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.
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glutamic pyruvic transaminase (SGPT) with otherwise normal liver function; seven patients (Ayurvedic intervention) were withdrawn and SGPT normalized after stopping the drug.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.


CONCLUSIONS
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.


BACKGROUND
Clinical Drug Trial Registry-India, www.ctri.nic.in, CTRI/2008/091/000063.
Center for Rheumatic Diseases, 1988 Convent Street, Camp, Pune, India. crdp@vsnl.net
Arvind
A
Chopra
Manjit
M
Saluja
Girish
G
Tillu
Sanjeev
S
Sarmukkaddam
Anuradha
A
Venugopalan
Gumdal
G
Narsimulu
Rohini
R
Handa
Venil
V
Sumantran
Ashwinikumar
A
Raut
Lata
L
Bichile
Kalpana
K
Joshi
Bhushan
B
Patwardhan
D000368:Aged; D000704:Analysis of Variance; D000068579:Celecoxib; D016001:Confidence Intervals; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D020939:Zingiber officinale; D005944:Glucosamine / Q000627:therapeutic use*; D006801:Humans; D007194:India; D008297:Male; D008515:Medicine, Ayurvedic; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000188:drug therapy*; D010147:Pain Measurement; D018579:Patient Selection; D010936:Plant Extracts / Q000627:therapeutic use*; D011720:Pyrazoles / Q000627:therapeutic use*; D016059:Range of Motion, Articular / Q000187:drug effects / Q000502:physiology; D020127:Recovery of Function; D018570:Risk Assessment; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000627:therapeutic use*; D031610:Tinospora; D016896:Treatment Outcome
D052246:Cyclooxygenase 2 Inhibitors; D010936:Plant Extracts; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib; D005944:Glucosamine
Ayurvedic medicines; analgesics; arthritis; chondroprotective agents; drug trials; equivalence drug trials; ethnic medicine; herbal drugs; non-steroidal anti-inflammatory drugs (NSAIDs); osteoarthritis