Fenbufen compared with indomethacin in osteoarthrosis

Area of Science:

• Rheumatology
• Pharmacology
• Clinical Medicine

Background:

• Osteoarthritis (OA) management requires effective and safe anti-inflammatory drugs.
• Propionic acid derivatives are a class of non-steroidal anti-inflammatory drugs (NSAIDs) used for OA.
• Evaluating novel NSAIDs against established treatments and placebo is crucial for clinical practice.

Purpose of the Study:

• To compare the efficacy and safety of fenbufen, a new propionic acid derivative, against indomethacin and placebo in osteoarthrosis patients.
• To assess the therapeutic effects of fenbufen and indomethacin using multiple assessment indices.
• To investigate potential adverse effects, specifically liver function abnormalities, associated with fenbufen therapy.

Main Methods:

• A double-blind, crossover clinical trial involving 20 osteoarthrosis patients.
• Comparison of fenbufen (600 mg/day) and indomethacin (75 mg/day) against a placebo.
• Utilized various assessment indices to evaluate drug efficacy and monitored biochemical liver function tests.

Main Results:

• Both fenbufen and indomethacin demonstrated significant improvements over placebo on several assessment indices.
• Indomethacin showed superior efficacy compared to fenbufen across multiple indices in the tested dosages.
• Five patients experienced biochemical liver function abnormalities (elevated alkaline phosphatase and/or SGOT) during fenbufen treatment, with none observed during indomethacin therapy.

Conclusions:

• Indomethacin appeared more effective than fenbufen at the dosages tested.
• The occurrence of liver function abnormalities in fenbufen-treated patients necessitates further investigation.
• Fenbufen's clinical use should be paused pending a thorough evaluation of its hepatotoxicity incidence and significance.