China, the method of clearing heat and removing dampness medicine of Chinese traditional medicine has been widely used on gout. However, the clinical effects are various and not summarized systematically.Methods.In this study, a large number of randomized controlled clinical trials were reviewed and analyzed and the clinical efficacy and adverse reactions of traditional Chinese medicine with clearing heat and removing dampness effects for the treatment of gout were systematically evaluated. A comprehensive search of databases including pubMed, China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database, Wanfang Data, and SinoMed was performed.Results. There are 69 randomized controlled trials with 5915 sample sizes meeting the criteria in the study. The results of the meta-analysis indicate that the effects of clearing heat and removing dampness medicine were slightly better than western medicine in the treatment of gout based on the following parameters: serum uric acid (standardized mean difference (SMD):-62.14, 95% confidence interval (CI): -78.12 to-46.15), C reactive protein (SMD: -4.21, 95% CI: -6.19 to -2.23), erythrocyte sedimentation rate (SMD: -6.23, 95% CI: -8.39 to-4.06), and overall clinical response (relative risk (RR): 1.11, 95% CI: 1.08 to 1.15) and, in the profile of adverse drug reactions, the clearing heat and removing dampness medicine showed less adverse reactions than traditional Western medicine (RR: 0.18, 95% CI: 0.10 to 0.32).Conclusions. Through a systemic evaluation of the clinical efficacy of the clearing heat and removing dampness medicine of traditional Chinese medicine and western medicine on gout, the clearing heat and removing dampness medicine and western medicine possessed similar clinical efficacy, but traditional Chinese medicine treatments are superior to western medicine in controlling adverse reactions.


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## Body

## 1. Introduction

With the change of lifestyle and dietary factor, gout has been the global burden [1], mainly because of its high incidence in not only elderly people but also younger people [2]. Gout is a crystal deposition disease which results from local uric acid supersaturation as a consequence of systemic uric acid overload, leading to the formation of monosodium urate (MSU) crystals in the around joints, which caused severe pain and had a strong impact on quality of life. The most common clinical manifestation of gout is recurrent attacks of acute arthritis involving one joint at a time [3]; in some cases, joint injury and renal insufficiency will even occur in patient with gout.In clinical, western medicines including corticosteroids, allopurinol, and NSAIDs are widely used in treating acute attack of gout [4]. But they all possessed various degrees of side-effect such as gastrointestinal tract reaction, tissue and organ damage, and other adverse reactions. In recent years, IL-1R antagonists appeared and was used for the patients who have contraindications to colchicine and nonsteroidal anti-inflammatory drugs and hormones (oral or injection) [5]. However, the mechanism was unclear and the side effect was also not mentioned. Traditional Chinese medicine (TCM) has been used for preventing and treating gout with unique clinical effects since 200AD in China [6]. Clearing heat and removing dampness is a special medical method for treating patients with gout based on the theory of Chinese traditional medicine, which indicated that the pathogenesis of gout disease is closely related to the heat evil and wetness evil attacking [7]. Many randomized controlled trials (RCTs) in clinical published have selected heat and removing dampness method of Traditional Chinese Medicine to treat gout, and most have clearly shown that Traditional Chinese Medicine have achieved positive results in treating gout.Meta-analysis, which is the statistical synthesis of relative literature to develop evidence-based conclusions, is able to systematically evaluate and summarize the consistency of multiple studies on the same topic [8]. To the best of our knowledge, there is no meta-analysis of the treatment of gout with heat and removing dampness method of Traditional Chinese Medicine. We need to have a clearer understanding of the application of heat and removing dampness method of Traditional Chinese Medicine in the treatment of gout and to evaluate its effectiveness of in the treatment of gout. The efficacy and side effect of clearing heat and removing dampness medicine and western medicine in the treatment of gout were compared using meta-analysis method in this study. The results will lay a foundation for the treatment of gout with clearing heat and removing dampness methods.


## 2. Methods

### 2.1. Experimental Design

The clinical designs in all reports selected in this study were clinical randomized controlled trials (RCTs). Based on the intervention method, the trials were divided into experimental and control groups, oral administration of Chinese herbal decoction and disposition with other methods of traditional Chinese medicine were included in the experimental group, while oral administration of western medicine was regarded as the control group. The publication time was restricted to the period from January 2000 to May 2017, and the journals’ languages were restricted in Chinese and English.


### 2.2. Subjects

According to the diagnostic criteria created by the 1977 American College of Rheumatology classification criteria and Guidelines for the diagnosis and treatment of primary gout established by the Chinese Rheumatology Association, etc., all subjects selected in the study were diagnosed with primary gout in the phase of acute arthritis. Subjects with other comorbidities were excluded.


### 2.3. Database Search Strategy

The titles of “Clearing heat and removing dampness” and “hyperuricemia” or “Clearing heat and removing dampness” and “gout” were searched from the databases including PubMed, China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database, Wanfang Data, and China Biology Medicine disc during the period from January 2000 to May 2017.


### 2.4. Data Analysis

Three investigators who participated in the study extracted data from all publications selected in this study. The information of the first author, the year of publication, the number of cases in the experimental group and the control group, the intervention method, the end point evaluation index, and the Jadad score were included. One investigator did the first data extraction, the second investigator reviewed the literatures and confirmed the results afterwards, and the third investigator participated in the discussion when the disagreement occurred and reached a consensus with the other two finally.


### 2.5. Endpoint Indicators

The evaluations of effective and ineffective were reached artificially based on the indicators of measurement data, such as Serum uric acid (SUA), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). And the evaluations of SUA, CRP, and ESR were collected after the period of gout attack. The reducing of blood uric acid, ESR, and CRP and the relieving of the clinical symptoms were regarded as effective. On the contrary, it was ineffective. The respective measurement data of blood uric acid, ESR, and CRP were also regarded as the primary indicators.


### 2.6. Assessment of Methodological Quality

Assessment of methodological quality is based on the validated Jadad scale by two reviewers (XN and CH) and the Jadad scale has three scoring points. The first is if the study was described as randomized, and with detailed descriptions. The second is if the blind method was adopted in the study and with detailed descriptions. And the third is if there was a description of withdrawals and dropouts. A paper reporting could therefore receive a Jadad score from 0 to 7, in which the scores with 1-3 and 4-7 were considered as low and high quality, respectively.


### 2.7. Statistical Methods

The measurement data were evaluated using the mean difference (MD) and 95% confidence interval (CI), or the relative risk (RR) and 95% confidence interval. If the heterogeneity of the study was within the acceptable range (I2≤ 50%), the fixed effect model was used. Otherwise, the random effects model was used. The collected data in clinical research were analyzed by RevMan 5.0 software.


## 2.1. Experimental Design

The clinical designs in all reports selected in this study were clinical randomized controlled trials (RCTs). Based on the intervention method, the trials were divided into experimental and control groups, oral administration of Chinese herbal decoction and disposition with other methods of traditional Chinese medicine were included in the experimental group, while oral administration of western medicine was regarded as the control group. The publication time was restricted to the period from January 2000 to May 2017, and the journals’ languages were restricted in Chinese and English.


## 2.2. Subjects

According to the diagnostic criteria created by the 1977 American College of Rheumatology classification criteria and Guidelines for the diagnosis and treatment of primary gout established by the Chinese Rheumatology Association, etc., all subjects selected in the study were diagnosed with primary gout in the phase of acute arthritis. Subjects with other comorbidities were excluded.


## 2.3. Database Search Strategy

The titles of “Clearing heat and removing dampness” and “hyperuricemia” or “Clearing heat and removing dampness” and “gout” were searched from the databases including PubMed, China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database, Wanfang Data, and China Biology Medicine disc during the period from January 2000 to May 2017.


## 2.4. Data Analysis

Three investigators who participated in the study extracted data from all publications selected in this study. The information of the first author, the year of publication, the number of cases in the experimental group and the control group, the intervention method, the end point evaluation index, and the Jadad score were included. One investigator did the first data extraction, the second investigator reviewed the literatures and confirmed the results afterwards, and the third investigator participated in the discussion when the disagreement occurred and reached a consensus with the other two finally.


## 2.5. Endpoint Indicators

The evaluations of effective and ineffective were reached artificially based on the indicators of measurement data, such as Serum uric acid (SUA), C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR). And the evaluations of SUA, CRP, and ESR were collected after the period of gout attack. The reducing of blood uric acid, ESR, and CRP and the relieving of the clinical symptoms were regarded as effective. On the contrary, it was ineffective. The respective measurement data of blood uric acid, ESR, and CRP were also regarded as the primary indicators.


