Rofecoxib for dysmenorrhoea
Clinical bottom line
Rofecoxib 50 mg once daily is effective for the control of pain in dysmenorrhoea. Over 12 hours the NNT for at least half pain relief is 3-4, and 60% of women will have this outcome.
Background
Bandolier 120 looked at a systematic review [1] of NSAIDs for dysmenorrhoea, and Bandolier 121 found four randomised trials of coxibs for dysmenorrhoea. Pain with dysmenorrhoea usually lasts for about three days, though with considerable individual variation. Trials of analgesics can have various forms. The simplest might be to give the same analgesic for the whole of the painful cycle, and ask a global question concerning efficacy at the end. Women might then be crossed over to a different treatment at the next cycle. This was the design used for NSAID comparisons with placebo, with the outcome of at least moderate pain relief over the cycle.
A variation would be to use the same basic structure, but make more detailed evaluations of pain or pain relief over a limited time during the first day. This was the approach used in the coxib trials in Bandolier 121, and in two new reviews, including an individual patient meta-analysis for rofecoxib, and report of two trials with lumiracoxib, one of which used rofecoxib as a comparator.
References
JE Edwards et al. Rofecoxib for dysmenorrhoea: meta-analysis using individual patient data. BMC Women's Health 2004 4:5 (http:www.biomedcentral.com/1472-6874/4/5.
M Bitner et al. Efficacy and tolerability of lumiracoxib in the treatment of primary dysmenorrhoea. International Journal of Clinical practice 2004 58: 340-345.
Systematic review
- Date review completed: 2004
- Number of trials included: 3
- Number of patients:) 571
- Control groups: Placebo, naproxen sodium 550 mg, ibuprofen 400 mg
- Main outcomes: Half pain relief at 6, 8, and 12 hours, and remedication. Pain relief over the first dose calculated as at least 50% pain relief.
Individual patient information was available.
Results
Table 1 shows the results for rofecoxib 50 mg compared with placebo, with results over six, eight, and 12 hours. The NNT for rofecoxib 50 mg was consistently about 3, with about 60% of women having half pain relief. The proportion of women needing additional analgesia within these times was 22%, 24%, and 27% respectively. The most commonly reported adverse effects over a single dose were somnolence and nausea, but these were reported infrequently.
Table 1: Results for single dose rofecoxib 50 mg in dysmenorrhoea
| % improved |
||||||
| Drug and dose (mg) |
Number of trials |
Number of patients |
Active |
Placebo |
Relative risk (95% CI) |
NNT (95% CI) |
| Six hour outcomes | ||||||
| Rofecoxib 50 | 3 |
451 |
62 |
31 |
2.0 (1.6 to 2.5) |
3.2 (2.4 to 4.5) |
| Eight hour outcomes | ||||||
| Rofecoxib 50 | 3 |
451 |
65 |
32 |
2.0 (1.6 to 2.5) |
3.1 (2.4 to 9.0) |
| Twelve hour outcomes | ||||||
| Rofecoxib 50 | 3 |
451 |
60 |
33 |
1.8 (1.5 to 2.3) |
3.7 (2.8 to 5.6) |
One additional trial where rofecoxib 50 mg was used as a comparator had 60% of women with good or excellent outcomes with rofecoxib 50 mg at 72 hours, compared with 26% with placebo.
Comment
We have here a substantial amount of information (in terms of dysmenorrhoea trials of analgesics), with good efficacy in single doses.