scholarly journals Efficacy and Safety of Modified Duhuo Jisheng Decoction in the Treatment of Lumbar Disc Herniation: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Zhencheng Xiong ◽  
Ping Yi ◽  
Liubo Zhang ◽  
Haoning Ma ◽  
Wenhao Li ◽  
...  
Keyword(s):  
Adverse Events ◽  
Western Medicine ◽  
Total Effective Rate ◽  
Lumbar Disc ◽  
Meta Analysis ◽  
Diclofenac Sodium ◽  
Effective Rate ◽  
Efficacy And Safety ◽  
Cure Rate ◽  
Enteric Coated

Objective. Lumbar disc herniation (LDH) is based on the degenerative changes of the intervertebral disc. Many drugs are used to treat and prevent LDH, including Western medicine and Chinese medicine. Duhuo Jisheng Decoction (DHJSD) is one of the most classic Chinese medicine prescriptions. The purpose of our meta-analysis is to evaluate the efficacy and safety of modified DHJSD in the treatment of LDH. Methods. We searched multiple databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI) databases, Wanfang Database, and Chinese Scientific Journal Database (VIP) to identify studies that met the inclusion criteria. This meta-analysis was registered at INPLASY with reference number ID: INPLASY202060053. Results. Fourteen randomized controlled trials (RCTs) were identified, including 1560 patients. This meta-analysis showed that the total effective rate and cure rate of modified DHJSD are higher than those of diclofenac sodium enteric-coated tablets (total effective rate: RR = 1.18, 95% CI: 1.12 to 1.25, P<0.0001, I2 = 0%; cure rate: RR = 1.60, 95% CI: 1.30 to 1.97, P<0.00001, I2 = 2%), diclofenac sodium enteric-coated tablets plus ibuprofen and indomethacin (total effective rate: RR = 1.23, 95% CI: 1.11 to 1.37, P=0.0001, I2 = 0%; cure rate: RR = 1.58, 95% CI: 1.22 to 2.04, P=0.0005, I2 = 0%), and diclofenac sodium sustained-release capsule (total effective rate: RR = 1.49, 95% CI: 1.27 to 1.74, P<0.00001, I2 = 0%; cure rate: RR = 10.07, 95% CI: 3.29 to 30.88, P<0.00001, I2 = 5%). Modified DHJSD was also better than Western medicine (MD = −1.56, 95% CI: −2.42 to −0.70, P=0.0004, I2 = 74%) in terms of visual analogue scale (VAS) scores. Three RCTs showed no adverse events in the modified DHJSD group, but adverse events existed in the Western medicine group. Conclusion. This meta-analysis showed that modified DHJSD had a more favorable effect on the treatment of LDH than Western medicine, and there were no obvious adverse events. More high-quality RCTs are needed to complement existing conclusions.

Acupuncture for Lumbar Disc Herniation: A Systematic Review and Meta-Analysis

2018 ◽  
Vol 36 (2) ◽  
pp. 62-70 ◽  
Author(s):  
Shujie Tang ◽  
Zhuomao Mo ◽  
Renwen Zhang
Keyword(s):  
Lumbar Disc Herniation ◽  
Disc Herniation ◽  
Total Effective Rate ◽  
Lumbar Disc ◽  
Meta Analysis ◽  
Diclofenac Sodium ◽  
Effective Rate ◽  
Lumbar Traction ◽  
Vas Scores ◽  
Better Than

