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Dextropropoxyphene for acute migraine

Clinical bottom line:

Based on very limited data of poor validity, dextropropoxyphene compounds were shown to be as effective as ergotamine 1 to 2 mg for the treatment of acute migraine. No placebo controlled trials or controlled trials of dextropropoxyphene alone were found. These trials were unable to demonstrate how effective these compounds were, so direct comparison with other migraine drugs is not possible.


Dextropropoxyphene, a weak opiate is a poor analgesic for acute postoperative pain. The NNT for dextropropoxyphene 65 mg for at least 50% pain relief for patients with moderate to severe postoperative pain is about 8 to 9 based on about 500 patients. It is often given in combination with aspirin or paracetamol to improve the analgesic effect. In the absence of a published systematic review of dextropropoxyphene, Bandolier searched for the evidence.

Inclusion criteria were: treatment of acute migraine with dextropropoxphene by any route; randomised allocation to treatment groups; double-blind design; adult population and headache outcomes.

Search

Comprehensive searches of the following databases were made: MEDLINE (1966 - July 2000), EMBASE (1980 - June 2000), Cochrane Library (Issue 3, 2000) and the Oxford Pain Relief Database (1950 - 1994). A series of free text searches were undertaken, using generic and trade names for dextropropoxyphene. There was no restriction to language. Retrieved reports were searched for additional trials. Neither individual authors nor pharmaceutical companies were contacted for unpublished data.

Findings

Only two randomised, double blind trials were found investigating two different oral dextropropoxyphene compounds, Doleron and Doleron novum ( Table ). Neither trials had placebo groups, but compared dextropropoxyphene with ergotamine 1 to 2 mg and aspirin 500 to 1000 mg. The trials scored three and four out of a maximum of five using a scale that rates trial quality based on randomisation, blinding and withdrawals. However, the trials were of low methodological quality based on other aspects of trial design. Neither report stated which diagnostic criteria were used, it was unclear when the outcomes were assessed, therefore results would have been for single and multiple doses of each study medication. The trials were of a crossover design, and authors failed to either report on the absence or presence of carryover effects, or describe a minimum period between attacks to avoid these effects. Finally, it was not clear if all patients had sufficient pain at baseline which is of particular importance in the absence of a placebo group to demonstrate trial assay sensitivity.

Both trials included three treatment groups: dextropropoxyphene compound one to two tablets, aspirin 500 to 1000 mg and ergotamine tartrate one to two mg. Each patient in each trial took each drug seven times for a total of 21 consecutive migraine attacks. Authors reported significantly better pain relief and shorter duration of migraine attacks in both dextropropoxyphene groups compared with aspirin. There were no significant differences for these main outcomes between dextropropoxyphene and ergotamine groups.

Adverse effects

In one of the trials dextropropoxyphene and aspirin produced significantly fewer adverse effects than ergotamine, and in the other trial there were no differences.

References

Hakkarainen H, Gustafsson B, Stockman O. A comparative trail of ergotamine tartrate, acetyl salicylic acid and a dextropropoxyphene compound in acute migraine attacks. Headache 1978; 18:35-9

Hakkarainen H, Quiding H, Stockman O. Mild analgesics as an alternative to ergotamine in migraine. A comparative trial with acetylsalicylic acid, ergotamine tartrate, and a dextropropoxyphene compound. J Clin Pharmacol 1980; 20:590-5