## 2.6. Assessment of Methodological Quality

Assessment of methodological quality is based on the validated Jadad scale by two reviewers (XN and CH) and the Jadad scale has three scoring points. The first is if the study was described as randomized, and with detailed descriptions. The second is if the blind method was adopted in the study and with detailed descriptions. And the third is if there was a description of withdrawals and dropouts. A paper reporting could therefore receive a Jadad score from 0 to 7, in which the scores with 1-3 and 4-7 were considered as low and high quality, respectively.


## 2.7. Statistical Methods

The measurement data were evaluated using the mean difference (MD) and 95% confidence interval (CI), or the relative risk (RR) and 95% confidence interval. If the heterogeneity of the study was within the acceptable range (I2≤ 50%), the fixed effect model was used. Otherwise, the random effects model was used. The collected data in clinical research were analyzed by RevMan 5.0 software.


## 3. Results

### 3.1. Selection of Studies

971 articles about the treatment of gout using clearing heat and removing dampness medicine of Chinese traditional medicine were retrieved from five electronic databases, in which 442 duplicated publications articles were excluded. Then two reviewers independently screened the full texts of the remaining 529 articles. 109 non-RCT articles, 8 articles based on animal experiments, 88 articles had inconformity to inclusion standard but included the experimental group or the control group, 19 articles without diagnostic criteria, 143 articles about review and experience summary, and 93 articles about other directions. Finally, 69 articles were included in this study [9–77] (Figure 1). The characteristics of these studies were shown in Tables 1 and 2.Table 1
Characteristics of included studies.
Author, year Sample size Age Intervention methods Duration treatment Effective number Jadad scale EG CG EG CG EG CG EG CG EG CG Yan Zhang,2016 27 25 47.04±12.92 47.72±8.69 Qingrelishi side Low purine diet + meloxicam 14 14 25 23 3 Fang Zuo,2001 58 30 N/A N/A BaiHuGuiZhiDecoction+ Simiao  Powder allopurinol 14 14 52 22 1 Yihui Yan,2006 36 36 N/A N/A BiNing Decoction allopurinol 28 28 33 28 1 Xubin Zhao,2014 25 25 N/A N/A Blood-letting puncture and cupping+ Microwave therapy Colchicine+Diclofenac Sodium Sustained Release Capsules 3~7 1~7 25 23 1 Li Cheng,2009 32 30 N/A N/A DanghuiniantongDecoction Meloxicam 7 7 31 29 1 Guicai Sun,2007 65 65 N/A N/A Compound xiqiancao capsule Voltaren+ allopurinol 21 21 58 54 1 Yuhong Zhang,2003 45 43 N/A N/A Modified SanmiaoPowder Colchicine 21 21 39 42 1 Shengyun Wu,2017 34 34 35.9±6.1 35.9±6.1 Simiao Powder+Xinhuang  Tablet(external) Colchicine 14 14 33 18 1 Qingsheng He,2016 50 50 34.5±4.7 32.7±3.2 Modified SimiaoPowder+  Xinhuang  Tablet(external) Colchicine 7 7 49 44 3 Lixin Wang,2001 69 35 N/A N/A Modified Simiao pill Colchicine N/A N/A 67 33 1 Zhonghua Yang,2007 60 30 N/A N/A Jianpi qingrelishiTongluo Decoction Colchicine 15 15 55 27 1 Wenping Cao,2008 44 43 N/A N/A JunHu analgesicpowder(external)+  acupuncture treatment colchicine 3 3 44 38 1 Yanhong Zou,2010 40 40 N/A N/A Lizhuodingtong decoction Nimesulide 10 10 34 32 1 Jincheng Cai,2006 54 46 N/A N/A Niantongxiaofeng prescription colchicine 15 15 52 43 1 Wei Li,2016 58 58 N/A N/A Qingrechushi prescription Etoricoxib Tablets 14 14 N/A N/A 3 Yingxu Wang,2014 33 31 46.97±9.65 41.16±9.72 Discriminate treatment of Chinese medicine by clearing away heat and resolving turbid Diclofenac Sodium Sustained ReleaseTablets+  Benzbromarone  Tablets 31 31 31 27 1 Wei Liu, 2016 36 35 46.73±16.25 47.06±15.82 Compound Chinese medicine decoction of Clearing heat-toxin and eliminating dampness method Diclofenac SodiumSustained Release  Tablets 14 14 30 29 3 Feng Yue,2005 30 30 N/A N/A Clearing heat-toxin and eliminating dampness method+ Gold paste(external) colchicine 7 7 30 30 1 Yanming Ren,2007 60 30 N/A N/A Acid fat clear capsule colchicine 7 7 52 27 1 Huilian Wang,2012 40 40 48.4±12.8 49.1±13.1 Gouty granule Nimesulide 10 10 34 33 1 Wei Jin,2013 32 32 C N/A Self-prepared gout recipe+ Jiawei Jinhuang powder colchicine 7 7 30 24 1 Hong Tu,2015 30 30 44.9±9.1 45.1±8.1 Gout clear granules Diclofenac Sodium Sustained Release Tablets 7 7 29 24 1 Binchu Wang,2000 52 38 N/A N/A Gout decoction Ibuprofen+Probenecid52 10 10 49 33 1 Haifeng Li,2012 73 80 45.6±10.1 47.2±12.4 Xuanbi decoction allopurinol 30 30 67 69 1 Hongtao Yan,2006 20 20 N/A N/A Xuanbi decoction Indomethacin 7 7 18 16 3 Weigang Zeng,2010 55 50 N/A N/A Yushantongfeng decoction 2 allopurinol 7 7 54 32 1 Weigang Zeng,2007 120 116 N/A N/A Yushantongfeng decoction colchicine N/A N/A 118 108 1 Jiang Wu,2015 36 36 51.34±6.28 52.46±7.4 Acupuncture+Sanren decoction and Sijunzi decoction Diclofenac Sodium Sustained Release Tablets 7 7 33 30 1 Jing Chen,2017 61 55 52.1±1.2 51.5±1.4 Chinese medicine and acupuncture Colchicine+allopurinol 7 7 58 47 1 Minghai Zhou,2014 20 20 N/A N/A Simiao powder and acupuncture Ibuprofen Sustained-release Capsules 7 7 19 15 1 Guangheng Cui,2011 60 60 N/A N/A HoveniaacerbalindlTongfeng Decoction Meloxicam 7 7 55 56 1 Yangang Wang,2005 35 35 45.0±6.5 46.0±5.7 Compound decoction of Chinese herbal medicine Colchicine+ allopurinol 7 7 N/A N/A 1 Hai Lu,2013 30 30 N/A N/A Simiao pill and Gouty ointment Allopurinol+ Sodium BicarbonateTablets(oral)+  Qingpeng  Paste(external) 7 7 29 25 2 Bo Duan,2016 54 54 40.26±10.98 42.31±11.77 Oral administration of Chinese medicine decoction+Rebiqing granules(oral)+Chinese medicine(external) Colchicine Tablets 7 7 47 46 2 Guoying Han,2010 42 39 N/A N/A Rabdosia rubescens, coix