Review
A meta-analysis of randomized controlled trials of Yiyiren Decoction in the treatment
of rheumatoid arthritis
Hai-Yu Wang1, Chen-Hui Song1, Fang-Kai Li2, Xiao-Ping Liu 2, Wei Zhen1, Yu-Ting Zhang1, Y ue-Lan Zhu2, Xiu-Juan Hou2*
1Beijing University of Chinese Medicine, Beijing, China. 2Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.
*Correspondence to:Xiu-Juan Hou, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China. E-mail: houxiujuan2008 @ 163.
Highlights
The article systematically evaluated the efficacy and safety of Yiyiren Decoction combined with western medicine and western medicine alone in the treatment of rheumatoid arthritis. The results of this meta-analysis showed that Yiyiren Decoction combined with western medicine had certain advantages over the clinical symptoms and laboratory indicators of rheumatoid arthritis.
Citation:Wang HY, Song CH, Li FK, et al. A meta-analysis of randomized controlled trials of Yiyiren Decoction in the treatment of rheumatoid arthritis. TMR Modern Herbal Medicine, 2018, 1(2): 102-110.
DOI: 10.12032/TMRmhm2018B08
Submitted: 30 October 2017, Accepted: 9 January 2018, Online: 25 March 2018.
Abstract
Objective: To systematically evaluate the efficacy and safety of Yiyiren Decoction combined with western medicine and western medicine alone in the treatment of rheumatoid arthritis. Methods: Databases of CNKI, VIP, Wanfang Data, PubMed, Medline, Cochrane Library, and Embase were retrieved by computers. The references of the included studies, relevant dissertations, and conference proceedings were manually retrieved. The search intervals were from the database inception until July 2017. The retrieval and screening of studies were carried out respectively by 2 researchers, and the quality and data were evaluated and extracted according to Jadad quality scale. Meta-analysis was performed with RevMan5.3 software. Results: (1) A total of 7 randomized controlled trials and 485 patients were enrolled, among which 262 cases were in experimental group and 223 cases were in control group. The point of 2 studies was 3, other studies were 1-2. The studies included indicated that
the group baselines were comparable. (2)The total effective rate of Yiyiren Decoction with western medicine group was higher than that of western medicine group (RR = 0.85, 95%CI [0.78, 0.92]. Improved Conditions of tender joint count (MD = -2.79, 95%CI [-3.47, -2.12]); erythrocyte sedimentation rate (MD = -9.5, 95%CI [15.67, -3.33]); and C-reactive protein (MD = -3.36, 95%CI [-5.45, -1.27]) were superior to control group. There was no significant difference on the side effects of drugs and the rheumatoid factor between the two groups. Conclusion: Yiyiren Decoction with western medicine had advantages in alleviating clinical symptoms and laboratory index of rheumatoid arthritis patients. While, the quality of included studies was low and possible publication bias was present, further multi-center double-blind randomized control trials with larger sample are needed.
Keywords: Rheumatoid arthritis, Yiyiren Decoction, Meta-analysis
摘要
目的：系统评价薏苡仁汤联合西药与西药类风湿关节炎的有效性和安全性。
方法：计算机检索中国期刊全文数据库、维普期刊资源整合平台、万方数据库、PubMed、Medline、
Cochrane library、Embase数据库；并手工检索纳入文献的参考文献，相关学位论文和会议论文集。
检索时间为建库至2017年7月。由2名研究人员分别独立的进行文献的检索和筛选工作，各自独立
依据Jadad评分量表对纳入的研究进行质量评价和数据的提取工作，用RevMan5.3软件进行meta分
析。
结果：①共纳入7篇RCT，485例患者，其中试验组262例，对照组223例。3分的文献2篇，其余
文献均为1～2分。纳入的研究均明确指出组间基线具有可比性。②薏苡仁汤联合西药组总有效率高
于单纯西药组（RR = 0.85，95%CI [0.78，0.92]）；关节压痛个数（MD = -2.79，95%CI [-3.47，-2.12]）、
红细胞沉降率（MD = -9.5，95%CI [15.67，-3.33]）、C反应蛋白（MD = -3.36，95%CI [-5.45，-1.27]）
改善情况均优于对照组。药物的不良反应及类风湿因子方面两组差异无统计学意义。
结论：薏苡仁汤联合西药较单纯西药对类风湿关节炎患者的临床症状及实验室指标的改善上有一定
优势，由于受纳入研究质量限制和可能存在的发表偏倚影响，尚需要大样本、多中心、随机双盲对
照试验进一步证实。
关键词：类风湿关节炎；薏苡仁汤；meta分析
Abbreviation:RA, Rheumatoid arthritis; RCTs, Randomized controlled trials; ESR, Erythrocyte sedimentation rate; CRP, C-reactive protein; MD, Mean difference; SMD, Standard mean difference; RR, Relative risk; OR, Odds ratio; RF, Rheumatoid factor; CI, confidence interval.