Objective To evaluate evidence for the effectiveness of acupuncture in the treatment of lumbar disc herniation (LDH). Methods Electronic databases were searched to identify randomised controlled trials (RCTs) of acupuncture for LDH. A meta-analysis was conducted using RevMan 5.3 and the evidence level was assessed using GRADE methodology. Results Thirty RCTs involving 3503 participants were included in the study. Meta-analysis showed that acupuncture had a higher total effective rate than lumbar traction (RR=1.1, 95% CI 1.05 to 1.15; p<0.001), ibuprofen (RR=1.24, 95% CI 1.03 to 1.48; p=0.02), diclofenac sodium (RR=1.44, 95% CI 1.24 to 1.67; p<0.001) and meloxicam (RR=1.16, 95% CI 1.03 to 1.31; p=0.01). Acupuncture was also better than lumbar traction (SMD −1.33, 95% CI −1.82 to −0.84; p<0.001) and diclofenac sodium (SMD −1.36, 95% CI −2.59 to −0.13; p=0.03) in terms of visual analogue scale (VAS) scores, and better than lumbar traction (SMD 0.96, 95% CI 0.48 to 1.45; p=0.0001) with respect to Japanese Orthopaedic Association (JOA) scores. In addition, the total effective rate in five individual trials was greater for acupuncture than for mannitol plus dexamethasone and mecobalamin, ibuprofen plus fugui gutong capsule, loxoprofen, mannitol plus dexamethasone and huoxue zhitong decoction, respectively. Additionally, two individual trials showed a superior effect of acupuncture in VAS scores comparedwith ibuprofen or mannitol plus dexamethasone, respectively. Conclusions Acupuncture showed a more favourable effect in the treatment of LDH than lumbar traction, ibuprofen, diclofenac sodium, meloxicam, mannitol plus dexamethasone and mecobalamin, fugui gutong capsule plus ibuprofen, mannitol plus dexamethasone, loxoprofen and huoxue zhitong decoction. However, further rigorously designed, large-scale RCTs are needed to confirm these findings.

scholarly journals Efficacy and Safety of Traditional Chinese Medicine on Nonerosive Reflux Disease: A Meta-Analysis of Randomized Controlled Trials

2018 ◽  
Vol 2018 ◽  
pp. 1-13 ◽  
Author(s):  
Jiao Xiao ◽  
Yunfeng Yang ◽  
Yuanrong Zhu ◽  
Yan Qin ◽  
Yifan Li ◽  
...  
Keyword(s):  
Chinese Medicine ◽  
Western Medicine ◽  
Total Effective Rate ◽  
Therapy Group ◽  
Symptom Relief ◽  
Effective Rate ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Nonerosive Reflux Disease ◽  
Randomized Controlled

Objectives. Traditional Chinese medicine (TCM) therapy for nonerosive reflux disease (NERD) remains controversial. The aim of this study was to evaluate the efficacy and safety of TCM regimens in NERD treatment. Methods. Randomized controlled trials (RCTs) of TCM treatment for NERD through September 31, 2017, were systematically identified in PubMed, Wanfang Data, CNKI, VIP, CBM, Ovid, Web of Science, and Cochrane Library databases. Quality assessment was performed by employing the Cochrane Risk of Bias assessment tool. Results. A total of 725 and 719 patients in 14 RCTs were randomly divided into TCM alone and conventional Western medicine groups, respectively. The clinical total effective rate of the TCM group was markedly higher than that of the single proton pump inhibitors (PPIs) or Prokinetics therapy group (RR = 1.19, 95% CI = 1.07–1.31, and P = 0.0008), while it was comparable to that of the combination of PPIs and Prokinetics therapy group (RR = 1.14, 95% CI = 1.00–1.29, and P = 0.05). Compared with Western medicine group, the TCM group showed improved symptom relief through a reduced RDQ score (SMD = −0.91; 95% CI = −1.68–−0.15; and P = 0.02). Additionally, TCM clearly decreased the recurrence rate (RR = 0.38, 95% CI = 0.28–0.52, and P < 0.00001). Adverse events, such as constipation, sickness, fever, abdominal distension, and stomach noise, were slight for both the TCM and Western medicine groups and disappeared after the easement of pharmacological intervention; in particular, TCM possessed fewer side effects. Conclusion. Compared with PPIs or Prokinetics therapy alone, TCM single therapy can better improve the clinical total effective rate and symptom relief and decrease the recurrence rate and adverse events in the treatment of NERD. Our results suggest that TCM will be a promising alternative therapy for NERD patients in the future.

scholarly journals Efficacy and Safety of Modified Yunu-Jian in Patients with Periodontitis: A Meta-Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Yuanyuan Yue ◽  
Meng Gao ◽  
Yanru Deng ◽  
Jiemin Shao ◽  
Yingguang Sun
Keyword(s):  
Western Medicine ◽  
Combined Therapy ◽  
Meta Analysis ◽  
Effective Rate ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
China National Knowledge Infrastructure ◽  
Knowledge Infrastructure ◽  
Oral Inflammation

