Phytalgic, a food supplement, vs placebo in patients with osteoarthritis of the knee or hip: a randomised double-blind placebo-controlled clinical trial

Alain Jacquet, Pierre-Olivier Girodet, Antoine Pariente, Karelle Forest, Laurent Mallet, Nicholas Moore, Alain Jacquet, Pierre-Olivier Girodet, Antoine Pariente, Karelle Forest, Laurent Mallet, Nicholas Moore

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, on pain and function in patients with osteoarthritis and their use of analgesic and NSAIDs.

Methods: A randomized double-blind parallel-groups clinical trial compared Phytalgic (fish-oil, vitamin E, Urtica dioica) to a placebo for three months, in 81 patients with OA of the knee or hip using NSAIDs and/or analgesics regularly. The 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 three 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 (respectively 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.

Figures

Figure 1
Figure 1
Patient disposition in the study (CONSORT diagram).
Figure 2
Figure 2
Mean use of analgesics per week in active and placebo-treated patients. (Mean number of tablets per week ± SEM). Preinclusion: the month before inclusion. M1, M2, M3, results after respectively one, two and three months of treatment.
Figure 3
Figure 3
Mean use of NSAIDs in DDD per day in active and placebo-treated patients (Mean number of DDD per day ± SEM). Preinclusion: the month before inclusion. M1, M2, M3, results after respectively one, two and three months of treatment.
Figure 4
Figure 4
Total WOMAC scores (mean ± SEM) at preinclusion and after one, two or three months of treatment. Randomized to active or placebo treatment. Difference from preinclusion was significant at all subsequent times for active, but not for placebo.

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