Ayurvedic medicine offers a good alternative to glucosamine and celecoxib in the treatment of symptomatic knee osteoarthritis: a randomized, double-blind, controlled equivalence drug trial

Rheumatology (Oxford). 2013 Aug;52(8):1408-17. doi: 10.1093/rheumatology/kes414. Epub 2013 Jan 30.

Abstract

Objective: To demonstrate clinical equivalence between two standardized Ayurveda (India) formulations (SGCG and SGC), glucosamine and celecoxib (NSAID).

Methods: Ayurvedic formulations (extracts of Tinospora cordifolia, Zingiber officinale, Emblica officinalis, Boswellia serrata), glucosamine sulphate (2 g daily) and celecoxib (200 mg daily) were evaluated in a randomized, double-blind, parallel-efficacy, four-arm, multicentre equivalence drug trial of 24 weeks duration. A total of 440 eligible patients suffering from symptomatic knee OA were enrolled and monitored as per protocol. Primary efficacy variables were active body weight-bearing pain (visual analogue scale) and modified WOMAC pain and functional difficulty Likert score (for knee and hip); the corresponding a priori equivalence ranges were ±1.5 cm, ±2.5 and ±8.5.

Results: Differences between the intervention arms for mean changes in primary efficacy variables were within the equivalence range by intent-to-treat and per protocol analysis. Twenty-six patients showed asymptomatic increased serum glutamic pyruvic transaminase (SGPT) with otherwise normal liver function; seven patients (Ayurvedic intervention) were withdrawn and SGPT normalized after stopping the drug. Other adverse events were mild and did not differ by intervention. Overall, 28% of patients withdrew from the study.

Conclusion: In this 6-month controlled study of knee OA, Ayurvedic formulations (especially SGCG) significantly reduced knee pain and improved knee function and were equivalent to glucosamine and celecoxib. The unexpected SGPT rise requires further safety assessment.

Trial registration: Clinical Drug Trial Registry-India, www.ctri.nic.in, CTRI/2008/091/000063.

Keywords: Ayurvedic medicines; analgesics; arthritis; chondroprotective agents; drug trials; equivalence drug trials; ethnic medicine; herbal drugs; non-steroidal anti-inflammatory drugs (NSAIDs); osteoarthritis.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Analysis of Variance
  • Celecoxib
  • Confidence Intervals
  • Cyclooxygenase 2 Inhibitors / therapeutic use
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Ginger
  • Glucosamine / therapeutic use*
  • Humans
  • India
  • Male
  • Medicine, Ayurvedic*
  • Middle Aged
  • Osteoarthritis, Knee / diagnosis
  • Osteoarthritis, Knee / drug therapy*
  • Pain Measurement
  • Patient Selection
  • Plant Extracts / therapeutic use*
  • Pyrazoles / therapeutic use*
  • Range of Motion, Articular / drug effects
  • Range of Motion, Articular / physiology
  • Recovery of Function
  • Risk Assessment
  • Severity of Illness Index
  • Sulfonamides / therapeutic use*
  • Tinospora
  • Treatment Outcome

Substances

  • Cyclooxygenase 2 Inhibitors
  • Plant Extracts
  • Pyrazoles
  • Sulfonamides
  • Celecoxib
  • Glucosamine