Background. Modified Yunu-Jian (mYJ), a Chinese medicine (CM) formula, is thought to clear heat and nourish yin. Clinically, it is often used to treat oral inflammation. However, its efficacy remains controversial. Methods. The study aims to evaluate the efficacy and safety of mYJ for treating patients with periodontitis. We searched electronic databases (PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure, Wanfang database, VIP database, and CBM) from inception to December 2020. Only randomized controlled trials investigating modified Yunu-Jian, with or without other medications, against controlled intervention in the treatment of patients diagnosed with periodontitis were included. Both Review Manager 5.3 and Stata 15.0 software were used to analyze the data. The Cochrane Collaborations risk of bias tool was used to assess the quality of the methods. Results. Thirteen clinical trials, involving 1179 participants, were included in our investigation. The results showed that the combination of mYJ with western medicine improved the total effective rate compared with western medicine alone (RR = 1.17, 95% CI (1.12, 1.23), P  < 0.00001). The sensitivity analysis and Harbord’s test ( P  = 0.255) both showed that the results were statistically robust. Moreover, the periodontal indexes (GI, SBI, PLI, and PD; P  < 0.00001) of patients with periodontitis were also significantly improved after receiving the combined therapy. No serious adverse reactions were observed in the experimental groups. Conclusions. Evidence from the meta-analysis suggested that mYJ appeared to be effective and relatively safe for treating periodontitis. Because of the low quality of the methods used in the included RCTs, further studies with larger sample sizes and well-designed models are required to confirm our findings.

scholarly journals The Effectiveness and Safety of Thunder Fire Moxibustion for Treating Allergic Rhinitis: A PRISMA Compliant Systematic Review and Meta-Analysis

2020 ◽  
Vol 2020 ◽  
pp. 1-13
Author(s):  
Ting Yuan ◽  
Jun Xiong ◽  
Jun Yang ◽  
Xue Wang ◽  
Yunfeng Jiang ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Adverse Events ◽  
Assessment Tool ◽  
Total Effective Rate ◽  
Meta Analysis ◽  
Effective Rate ◽  
Cochrane Library ◽  
Level Of Evidence ◽  
Randomized Controlled ◽  
Significant Difference

Background. Allergic rhinitis (AR) is a noninfectious inflammatory disease caused by allergic individuals exposed to allergens. Western medicine therapy for treating AR causes obvious adverse events, while thunder fire moxibustion (TFM) is known as a safe and effective treatment for AR. Therefore, we conducted this meta-analysis to evaluate the effectiveness and safety of TFM for treating AR. Methods. PubMed, Web of Science, Embase, the Cochrane Library, CNKI, WanFang, VIP, and CBM from inception to April 5, 2020, were searched without any language restriction. Reviewers identified studies, extracted data, and assessed the quality, independently. The primary outcomes were the total effective rate and the TNSS. The secondary outcomes included TNNSS, RQLQ, VAS, serum IgE, IgA, or IgG level, and adverse events. Randomized controlled trials (RCTs) were collected; methodological quality was evaluated using the Cochrane risk of bias assessment tool (RoB), and the level of evidence was rated using the GRADE approach. Meta-analysis was performed using the RevMan5.3.0 software. Results. A total of 18 RCTs were included, including 1600 patients. The results of this meta-analysis showed a statistically significant effect in a total effective rate of T = TFM (RR = 1.07; 95% CI [1.03, 1.12]; P=0.45; I2 = 0%) and T = TFM + other treatments (RR = 1.18; 95% CI [1.11, 1.25]; P=0.03; I2 = 53%). In addition, TFM intervention also showed significant difference in total symptom score (T = TFM + other treatments) (MD = −1.42; 95% CI [−1.55, −1.29]; P=0.03; I2 = 60%) in patients with AR. Conclusion. Existing evidence shows that TFM is safe and effective for AR. Due to the universal low quality of the eligible trials and low evidence level, we should draw our conclusions with caution. Therefore, clinical researchers should carry out more large-sample, multicentre, high-quality randomized controlled clinical trials in the future to verify the clinical efficacy of TFM in treating AR.

scholarly journals Efficacy and Safety of the TCM Qi-Supplementing Therapy in Patients with Myasthenia Gravis: A Systematic Review and Meta-Analysis

2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Xi-qian Yang ◽  
Ling Liu ◽  
Wen-yu Yang ◽  
Huan-huan Dong ◽  
Yi-ran Yang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Myasthenia Gravis ◽  
Relapse Rate ◽  
Response Rate ◽  
Meta Analysis ◽  
Effective Rate ◽  
Efficacy And Safety ◽  
Total Response ◽  
Total Response Rate

