Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.
Health Intervention and Technology Assessment Program, Ministry of Public Health, Nonthaburi, Thailand.
Int J Technol Assess Health Care. 2021 Mar 17;37:e45. doi: 10.1017/S0266462321000179.
Traditional and complementary medicines are increasingly considered possible options for prevention and symptomatic treatment of the novel coronavirus, COVID-19. With renewed attention on these therapies from researchers and policy makers alike, the well-documented challenges of evaluating their safety and efficacy are once again of global concern. Between 2005 and 2018, the World Health Organization conducted a series of surveys, in which 88 percent of responding member states confirmed that their biggest challenge in traditional medicine was the need for technical guidance on research and evaluation. As a first step in pursuing this need, our commentary summarizes thirteen international and regional guidance documents by three broad categories on evaluating safety, efficacy, and product quality for market-based approval and distribution of these treatments. We highlight the paucity of updated international recommendations on these subjects and identify gaps that could inform the current evidence base. All available guidance note the need for evidence surrounding the efficacy of these treatments and practices but are also quick to caution against methodological difficulties in the conduct of such evaluations. Evidence suggests that improved evaluation methods on efficacy and effectiveness are crucial toward expanding future research into establishing the cost-effectiveness of these therapies, in the context of shifting acceptance, interest, and integration of traditional medicines into health systems, and as another step toward Universal Health Coverage.
传统医学和补充医学越来越被认为是预防和治疗新型冠状病毒(COVID-19)的可能选择。由于研究人员和政策制定者重新关注这些疗法,评估其安全性和有效性的记录在案的挑战再次引起全球关注。在 2005 年至 2018 年期间,世界卫生组织进行了一系列调查,其中 88%的回应成员国证实,它们在传统医学方面面临的最大挑战是需要关于研究和评估的技术指导。作为满足这一需求的第一步,我们的评论总结了评价基于市场的安全性、有效性和产品质量以批准和分发这些治疗方法的十三个国际和区域指导文件,分为三大类。我们强调了在这些主题上缺乏更新的国际建议,并确定了可以为当前证据基础提供信息的差距。所有可用的指导文件都指出需要围绕这些治疗方法和实践的疗效提供证据,但也很快警告在进行此类评估时存在方法学困难。有证据表明,改进对疗效和有效性的评估方法对于扩大未来的研究至关重要,以确定在接受、兴趣和整合传统医学方面具有成本效益的疗法,这是实现全民健康覆盖的又一步。