seed, Poria cocos, Shi Wei, Rhizoma Atractylodis, Cortex Phellodendri, Achyranthes bidentata, rhubarb, Eupatorium adenophorum Allopurino+Celecoxib 31 31 39 29 1 Min Dai,2015 39 39 35±2.5 35±2.5 Atractylodes rhizome, Achyranthes bidentata, Smilax glabra, Cortex Phellodendri, honeysuckle vine, liquorice, 2corydalis tuber, astragalus root and coix seed Diclofenac Sodium Sustained Release Tablets 14 14 36 29 1 Xiaohong He,2008 28 26 42.5±7.7 46±11.8 Simiao powder+Sihuang powder Colchicine 3 3 27 20 1 Xiaoxia Wang,2010 30 30 48.5±15.5 49.1±13.7 Self-made prescription: Mountain arrowhead, clematis, peach, Atractylodes, Poria, Alisma, Adenophora, Polygonum cuspidatum, rice, Bixie Colchicine 10 10 28 29 1 Huijuan Yao,2010 56 54 N/A N/A ModifiedGuizhishaoyaozhimu decoction Colchicine 10 10 51 52 1 Lei Zhang,2016 37 37 44.43±11.29 45.02±12.1 Oral administration of Bixie decoction Diclofenac Sodium Sustained Release Tablets 7 7 33 31 1 Bo Shi,2010 45 40 49±16 48±14 Clearing heat and dmp elimination tongluo+Relieving stasis and pain Colchicine 10 10 38 25 1 Liping Yan,2012 38 31 N/A N/A Clearing heat and dmp elimination prescription Colchicine 7 7 35 23 1 Yulei Wu,2015 38 38 N/A N/A Clearing heat and removing dampness and activating blood circulation method Sodium Bicarbonate Tablets+ Diclofenac Sodium Sustained Release Tablets N/A N/A 38 32 1 Yueqi Wang,2013 32 32 N/A N/A Chinese medicine of Clearing heat and removing dampness and activating blood circulation method Diclofenac acid enteric coated tablets 7 7 30 29 1 Rong Li,2014 75 75 50.24±12.37 49.15±13.06 Bixieshenshi decoction and Taohongsiwu decoction Celecoxib+ Sodium Bicarbonate Tablets 10 10 69 62 1 Shanshan Yu,2008 40 40 48.2±8.6 46±9.7 Dampness detoxification method Nimesulide tablets N/A N/A 38 34 1 Weidong Qian,2007 60 40 N/A N/A Xitong Granule Colchicine 7 7 53 34 1 Zheng Huang,2013 32 30 N/A N/A Qingrelishi TongluoDecoction Nimesulide tablets 10 10 28 27 1 Chongyu Tan,2013 52 46 N/A N/A Self-made Clearing heat and dmp elimination tongluo prescription Colchicine+ Fenbid 7 7 48 34 2 Chun Kang,2012 30 30 70.2±5.3 69.9±6.1 Self-made Clearing heat and dmp elimination tongluo decoction Ibuprofen Sustained-release Capsules+Sodium Bicarbonate Tablets 7 7 28 24 2 Xiaowu Fan,2013 50 48 N/A N/A Clearing heat and dmp elimination tongluo decoction Fenbid 7 7 48 38 2 Jianchong Shen,2014 61 61 45.78±7.45 46.47±8.35 Laoshitongfeng prescription+acupuncture Colchicine+ Sodium Bicarbonate Tablets 7 7 57 49 1 Guiqiong Huang,2016 60 60 53.82±10.95 54.05±12.31 Clearing heat and dmp elimination tongluo prescription Colchicine 7 7 55 38 1 Xin Ouyang,2004 30 30 57.77±6.62 56.37±6.74 Bixiehuadu decoction Butazolidin 14 14 28 25 1 Zhimin Qi,2016 105 105 45.3±9.2 44.1±9.6 Qingrelishi ZhuyuDecoction Colchicine+Dexketoprofen  Trometamol Tablets 7 7 101 93 2 Yaping Chen,2014 45 43 N/A N/A Clearing heat and dredging collaterals to clear turbid decoction Diclofenac Sodium Sustained Release Tablets 14 14 40 37 1 Demei Li,2012 40 40 N/A N/A Clearing heat and dampness, blood stasis, relieving pain Tongluo Decoction; Qingre Tongluo releasing pain prescription Colchicine+ Celecoxib Capsules+ Votalin(external) 7 7 38 34 1 Yanzhi Lin,2009 30 30 53.55±10.67 55.73±11.92 Self-made Sanjin decoction and Sanmiao powder Colchicine+allopurinol 30 30 28 22 2 Dehe Li,2007 40 36 44.3±5.2 43.1±4.5 Shandayanhesimiao decoction Colchicine 14 14 36 26 1 Jun Hao,2014 30 30 46±8.03 45.16±7.97 Gout mixture Colchicine 15 15 29 23 1 Chongqing Yang,2006 30 30 N/A N/A Gout prescription Votalin 7 7 27 28 3 Lin Wang,2011 29 29 N/A N/A Tongbi prescription Diclofenac Sodium Sustained Release Tablets 7 7 26 27 4 Ayijiaman,2012 56 44 44.3±4.3 44.9±3.9 Tanrebi decoction Sodium acetate 14 14 54 37 1 Chifeng Wang,2014 36 36 51.7±3.2 52.1±2.9 Simiao pill Meloxicam N/A N/A 33 30 1 Jianping Luo,2010 30 30 N/A N/A Modified SimiaoPowder Diclofenac Sodium Enteric-coatedTablets+ Colchicine 3 3 N/A N/A 1 Xianzhang Zeng,2013 60 58 N/A N/A Modified SimiaoPowder Colchicine+allopurinol 14 14 58 51 1 Jinjin Jia,2010 28 26 43±10.8 44±11.3 Modified SimiaoPowder Colchicine 14 14 26 23 1 Xiaozhong Yu,2013 32 30 N/A N/A Simiao powder Ibuprofen+ Colchicine 14 14 31 28 1 Jinfeng Li,2013 35 35 N/A N/A Simiaomaqian powder Diclofenac Sodium Sustained Release Tablets 7 7 34 33 1Table 2
Outcome of the meta-analyses for the comparison between clearing heat and removing dampness method of Chinese traditional medicine and western medicine, according to study design.
Author, year Effective number SUA CRP ESR Adverse reactions EG CG EG CG EG CG EG CG EG CG Yan Zhang, 2016 25 23 N/A N/A N/A N/A N/A N/A N/A N/A Fang Zuo, 2001 52 22 N/A N/A N/A N/A N/A N/A N/A N/A Yihui Yan, 2006 33 28 487.27± 98.88/374.88± 95.48 469.26± 114.41/414.52± 102.13 N/A N/A N/A N/A N/A N/A Xubin Zhao, 2014 25 23 N/A N/A N/A N/A N/A N/A N/A N/A Li Cheng, 2009 31 29 N/A N/A N/A N/A N/A N/A 0 9 Guicai Sun, 2007 58 54 568.6±21.2/397.2±36.7 572.5±27.6/385.8±30.2 N/A N/A 59.2±7.4/17.1±4.6 53.7±8.7/15±4.3 N/A N/A Yuhong Zhang, 2003 39 42 N/A N/A N/A N/A N/A N/A N/A N/A Shengyun Wu, 2017 33 18 N/A N/A 35.5±3.5/8.9±1.1 35.7±3.3/10.1±1.2 45.7±9.3/14.6±9.4 46.9±9.1/21.8±9.2 N/A N/A Qingsheng He, 2016 49 44 511±47.77/370±21.56 497±50.12/476±19.57 31.34±9.12/8.04±1.29 29.77±8.9/9.26±2.55 45±11.26/17±6.78 47±12.57/21±5.91 0 5 Lixin Wang, 2001 67 33 N/A N/A N/A N/A N/A N/A 0 32 Zhonghua Yang, 2007 55 27 N/A N/A N/A N/A N/A N/A N/A N/A Wenping Cao, 2008 44 38 N/A N/A N/A N/A N/A N/A N/A N/A Yanhong Zou, 2010 34 32 442.15±60.12/399.76±38.27 438.58±67.45/417.12±41.45 67.12±30.23/33.46±15.23 60.58±29.40 64.12±25.78/34.28±12.21 60.10±23.69/40.79±13.08 N/A N/A Jincheng Cai, 2006 52 