title: Phytalgic, a food supplement, vs placebo in patients with osteoarthritis of the knee or hip: a randomised double-blind placebo-controlled clinical trial.
abstract: BACKGROUND
  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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00666523.
authors.affiliation: Department of Pharmacology, University of Bordeaux, 146 rue Léo Saignat, 33076, Bordeaux, France. docteur.alain.jacquet@wanadoo.fr
authors.forename: Alain
authors.initials: A
authors.lastname: Jacquet
authors.forename: Pierre-Olivier
authors.initials: PO
authors.lastname: Girodet
authors.forename: Antoine
authors.initials: A
authors.lastname: Pariente
authors.forename: Karelle
authors.initials: K
authors.lastname: Forest
authors.forename: Laurent
authors.initials: L
authors.lastname: Mallet
authors.forename: Nicholas
authors.initials: N
authors.lastname: Moore
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005395:Fish Oils / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy; D008517:Phytotherapy; D010919:Placebos; D026982:Urtica dioica / Q000737:chemistry; D014810:Vitamin E / Q000627:therapeutic use*
chemical_list: D000700:Analgesics; D000894:Anti-Inflammatory Agents, Non-Steroidal; D005395:Fish Oils; D010919:Placebos; D014810:Vitamin E; D000082:Acetaminophen