Sarmukaddam Sanjeev, Chopra Arvind, Tillu Girish
Centre for Rheumatic Diseases, Hermes Elegance, 1988 Convent St, Camp, Pune - 411 008, Maharashtra, India.
Int J Ayurveda Res. 2010 Jul;1(3):175-80. doi: 10.4103/0974-7788.72491.
Ayurvedic drugs have begun to be evaluated in controlled clinical trials. The trials, often placebo controlled, are usually designed to demonstrate superiority. Though the results have been usually reported as encouraging, statistical significance has been elusive. In this melee to show efficacy, several positive results related to safety and other purported advantages with Ayurvedic drugs, including improved quality of life, easy drug availability and less cost, get drowned. Though safety is the prime concern, efficacy ultimately matters in trials. Excellent safety profile offset modest efficacy, especially for long-term management of chronic difficult to treat disorders. There is a trade-off between efficacy and safety but we have no means to put them together in a mathematical evaluation to judge the overall performance of a drug. However, we need more suitable modern science methods/techniques to unravel the true therapeutic role of Ayurvedic drugs. We propose "equivalence trials" using modern medicine benchmark as a comparator and a "safety/tolerability index" on this perspective. We believe that several Ayurvedic drugs are capable of demonstrating equal efficacy but superior safety. Our concept may also be applicable for pragmatic trials that are more suitable for Ayurvedic therapy.
阿育吠陀药物已开始在对照临床试验中进行评估。这些试验通常采用安慰剂对照，旨在证明其优越性。尽管结果通常报告令人鼓舞，但统计学意义却难以捉摸。在这场展示疗效的混战中，一些与阿育吠陀药物安全性及其他所谓优势相关的积极结果，包括生活质量改善、药物易于获取和成本较低等，都被淹没了。尽管安全性是首要关注点，但在试验中疗效最终才是关键。出色的安全性可弥补适度的疗效，特别是对于慢性难治性疾病的长期管理。疗效和安全性之间存在权衡，但我们无法通过数学评估将它们结合起来以判断药物的整体性能。然而，我们需要更合适的现代科学方法/技术来揭示阿育吠陀药物的真正治疗作用。从这个角度出发，我们提出以现代医学基准作为对照的“等效性试验”和“安全性/耐受性指数”。我们相信，几种阿育吠陀药物能够证明具有同等疗效但更高的安全性。我们的概念也可能适用于更适合阿育吠陀疗法的实用性试验。
