Ibuprofen versus Buffered Phenylbutazone in the Treatment of Osteoarthritis: Double‐Blind Trial

Abstract

In a double-blind multiclinic trial, a new nonsteroidal anti-inflammatory agent (ibuprofen) was compared with an established therapeutic agent (phenylbutazone-alka) for the treatment of osteoarthritis. Of the 159 patients from the 17 contributing clinics, 144 completed the four weeks of therapy. More than 60 per cent of them reported improvement in exercise-related pain by week 4, and there was no significant difference between treatment groups. The patients' and the physicians' evaluations of the total state of disease, as well as range-of-motion and functional tests, demonstrated similar degrees of improvement in both treatment groups. The incidence of side effects was within acceptable limits, and the frequency distribution was similar in both groups. Of the 70 reported side effects, 29 were considered by the investigator (blind trial) to be drug-related-11 in association with ibuprofen and 18 with phenylbutazone-alka. Hematologic and blood chemical studies, as well as urine and stool examinations, yielded normal results with the exception of a reduced mean value for serum uric acid and a slightly elevated mean value for SGPT in the phenylbutazone-alka group.

A critique of the 2000 update of the American College of Rheumatology recommendations for management of hip and knee osteoarthritis

“…Is there evidence to support the ACR recommendation that an NSAID may be preferable to acetaminophen as initial drug therapy in patients with clinical signs of inflammation? The guidelines give little weight to support-ing evidence from several other studies that failed to demonstrate superiority of antiinflammatory dosages of NSAIDs (including the very potent agent phenylbutazone) in comparison with analgesics, in the treatment of OA (9)(10)(11)(12). The guidelines do not define inflammation.…”

A Case of Anaphylaxis Due to Ibuprofen

“…Additionally, erythema multiforms, vesiculobullous eruption, fixed drug eruption, and Stevens:Johnson syndrome have been reported (1)(2)(3)(4). In all the clinical trials of IBP, none of the adverse cutaneous reactions were comfirmed by any in vivo or in vitro examinations, including patch testing, prick testing, and provocative tests (5)(6)(7)(8).…”

Mefenamic acid versus ibuprofen in osteoarthritis — a double‐blind cross‐over study

“…A review of 28 clinical studies of ibuprofen in the treatment of osteoarthritis 9 concluded that at a dose of 1200 mg daily, ibuprofen was superior to placebo, and at doses ranging from 1200 to 1800 mg/daily, as effective as 3.6g aspirin daily. Studies comparing ibuprofen with indomethacin 10 , diflunisal 11 , meclofenamate sodium 12 and phenylbutazone 13 found the drugs equally effective in the treatment of osteoarthritis. Other comparative studies have shown that benoxaprofen, fenclofenac and indoprofen 14–16 are superior to ibuprofen.…”