Background. The Traditional Chinese Medicine (TCM) Qi-supplementing therapy has been used widely for treating myasthenia gravis (MG) in China. The purpose of this meta-analysis was to evaluate the efficacy and safety of Qi-supplementing therapy as an adjunctive therapy in MG patients. Methods. Seven electronic databases were searched through June 2016. Randomized controlled trials (RCTs) evaluating the add-on effect of Qi-supplementing therapy in MG patients were included. The outcome measures were the total effective rate, relapse rate, and adverse events. Results. Twenty-three RCTs involving 1,691 MG patients were included. The included studies were of low-to-moderate quality. Meta-analysis showed that Qi-supplementing therapy combined with Western medicine (WM) significantly improved the total response rate and reduced the relapse risk during 6–24 months of follow-up. Subgroup analysis showed that Qi-supplementing therapy only affected the total response rate within the first 6 months of treatment. Moreover, the rate of adverse events was lower with the addition of Qi-supplementing therapy to WM than with WM only. Conclusions. Short-term Qi-supplementing therapy combined with WM appears to be superior to WM for improving the total response rate and reducing the relapse rate. However, more high-quality RCTs are warranted owing to methodological flaws of previous trials.

scholarly journals Efficacy of Longdan Xiegan Decoction on the Treatment of Eczema: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-13
Author(s):  
Ziteng Hu ◽  
Lidong Gao ◽  
Chengxian Li ◽  
Alberto Cucco ◽  
Shang Wang ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Total Effective Rate ◽  
Meta Analysis ◽  
Effective Rate ◽  
Biomedical Literature ◽  
Cure Rate ◽  
Quality Of Evidence ◽  
Moderate Quality ◽  
Quality Evidence

Background. Longdan Xiegan decoction (LDXGD) has been widely used in the treatment of eczema. In recent years, randomized controlled trials (RCTs) of LDXGD for the treatment of eczema have gradually increased. Most of the results show that LDXGD is effective in treating eczema. However, whether these conclusions are reliable or not requires meta-analysis. Objective. This study aimed to systematically evaluate the clinical efficacy of LDXGD in the treatment of eczema. Materials and Methods. Seven electronic databases, including PubMed, Excerpta Medica Database (EMBASE), Cochrane Library, Chinese Biomedical Literature on Disc (CBM), China National Knowledge Infrastructure (CNKI), WanFang, and Chinese Science and Technology Periodical Database (VIP) were systematically searched from their inception until January 2021. Risk of bias was assessed using criteria from the Cochrane Collaboration and meta-analysis was conducted on the screened literature data using Review Manage (RevMan 5.3). Then, to assess the quality of evidence, the GRADE criteria was adopted. Results. 14 RCTs with 1080 participants were identified. Meta-analysis indicated that compared with western medicine (WM), the cure rate and the total effective rate of LDXGD in treating eczema were higher. Meanwhile, the recurrence rate and the levels of interleukin-6 (IL-6), interleukin-8 (IL-8), and tumor necrosis factor (TNF-α) after treatment were lower. The adverse reaction was reported in 5 out of 14 studies without significant statistical difference. According to GRADE criteria, the quality of evidence was low for all outcomes except for the cure rate (moderate-quality evidence) and the total effective rate (moderate-quality evidence). Conclusion. The clinical efficacy of LDXGD in the treatment of eczema was more effective compared with the one of conventional WM alone. However, due to the limitation of the quality of the included studies, additional studies are required to further confirm these results.

scholarly journals Efficacy and Safety of Chaihu Jia Longgu Muli Decoction in the Treatment of Poststroke Depression: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 2021 ◽  
pp. 1-13
Author(s):  
Renhong Wan ◽  
Ruiwen Song ◽  
Yihua Fan ◽  
Linhui Li ◽  
Jiangxin Zhang ◽  
...  
Keyword(s):  
Oral Administration ◽  
Barthel Index ◽  
Total Effective Rate ◽  
Meta Analysis ◽  
Effective Rate ◽  
Biomedical Literature ◽  
Current Evidence ◽  
Efficacy And Safety ◽  
Poststroke Depression ◽  
Significant Difference