43 585±155/458±162 592±142/587±148 N/A N/A N/A N/A N/A N/A Wei Li, 2016 N/A N/A 536.24±54.16/316.49±48.28 529.75±52.67/376.62±35.39 32.94±5.84/13.26±8.49 33.18±5.63/20.17±9.64 24.21±9.64/10.26±5.35 23.68±9.71/14.86±5.47 N/A N/A Yingxu Wang, 2014 31 27 605.21±132/474.63±85.4 601.16±114.2/454.51±92.2 N/A N/A N/A N/A N/A N/A Wei Liu, 2016 30 29 548.25±96.31/394.34±32.69 541.45±48.11/46 N/A N/A N/A N/A N/A N/A Feng Yue, 2005 30 30 N/A N/A N/A N/A N/A N/A N/A N/A Yanming Ren, 2007 52 27 544.36±86.27/341.25±79.34 567.74±91.13/387.32±64.64 N/A N/A 52.61±12.35/28.37±9.36 48.22±11.79/42.72±0.24 N/A N/A Huilian Wang, 2012 34 33 N/A N/A 49.7±11.6/18.5±6.4 47.6±12.6/18.2±5.7 9.0±3.0/3.9±1.2 8.9±2.9/4.0±2.0 N/A 6 Wei Jin, 2013 30 24 N/A N/A N/A N/A N/A N/A N/A N/A Hong Tu, 2015 29 24 N/A N/A 26.28±7.89/5.47±3.01 24.16±6.99/12.12±4.21 39.62±16.51/14.71±8.97 37.74±14.63/24.07±12.61 1 5 Binchu Wang, 2000 49 33 489±23.1/345±20.1 486±21.5/371±19.1 N/A N/A N/A N/A N/A N/A Haifeng Li, 2012 67 69 287.6±56.4 426.1±89.2 N/A N/A 21.1±5.4 38.3±10.0 N/A N/A Hongtao Yan, 2006 18 16 537.85±39.72/425.3±16.24 558.5±31.27/550.8±25.09 N/A N/A 45.30±7.97/40±5.39 44.55±8.11/43.95±5.85 1 8 Weigang Zeng, 2010 54 32 N/A N/A N/A N/A N/A N/A 0 2 Weigang Zeng, 2007 118 108 N/A N/A N/A N/A N/A N/A 0 60 Jiang Wu, 2015 33 30 528.46±78.42/436.14±83.27 521.47±80.12/446.72±67.46 26.24±12.08/10.37±2.58 27.18±11.83/12.43±3.19 40.72±13.06/16.87±2.26 39.24±13.27/24.35±4.03 2 6 Jing Chen, 2017 58 47 542.15±36.79/384.20±47.28 538.76±42.53/437.21±42.13 N/A N/A N/A N/A N/A N/A Minghai Zhou, 2014 19 15 N/A N/A N/A N/A N/A N/A 0 3 Guangheng Cui, 2011 55 56 N/A N/A N/A N/A N/A N/A N/A N/A Yangang Wang, 2005 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A Hai Lu, 2013 29 25 564±80.5/326±20.3 518±75.4/349±34.7 36.1±4.3/14.6±5.6 34.2±6.8/18.4±3.9 65.7±18.5/22.6±7.3 63.4±11.7/29.6±6.9 2 1 Bo Duan, 2016 47 46 673.31±25.26/421.43±58.90 666.42±31.54/432.27±70.11 36.83±9.62/15.42±8.94 34.56±10.11/17.02±7.78 20.52±9.98/8.23±5.83 18.95±10.01/8.99±6.37 19 24 Guoying Han, 2010 39 29 568.6±92.5/412.5±94.7 581.7±102.4/483.4±107.6 N/A N/A N/A N/A N/A N/A Min Dai, 2015 36 29 N/A N/A N/A N/A N/A N/A N/A N/A Xiaohong He, 2008 27 20 508.0±63.6/276.1±23.2v 512.2±57.6/408.3±30.9 N/A N/A 56.5±10.2/17.4±5.7 54.9±11.5/30.6±8.3 N/A N/A Xiaoxia Wang, 2010 28 29 N/A N/A N/A N/A N/A N/A N/A N/A Huijuan Yao, 2010 51 52 N/A N/A N/A N/A N/A N/A N/A N/A Lei Zhang, 2016 33 31 546.69±34.23/393.02±62.69 542.43±43.65/479.81±71.81 N/A N/A 28.59±6.69/17.54±4.74 29.59±5.59/23.22±6.08 0 0 Bo Shi, 2010 38 25 N/A N/A N/A N/A N/A N/A N/A N/A Liping Yan, 2012 35 23 573.4±113.6/369.1±117.2 587.5±109.7/421.8±121.3 N/A N/A N/A N/A N/A N/A Yulei Wu, 2015 38 32 573.7±102.9/428.5±122.5 582.7±112.5/368.4±117.8 N/A N/A N/A N/A N/A N/A Yueqi Wang, 2013 30 29 542.36±54.55/351.12±43.92 534.99±58.81/424.73±56.79 30.90±10.15/6.70±5.11 31.45±10.75/12.65±5.26 28.90±6.53/6.74±3.14 29.45±11.58/7.67±4.11 0 7 Rong Li, 2014 69 62 525.68±114.85/308.30±50.96 537.01±126.46/375.60±61.17 N/A N/A N/A N/A N/A N/A Shanshan Yu, 2008 38 34 552.80±92.76/284.43±58.39 560.48±89.37/363.22±63.21 N/A N/A N/A N/A 1 11 Weidong Qian, 2007 53 34 N/A N/A N/A N/A N/A N/A 1 5 Zheng Huang, 2013 28 27 477.16±97.33/430.65±88.97 465.52±90.13/451.91±89.48 N/A N/A N/A N/A N/A N/A Chongyu Tan, 2013 48 34 568.73±38.29/326.81±38.14 573.77±39.87/371.90±38.39 N/A N/A N/A N/A 4 16 Chun Kang, 2012 28 24 485.65±53.11/303.22±46.35 489.18±52.61/396.43±41.91 N/A N/A N/A N/A 1 9 Xiaowu Fan, 2013 48 38 N/A N/A N/A N/A N/A N/A N/A N/A Jianchong Shen, 2014 57 49 495.99±50.73/312.78±54.03 485.50±47.58/378.07±50.89 N/A N/A N/A N/A 1 5 Guiqiong Huang, 2016 55 38 547.48±50.93/304.28±60.14 546.37±46.65/415.96±51.86 26.17±10.28/5.98±1.45 25.94±9.45/16.05±1.76 35.18±8.82/15.79±4.21 34.95±7.88/23.57±4.52 N/A 17 Xin Ouyang, 2004 28 25 492.54±76.03/287.53±93.04 498.00±83.46/367.53±93.81 N/A N/A 54.65±11.78/23.43±16.71 53.10±10.82/32.03±17.42 0 18 Zhimin Qi, 2016 101 93 515.13±118.04/318.57±76.12 508.67±121.38/392.06±78.39 24.60±7.68/8.82±2.58 23.86±7.44/12.26±2.71 48.91±12.68/17.58±5.22 48.36±12.27/22.14±6.15 4 16 Yaping Chen, 2014 40 37 N/A N/A N/A N/A N/A N/A 15 32 Demei Li, 2012 38 34 496±66.9/266±48.6 498±49.6/562±51.6 35.4±6.5/15.6±5.2 38.5±7.8/21.9±6.1 68.3±15.6/21.5±12.5 64.9±12.6/30.2±7.9 5 16 Yanzhi Lin, 2009 28 22 506.57±119.90/352.41±79.93 548.70±83.98/402.42±85.53 8.15±1.25/4.64±0.97 8.52±1.23/6.32±1.09 32.62±13.82/17.9±5.2 32.40±13.93/26.4±10.87 N/A 17 Dehe Li, 2007 36 26 N/A N/A N/A N/A N/A N/A N/A N/A Jun Hao, 2014 29 23 N/A N/A N/A N/A N/A N/A 0 11 Chongqing Yang, 2006 27 28 487.27±98.87/404.88±95.48 N/A N/A N/A N/A N/A N/A N/A Lin Wang, 2011 26 27 498.33±87.25/491.13±86.89 498.28±128.18/482.23±116.51 29.94±22.06/9.24±5.7 52.46±56.82/18.16±28.10 N/A N/A 0 1 Ayijiaman, 2012 54 37 539.16±34.49/376.3±52.85 552.29±46.15/425.79±48.69 N/A N/A N/A N/A N/A N/A Chifeng Wang, 2014 33 30 482.5±51.3/388.3±50.4 481.5±50.9/420.2±55.9 24.4±3.6/15±2.6 24.34±3.7/16±2.9 26.3±4.3/13.6±7.2 26.2±4.5/15.8±6.8 N/A N/A Jianping Luo, 2010 N/A N/A 545.1±5.1/501.2±5.2 546.9±4.9/518.1±5 N/A N/A N/A N/A N/A N/A Xianzhang Zeng, 2013 58 51 589.35±92.87/317.26±89.23 578.34±95.31/323.44±92.59 N/A N/A N/A N/A N/A N/A Jinjin Jia, 2010 26 23 488.3±78.4/285.75±75.6 490.2±72.5/433.5±77.5 N/A N/A N/A N/A 0 5 Xiaozhong Yu, 2013 31 28 556±23.1/216.12.6 552.±21.8/221±15.2 N/A N/A N/A N/A 1 15 Jinfeng Li, 2013 34 33 468.39±100.28/342.47±90.26 452.28±98.75/437.65±94.57 N/A N/A N/A N/A N/A N/A aEG: experimental group, CG: control group; bSUA: serum uric acid; cCRP: C-reactive protein; dESR: Erythrocyte Sedimentation Rate; eN/A: not applicable.Figure 1
Flow diagram of study selection.


