IntroductionChinese medicine is commonly used to combine with pharmacotherapy for the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Six Chinese herb formulas involving Weijing decoction, Maxingshigan decoction, Yuebijiabanxia decoction, Qingqihuatan decoction, Dingchuan decoction and Sangbaipi decoction are recommended in Chinese medicine clinical guideline or textbook, to relieve patients with phlegm-heat according to Chinese syndrome differentiation. However, the comparative effectiveness among these six formulas has not been investigated in published randomised controlled trials. We plan to summarise the direct and indirect evidence for these six formulas combined with pharmacotherapy to determine the relative merits options for the management of AECOPD.Methods and analysisWe will perform the comprehensive search for the randomised controlled trials to evaluate the effectiveness of six Chinese herb formulas recommended in Chinese medicine clinical guideline or textbook. The combination of pharmacotherapy includes bronchodilators, antibiotics and corticosteroids that are routinely prescribed for AECOPD. The primary outcome will be lung function, arterial blood gases and length of hospital stay. The data screening and extraction will be conducted by two different reviewers. The quality of RCT will be assessed according to the Cochrane handbook risk of bias tool. The Bayes of network meta-analysis (NMA) will be conducted with WinBUGS to compare the effectiveness of six formulas. We will also use the surface under the cumulative ranking curve (SUCRA) to obtain the comprehensive rank for these treatments.Ethics and disseminationThis review does not require ethics approval and the results of NMA will be submitted to a peer-review journal.Trial registration numberPROSPERO (CRD42016052699).
Background: Six Chinese herb formulas, namely, the Weijing decoction (WJ), the Maxingshigan decoction (MXSG), the Yuebijiabanxia decoction (YBBX), the Qingqihuatan decoction (QQHT), the Dingchuan decoction (DC) and the Sangbaipi decoction (SBP), are commonly used, along with routine pharmacotherapy, to manage the acute exacerbation of chronic obstructive pulmonary disease (AECOPD). In this study, we conducted a systematic review to summarize the efficacy of these six formulas, and we also conducted a network meta-analysis (NMA) to rank these formulas. Methods: We searched five English databases and four Chinese databases, with dates ranging from the starting dates of these databases to December 2016. Randomized controlled trials that evaluated any of the six Chinese herb formulas combined with the use of pharmacotherapy for AECOPD were identified. Results: Fifty-five studies involving 4560 participants were included. The pairwise meta-analyses showed that WJ and QQHT had superior effects on the improvement of lung function (forced expiratory volume in 1 seconds; FEV1) (mean difference (MD): 0.25, 95% confidence interval (CI): 0.19-0.30 and 0.34, 95%CI: 0.10-0.58). MXSG, WJ and QQHT were found to be more effective for improving arterial blood gases (PaO2 and PaCO2). In terms of effective rates, all of these formulas had additional favourable effects compared to routine pharmacotherapy. The results of the NMA analyses indicated that only MXSG showed superior add-on effects for the improvement of FEV1 (MD: 0.37, 95% credible interval (CrI): 0.03-0.72). Most of the formulas combined with routine pharmacotherapy were superior to pharmacotherapy alone for the improvement of arterial blood gases and effective rates. The ranking tests suggested that QQHT and MXSG combined with routine pharmacotherapy might be optimal options for the treatment of AECOPD. Conclusions: This NMA indicated that QQHT and MXSG might be more effective treatment regimens for AECOPD. Further well-designed studies that specifically examine the direct comparisons of these formulas are needed to support our conclusions.
Background As a common disorder of the gastrointestinal tract, irritable bowel syndrome (IBS) can have negative effects on patients and society, with irritable bowel syndrome with constipation(IBS-C) accounting for a large proportion of these effects. The main clinical manifestations of IBS-C are constipation, abdominal pain, and abdominal distension, which seriously impact the quality of life of patients. The mechanisms of IBS are complex, and the gut-brain axis has been an emerging and recognized theoretical system in recent years. Based on the theory of the gut-brain axis and the theory of Chinese medicine, we designed this study to evaluate the efficacy of one-finger meditation massage in treating IBS-C. Methods/design Thisis a randomized controlled trial. Eligible patients with irritable bowel syndrome (IBS-C) were randomized 1:1 to a test group (massage plus probiotics) and a control group (probiotics). Patients in the test group were treated once every 10 days for three consecutive courses of treatment (i.e., three months) and were given Bifidobacterium trifolium capsules 630 mg/dose three times daily 30 mins after meals every day during the treatment period, with follow-up observations at the end of the third and sixth months of thetreatment period. The control group were given Bifidobacterium trifolium capsules 630mg/dose, 3 times a day for 3 months, with follow-up observations at the end of the third and sixth months of the treatment period. The primary outcome indicators are the concentrations of 5-HT and substance P and the IBS Severity Scale (IBS-SSS) assessment. Secondary outcomes are the Bristol Rating Scale (BRSA) score, the IBS Quality of Life Questionnaire (IBS-QOL scale) score, and the assessment of the effectiveness of the evidence. The results were assessed at the pretreatment, posttreatment, and follow-up stages. Any side effects were subject to assessment. Discussion The aim of this trial is to provide a new method of treatment based on pharmacological treatment that is easy to use, easy to promote and has proven efficacy and to establish the efficacy and safety of treating IBS-C through this trial. Registration for Trial Chinese Clinical Trial Registry ChiCTR2200066417 on 5 December 2022.
Background As a common disorder of the gastrointestinal tract, irritable bowel syndrome (IBS) can have negative effects on patients and society, with irritable bowel syndrome with constipation(IBS-C) accounting for a large proportion of these effects. The main clinical manifestations of IBS-C are constipation, abdominal pain, and abdominal distension, which seriously impact the quality of life of patients. The mechanisms of IBS are complex, and the gut-brain axis has been an emerging and recognized theoretical system in recent years. Based on the theory of the gut-brain axis and the theory of Chinese medicine, we designed this study to evaluate the efficacy of one-finger meditation massage in treating IBS-C. Methods/design This is a randomized controlled trial. Eligible patients with irritable bowel syndrome (IBS-C) wererandomized 1:1 to a test group (massage plus probiotics) and a control group (probiotics). Patients in the test group weretreated once every 10 days for three consecutive courses of treatment (i.e., three months) and weregiven Bifidobacterium trifolium capsules 630 mg/dose three times daily 30 min after meals every day during the treatment period, with follow-up observations at the end of the third and sixth months of the treatment period. The control group weregiven Bifidobacterium trifolium capsules 630 mg/dose, 3 times a day for 3 months, with follow-up observations at the end of the third and sixth months of the treatment period. The primary outcome indicators are the concentrations of 5-HT and substance P and the IBS Severity Scale (IBS-SSS) assessment. Secondary outcomes are the Bristol Rating Scale (BRSA) score, the IBS Quality of Life Questionnaire (IBS-QOL scale) score, and the assessment of the effectiveness of the evidence. The results wereassessed at the pretreatment, posttreatment, and follow-up stages. Any side effects weresubject to assessment. Discussion The aim of this trial is to provide a new method of treatment based on pharmacological treatment that is easy to use, easy to promote and has proven efficacy and to establish the efficacy and safety of treating IBS-C through this trial. Registration for Trial Chinese Clinical Trial Registry ChiCTR2200066417 on 5 December 2022. https://www.chictr.org.cn/bin/project/edit?pid=183461
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