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Safety and efficacy of Chinese herbal bath for psoriasis vulgaris: A protocol for systematic review and meta-analysis.

ABSTRACT: BACKGROUND:Psoriasis is a common, chronic, and recurrent skin inflammatory disease, with psoriasis vulgaris considered as the most prevalent type of psoriasis. Chinese herbal bath, a type of traditional Chinese medicine, is an external therapy widely used to treat psoriasis vulgaris in China, and it has achieved satisfactory clinical effects. However, there are few studies evaluating the safety and efficacy of Chinese herbal bath compared with other external therapies administered under similar conditions. The purpose of this study is to comprehensively evaluate the clinical safety and efficacy of Chinese herbal bath in the treatment of psoriasis vulgaris through a systematic evaluation of the literature, so as to provide a reference basis for future clinical applications. METHODS:PubMed, Embase, CENTRAL, the Web of Science, the China Biology Medicine Database (CBM), the China National Knowledge Database (CNKI), the Wan Fang Database, and the Chong Qing VIP Database will be searched to collect randomized controlled trials of Chinese herbal bath used to treat psoriasis vulgaris. The search time limits will be from the establishment of the database to December 2019. Two researchers will independently screen the studies, extract data, and evaluate the risk of bias of the studies. Meta-analysis will be carried out with the RevMan5.3 software. The mean difference will be used as the effect index for the measurement data, and the odds ratio will be used as the effect index for the enumeration data. The 95% confidence interval will be provided for each effect. Heterogeneity among the results of each study will be evaluated by the Chi-square test. RESULTS:This study will comprehensively evaluate the clinical safety and efficacy of Chinese herbal bath in the treatment of psoriasis vulgaris, so as to provide a reference basis for future clinical applications. CONCLUSION:This study will provide a theoretical basis for the standardized administration of Chinese herbal bath. OSF REGISTRATION NUMBER:: doi: 10.17605/OSF.IO/4HRPJ.

SUBMITTER: Lin W

PROVIDER: S-EPMC7249964 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Safety and efficacy of Chinese herbal bath for psoriasis vulgaris: A protocol for systematic review and meta-analysis.

Lin Wenxia W Yu Qianying Q Qin Yuesi Y Xiao Jianhua J Peng Li L Zhang Jie J He Jia J Xiang Haoyu H Xiao Min M Chen Mingling M

Medicine 20200501 21

<h4>Background</h4>Psoriasis is a common, chronic, and recurrent skin inflammatory disease, with psoriasis vulgaris considered as the most prevalent type of psoriasis. Chinese herbal bath, a type of traditional Chinese medicine, is an external therapy widely used to treat psoriasis vulgaris in China, and it has achieved satisfactory clinical effects. However, there are few studies evaluating the safety and efficacy of Chinese herbal bath compared with other external therapies administered under ...[more]

PMID: 32481354

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Project description:INTRODUCTION:Psoriasis vulgaris is a common skin disease that is characterised by persistent localised erythematous scaly plaques. Yinxieling is a Chinese herbal formula for psoriasis that has been used for more than 20 years in China. To facilitate application, PSORI-CM01 was developed based on the optimisation and simplification of Yinxieling tablets performed in a previous study and in clinical practice. However, the scientific evidence regarding whether PSORI-CM01 is more effective for psoriasis than the original Yinxieling remains insufficient. Therefore, we designed a randomised clinical trial to investigate the effect, safety and cost-effectiveness of PSORI-CM01 granules compared with those of Yinxieling tablets for the treatment of patients with psoriasis. METHODS AND ANALYSIS:This ongoing study is a two-arm parallel, randomised, double-blind, double-dummy clinical trial. Five hundred and fifty-six participants with psoriasis will be recruited and then randomly allocated into two groups in a 1:1 ratio. Participants in PSORI-CM01 group will receive a 5.5?g granule of PSORI-CM01 two times daily and five placebo tablets three times daily for 12 weeks. The participants in the Yinxieling group will receive five Yinxieling tablets three times daily and a placebo granule two times daily for 12 weeks. The primary outcome is the reduction of the Psoriasis Area and Severity Index. The secondary outcomes include relapse rate, Visual Analogue Scale scores, body surface area and the Dermatology Life Quality Index. Cost-effectiveness analysis will be performed from a health and community care provider perspective. ETHICS AND DISSEMINATION:This research protocol had been reviewed and approved by the institutional review boards of three trial centres (Guangdong Provincial Hospital of Chinese Medicine (B2014-026-01), Affiliated Hospital of Tianjin Chinese Medicine Academy (2014-KY-001) and Third Hospital of Hangzhou (B2014-026-01)). The findings will be disseminated to the public through conference presentations and open-access journals. TRIAL REGISTRATION NUMBER:Chinese Clinical Trial Registry (ChiCTR-TRC-14005185); Pre-results.

