Phase IV evaluation of piroxicam in acute and chronic painful inflammatory disorders: an Indian study

We report the first phase-IV computerized study on Piroxicam in Indian patients. Comprehensive subject record sheets were distributed to 1,000 doctors. Piroxicam at 20 mg/day was given to patients categorized as suffering from rheumatoid arthritis (RA), osteoarthritis (OA), cervical spondylitis (CS), ankylosing spondylosis (AS), soft-tissue & other pains (ST) for up to 12 weeks. Assessments of pain, tenderness, swelling, range of movements, morning stiffness as well as the grip test and walking test, were made at 24 and 72 h, and 1, 4 and 8 weeks after therapy. All side-effects were noted. Data entry and statistical analysis (95% confidence interval) for proportions expressed as percentages) were handled by computer. A total of 174 doctors (17.4%) co-operated by giving data for 844 patients, consisting of the following cases: RA (306), OA (253), AS (52), CS (113) and ST (120). Piroxicam was found to be uniformly effective in the above disorders, a favourable response to the treatment being obtained in 82%-96% of the patients. The overall response rates (with 95% confidence interval in brackets) were 93% (91-95%) in pain, 93% (91-95%) in tenderness, 90% (80-93%) in swelling, 90% (87-92%) in range of movements and 86% (83-89%) in morning stiffness. The average duration of therapy ranged from 22 to 42 days. A total of 88 (10.4%) patients reported 224 incidences of side-effects, 91% of them being gastrointestinal, but no patient had ulcer or GI bleeding. In 1.9% of the patients, therapy was stopped due to an adverse reaction.(ABSTRACT TRUNCATED AT 250 WORDS)