M Akashlal, Nair Pratibha P, Nair Devi R, Ahmad Azeem, Chandrasekhararao B, Sudhakar D, Narayanam Srikanth, Acharya Rabinarayan
Department of Ayurveda, Regional Ayurveda Research Institute (CCRAS, M/O Ayush, Govt. India), Port Blair, Andaman & Nicobar Islands, India.
Department of Kayachikitsa, VPSV Ayurveda College, Kottakkal, Kerala, India.
J Evid Based Integr Med. 2025 Jan-Dec;30:2515690X241304523. doi: 10.1177/2515690X241304523.
The study's objective is to conduct a comprehensive systematic review for assessing the safety and efficacy of Ayurvedic interventions in managing hemiplegia/Pakshaghata. The study involved a search across multiple online databases and online clinical trial registries. Additionally, major Ayurveda postgraduate institutes were contacted to acquire unpublished trial data related to hemiplegia/Pakshaghata. The review covered articles published until July 2023. Two reviewers independently performed data extraction and risk of bias assessment. The risk of bias assessment utilised the RoB 2 tool for randomised trials and the ROBINS-I tool for non-randomised trials. The screening process identified 28 articles from online databases and two dissertations from online repositories. However, practical challenges prevented access to grey literature from Ayurveda institutes. The 30 studies selected for this review, comprises nine randomised controlled trials (RCTs), eight non-randomised comparative trials, and thirteen pre-post studies. Quantitative analysis was unfeasible due to inadequate studies, leading to a qualitative analysis. All studies, except one, exhibited substantial bias upon risk of bias assessment. Moreover, most studies demonstrated methodological weaknesses attributed to a lack of masking, improper sampling techniques, non-validated outcome measurement tools, inadequate follow-up procedures, and confounding factors. The trials frequently did not document safety parameters, adverse events (AE), and adverse drug reactions (ADR). Current review could not definitively establish the efficacy and safety of Ayurvedic interventions in hemiplegia/Pakshaghata. Hence, the authors strongly advocate for good quality research incorporating proper methodology.
本研究的目的是进行一项全面的系统评价,以评估阿育吠陀干预措施在治疗偏瘫/半身不遂方面的安全性和有效性。该研究涉及在多个在线数据库和在线临床试验注册库中进行检索。此外,还联系了主要的阿育吠陀研究生院校,以获取与偏瘫/半身不遂相关的未发表试验数据。该评价涵盖截至2023年7月发表的文章。两名评价者独立进行数据提取和偏倚风险评估。偏倚风险评估使用随机试验的RoB 2工具和非随机试验的ROBINS-I工具。筛选过程从在线数据库中识别出28篇文章,从在线知识库中识别出两篇论文。然而,实际困难阻碍了获取阿育吠陀院校的灰色文献。本次评价所选的30项研究包括9项随机对照试验(RCT)、8项非随机对照试验和13项前后对照研究。由于研究不足,无法进行定量分析,因此进行了定性分析。除一项研究外,所有研究在偏倚风险评估中均表现出严重偏倚。此外,大多数研究显示出方法学上的弱点,原因包括缺乏盲法、抽样技术不当、结局测量工具未经验证、随访程序不足以及存在混杂因素。试验经常未记录安全参数、不良事件(AE)和药物不良反应(ADR)。当前的评价无法明确确定阿育吠陀干预措施在偏瘫/半身不遂治疗中的有效性和安全性。因此,作者强烈主张开展采用适当方法的高质量研究。