Table: Randomised, double blind controlled trials of transnasal or intramuscular butorphanol for acute migraine treatment
Reference Patients Design Intervention Outcomes Results (main outcomes) Quality
Intanasal studies
Diamond et al 1992 Adults with migraine with or without aura, DNS diagnostic criteria, baseline pain at least moderate to very severe, n=96 RCT, DB, P, rescue med allowed 1.25 hours after 2nd study dose 1. Butorphanol 1 mg + 1 mg after 1 hour IN, n=32 2. Methadone 10 mg IM, n=32 3. Placebo, n=32 Pain intensity, (0=none, 1=mild, 2=moderate, 3=severe, 4=incapacitating) Pain relief, (0=none, 1=little, 2=some, 3=a lot, 4=complete), nausea, patient assessed global n=95 analysed. Significantly better pain relief from 15 minutes with butophanol compared with placebo. # patients with at least 50% pain relief at 2 hours: Butorphanol 2 mg 15/32 (47%) Methadone 10 mg 10/32 (31%) Placebo 2/32 (6%) NNT Butorphanol v placeb R=1 DB=2 W=1 Total=4
Hoffert et al 1995 Adults with migraine with or without aura according to IHS criteria, baseline pain moderate to severe/incapacitating RCT, DB, P, rescue med allowed after 90 minutes, additional doses of butorphanol allowed 2 to 4 hourly if needed 1. Butorphanol 1 to 2mg (IN) n=107 2. Placebo n=50 Pain intensity (none, slight, moderate, severe, incapacitating), nausea, vomiting n=157 analysed Significantly better pain relief from 30 minutes with butophanol compared with placebo. # patients reporting complete pain relief by 1.5 hours: Butorphanol 1 to 2 mg 26/107 (24%) Placebo 4/50 (8%) NNT 4.4 (3.2 to 6.9) Adverse effects: 26% b R=1 DB=1 W=1 Total=3
Goldstein et al 1998 Adults with migraine with or without aura according to IHS criteria, baseline pain moderate to severe RCT, DB, P, rescue med allowed 2.5 hours after 2nd dose repeat doses 4 hourly 1. Butorphanol 1 to 2 mg (IN) n=161 2. Fiorinal C 1 cap (oral) n=160 Pain intensity (0=none, 3=severe), pain relief (0=none, 4=complete), associated symptoms, functional ability, analgesic consumption, patient global assessment n=275 analysed Butorphanol significantly better than fiorinal on all pain outcomes at most time points up to 2 hours. # patients reporting mild or no pain at 2 hours: Butorphanol 1 to 2 mg 82/136 (60%) Fiorinal C 65/138 (47%) # patients pain free at 90 mi R=2 DB=1 W=0 Total=3
Intramuscular studies
Elenbaas et al 1991 Adults with migraine with or without aura or cluster headache, non-IHS diagnostic criteria, baseline pain severe or incapacitating in most patients, n=52 RCT, DB, P, rescue med allowed after 1 hour 1. Butorphanol 1 mg IM n=15 2. Butorphanol 2 mg IM n=16 3.Butorphanol 3 mg n=19 Pain intensity, and pain relief VAS (0-100), associated symptoms n=51 analysed Significant reduction in pain from baseline in all 3 groups. 2 mg and 3 mg significantly better than 1 mg, NSD between 2 mg and 3 mg. # patients reporting at least 50% pain relief by one hour: Butorphanol 1 mg 4/15 (27%) Butorphanol 2 mg 11/ R=2 DB=2 W=1 Total=5
Abbreviations: IHS=International Headache Society; RCT=randomised controlled trial; DB=double blind; P=parallel; IN=intranasal; VAS=visual analogue scale; NNT=number-needed-to-treat; NSD=no significant difference; R=randomised; W=withdrawals and dropouts;

Last Updated on 3/1/01
By Andrew Moore