Objective. Chaihu Jia Longgu Muli decoction (CLMD) is widely used in the treatment of poststroke depression (PSD) in China. Some evidences show that it has advantages, but there lacks reliable evidence. This study aims to systematically evaluate the efficacy and safety of CLMD in the treatment of PSD. Methods. All randomized controlled trials (RCTs) of CLMD in the treatment of PSD were searched from the following databases: PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang Database, VIP Database, and Chinese Biomedical Literature Service System (CBM), from their inception to May 2021. Two researchers independently screened the literature, extracted the data, and evaluated the risk of bias in the included studies. Meta-analysis was performed using RevMan5.3 software. Results. A total of 13 RCTs involving 1665 patients were finally included in this study, among which 5 RCTs were oral CLMD alone versus antidepressants, and 8 RCTs were oral CLMD with antidepressants versus antidepressants. Meta-analysis results showed that oral administration of CLMD could improve Hamilton’s Depression Scale (HAMD) and the Modified Edinburgh-Scandinavian Stroke Scale (MESSS) scores, improve the Barthel index, and have a low rate of adverse reactions, but there was no significant difference in the total effective rate ( p = 0.21 > 0.05) and the National Institute of Health Stroke Scale (NIHSS) score ( p = 0.47 > 0.05) between the antidepressants group and the oral administration of the CLMD group. Oral CLMD combined with antidepressants could improve the total effective rate, HAMD, and MESSS score, but there was no significant difference in Barthel index ( p = 0.06 > 0.05) and the adverse reaction rate ( p = 0.14 > 0.05) between the two groups. Conclusion. Current evidence suggests that oral CLMD alone or with antidepressants is more effective and safer in the treatment of PSD than oral antidepressants. Due to the limitation of the quality and quantity of the included studies, more high-quality studies are needed to confirm the above conclusion.

scholarly journals Clinical Efficacy and Safety of Shensong Yangxin Capsule-Amiodarone Combination on Heart Failure Complicated by Ventricular Arrhythmia: A Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 12 ◽  
Author(s):  
Xinfu Cao ◽  
Mingxue Zhou ◽  
Hongxu Liu ◽  
Xiufen Chen ◽  
Xiang Li ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ventricular Arrhythmia ◽  
Methodological Quality ◽  
Total Effective Rate ◽  
Meta Analysis ◽  
Effective Rate ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled

Background: Shensong Yangxin capsule (SSYX) is a well-known traditional Chinese patent medicine for treating arrhythmia. Recently, a flurry of randomized controlled trials (RCTs) of SSYX combined with amiodarone (SSYX-amiodarone) was reported in the treatment of heart failure (HF) complicated by ventricular arrhythmia (VA) in China. However, these RCTs have not been systematically evaluated. Therefore, this study aimed to evaluate the efficacy and safety of SSYX-amiodarone in the treatment of heart failure complicated by ventricular arrhythmia (HF-VA).Methods: Seven electronic literature databases (the Cochrane Library, PubMed, EMBASE, China Biomedical database web, China National Knowledge Infrastructure Databases, Chinese Scientific Journal database and Wanfang database) were searched from their inceptions to June 1, 2020 to identify RCTs of SSYX-amiodarone in the treatment of HF-VA. The primary outcomes included the total effective rate and adverse events (ADRs). The secondary outcomes included the frequency of ventricular premature complexes, left ventricular ejection fraction, N terminal pro Btype natriuretic peptide (NT-proBNP), and QT dispersion (QTd). The quality of the included RCTs was assessed using the Cochrane risk-of-bias tool. All data was analyzed using RevMan 5.3 software. The registration number of this protocol is PROSPERO CRD42020196689.Results: There are Eighteen trials involving 1,697 patients were included in this study. Meta-analysis showed that SSYX-amiodarone group was superior to the amiodarone group in improving the total effective rate [RR = 1.21; 95%CI (1.16, 1.27); p &lt; 0.01], meanwhile reducing the ADRs [RR = 0.65; 95%CI (0.45, 0.95); p = 0.03], VPCs [MD = 170.96; 95%CI (159.88, 182.04); p &lt; 0.01] and QTd [MD = 8.39; 95%CI (6.91, 9.87); p &lt; 0.01]. No significant difference of enhancing LVEF [MD = 4.32; 95%CI (−0.56, 9.20); p = 0.08] and reducing NT-proBNP [SMD = 0.17; 95%CI (−0.81, 1.14); p = 0.73] was observed between SSYX-amiodarone and amiodarone group.Conclusions: Despite the apparent positive findings reported, the evidence provided by this meta-analysis was still insufficient to support the routine use of SSYX-amiodarone for HF-VA due to the poor methodological quality of included studies. The overall effect should to be verified in further through more well-design clinical studies with reasonable sample and good methodological quality.

