title: Efficacy of dosing and re-dosing of two oral fixed combinations of indomethacin, prochlorperazine and caffeine compared with oral sumatriptan in the acute treatment of multiple migraine attacks: a double-blind, double-dummy, randomised, parallel group, multicentre study.
abstract: OBJECTIVE
  In this double-blind, double-dummy, randomised, parallel group, multicentre study, the efficacy of dosing and re-dosing of a fixed combination of indomethacin, prochlorperazine and caffeine (Indoprocaf) was compared with encapsulated sumatriptan in the acute treatment of two migraine attacks. Additionally, in the group taking Indoprocaf, two different oral formulations were tested: effervescent tablets and encapsulated coated tablets.
  
  
  RESULTS
  Of 297 patients randomised (150 assigned to Indoprocaf and 147 to sumatriptan), 281 were included in the intention-to-treat efficacy analysis. The initial dosing of Indoprocaf and sumatriptan was similarly effective with pain-free rates higher than 30% (95% CI of odds-ratio: 0.57-1.28) and headache relief rates of about 60% (95% CI of odds-ratio: 0.82-1.84) with both the drugs. The efficacy of re-dosing of Indoprocaf as rescue medication was more effective than that of sumatriptan with pain-free values of 47% vs. 27% in the total attacks with a statistically significant difference in the first migraine attack in favour of Indoprocaf. The efficacy of re-dosing to treat a recurrence/relapse was very high without differences between the drugs (pain-free: 60% with Indoprocaf and 50% with sumatriptan in the total attacks). Indoprocaf and sumatriptan were well-tolerated.
  
  
  CONCLUSIONS
  The study demonstrated that the efficacy of the initial dosing of Indoprocaf was not higher than that of sumatriptan, but that the strategy to use the lowest effective dose as soon as the headache occurred, followed by a second dose if the headache has not relieved or to treat a relapse, was very effective, especially with Indoprocaf.
authors.affiliation: University Centre for Adaptive Disorders and Headache (UCADH), IRCCS C. Mondino Institute of Neurology Foundation, Pavia, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Sandrini
authors.forename: R
authors.initials: R
authors.lastname: Cerbo
authors.forename: E
authors.initials: E
authors.lastname: Del Bene
authors.forename: A
authors.initials: A
authors.lastname: Ferrari
authors.forename: S
authors.initials: S
authors.lastname: Genco
authors.forename: I
authors.initials: I
authors.lastname: Grazioli
authors.forename: P
authors.initials: P
authors.lastname: Martelletti
authors.forename: G
authors.initials: G
authors.lastname: Nappi
authors.forename: L
authors.initials: L
authors.lastname: Pinessi
authors.forename: P
authors.initials: P
authors.lastname: Sarchielli
authors.forename: P
authors.initials: P
authors.lastname: Tamburro
authors.forename: C
authors.initials: C
authors.lastname: Uslenghi
authors.forename: G
authors.initials: G
authors.lastname: Zanchin
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects; D002110:Caffeine / Q000008:administration & dosage / Q000009:adverse effects*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D011346:Prochlorperazine / Q000008:administration & dosage / Q000009:adverse effects*; D012008:Recurrence; D018170:Sumatriptan / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D004338:Drug Combinations; C524793:Indoprocaf; D002110:Caffeine; D018170:Sumatriptan; D007213:Indomethacin; D011346:Prochlorperazine