Competing interests: The authors declare that there is no conflict of interests regarding the publication of this paper. Copyright: ©2018 TMR Publishing Group Limited. This is an open access article distributed under the terms of the Creative Commons Attribution Non Commercial license.
Executive Editor: Zi-Qi Jin.
Background
Rheumatoid arthritis (RA) is one of the most common inflammatory arthritis [1], the longer sick period, the higher the disability rate, which often brings an economist burden and mental stress to the patients and families. Therefore, it will have great significance to choose the realizable and effective treatment for patients with RA to improve the quality of life, and reduce economic as well as psychological burde
n. The disease has no way to cure currently, and non-steroidal anti-inflammatory drugs, diseases modifying anti-rheumatic drugs, glucocorticoids, biological agents and other commonly used clinical drugs will cause varying degrees of adverse reactions [2], thus affecting the long-term treatment of this disease. Chinese medicine has a better advantage in the treatment of the disease. Yiyiren Decoction from the Leizhengzhicai is a classic prescription in the treatment of RA induced by cold and dampness. At present, a number of studies have proved the effectiveness and safety of Yiyiren Decoction combined with western medicine in the treatment of RA [3]. Due to the small sample size, the clinical significance of guiding the clinical treatment is limited. In this study, the meta-analysis method was used to evaluate the efficacy and safety of Yiyiren Decoction combined with western medicine in the treatment of RA, and to provide some evidence for clinical diagnosis and treatment. Materials and methods
Inclusion and exclusion criteria
Study type. Randomized controlled trials (RCTs) published at home and abroad and language limited to Chinese and English.
Subjects of study.All included cases were in line with the diagnostic criteria for RA established in the U
nited States in 1987. Chinese medical syndrome, age, and gender were not limited. Exclusion criteria: (1) Pregnant and lactating women. (2) People who were allergic to drugs. (3) Patients with severe liver and kidney function and hematopoietic system damage. (4) People with mental abnormalities. (5) Literature without the full text. Intervention measures.Patients in experimental group were given Yiyiren Decoction combined with western medicine treatment. The control group was treated with western medicine alone. The western medicine used in two groups was exactly the same. Different western medicine or combined with other traditional Chinese medicine preparations and massage therapy were excluded.
Outcome indicators.The effective indicators: total effective rate; clinical quantitative indicators: morning stiffness time, tender joint count. The main laboratory indicators: erythrocyte sedimentation rate (ESR), C-reactive protein (CRP). Adverse reactions: blood toxicity, gastrointestinal reactions, liver and kidney injury, etc.
Search strategy
To retrieve literature published at home and abroad. The database of CNKI, VIP, Wanfang, PubMed, Medline, Cochrane library, and Embase were searched from database inception until 2017 July. At the
same time, references of the literature were also retrieved. Search terms were used:#1 yiyirenDecoction, #2 Rheumatoid Arthritis (RA), #3 “randomized controlled trials” OR “random” OR “control” OR “trials”, #4 #1 and #2 and #3. Screening the data included
Two researchers independently completed the literature screening and data extraction. In case of disagreements, they discussed to come to an agreement. By reading the title and abstract of literature, the literature not meeting the inclusion criteria were initially screened. For the literature which may meet the inclusion criteria, it is needed to read the full text to decide whether or not to be included. If the opinion is inconsistent, it will be determined by the experienced third party in the team. Data Extraction and Quality Assessment
The quality of included studies was evaluated by the revised Jadad quality scale [4] (low quality: 1-3 points, high quality: 4-7 points). Evaluation content: (1) the generation of random sequences; (2) allocation of hidden;
(3) blind method; (4) quit/lost to follow-up. The methodological quality evaluation was performed by two reviewers independently. In case of disagreement, the third party would discuss and resolve it.
Statistical methods
Meta-analysis of the extracted outcome was performed using the Rev Man 5.3 software provided by the Cochrane Collaboration Network. Continuous variable was represented as mean difference (MD), the standard mean difference (SMD) was used when the measurement scale of the outcome indicator is different; the relative risk (RR) or odds ratio (OR) was used for the dichotomous data, with 95% confidence interval (CI). I2 < 50% suggested there was no statistical heterogeneity among the studies, and fixed effect model was adopted; and I2 > 50% suggested the heterogeneity existed in the study, and random effects model was adopted; P< 0.05 was considered statistically significant.
Results
Characteristics of included studies
We screened 54 literature initially and 7 literature were included eventually [5-11]. The flowchart of literature screening process was shown in Figure 1, and the characteristics of the literature were shown in Table 1.
