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;11(6):R192. doi: 10.1186/ar2891. Epub 2009 Dec 16.

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.

Publication types

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

MeSH terms

  • Acetaminophen / therapeutic use
  • Adult
  • Aged
  • Analgesics / therapeutic use
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Dietary Supplements*
  • Double-Blind Method
  • Female
  • Fish Oils / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Osteoarthritis / drug therapy*
  • Pain / drug therapy
  • Phytotherapy*
  • Placebos
  • Urtica dioica / chemistry
  • Vitamin E / therapeutic use*

Substances

  • Analgesics
  • Anti-Inflammatory Agents, Non-Steroidal
  • Fish Oils
  • Placebos
  • Vitamin E
  • Acetaminophen

Associated data

  • ClinicalTrials.gov/NCT00666523