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
T Pincus, G Koch, H Lei, B Mangal, T Sokka, R Moskowitz, F Wolfe, A Gibofsky, L Simon, S Zlotnick, J G Fort, T Pincus, G Koch, H Lei, B Mangal, T Sokka, R Moskowitz, F Wolfe, A Gibofsky, L Simon, S Zlotnick, J G Fort
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.
Figures
References
- Arthritis Res. 2001;3(2):98-101
- J Rheumatol. 2000 Nov;27(11):2635-41
- Arthritis Rheum. 2001 Jul;44(7):1587-98
- Curr Rheumatol Rep. 2001 Dec;3(6):473-8
- JAMA. 2002 Jan 2;287(1):64-71
- Arthritis Rheum. 2002 Nov;46(11):2831-5
- Arthritis Rheum. 2002 Nov;46(11):3046-54
- Arch Intern Med. 2003 Jan 27;163(2):169-78
- Arthritis Rheum. 1980 Feb;23(2):137-45
- Arthritis Rheum. 1983 Nov;26(11):1346-53
- Ann Intern Med. 1988 Sep 1;109(5):359-63
- Ann Intern Med. 1989 Feb 15;110(4):259-66
- J Rheumatol. 1988 Dec;15(12):1833-40
- Pain. 1989 Jul;38(1):29-33
- N Engl J Med. 1991 Jul 11;325(2):87-91
- Stat Med. 1991 Jun;10(6):871-89; discussion 889-90
- Am J Med. 1991 Sep;91(3):213-22
- Med Care. 1992 Jun;30(6):473-83
- Med Care. 1993 Mar;31(3):247-63
- Arthritis Rheum. 1993 Sep;36(9):1196-206
- Arthritis Rheum. 1995 Nov;38(11):1535-40
- Arthritis Rheum. 1995 Nov;38(11):1541-6
- Arch Fam Med. 1995 Dec;4(12):1049-55
- Arthritis Rheum. 1999 Oct;42(10):2220-30
- Arthritis Rheum. 2001 Jul;44(7):1477-80
- JAMA. 1999 Nov 24;282(20):1921-8
- Arthritis Rheum. 2000 Feb;43(2):378-85
- J Rheumatol. 2000 Apr;27(4):1020-7
- Arthritis Rheum. 2000 May;43(5):978-87
- Arthritis Rheum. 2000 Sep;43(9):1905-15
Source: PubMed