Comparative efficacy and safety of Chinese herbal medicine for knee osteoarthritis: A protocol for systematic review and network meta-analysis.
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ABSTRACT: Background
Knee osteoarthritis (OA) is a major public health concern causing chronic disability as well as a substantial burden on health care and the economy. However, effective treatments for knee OA were still not available. Numerous clinical studies have suggested that Chinese herbal medicine (CHM) seems to be clinically effective in treating knee OA. Thus, this study aims to evaluate the efficacy and safety of CHM in the treatment of knee OA through a systematic review and network meta-analysis.Methods
A comprehensive search will be performed in PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure, VIP Database, Wanfang Database, Chinese Biomedical Database, and 3 clinical trials registration websites, from the database inception to May 2021. Randomized controlled trials meeting the eligible criteria based on the PICOS framework will be included. All studies fulfilling the eligible criteria will be assessed for risk of bias using the Cochrane Collaboration's tool. The primary outcome will be the visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index, and total effective rate. The secondary outcome is the incidence of adverse events. Data analysis will be performed using Stata, Addis, and WinBUGS.Discussion
This study will provide a reliable evidence to assess effectiveness and safety of CHM for knee OA, which may provide guidance for clinical practice.Systematic review registration
This study protocol has been registered on INPLASY202160060.
SUBMITTER: Yang L
PROVIDER: S-EPMC8294919 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveThis systematic review and meta-analysis were performed to investigate the efficacy and safety of Chinese herbal medicine (CHM) in the treatment of knee osteoarthritis (KOA).MethodsAn electronic search was conducted in eight databases (PubMed, EMBASE, Web of Science, Cochrane Library, Chinese National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese VIP Database, and Wanfang Database) from inception until December 2019. The risk of bias assessment of the included RCTs was evaluated by Cochrane collaboration's tool. The inclusion criteria were RCTs that investigated the efficacy and safety of CHM in the treatment of KOA, with no restrictions on publication status or language. The exclusion criteria included nonrandomized or quasi-RCTs, no clear KOA diagnostic approach, combined Chinese medicinal herbs with other traditional Chinese medicine treatment modalities, and published using repeated data and missing data. We computed the relative risk (RR) and the standard mean difference (SMD) for dichotomous outcomes and continuous outcomes, respectively. When heterogeneity was detected or there was significant statistical heterogeneity (P < 0.05 or I 2 > 50%), a random-effects model was employed, followed by further subgroup analysis and metaregression estimations to ascertain the origins of heterogeneity. Otherwise, we used a fixed-effects model (P ≥ 0.05 or I 2 ≤ 50%). The primary outcome measures were visual analog score (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lysholm score, and Lequesne index. Secondary outcome measures were the total clinical effective rate and adverse events. The meta-analysis was performed using the Stata 14.0 software.ResultsA total of 56 RCTs comprising 5350 patients met the inclusion criteria. This meta-analysis showed that application of CHM as adjuvant therapy or monotherapy for KOA can significantly decrease VAS, WOMAC, and the Lequesne index and improve the Lysholm score as well as the total effective rate. In addition, this treatment has fewer adverse effects, suggesting that CHM is generally safe and well tolerated among patients with KOA.ConclusionOur study offers supportive evidence that CHM, either adjuvant therapy or monotherapy, reduces the VAS, WOMAC, and Lequesne index and improves the Lysholm score and overall effective rate in patients with KOA. Additionally, CHM was well tolerated and safe in KOA patients. We found frequently used CHMs that might contribute to the formulation of a herbal formula that could be considered for further clinical use. However, given the heterogeneity and limited sample size in this study, larger multicenter and high-quality RCTs are needed to validate the benefits of CHM in the treatment of KOA.
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Project description:Objective. To assess the current clinical evidence of manufactured Chinese herbal formulae (MCHF) for knee osteoarthritis (KOA). Methods. Seven databases were searched from inception to May 2015. Eligible randomized controlled trials investigating the effectiveness of MCHF for KOA were included. Data extraction, methodological assessment, and meta-analyses were conducted according to the Cochrane standards. Results. A total of 17 kinds of MCHF were identified from the twenty-six included trials. Meta-analyses showed that MCHF significantly relieved the global pain of knee joints, either used alone or combined with routine treatments. Additionally, MCHF plus routine treatments significantly decreased the scores of WOMAC and Lequesne index. However, there were no statistical differences between MCHF group and routine treatment group in walk-related pain and WOMAC scores. No significant differences were found in Lysholm scores. There were twenty-one trials that mentioned adverse events. A pooled analysis showed that adverse events occurred more frequently in control group compared with MCHF group. Conclusions. Our results indicated that MCHF showed some potential benefits for KOA. However, we still cannot draw firm conclusions due to the poor methodological quality of included trials. More high-quality RCTs would help to confirm the evidence.