### 3.2. Risk of Bias

All of the selected trials adopted the method of randomization [9–77], which involved sealed envelopes11, randomized block [9, 10, 12, 13, 15, 17–33, 36–38, 40–51, 53–77], and random number table [14, 16, 34, 35, 39, 52]. Therefore, those trials were considered low risks in terms of selection bias. Only one trial involved the method of blinding [36]. These parameters were considered low risk in terms of incomplete outcome data. Detection bias, reporting bias, and other potential biases were unclear in all studies (Figures 2 and 3).Figure 2
Risk of bias summary.Figure 3
Risk of bias graph.


### 3.3. Adverse Reactions

Adverse reactions data were provided from twenty-five RCTs, including 2217 patients (1147 cases in the experimental group and 1070 cases in the control group) [11, 20, 23, 24, 27, 30, 32, 34–36, 38–40, 42, 47, 48, 53–59]. The random model was applied finally because of its heterogenicity withI2 = 68% (Figure 4). The results indicated that the adverse reactions rate of patients taking Chinese herb and (or) receiving other traditional Chinese medicine treatment was lower than that of patients who take western medicine (0.18 times), and the difference was statistically significant (P< 0.00001).Figure 4
An analysis of the adverse reactions caused by clearing heat and removing dampness method and western medicine in the treatment of gout.


### 3.4. Efficacy

The effective rate data were provided from sixty-six RCTs, including 5669 patients (2952 cases in the experimental group and 2717 cases in the control group) [9–13, 15–44, 46–69, 71–77]. The random model was used because of its heterogeneity withI2= 75% (Figure 5). The results indicated that the effective rate of patients who took Chinese herb and (or) treated with other traditional Chinese medicine methods were higher than that of those who used Western Medicine (1.11 times). The difference was statistically significant (P< 0.00001).Figure 5
An analysis of the effective of clearing heat and removing dampness method and western medicine in the treatment of gout.


### 3.5. Serum Uric Acid Concentration (μmol/L)

The serum uric acid concentration data were provided from forty-one RCTs, including 3549 patients (1834 cases in the experimental group and 1715 cases in the control group) [9–49]. The random model was adopted according toI2= 98% (Figure 6). Compared with the patients in the control group who only took western medicine, the level of serum uric acid concentration was reduced by 62.14% in patients who took traditional Chinese herb and (or) treated with other traditional Chinese medicine methods. The results were statistically significant (P< 0.00001).Figure 6
Effects of clearing heat and removing dampness method and western medicine on serum uric acid in the treatment of gout.


### 3.6. C-Reactive Protein (mg/L)

The C-reactive protein data was provided from sixteen RCTs, including 1408 patients (704 cases in the experimental group and 704 cases in the control group) [12, 14, 21, 23, 24, 30, 37–42, 44, 50–52]. A random model was adopted according toI2= 98% (Figure 7). Compared with the patients in the control group who only took western medicine, the level of C-reactive protein was reduced by 4.21% in patients who took traditional Chinese herb and (or) treated with other traditional Chinese medicine methods. They were statistically significant on the difference of two intervention methods to reduce C-reactive protein levels (P<0.0001).Figure 7
Effects of clearing heat and removing dampness method and western medicine on C-reactive protein in the treatment of gout.


### 3.7. Erythrocyte Sedimentation Rate (ESR) (mm/h)

The Erythrocyte sedimentation rate data was provided from twenty-two RCTs, including 1951 patients (988 cases in the experimental group and 963 cases in the control group) [10–12, 14, 17, 19, 20, 23, 24, 26, 27, 30, 37–41, 44, 50–52]. A random model was adopted according toI2 = 95% (Figure 8). Compared with the patients in the control group who only took western medicine, the level of Erythrocyte sedimentation rate was reduced by 6.23% in patients who took traditional Chinese herb and (or) treated with other traditional Chinese medicine methods. There was significant difference between the experimental group and the control group on ESR (P< 0.00001).Figure 8
Effects of clearing heat and removing dampness method and western medicine on ESR in the treatment of gout.


