Patient Preference for Placebo, Acetaminophen (paracetamol) or Celecoxib Efficacy Studies (PACES): two randomised, double blind, placebo controlled, crossover clinical trials in patients with knee or hip osteoarthritis.

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:

Osteoarthritis of knee or hip.

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.

• 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)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Antirheumatic Agents
• Pyrazoles
• Sulfonamides
• Acetaminophen
• Celecoxib

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