Figure 1 Flow chart of literature screening
Table 1 Characteristics of inclusion literatures
First author and year of publication Sample size Gender: (Male /Female) Average age (years)  Interventions Course of treat- ment Outcome indicator Test group Control group Test group Control group Test group Control group Test group Control
group
J in SC, 2016 39 38 / / / / Yiyiren
Decoction +①+②+⑥ ①+②+⑥ Two
months
A
Liu L, 2015 40 40 21/19 20/20 48.4 ± 4.2 48.3 ± 4.6 Yiyiren Decoction +①+③+④
①+③+④ Three
months
C
Li XL, 2014 41 41 15/26 13/28 42.4 + 6.9 41.9 ±
6.8
Yiyiren Decoction +①+⑤ ①+⑤ Twenty
four weeks ABCD
Liang JM, 2012 25 25 7/18 6/19 40.71 ± 8.58 42.83 ± 7.63 Yiyiren
Decoction +①+②+⑥
①+② One
year
ABCD
Jin J, 2008 35 35 13/22 11/24 54.66 ± 15.92 50.69 ± 14.55 Yiyiren
Decoction +③
③ Two
weeks
AC
Tao JT, 2017 50 50 / / / / Yiyiren
Decoction +③ ③ One
month
AC
Yu M, 2014 32 32 12/20 11/21 38.2 ± 6.8 38.5 ± 7.2 Yiyiren
Decoction +①+③+④
①+③+④ Twelve
weeks
ACD
reactive materials studiesNote ：①Methotrexate ②Leflunomide ③Diclofenac sodium enteric -coated capsules ④Sulfasalazine tablets ⑤Thalidomide ⑥Folic acid
The main outcome indicators: A: total effective rate; B: adverse reactions: blood toxicity, gastrointestinal reactions, liver and kidney damage; C: main clinical quantitative indicators: morning stiffness time, the number of joint swelling, joint tender count; D: main experimental indicators: erythrocyte sedimentation rate, C -reaction protein, rheumatoid factor.
Pubmed, Cochrane library, Embase, Medline, Wanfang, VIP, and CNKI were retrieved and 54 literature were enrolled. English: 0. Chinese: 54.
8 repetitive literature were excluded.
46 literature were remained.
33 literature about animal experiments, non -RCT, treatment experience, treatment of non -RA disease and the test group contains other prescription or external treatment of traditional Chinese medicine were excluded.
13 literature were remained.
6 literature which had incomplete data or the outcome indicators did not meet the included standard were excluded.
7 literature were eligible.
Quality evaluation results
In this study, a total of 7 Chinese literature were included. The quality evaluation of all the literature was performed according to the Jadad quality scale. Among them, there were 2 literature with 3 points [7-8], and the remaining literature were 1-2 points [5-6, 9-11]. All of the included literature referred to randomization, of which four studies had shown the method of randomization [5, 7-8, 10]. None of the seven studies referred to allocation concealment and blind method. Seven studies were randomized and indicated that the baseline between groups was comparable, without uncompleted report outcome, and selective report outcome. Specific design methods and quality evaluation were shown in Table 2.
Table 2 Methodological evaluation of studies included
Studies included The generation of random
sequences Allocation
concealment
Blind
method
Lost to
follow up
or quit
Baseline
Jadad
score
(points)
Jin SC 2016
The odd and even number at the
end of the medical record number
Not clear
Not
mentioned
None Consistent
1
Liu L 2015 Random was mentioned without
specific method.
Not clear
Not
mentioned
None Consistent
2
Li XL 2014 Random number table method Not clear
Not
mentioned
None Consistent
3
Yu M 2014 Random number table method Not clear
Not
mentioned
None Consistent
3
Liang JM 2012 Random was mentioned without
specific method.
Not clear
Not
mentioned
None Consistent
2
Jin J 2008 According to the order of treatment Not clear
Not
mentioned
None Consistent
1
Tao JT 2017 Random was mentioned without
specific method.
Not clear
Not
mentioned
None Consistent
2
Meta-analysis of the results
Effective rate. Six studies including 405 patients were reported total effective rate [5, 7-11]. There was no heterogeneity among the studies (P = 0.91, I2 = 0), and a fixed effect model was selected (Figure 2). Results of meta-analysis showed that the total effective rate of the experimental group was significantly higher than that of control group, the difference was statistically significant (RR = 0.85, 95%CI [0.78, 0.92], P < 0.001).
Figure 2 Meta-analysis forest map of two groups of total effective rate
Meta-analysis forest map of CRP in both groups. CRP was reported in 3 literature [7-9]. Meta-analysis showed that the experimental group was superior to the control group in the aspect of CRP, and the difference was statistically significant. (MD = -3.36, 95%CI [-5.45, -1.27], P = 0.202) (Figure 3).

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