## 3.1. Selection of Studies

971 articles about the treatment of gout using clearing heat and removing dampness medicine of Chinese traditional medicine were retrieved from five electronic databases, in which 442 duplicated publications articles were excluded. Then two reviewers independently screened the full texts of the remaining 529 articles. 109 non-RCT articles, 8 articles based on animal experiments, 88 articles had inconformity to inclusion standard but included the experimental group or the control group, 19 articles without diagnostic criteria, 143 articles about review and experience summary, and 93 articles about other directions. Finally, 69 articles were included in this study [9–77] (Figure 1). The characteristics of these studies were shown in Tables 1 and 2.Table 1
Characteristics of included studies.
Author, year Sample size Age Intervention methods Duration treatment Effective number Jadad scale EG CG EG CG EG CG EG CG EG CG Yan Zhang,2016 27 25 47.04±12.92 47.72±8.69 Qingrelishi side Low purine diet + meloxicam 14 14 25 23 3 Fang Zuo,2001 58 30 N/A N/A BaiHuGuiZhiDecoction+ Simiao  Powder allopurinol 14 14 52 22 1 Yihui Yan,2006 36 36 N/A N/A BiNing Decoction allopurinol 28 28 33 28 1 Xubin Zhao,2014 25 25 N/A N/A Blood-letting puncture and cupping+ Microwave therapy Colchicine+Diclofenac Sodium Sustained Release Capsules 3~7 1~7 25 23 1 Li Cheng,2009 32 30 N/A N/A DanghuiniantongDecoction Meloxicam 7 7 31 29 1 Guicai Sun,2007 65 65 N/A N/A Compound xiqiancao capsule Voltaren+ allopurinol 21 21 58 54 1 Yuhong Zhang,2003 45 43 N/A N/A Modified SanmiaoPowder Colchicine 21 21 39 42 1 Shengyun Wu,2017 34 34 35.9±6.1 35.9±6.1 Simiao Powder+Xinhuang  Tablet(external) Colchicine 14 14 33 18 1 Qingsheng He,2016 50 50 34.5±4.7 32.7±3.2 Modified SimiaoPowder+  Xinhuang  Tablet(external) Colchicine 7 7 49 44 3 Lixin Wang,2001 69 35 N/A N/A Modified Simiao pill Colchicine N/A N/A 67 33 1 Zhonghua Yang,2007 60 30 N/A N/A Jianpi qingrelishiTongluo Decoction Colchicine 15 15 55 27 1 Wenping Cao,2008 44 43 N/A N/A JunHu analgesicpowder(external)+  acupuncture treatment colchicine 3 3 44 38 1 Yanhong Zou,2010 40 40 N/A N/A Lizhuodingtong decoction Nimesulide 10 10 34 32 1 Jincheng Cai,2006 54 46 N/A N/A Niantongxiaofeng prescription colchicine 15 15 52 43 1 Wei Li,2016 58 58 N/A N/A Qingrechushi prescription Etoricoxib Tablets 14 14 N/A N/A 3 Yingxu Wang,2014 33 31 46.97±9.65 41.16±9.72 Discriminate treatment of Chinese medicine by clearing away heat and resolving turbid Diclofenac Sodium Sustained ReleaseTablets+  Benzbromarone  Tablets 31 31 31 27 1 Wei Liu, 2016 36 35 46.73±16.25 47.06±15.82 Compound Chinese medicine decoction of Clearing heat-toxin and eliminating dampness method Diclofenac SodiumSustained Release  Tablets 14 14 30 29 3 Feng Yue,2005 30 30 N/A N/A Clearing heat-toxin and eliminating dampness method+ Gold paste(external) colchicine 7 7 30 30 1 Yanming Ren,2007 60 30 N/A N/A Acid fat clear capsule colchicine 7 7 52 27 1 Huilian Wang,2012 40 40 48.4±12.8 49.1±13.1 Gouty granule Nimesulide 10 10 34 33 1 Wei Jin,2013 32 32 C N/A Self-prepared gout recipe+ Jiawei Jinhuang powder colchicine 7 7 30 24 1 Hong Tu,2015 30 30 44.9±9.1 45.1±8.1 Gout clear granules Diclofenac Sodium Sustained Release Tablets 7 7 29 24 1 Binchu Wang,2000 52 38 N/A N/A Gout decoction Ibuprofen+Probenecid52 10 10 49 33 1 Haifeng Li,2012 73 80 45.6±10.1 47.2±12.4 Xuanbi decoction allopurinol 30 30 67 69 1 Hongtao Yan,2006 20 20 N/A N/A Xuanbi decoction Indomethacin 7 7 18 16 3 Weigang Zeng,2010 55 50 N/A N/A Yushantongfeng decoction 2 allopurinol 7 7 54 32 1 Weigang Zeng,2007 120 116 N/A N/A Yushantongfeng decoction colchicine N/A N/A 118 108 1 Jiang Wu,2015 36 36 51.34±6.28 52.46±7.4 Acupuncture+Sanren decoction and Sijunzi decoction Diclofenac Sodium Sustained Release Tablets 7 7 33 30 1 Jing Chen,2017 61 55 52.1±1.2 51.5±1.4 Chinese medicine and acupuncture Colchicine+allopurinol 7 7 58 47 1 Minghai Zhou,2014 20 20 N/A N/A Simiao powder and acupuncture Ibuprofen Sustained-release Capsules 7 7 19 15 1 Guangheng Cui,2011 60 60 N/A N/A HoveniaacerbalindlTongfeng Decoction Meloxicam 7 7 55 56 1 Yangang Wang,2005 35 35 45.0±6.5 46.0±5.7 Compound decoction of Chinese herbal medicine Colchicine+ allopurinol 7 7 N/A N/A 1 Hai Lu,2013 30 30 N/A N/A Simiao pill and Gouty ointment Allopurinol+ Sodium BicarbonateTablets(oral)+  Qingpeng  Paste(external) 7 7 29 25 2 Bo Duan,2016 54 54 40.26±10.98 42.31±11.77 Oral administration of Chinese medicine decoction+Rebiqing granules(oral)+Chinese medicine(external) Colchicine Tablets 7 7 47 46 2 Guoying Han,2010 42 39 N/A N/A Rabdosia rubescens, coix seed, Poria cocos, Shi Wei, Rhizoma Atractylodis, Cortex Phellodendri, Achyranthes bidentata, rhubarb, Eupatorium adenophorum Allopurino+Celecoxib 31 31 39 29 1 Min Dai,2015 39 39 35±2.5 35±2.5 Atractylodes rhizome, Achyranthes bidentata, Smilax glabra, Cortex Phellodendri, honeysuckle vine, liquorice, 2corydalis tuber, astragalus root and coix seed Diclofenac Sodium Sustained Release Tablets 14 14 36 29 1 Xiaohong He,2008 28 26 42.5±7.7 46±11.8 Simiao powder+Sihuang powder Colchicine 3 3 27 20 1 Xiaoxia Wang,2010 30 30 48.5±15.5 49.1±13.7 Self-made prescription: Mountain arrowhead, clematis, peach, Atractylodes, Poria, Alisma, Adenophora, Polygonum cuspidatum, rice, Bixie Colchicine 10 10 28 29 1 Huijuan Yao,2010 56 54 N/A N/A ModifiedGuizhishaoyaozhimu decoction Colchicine 10 10 51 52 1 Lei Zhang,2016 37 37 44.43±11.29 45.02±12.1 Oral administration of Bixie decoction Diclofenac Sodium Sustained Release Tablets 7 7 33 31 1 Bo Shi,2010 45 40 49±16 48±14 Clearing heat and dmp elimination tongluo+Relieving stasis and pain Colchicine 10 10 38 25 1 Liping Yan,2012 38 31 N/A N/A Clearing heat and dmp elimination prescription Colchicine 7 7 35 23 1 Yulei Wu,2015 38 38 N/A N/A Clearing heat and removing dampness and activating blood circulation method Sodium Bicarbonate Tablets+ Diclofenac Sodium Sustained Release Tablets N/A N/A 38 32 1 Yueqi Wang,2013 32 32 N/A N/A Chinese medicine of Clearing heat and removing dampness and activating blood circulation method Diclofenac acid enteric coated tablets 7 7 30 29 1 Rong Li,2014 75 75 50.24±12.37 49.15±13.06 Bixieshenshi decoction and Taohongsiwu decoction Celecoxib+ Sodium Bicarbonate Tablets 10 10 69 62 1 Shanshan Yu,2008 40 40 48.2±8.6 46±9.7 Dampness detoxification method Nimesulide tablets N/A N/A 38 34 1 Weidong Qian,2007 60 40 N/A N/A Xitong Granule Colchicine 7 7 53 34 1 Zheng Huang,2013 32 30 N/A N/A Qingrelishi TongluoDecoction Nimesulide tablets 10 10 28 27 1 Chongyu Tan,2013 52 46 N/A N/A Self-made Clearing heat and dmp elimination tongluo prescription Colchicine+ Fenbid 7 7 48 34 2 Chun Kang,2012 30 30 70.2±5.3 69.9±6.1 Self-made Clearing heat and dmp elimination tongluo decoction Ibuprofen Sustained-release Capsules+Sodium Bicarbonate Tablets 7 7 28 24 2 Xiaowu Fan,2013 50 48 N/A N/A Clearing heat and dmp elimination tongluo decoction Fenbid 7 7 48 38 2 Jianchong Shen,2014 61 61 45.78±7.45 46.47±8.35 Laoshitongfeng prescription+acupuncture Colchicine+ Sodium Bicarbonate Tablets 7 7 57 49 1 Guiqiong Huang,2016 60 60 53.82±10.95 54.05±12.31 Clearing heat and dmp elimination tongluo prescription Colchicine 7 7 55 38 1 Xin Ouyang,2004 30 30 57.77±6.62 56.37±6.74 Bixiehuadu decoction Butazolidin 14 14 28 25 1 Zhimin Qi,2016 105 105 45.3±9.2 44.1±9.6 Qingrelishi ZhuyuDecoction Colchicine+Dexketoprofen  Trometamol Tablets 7 7 101 93 2 Yaping Chen,2014 45 43 N/A N/A Clearing heat and dredging collaterals to clear turbid decoction Diclofenac Sodium Sustained Release Tablets 14 14 40 37 1 Demei Li,2012 40 40 N/A N/A Clearing heat and dampness, blood stasis, relieving pain Tongluo Decoction; Qingre Tongluo releasing pain prescription Colchicine+ Celecoxib Capsules+ Votalin(external) 7 7 38 34 1 Yanzhi Lin,2009 30 30 53.55±10.67 55.73±11.92 Self-made Sanjin decoction and Sanmiao powder Colchicine+allopurinol 30 30 28 22 2 Dehe Li,2007 40 36 44.3±5.2 43.1±4.5 Shandayanhesimiao decoction Colchicine 14 14 36 26 1 Jun Hao,2014 30 30 46±8.03 45.16±7.97 Gout mixture Colchicine 15 15 29 23 1 Chongqing Yang,2006 30 30 N/A N/A Gout prescription Votalin 7 7 27 28 3 Lin Wang,2011 29 29 N/A N/A Tongbi prescription Diclofenac Sodium Sustained Release Tablets 7 7 26 27 4 Ayijiaman,2012 56 44 44.3±4.3 44.9±3.9 Tanrebi decoction Sodium acetate 14 14 54 37 1 Chifeng Wang,2014 36 36 51.7±3.2 52.1±2.9 Simiao pill Meloxicam N/A N/A 33 30 1 Jianping Luo,2010 30 30 N/A N/A Modified SimiaoPowder Diclofenac Sodium Enteric-coatedTablets+ Colchicine 3 3 N/A N/A 1 Xianzhang Zeng,2013 60 58 N/A N/A Modified SimiaoPowder Colchicine+allopurinol 14 14 58 51 1 Jinjin Jia,2010 28 26 43±10.8 44±11.3 Modified SimiaoPowder Colchicine 14 14 26 23 1 Xiaozhong Yu,2013 32 30 N/A N/A Simiao powder Ibuprofen+ Colchicine 14 14 31 28 1 Jinfeng Li,2013 35 35 N/A N/A Simiaomaqian powder Diclofenac Sodium Sustained Release Tablets 7 7 34 33 1Table 2
