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Ann Rheum Dis. Aug 2004; 63(8): 931–939.
Published online Apr 13, 2004. doi:  10.1136/ard.2003.020313
PMCID: PMC1755088

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.

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.
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Figures and Tables

Figure 1
 Summary of protocol of PACES—double blind, double dummy, clinical trials. Each patient received a drug and a placebo or two placebos in each period.
Figure 2
 Change in scores for WOMAC (A and B) and pain visual analogue scale scores on the MDHAQ (C and D) of patients who received 6 weeks' treatment with celecoxib, acetaminophen, or placebo, after a 1 week washout period, in PACES-a and PACES-b.
Figure 3
 Patient Preference for Placebo, Acetaminophen or Celecoxib in PACES-a (A) and PACES-b (B). Each patient took two of the three treatments for 6 weeks each. At the final visit, the patient questionnaire asked: "Please compare control of your arthritis ...

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