Ayurvedic Medicine for Symptomatic Knee Osteoarthritis
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glutamic pyruvic transaminase (SGPT) with otherwise normal liver function; seven patients (Ayurvedic intervention) were withdrawn and SGPT normalized after stopping the drug.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.
Therapeutic options for chronic knee OA, a ubiquitous disorder. are grossly limited to principally providing symptomatic long-term pain relief that exposes patients to potentially serious toxicity. Glucosamine is widely used to treat OA and is allegedly a chondroprotective drug, but its efficacy remains contentious. Eventually patients may deteriorate to end-stage arthritis requiring joint replacement surgery, which is expensive and not universally accessible.
The ancient Ayurveda medicinal system is popularly practised in the Indian subcontinent. The government of India recently launched the New Millennium Indian Technology Leadership Initiative (NMITLI) programme and included Ayurveda. Knee OA was chosen as a key therapeutic target to validate some potential Ayurvedic drugs. We carried out several experimental studies and drug trials. The results of the final drug trial are presented.
Abstract and Introduction
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.
Introduction
Therapeutic options for chronic knee OA, a ubiquitous disorder. are grossly limited to principally providing symptomatic long-term pain relief that exposes patients to potentially serious toxicity. Glucosamine is widely used to treat OA and is allegedly a chondroprotective drug, but its efficacy remains contentious. Eventually patients may deteriorate to end-stage arthritis requiring joint replacement surgery, which is expensive and not universally accessible.
The ancient Ayurveda medicinal system is popularly practised in the Indian subcontinent. The government of India recently launched the New Millennium Indian Technology Leadership Initiative (NMITLI) programme and included Ayurveda. Knee OA was chosen as a key therapeutic target to validate some potential Ayurvedic drugs. We carried out several experimental studies and drug trials. The results of the final drug trial are presented.
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