Abstract | BACKGROUND:
Acetaminophen ( paracetamol) is recommended as the initial pharmacological treatment for knee or hip osteoarthritis. However, survey and clinical trial data indicate greater efficacy for non-steroidal anti-inflammatory drugs and cyclo-oxygenase-2 specific inhibitors. DESIGN: Two randomised, double blind, placebo controlled, crossover multicentre clinical trials, Patient Preference for Placebo, Acetaminophen or Celecoxib Efficacy Studies (PACES). PATIENTS: INTERVENTION: "Wash out" of treatment; randomisation; 6 weeks of celecoxib 200 mg/day, acetaminophen 1000 mg four times a day, or placebo; second "wash out;" crossover to 6 weeks of second treatment. MEASUREMENTS: Western Ontario McMaster Osteoarthritis Index (WOMAC), visual analogue pain scale, patient preference between two treatments. RESULTS:
Celecoxib was more efficacious than acetaminophen in both periods in both studies; WOMAC and pain scale scores differed at p<0.05 in period II and both periods combined of PACES-a and in periods I and II and both periods combined in PACES-b, but not in period I of PACES-a. Acetaminophen was more efficacious than placebo, generally p<0.05 in PACES-b, and >0.05 in PACES-a. Patient preferences were 53% celecoxib v 24% acetaminophen in PACES-a (p<0.001) and 50% v 32% in PACES-b (p = 0.009); 37% acetaminophen v 28% placebo in PACES-a (p = 0.340) and 48% v 24% in PACES-b (p = 0.007). No clinically or statistically significant differences were seen in adverse events or tolerability among the three treatment groups. CONCLUSIONS: Greater efficacy was seen for celecoxib v acetaminophen v placebo, while adverse events and tolerability were similar. Variation in results and statistical significance in the two different trials are of interest.
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Authors | T Pincus, G Koch, H Lei, B Mangal, T Sokka, R Moskowitz, F Wolfe, A Gibofsky, L Simon, S Zlotnick, J G Fort |
Journal | Annals of the rheumatic diseases
(Ann Rheum Dis)
Vol. 63
Issue 8
Pg. 931-9
(Aug 2004)
ISSN: 0003-4967 [Print] England |
PMID | 15082468
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Antirheumatic Agents
- Pyrazoles
- Sulfonamides
- Acetaminophen
- Celecoxib
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Topics |
- Acetaminophen
(adverse effects, therapeutic use)
- Aged
- Anti-Inflammatory Agents, Non-Steroidal
(adverse effects, therapeutic use)
- Antirheumatic Agents
(adverse effects, therapeutic use)
- Celecoxib
- Cross-Over Studies
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Osteoarthritis, Hip
(drug therapy)
- Osteoarthritis, Knee
(drug therapy)
- Pain Measurement
- Patient Satisfaction
- Pyrazoles
- Severity of Illness Index
- Sulfonamides
(adverse effects, therapeutic use)
- Treatment Outcome
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