Project description:BACKGROUND:Functional constipation refers to constipation without organic lesions caused by dietary factors, mood depression, changes in life rules, and poor bowel habits. Clinically, constipation is mainly manifested by changes of stool texture, difficulty or lack of bowel movement, and dry stool. Sometimes, it can be accompanied by abdominal distension and abdominal discomfort. Chinese herbal compound is a prescription which is composed of 2 or more medicinal flavors and is designed for relatively certain diseases and syndromes. Clinical studies have shown that TCM compounds have a good therapeutic effect on functional constipation, but there is no evidence of evidence-based medicine. The purpose of this study is to systematically evaluate the efficacy and safety of TCM compounds in the treatment of functional constipation, and to provide evidence-based basis for the clinical application of TCM compounds in the treatment of constipation. METHODS:A systematic search was performed on English database (PubMed, Embase, Web of Science, the Cochrane Library) and Chinese database (CNKI, Wanfang, Weipu (VIP), CBM), in addition to the manual retrieval of Baidu and Google academic for randomized controlled trials (RCTs) on the treatment of functional constipation with Chinese herbal compound. The retrieval time limit was from the establishment of the database to August 2020. Two researchers independently screened the literature, extracted the data and evaluated the quality of the included studies. A meta-analysis was performed using RevMan5.3 software. RESULTS:In this study, the efficacy and safety of TCM herbal compounds in the treatment of functional constipation were evaluated by the overall effective rate, recovery rate, colonic transmission function, and other indicators. CONCLUSIONS:This study will provide reliable evidence-based evidence for the clinical application of Chinese herbal compound in the treatment of functional constipation. OSF REGISTRATION NUMBER:DOI 10.17605/OSF.IO/D5ECF.

Project description:BACKGROUND:Psoriasis vulgaris (PV) is a chronic, immune-mediated dermatological disease that significantly affects the patient's health and quality of life. At present, cupping has been widely used in the treatment of psoriasis. However, the effectiveness and safety of cupping in patients with PV are still controversial. Therefore, this review aims to evaluate the efficacy and safety of cupping therapy on PV. METHODS:The following databases will be searched from their inceptions to April 2020 with a language limitation of English and Chinese: Pubmed, Medline, Embase, Cochrane Central Register of Controlled Trials, Chinese Biomedical Literature Databas, China National Knowledge Infrastructure Database, Wanfang database and Chinese Scientific Journal Database. The reference lists of eligible studies and other resources will also be searched. Two researchers will independently perform the selection of studies, data extraction, and data analysis. A fixed or random-effect model will be applied to synthesize data depend on the heterogeneity test. The primary outcome is the proportion of patients achieving at least a 60% improvement in psoriasis area and severity index (PASI) score from baseline (PASI 60). Secondary outcomes include the proportion of patients achieving at least a 90% improvement in PASI score from baseline (PASI 90), the mean change of PASI and dermatology life quality index score, the itching index, adverse events, and recurrence rate. RevMan V.5.3 software will be used for meta-analysis. RESULTS:The study will provide a high-quality evidence-based review of cupping for PV. CONCLUSIONS:The study will be conducted to evaluate the efficacy and safety of cupping in the treatment of PV and supposed to provide clear evidence for the clinical application of cupping therapy. ETHICS AND DISSEMINATION:As the study is a protocol of systematic review and meta-analysis that does not involve individual data, ethical approval will not be required. The results will be published in a peer-reviewed journal. OSF REGISTRATION NUMBER:DOI 10.17605/OSF.IO/KV4CJ.

Project description:Background: In recent years, systematic reviews/meta-analyses (SRs/MAs) of Chinese herbal medicine (CHM) for psoriasis have continuously emerged. Their methods and evidence quality, however, are yet to be evaluated, and whether their conclusions can provide clinicians with reliable evidence is still debatable. Objectives: This overview aims to evaluate the methodological quality, risk of bias, and reporting quality of relevant SRs/MAs, as well as the current evidence of CHM for treating psoriasis. Methods: We searched nine electronic databases from their respective time of establishment to January 20, 2021, as well as the reference lists of the included SRs/MAs, protocol registries, and gray literature. Two reviewers independently used the following: A Measurement Tool to Assess Systematic Reviews (AMSTAR) 2, Risk of Bias in Systematic Reviews (ROBIS), the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA), and Grades of Recommendations, Assessment, Development and Evaluation (GRADE) to evaluate the methodological quality, risk of bias, reporting quality, and evidence quality of the included SRs/MAs. Results: This review included 14 SRs/MAs involving 45 outcomes, of which 12 (85.71%) SRs/MAs had a very low quality evaluated by AMSTAR 2 and 7 (50.00%) SRs/MAs had a high risk of bias assessed by ROBIS. The protocol and registration and funding statements were the major reporting flaws according to the PRISMA checklist. The evaluation with the GRADE system demonstrated no outcome of high-quality evidence, and inconsistent efficacy evaluations were found in this overview. Only 15 (33.33%) outcomes were moderate-quality evidence, supporting the claim that CHM plus Western medicine (WM) was superior to WM. Generally low quality of evidence showed no difference in the incidence of adverse events between the combined therapy and WM. However, the conclusion that CHM was superior to WM cannot be drawn due to the inconsistent results. Conclusion: Despite that CHM has the potential benefit and safety in the adjuvant treatment of psoriasis, the conclusion should be treated with caution because of the generally low quality of methodology and evidence. In the future, high-quality randomized controlled trials (RCTs) should be carried out, and the quality of relevant SRs should also be improved to promote their clinical application.

Dataset Information

Safety and efficacy of Chinese herbal bath for psoriasis vulgaris: A protocol for systematic review and meta-analysis.

Publications

Safety and efficacy of Chinese herbal bath for psoriasis vulgaris: A protocol for systematic review and meta-analysis.

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