Table.
Characteristics of randomised controlled trials included in review
| Study | Details of participants (disease, mean (range) age (years), % with previous gastrointestinal ulcer) | Drug, dose, and No randomised
|
Duration (weeks) | Efficacy | Upper gastrointestinal safety | ||
|---|---|---|---|---|---|---|---|
| Celecoxib | Placebo | NSAID | |||||
| Bensen, 19996 | Osteoarthritis of knee (n=801) and hip (n=74); 62 (21-89) years; 10% with ulcer | 100 mg bid (n=217); 200 mg bid (n=222) |
n=220 | Naproxen 500 mg bid (n=216) | 12 | WOMAC index | Not assessed |
| Zhao, 199913 | Osteoarthritis of knee; 62 (19-89) years; 17% with ulcer | 100 mg bid (n=239); 200 mg bid (n=237) | n=247 | Naproxen 500 mg bid (n=233) | 12 | WOMAC index | Incidence of ulcers detected by endoscopy |
| Simon, 19997 | Rheumatoid arthritis; 54 (20-90) years; 15% with ulcer | 100 mg bid (n=240); 200 mg bid (n=235); 400 mg bid (n=218) |
n=231 | Naproxen 500 mg bid (n=225) | 12 | ACR-20 responder index, changes in painful or tender and swollen joints | Incidence of ulcers detected by endoscopy |
| Zhao, 200012 | Rheumatoid arthritis; 55 (21-84) years; 8% with ulcer | 100 mg bid (n=228); 200 mg bid (n=219); 400 mg bid (n=217) | n=221 | Naproxen 500 mg bid (n=218) | 12 | ACR-20 responder index, changes in painful or tender and swollen joints | Not assessed |
| Emery, 199910 | Rheumatoid arthritis; 55 (20-85) years; 8% with ulcer | 200 mg bid (n=326) | — | Diclofenac 75 mg bid (n=329) | 24 | ACR-20 responder index, changes in painful or tender and swollen joints | Incidence of ulcers detected by endoscopy |
| Study 05414 | Osteoarthritis of hip; 63 (28-93) years; 12% with ulcer | 100 mg bid (n=207); 200 mg bid (n=213) | n=218 | Naproxen 500 mg bid (n=207) | 12 | WOMAC index | Not assessed |
| Study 0628 | 389 (72%) with osteoarthritis; 148 (28%) with rheumatoid arthritis; 57 (22-86) years; 21% with ulcer | 200 mg bid (n=270) | — | Naproxen 500 mg bid (n=267) | 12 | No disease specific efficacy outcome | Incidence of ulcers detected by endoscopy |
| Study 0719 | 812 (74%) with osteoarthritis; 287 (26%) with rheumatoid arthritis; 57 (22-87) years; 12% with ulcer | 200 mg bid (n=366) | — | Diclofenac 75 mg bid (n=387); ibuprofen 800 mg tid (n=346) | 12 | No disease specific efficacy outcome | Incidence of ulcers detected by endoscopy |
| Silverstein, 200011 | 5746 (73%) with osteoarthritis; 2183 (28%) with rheumatoid arthritis; 61 (18-90) years; 8% with ulcer | 400 mg bid (n=3987) | — | Diclofenac 75 mg bid (n=1996); ibuprofen: 800 mg tid (n=1985) | 26-52 weeks | No disease specific efficacy outcome | Incidence of symptomatic ulcers, bleeds, perforations, and obstructions confirmed by endoscopy |
WOMAC=Western Ontario and McMaster universities osteoarthritis index; ACR-20=American College of Rheumatology; bid=twice daily; tid=three times daily.