Rofecoxib for dysmenorrhoea: meta-analysis using individual patient data.

Area of Science:

• Pharmacology
• Clinical Trials
• Pain Management

Background:

• Primary dysmenorrhea is a common gynecological condition causing significant pain and impacting daily life.
• Non-steroidal anti-inflammatory drugs (NSAIDs) are standard treatments, but individual efficacy and safety profiles vary.
• Rofecoxib, a selective COX-2 inhibitor, was evaluated for its effectiveness and safety in managing dysmenorrhea.

Purpose of the Study:

• To determine the analgesic efficacy of single-dose rofecoxib compared to placebo and naproxen sodium in primary dysmenorrhea.
• To assess the incidence of adverse effects associated with single-dose rofecoxib.
• To provide data for evidence-based treatment decisions for menstrual pain.

Main Methods:

• Individual patient data meta-analysis from three randomized, double-blind, placebo- and active-controlled trials.
• Calculation of Number-Needed-to-Treat (NNT) for at least 50% pain relief.
• Assessment of rescue medication use and adverse event reporting over 12 hours.

Main Results:

• Single-dose rofecoxib 50 mg demonstrated analgesic efficacy comparable to naproxen sodium 550 mg.
• NNTs for 50% pain relief at 12 hours were similar for rofecoxib (3.7) and naproxen sodium (3.8).
• Fewer patients required rescue medication with rofecoxib (27%) and naproxen sodium (29%) compared to placebo (50%).

Conclusions:

• Single-dose rofecoxib 50 mg offers effective pain relief for primary dysmenorrhea, similar to naproxen sodium 550 mg.
• The duration of analgesia and safety profile suggest rofecoxib is a viable option for short-term management of menstrual pain.
• Adverse effects were uncommon, supporting the safety of short-term use of both rofecoxib and naproxen sodium.