Outcome of the meta-analyses for the comparison between clearing heat and removing dampness method of Chinese traditional medicine and western medicine, according to study design.
Author, year Effective number SUA CRP ESR Adverse reactions EG CG EG CG EG CG EG CG EG CG Yan Zhang, 2016 25 23 N/A N/A N/A N/A N/A N/A N/A N/A Fang Zuo, 2001 52 22 N/A N/A N/A N/A N/A N/A N/A N/A Yihui Yan, 2006 33 28 487.27± 98.88/374.88± 95.48 469.26± 114.41/414.52± 102.13 N/A N/A N/A N/A N/A N/A Xubin Zhao, 2014 25 23 N/A N/A N/A N/A N/A N/A N/A N/A Li Cheng, 2009 31 29 N/A N/A N/A N/A N/A N/A 0 9 Guicai Sun, 2007 58 54 568.6±21.2/397.2±36.7 572.5±27.6/385.8±30.2 N/A N/A 59.2±7.4/17.1±4.6 53.7±8.7/15±4.3 N/A N/A Yuhong Zhang, 2003 39 42 N/A N/A N/A N/A N/A N/A N/A N/A Shengyun Wu, 2017 33 18 N/A N/A 35.5±3.5/8.9±1.1 35.7±3.3/10.1±1.2 45.7±9.3/14.6±9.4 46.9±9.1/21.8±9.2 N/A N/A Qingsheng He, 2016 49 44 511±47.77/370±21.56 497±50.12/476±19.57 31.34±9.12/8.04±1.29 29.77±8.9/9.26±2.55 45±11.26/17±6.78 47±12.57/21±5.91 0 5 Lixin Wang, 2001 67 33 N/A N/A N/A N/A N/A N/A 0 32 Zhonghua Yang, 2007 55 27 N/A N/A N/A N/A N/A N/A N/A N/A Wenping Cao, 2008 44 38 N/A N/A N/A N/A N/A N/A N/A N/A Yanhong Zou, 2010 34 32 442.15±60.12/399.76±38.27 438.58±67.45/417.12±41.45 67.12±30.23/33.46±15.23 60.58±29.40 64.12±25.78/34.28±12.21 60.10±23.69/40.79±13.08 N/A N/A Jincheng Cai, 2006 52 43 585±155/458±162 592±142/587±148 N/A N/A N/A N/A N/A N/A Wei Li, 2016 N/A N/A 536.24±54.16/316.49±48.28 529.75±52.67/376.62±35.39 32.94±5.84/13.26±8.49 33.18±5.63/20.17±9.64 24.21±9.64/10.26±5.35 23.68±9.71/14.86±5.47 N/A N/A Yingxu Wang, 2014 31 27 605.21±132/474.63±85.4 601.16±114.2/454.51±92.2 N/A N/A N/A N/A N/A N/A Wei Liu, 2016 30 29 548.25±96.31/394.34±32.69 541.45±48.11/46 N/A N/A N/A N/A N/A N/A Feng Yue, 2005 30 30 N/A N/A N/A N/A N/A N/A N/A N/A Yanming Ren, 2007 52 27 544.36±86.27/341.25±79.34 567.74±91.13/387.32±64.64 N/A N/A 52.61±12.35/28.37±9.36 48.22±11.79/42.72±0.24 N/A N/A Huilian Wang, 2012 34 33 N/A N/A 49.7±11.6/18.5±6.4 47.6±12.6/18.2±5.7 9.0±3.0/3.9±1.2 8.9±2.9/4.0±2.0 N/A 6 Wei Jin, 2013 30 24 N/A N/A N/A N/A N/A N/A N/A N/A Hong Tu, 2015 29 24 N/A N/A 26.28±7.89/5.47±3.01 24.16±6.99/12.12±4.21 39.62±16.51/14.71±8.97 37.74±14.63/24.07±12.61 1 5 Binchu Wang, 2000 49 33 489±23.1/345±20.1 486±21.5/371±19.1 N/A N/A N/A N/A N/A N/A Haifeng Li, 2012 67 69 287.6±56.4 426.1±89.2 N/A N/A 21.1±5.4 38.3±10.0 N/A N/A Hongtao Yan, 2006 18 16 537.85±39.72/425.3±16.24 558.5±31.27/550.8±25.09 N/A N/A 45.30±7.97/40±5.39 44.55±8.11/43.95±5.85 1 8 Weigang Zeng, 2010 54 32 N/A N/A N/A N/A N/A N/A 0 2 Weigang Zeng, 2007 118 108 N/A N/A N/A N/A N/A N/A 0 60 Jiang Wu, 2015 33 30 528.46±78.42/436.14±83.27 521.47±80.12/446.72±67.46 26.24±12.08/10.37±2.58 27.18±11.83/12.43±3.19 40.72±13.06/16.87±2.26 39.24±13.27/24.35±4.03 2 6 Jing Chen, 2017 58 47 542.15±36.79/384.20±47.28 538.76±42.53/437.21±42.13 N/A N/A N/A N/A N/A N/A Minghai Zhou, 2014 19 15 N/A N/A N/A N/A N/A N/A 0 3 Guangheng Cui, 2011 55 56 N/A N/A N/A N/A N/A N/A N/A N/A Yangang Wang, 2005 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A Hai Lu, 2013 29 25 564±80.5/326±20.3 518±75.4/349±34.7 36.1±4.3/14.6±5.6 34.2±6.8/18.4±3.9 65.7±18.5/22.6±7.3 63.4±11.7/29.6±6.9 2 1 Bo Duan, 2016 47 46 673.31±25.26/421.43±58.90 666.42±31.54/432.27±70.11 36.83±9.62/15.42±8.94 34.56±10.11/17.02±7.78 20.52±9.98/8.23±5.83 18.95±10.01/8.99±6.37 19 24 Guoying Han, 2010 39 29 568.6±92.5/412.5±94.7 581.7±102.4/483.4±107.6 N/A N/A N/A N/A N/A N/A Min Dai, 2015 36 29 N/A N/A N/A N/A N/A N/A N/A N/A Xiaohong He, 2008 27 20 508.0±63.6/276.1±23.2v 512.2±57.6/408.3±30.9 N/A N/A 56.5±10.2/17.4±5.7 54.9±11.5/30.6±8.3 N/A N/A Xiaoxia Wang, 2010 28 29 N/A N/A N/A N/A N/A N/A N/A N/A Huijuan Yao, 2010 51 52 N/A N/A N/A N/A N/A N/A N/A N/A Lei Zhang, 2016 33 31 546.69±34.23/393.02±62.69 542.43±43.65/479.81±71.81 N/A N/A 28.59±6.69/17.54±4.74 29.59±5.59/23.22±6.08 0 0 Bo Shi, 2010 38 25 N/A N/A N/A N/A N/A N/A N/A N/A Liping Yan, 2012 35 23 573.4±113.6/369.1±117.2 587.5±109.7/421.8±121.3 N/A N/A N/A N/A N/A N/A Yulei Wu, 2015 38 32 573.7±102.9/428.5±122.5 582.7±112.5/368.4±117.8 N/A N/A N/A N/A N/A N/A Yueqi Wang, 2013 30 29 542.36±54.55/351.12±43.92 534.99±58.81/424.73±56.79 30.90±10.15/6.70±5.11 31.45±10.75/12.65±5.26 28.90±6.53/6.74±3.14 29.45±11.58/7.67±4.11 0 7 Rong Li, 2014 69 62 525.68±114.85/308.30±50.96 537.01±126.46/375.60±61.17 N/A N/A N/A N/A N/A N/A Shanshan Yu, 2008 38 34 552.80±92.76/284.43±58.39 560.48±89.37/363.22±63.21 N/A N/A N/A N/A 1 11 Weidong Qian, 2007 53 34 N/A N/A N/A N/A N/A N/A 1 5 Zheng Huang, 2013 28 27 477.16±97.33/430.65±88.97 465.52±90.13/451.91±89.48 N/A N/A N/A N/A N/A N/A Chongyu Tan, 2013 48 34 568.73±38.29/326.81±38.14 573.77±39.87/371.90±38.39 N/A N/A N/A N/A 4 16 Chun Kang, 2012 28 24 485.65±53.11/303.22±46.35 489.18±52.61/396.43±41.91 N/A N/A N/A N/A 1 9 Xiaowu Fan, 2013 48 38 N/A N/A N/A N/A N/A N/A N/A N/A Jianchong Shen, 2014 57 49 495.99±50.73/312.78±54.03 485.50±47.58/378.07±50.89 N/A N/A N/A N/A 1 5 Guiqiong Huang, 2016 55 38 547.48±50.93/304.28±60.14 546.37±46.65/415.96±51.86 26.17±10.28/5.98±1.45 25.94±9.45/16.05±1.76 35.18±8.82/15.79±4.21 34.95±7.88/23.57±4.52 N/A 17 Xin Ouyang, 2004 28 25 492.54±76.03/287.53±93.04 498.00±83.46/367.53±93.81 N/A N/A 54.65±11.78/23.43±16.71 53.10±10.82/32.03±17.42 0 18 Zhimin Qi, 2016 101 93 515.13±118.04/318.57±76.12 508.67±121.38/392.06±78.39 24.60±7.68/8.82±2.58 23.86±7.44/12.26±2.71 48.91±12.68/17.58±5.22 48.36±12.27/22.14±6.15 4 16 Yaping Chen, 2014 40 37 N/A N/A N/A N/A N/A N/A 15 32 Demei Li, 2012 38 34 496±66.9/266±48.6 498±49.6/562±51.6 35.4±6.5/15.6±5.2 38.5±7.8/21.9±6.1 68.3±15.6/21.5±12.5 64.9±12.6/30.2±7.9 5 16 Yanzhi Lin, 2009 28 22 506.57±119.90/352.41±79.93 548.70±83.98/402.42±85.53 8.15±1.25/4.64±0.97 8.52±1.23/6.32±1.09 32.62±13.82/17.9±5.2 32.40±13.93/26.4±10.87 N/A 17 Dehe Li, 2007 36 26 N/A N/A N/A N/A N/A N/A N/A N/A Jun Hao, 2014 29 23 N/A N/A N/A N/A N/A N/A 0 11 Chongqing Yang, 2006 27 28 487.27±98.87/404.88±95.48 N/A N/A N/A N/A N/A N/A N/A Lin Wang, 2011 26 27 498.33±87.25/491.13±86.89 498.28±128.18/482.23±116.51 29.94±22.06/9.24±5.7 52.46±56.82/18.16±28.10 N/A N/A 0 1 Ayijiaman, 2012 54 37 539.16±34.49/376.3±52.85 552.29±46.15/425.79±48.69 N/A N/A N/A N/A N/A N/A Chifeng Wang, 2014 33 30 482.5±51.3/388.3±50.4 481.5±50.9/420.2±55.9 24.4±3.6/15±2.6 24.34±3.7/16±2.9 26.3±4.3/13.6±7.2 26.2±4.5/15.8±6.8 N/A N/A Jianping Luo, 2010 N/A N/A 545.1±5.1/501.2±5.2 546.9±4.9/518.1±5 N/A N/A N/A N/A N/A N/A Xianzhang Zeng, 2013 58 51 589.35±92.87/317.26±89.23 578.34±95.31/323.44±92.59 N/A N/A N/A N/A N/A N/A Jinjin Jia, 2010 26 23 488.3±78.4/285.75±75.6 490.2±72.5/433.5±77.5 N/A N/A N/A N/A 0 5 Xiaozhong Yu, 2013 31 28 556±23.1/216.12.6 552.±21.8/221±15.2 N/A N/A N/A N/A 1 15 Jinfeng Li, 2013 34 33 468.39±100.28/342.47±90.26 452.28±98.75/437.65±94.57 N/A N/A N/A N/A N/A N/A aEG: experimental group, CG: control group; bSUA: serum uric acid; cCRP: C-reactive protein; dESR: Erythrocyte Sedimentation Rate; eN/A: not applicable.Figure 1
Flow diagram of study selection.


