Preprint / Version 1

Efficacy and safety of Ayurvedic medicines: Recommending equivalence trial design and proposing safety index

Authors

  • Sanjeev Sarmukaddam Centre for Rheumatic Diseases, Hermes Elegance, 1988 Convent St, Camp, Pune – 411 008, Maharashtra, India
  • Arvind Chopra Centre for Rheumatic Diseases, Hermes Elegance, 1988 Convent St, Camp, Pune – 411 008, Maharashtra, India
  • Girish Tillu Centre for Rheumatic Diseases, Hermes Elegance, 1988 Convent St, Camp, Pune – 411 008, Maharashtra, India

Keywords:

Efficacy, equivalence trials, safety index, safety of Ayurvedic medicines

Abstract

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. Keywords: Efficacy, equivalence trials, safety index, safety of Ayurvedic medicines

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