Abstract
IntroductionThe 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.MethodsA 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.ResultsAfter 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).ConclusionsThe food supplement tested appeared to decrease the need for analgesics and NSAIDs and improve the symptoms of osteoarthritis.Trial registrationClinicaltrials.gov NCT00666523.
Highlights
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
The food supplement tested appeared to decrease the need for analgesics and NSAIDs and improve the symptoms of osteoarthritis
NSAIDs, while generally safe when used at low doses and short term [4,5,6], can result in serious complications when used long-term or at higher doses in BOCF: baseline observation carried forward; defined daily doses (DDD): defined daily dose; intention to treat (ITT): intent to treat; NSAIDs: non-steroidal anti-inflammatory drugs; OA: osteoarthritis; PET: Paracetamol 500 mg-Equivalent Tablets; SD: standard deviation; WOMAC: Western Ontario-McMaster University Osteo-Arthritis Index
Summary
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. Osteoarthritis is one of the more common of the chronic degenerative diseases afflicting an increasingly older population. Osteoarthritis is one of the more common of the chronic degenerative diseases afflicting an increasingly older population It affects primarily the weight-bearing joints (knee, hip), causing pain, stiffness and impotence, crippling patients and reducing quality of life. Symptomatic pain relief can be obtained with analgesics such as paracetamol, or the more effective non-steroidal anti-inflammatory drugs (NSAIDs) [1,2,3]. NSAIDs, while generally safe when used at low doses and short term [4,5,6], can result in serious complications (gastrointestinal bleeding, renal failure, coronary heart disease) when used long-term or at higher doses in BOCF: baseline observation carried forward; DDD: defined daily dose; ITT: intent to treat; NSAIDs: non-steroidal anti-inflammatory drugs; OA: osteoarthritis; PET: Paracetamol 500 mg-Equivalent Tablets; SD: standard deviation; WOMAC: Western Ontario-McMaster University Osteo-Arthritis Index
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