## 3.2. Risk of Bias

All of the selected trials adopted the method of randomization [9–77], which involved sealed envelopes11, randomized block [9, 10, 12, 13, 15, 17–33, 36–38, 40–51, 53–77], and random number table [14, 16, 34, 35, 39, 52]. Therefore, those trials were considered low risks in terms of selection bias. Only one trial involved the method of blinding [36]. These parameters were considered low risk in terms of incomplete outcome data. Detection bias, reporting bias, and other potential biases were unclear in all studies (Figures 2 and 3).Figure 2
Risk of bias summary.Figure 3
Risk of bias graph.


## 3.3. Adverse Reactions

Adverse reactions data were provided from twenty-five RCTs, including 2217 patients (1147 cases in the experimental group and 1070 cases in the control group) [11, 20, 23, 24, 27, 30, 32, 34–36, 38–40, 42, 47, 48, 53–59]. The random model was applied finally because of its heterogenicity withI2 = 68% (Figure 4). The results indicated that the adverse reactions rate of patients taking Chinese herb and (or) receiving other traditional Chinese medicine treatment was lower than that of patients who take western medicine (0.18 times), and the difference was statistically significant (P< 0.00001).Figure 4
An analysis of the adverse reactions caused by clearing heat and removing dampness method and western medicine in the treatment of gout.


## 3.4. Efficacy

The effective rate data were provided from sixty-six RCTs, including 5669 patients (2952 cases in the experimental group and 2717 cases in the control group) [9–13, 15–44, 46–69, 71–77]. The random model was used because of its heterogeneity withI2= 75% (Figure 5). The results indicated that the effective rate of patients who took Chinese herb and (or) treated with other traditional Chinese medicine methods were higher than that of those who used Western Medicine (1.11 times). The difference was statistically significant (P< 0.00001).Figure 5
An analysis of the effective of clearing heat and removing dampness method and western medicine in the treatment of gout.


## 3.5. Serum Uric Acid Concentration (μmol/L)

The serum uric acid concentration data were provided from forty-one RCTs, including 3549 patients (1834 cases in the experimental group and 1715 cases in the control group) [9–49]. The random model was adopted according toI2= 98% (Figure 6). Compared with the patients in the control group who only took western medicine, the level of serum uric acid concentration was reduced by 62.14% in patients who took traditional Chinese herb and (or) treated with other traditional Chinese medicine methods. The results were statistically significant (P< 0.00001).Figure 6
Effects of clearing heat and removing dampness method and western medicine on serum uric acid in the treatment of gout.


## 3.6. C-Reactive Protein (mg/L)

The C-reactive protein data was provided from sixteen RCTs, including 1408 patients (704 cases in the experimental group and 704 cases in the control group) [12, 14, 21, 23, 24, 30, 37–42, 44, 50–52]. A random model was adopted according toI2= 98% (Figure 7). Compared with the patients in the control group who only took western medicine, the level of C-reactive protein was reduced by 4.21% in patients who took traditional Chinese herb and (or) treated with other traditional Chinese medicine methods. They were statistically significant on the difference of two intervention methods to reduce C-reactive protein levels (P<0.0001).Figure 7
Effects of clearing heat and removing dampness method and western medicine on C-reactive protein in the treatment of gout.


## 3.7. Erythrocyte Sedimentation Rate (ESR) (mm/h)

The Erythrocyte sedimentation rate data was provided from twenty-two RCTs, including 1951 patients (988 cases in the experimental group and 963 cases in the control group) [10–12, 14, 17, 19, 20, 23, 24, 26, 27, 30, 37–41, 44, 50–52]. A random model was adopted according toI2 = 95% (Figure 8). Compared with the patients in the control group who only took western medicine, the level of Erythrocyte sedimentation rate was reduced by 6.23% in patients who took traditional Chinese herb and (or) treated with other traditional Chinese medicine methods. There was significant difference between the experimental group and the control group on ESR (P< 0.00001).Figure 8
Effects of clearing heat and removing dampness method and western medicine on ESR in the treatment of gout.


## 4. Discussion

With the continuous improvement of people’s living standard, the change of dietary structure and the influence of environmental factors, the incidence of gout has been gradually increased every year all over the world. Nowadays, the patient with gout could only be alleviated but not cured with existing clinical treatments; thus searching for a better therapeutic method has been appeared to be very important. Our current study analyzed data from 69 RCTs that aimed to assess the therapeutic effect and safety of heat and removing dampness method of Traditional Chinese Medicine for gouty arthritis.In respect of adverse reaction rate, clearing heat and removing dampness method with or without other traditional Chinese medicine therapy are better than western medicine treatment (RR = 0.18). The adverse reactions often occurred during the process of using drugs, such as abdominal pain, diarrhea, vomiting, and inappetence, and even causing damage of liver and kidney in severe cases. Compared with western medicine, clearing heat and removing dampness method was shown to be more effective to the patients with gout, with less adverse reactions mentioned above at the same time, probably due to the synergistic action of multicomponents and multitargets in the traditional Chinese medicine and the integrity of human body. The clearing heat and removing dampness method which is the unique medical method based on Chinese traditional medicine has a good effect to treat patients with gout, mainly because of the pathogenesis of gout disease which is that the meridian is blocked by a pathogenic factor formed by blending of heat and wetness evils [7].According to our results, the clearing heat and removing dampness method of Chinese traditional medicine adjuvant treatment of Chinese medicine such as acupuncture and cupping could effectively reduce uric acid, C-reactive protein, and ESR in patients with gout. Different researchers have chosen different modalities of the clearing heat and removing dampness method of Chinese traditional medicine, such as Si Miao San [29–31], Xuan Bi Fang [38, 39], acupuncture and Chinese medicine combination [41, 59, 76], etc. Among them, the types of Chinese medicine, the dose, and the acupoint selection of acupuncture and acupuncture techniques are inconsistent. Therefore, our results cannot get a clear conclusion, we do not know which treatment method has the best effect on gout and the least adverse reactions.In this study, there are many shortcomings: a lot of randomized controlled trials are not amply descripted in grouping; it is not sufficient to prove that the randomization program is executed correctly. The overall methodological quality is poor, which limits the value of the effect of the clearing heat and removing dampness method of Chinese traditional medicine in the treatment of gout. Therefore, an indepth investigation and further extensive study were need in the future.



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*Source: 8591349-2018-11-13.xml*