Phytalgic, a food supplement, vs placebo in patients with osteoarthritis of the knee or hip: a randomised double-blind placebo-controlled clinical trial.
Arthritis Res Ther. 2009 Dec 16;11(6):R192. PMID: 20015358
ABSTRACT: INTRODUCTION: The medicinal treatment of osteoarthritis (OA) is mostly symptomatic to relieve pain and incapacity with analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), drugs with well-known risks. Complementary medicines might reduce the symptoms of OA and decrease the need for NSAIDs. This study tested the effects of a food supplement, Phytalgic(R), on pain and function in patients with osteoarthritis and their use of analgesic and NSAIDs. METHODS: Randomized double-blind parallel-groups clinical trial comparing Phytalgic(R) (fish-oil, vitamin E, urtica dioica) to placebo for 3 months, in 81 patients with OA of the knee or hip using NSAIDs and/or analgesics regularly. Main outcome measures were use of NSAIDs (in Defined Daily Doses per day - DDD/day) or analgesics (in 500 mg paracetamol-equivalent tablets per week (PET/week) measured each month, and Western Ontario-McMaster University Osteo-Arthritis Index (WOMAC) function scales RESULTS: After 3 months of treatment, the mean use of analgesics in the active arm (6.5 PET/week) vs. the placebo arm (16.5) was significantly different (P<0.001) with a group mean difference of -10.0 (95% CI : -4.9 to -15.1). That of NSAIDs in the active arm (0.4 DDD/day) vs the placebo arm (1.0 DDD/day) was significantly different (P=0.02) with a group mean difference of - 0.7 DDD/day (95% CI: -0.2 to -1.2). Mean WOMAC scores for pain, stiffness and function in the active arm (resp. 86.5, 41.4 and 301.6) vs the placebo arm (resp. 235.3, 96.3 and 746.5) were significantly different (P<0.001) with group mean differences respectively of -148.8 (95% CI: -97.7 to -199.9), -54.9 (95% CI: -27.9 to -81.9) and -444.8 (95% CI: -269.1 to -620.4). CONCLUSIONS: The food supplement tested appeared to decrease the need for analgesics and NSAIDs and improve the symptoms of osteoarthritis. Trial registration: Clinicaltrials.gov NCT00666523.