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Butorphanol for acute migraine

Clinical bottom line:

Butorphanol is effective for the acute treatment of migraine. Effictiveness ranged from 20% to 60%, depending on the dose and route, severity of migraine at baseline and when outcome measured. Adverse effects were reported to be severe and frequent.


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

Search methods

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) (Jadad et al 1996). A series of free text searches were undertaken, using generic and trade names for butorphanol. 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 Neither individual authors nor pharmaceutical companies were contacted for unpublished data.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

Four randomised, double blind trials were found; butorphanol was given by intranasal (IN) route in three, and intramuscular (IM) route in one (Table). The trials were of a high quality scoring at least three out of a maximum of five using a scale that rates trial quality based on randomisation, blinding and withdrawals (Jadad et al 1996). The trials were all of a parallel design, in most IHS migraine diagnostic criteria were used, all patients had adequate pain at baseline to facilitate measuring a change and the pain outcomes were clearly defined. Outcome data for each trial was reported for timepoints up to use of additional rescue medication. Therefore results represent efficacy of a single treatment dose that does not included rescue medication.

The trials were disparate with respect dosing regimes and outcome measures precluding pooling of data for quantitative analysis. A descriptive summary of each trial is provided in the Table , and a summary of the overall results below.

 

Intranasal studies

Two placebo controlled and one active controlled trial were found. In all three, butorphanol 1 to 2 mg was effective from as early as 15 minutes. In the two placebo controlled trials, significant pain relief was achieved by 2 hours in 24 to 47% of the patients most of whom had severe migraine pain at baseline. In one, the NNT for at least 50% pain relief at two hours was 2.5 (95% confidence interval: 1.7 to 4.7), and in the other the NNT for complete pain relief at 90 minutes was 4.4 (3.2 to 6.9). In the active controlled trial, butorphanol was significantly better than 1 capsule fiorinal C (caffeine 40 mg, butalbital 50 mg, aspirin 325 mg, codeine 30 mg) for up to two hours. The number of patients reporting no or mild pain at two hours was 60% with butorphanol 1 to 2 mg, and 47% with fiorinal C.

Intramuscular study

One active controlled trial was found investigating three doses of butorphanol 1, 2 and 3 mg. The number of patients with severe or incapacitating pain at baseline reporting at least 50% pain relief at one hour was 27%, 61% and 72%, respectively.

Adverse effects

The reporting of adverse effects with butorphanol was noteworthy. In all but one of the studies adverse effects were reported by about 80 to 90% of patients who received the drug. In one study, 26% of patients refused additional doses of the study drug, 36% of all of the adverse effects were rated as severe. In another trial one patient withdrew due to adverse effects.

Further reading

Diamond S, Freitag FG, Diamond ML, Urban G. Trananasal butorphanol in the treatment of migraine headache pain. Headache Quarterly, Current Treatment and Research 1992; 3:2:164-70.

Elenbaas RM, Iacono CU, Koellner KJ et al. Dose effectiveness and safety of butorphanol in acute migraine headache. Pharmacotherapy 1991; 11:56-63.

Goldstein J, Gawel MJ, Winner P et al. Comparison of butorphanol nasal spray and fiorinal with codeine in the treatment of migraine. Headache 1998; 38:516-22.

Hoffert MJ, Couch JR, Diamond S et al. Transnasal butorphanol in the treatment of acute migraine. Headache 1995; 35:65-9.