scholarly journals Clinical Effects and Safety of Zhi Sou San for Cough: A Meta-Analysis of Randomized Trials

2017 ◽  
Vol 2017 ◽  
pp. 1-11 ◽  
Author(s):  
Ningchang Cheng ◽  
Jia Zhu ◽  
Pinpin Ding
Keyword(s):  
Western Medicine ◽  
Total Effective Rate ◽  
Meta Analysis ◽  
Effective Rate ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Clinical Effects ◽  
Knowledge Infrastructure ◽  
Relative Safety ◽  
Central Register

Introduction. Zhi Sou San (ZSS), a traditional Chinese prescription, has been widely applied in treating cough. The purpose of this meta-analysis was to evaluate the effectiveness and safety of ZSS for cough. Methods. We searched relevant articles up to 5 March 2017 in seven electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PubMed, Chinese National Knowledge Infrastructure (CNKI), Cqvip Database (VIP), China Biology Medicine disc (CBM), and Wanfang Data. Randomized controlled trials (RCTs) were eligible, regardless of blinding. The primary outcome was the total effective rate. Results. Forty-six RCTs with a total of 4007 participants were identified. Compared with western medicine, ZSS significantly improved the total effective rate (OR: 4.45; 95% CI: 3.62–5.47) and the pulmonary function in terms of FEV1 (OR: 0.35; 95% CI: 0.24–0.46) and decreased the adverse reactions (OR: 0.05; 95% CI: 0.02–0.01) and the recurrence rate (OR: 0.30; 95% CI: 0.16–0.57). However, there was no significant improvement in the cough symptom score comparing ZSS with western medicine. Conclusions. This meta-analysis shows that ZSS has significant additional benefits and relative safety in treating cough. However, more rigorously designed investigations and studies, with large sample sizes, are needed because of the methodological flaws and low quality of the included trials in this meta-analysis.

scholarly journals Tian Wang Bu Xin Dan for Insomnia: A Systematic Review of Efficacy and Safety

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Xi-qian Yang ◽  
Ling Liu ◽  
Shu-ping Ming ◽  
Jie Fang ◽  
Dong-nan Wu
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Western Medicine ◽  
Random Sequence ◽  
Meta Analysis ◽  
Safety Information ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Efficacy And Safety ◽  
Insomnia Treatment

Background. The Traditional Chinese Medicine (TCM) Tian Wang Bu Xin Dan (TWBXD) has been used widely for treating insomnia in China. The purpose of this meta-analysis was to evaluate the efficacy and safety of TWBXD in the treatment of insomnia. Objective. This study evaluated the efficacy and safety of TWBXD for insomnia. Methods. We searched seven main databases including PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Chinese Biomedicine Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals Database (VIP), and Wan-fang. We identified randomized-controlled trials (RCTs) for insomnia treatment involving TWBXD, TWBXD combined with conventional Western medicine, and conventional Western medicine from their inception to May 2018. The quality of literature was evaluated by Cochrane assessing tool to reduce the risk of bias. Meta-analysis and heterogeneity of results across the trials were performed. RevMan 5.3 was used to synthesize the results. Results. 14 studies involving 1,256 participants were identified in this systematic review. Methodological deficiencies existed in most of the included trials. Few studies described the generation of a random sequence in detail, the concealment of allocation, and the methods of blinding. No placebo was used in treatment. 12 trials compared TWBXD with conventional Western medicine and 2 trials compared TWBXD combined with conventional Western medicine. The results of our meta-analysis showed relative benefits in effective rates in favor of TWBXD (Odds Ratio [OR] 2.71, 95% confidence interval [CI] 1.67 to 4.39, P < 0.00001) and TWBXD combined with conventional Western medicine (OR 5.05, 95% CI 1.58 to 16.12, P=0.006). The Pittsburgh Sleep Quality Index (PSQI) scores showed similar results, which favored TWBXD (Weighted Mean Difference [WMD] -1.82, 95% CI -3.00 to -0.64, P=0.003). Only 5 trials reported adverse events, whereas the other 9 trials did not provide the safety information. Conclusion. This review demonstrates that although the effects of TWBXD on insomnia were promising, they need to be interpreted with caution, due to the poor methodological quality and the small number of trials of the included studies. TWBXD seems to be generally safe, but there is insufficient evidence to make conclusions on the safety because fewer studies reported the adverse events. Further studies on a larger scale with more rigorous designs are required to evaluate the role of TWBXD in the insomnia treatment.

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