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Project description:Purpose: To conduct a real-world evaluation of the efficacy and safety of combined Chinese and Western medicine in treating knee osteoarthritis (KOA). Methods: A multicenter, prospective cohort study design was employed, enrolling 450 KOA patients (Kellgren-Lawrence score of 3 or less). The patients were divided into a Western medicine treatment group (WM group) and a combined Western and traditional Chinese medicine treatment group (WM-CM group). A 6-week treatment plan was administered, and follow-up visits occurred at 2 weeks, 4 weeks, and 6 weeks after initiating treatment. The primary outcome indicator was the total Western Ontario and McMaster Universities Arthritis Index (WOMAC) score after 6 weeks of treatment. Secondary outcome indicators included WOMAC subscales for pain, stiffness, and joint function, visual analogue scale (VAS) score, physical component summary (PCS), mental component summary (MCS), and clinical effectiveness. The incidence of drug-related adverse events was used as a safety evaluation indicator. Results: A total of 419 patients were included in the final analysis: 98 in the WM group and 321 in the WM-CM group. The baseline characteristics of the two groups were comparable, except for the incidence of stiffness symptoms and stiffness scores. After 6 weeks of treatment, the WM-CM group exhibited superior results to the WM group in improving the total WOMAC score (24.71 ± 1.38 vs. 16.36 ± 0.62, p < 0.001). The WM-CM group also outperformed the WM group in WOMAC pain and joint function scores, VAS score, PCS score, MCS score, and clinical effectiveness (p < 0.05), which was consistent with the findings of the main evaluation index. Subgroup analysis indicated that the combined Chinese and Western medicine treatment showed more pronounced benefits in patients under 65 years of age and in those with a Kellgren-Lawrence (K-L) classification of 0-I. Throughout the study, no adverse effects were observed in either group. Conclusion: The combination of Chinese and Western medicine demonstrated superiority over Western medicine alone in relieving knee pain symptoms, improving knee function, and enhancing the quality of life for KOA patients with a K-L score of 3 or less. Moreover, the treatment exhibited a good safety profile. Clinical Trial Registration: (https://www.chictr.org.cn/), identifier (ChiCTR1900027175).
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Project description:Cardiovascular diseases (CVDs) are a significant health burden with an ever-increasing prevalence. They remain the leading causes of morbidity and mortality worldwide. The use of medicinal herbs continues to be an alternative treatment approach for several diseases including CVDs. Currently, there is an unprecedented drive for the use of herbal preparations in modern medicinal systems. This drive is powered by several aspects, prime among which are their cost-effective therapeutic promise compared to standard modern therapies and the general belief that they are safe. Nonetheless, the claimed safety of herbal preparations yet remains to be properly tested. Consequently, public awareness should be raised regarding medicinal herbs safety, toxicity, potentially life-threatening adverse effects, and possible herb-drug interactions. Over the years, laboratory data have shown that medicinal herbs may have therapeutic value in CVDs as they can interfere with several CVD risk factors. Accordingly, there have been many attempts to move studies on medicinal herbs from the bench to the bedside, in order to effectively employ herbs in CVD treatments. In this review, we introduce CVDs and their risk factors. Then we overview the use of herbs for disease treatment in general and CVDs in particular. Further, data on the ethnopharmacological therapeutic potentials and medicinal properties against CVDs of four widely used plants, namely Ginseng, Ginkgo biloba, Ganoderma lucidum, and Gynostemma pentaphyllum, are gathered and reviewed. In particular, the employment of these four plants in the context of CVDs, such as myocardial infarction, hypertension, peripheral vascular diseases, coronary heart disease, cardiomyopathies, and dyslipidemias has been reviewed, analyzed, and critically discussed. We also endeavor to document the recent studies aimed to dissect the cellular and molecular cardio-protective mechanisms of the four plants, using recently reported in vitro and in vivo studies. Finally, we reviewed and reported the results of the recent clinical trials that have been conducted using these four medicinal herbs with special emphasis on their efficacy, safety, and toxicity.
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Project description:BackgroundOn account of deterioration of chronic heart failure (CHF) and extensive exploration of Chinese herbal injections (CHIs), we performed a network meta-analysis to investigate the efficacy of CHIs (Huangqi injection, Shenfu injection, Shengmai injection, Shenmai injection, Shenqi Fuzheng injection, Yiqifumai injection) on the basis of western medicine (WM) treatment in CHF.MethodsLiterature search was conducted in Embase, the Cochrane Library, Pubmed, Chinese Biological Medicine Database, China National Knowledge Infrastructure, Wanfang Database, Chinese Scientific Journal Database from inception to June 12nd 2017, and study selection was abided by a prior eligible criteria.ResultsUltimately, a total of 113 randomized controlled trials (RCTs) were enrolled. The clinical data of the effective clinical rate, left ventricular ejection fraction, cardiac output and others outcomes was estimated by Stata software and Winbugs software. Risk of bias was assessed by Cochrane Collaboration's tools. Integrating the each outcome's results, a combination of Shengmai injection/Shenmai injection and WM obtain a first rank in most outcomes, particularly primary outcomes.ConclusionsIn conclusion, on the basis of WM, Shengmai injection or Shenmai injection may be a perforable treatment in CHF. In terms of insufficient of this study, more high quality RCTs needed to implement to support our conclusions.
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