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Efficacy of topical Rose (Rosa damascena Mill.) oil for migraine headache: A randomized double-blinded placebo-controlled cross-over trial
Affiliation:1. Haemophilia PK & ADME, Haemophilia Research, Global Research, Novo Nordisk A/S, Maaloev, Denmark;2. Department of Veterinary Clinical Sciences, University of Copenhagen, Frederiksberg, Denmark;3. Quantitative Clinical Pharmacology, Novo Nordisk A/S, Soeborg, Denmark;4. Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden
Abstract:AimTo evaluate the effect of topical formulation of Rosa damascena Mill. (R. damascena) oil on migraine headache, applying syndrome diffrentiation model.Methods and materialsForty patients with migraine headache were randomly assigned to 2 groups of this double-blind, placebo-controlled cross-over trial. The patients were treated for the first 2 consecutive migraine headache attacks by topical R. damascena oil or placebo. Then, after one week of washout period, cross-over was done. Pain intensity of the patients' migraine headache was recorded at the beginnig and ten-sequence time schadule of attacks up to 24 h. In addition, photophobia, phonophobia, and nausea and/or vomitting (N/V) of the patients were recorded as secondary outcomes. Finally, gathered data were analysed in a syndrome differentiation manner to assess the effect of R. damascena oil on Hot- and Cold-type migraine headache.ResultsMean pain intensity of the patients' migraine headache in the different time-points after R. damascena oil or placebo use, was not significantly different. Additionally, regarding mean scores of N/V, photophobia, and phonophobia severity of the patients, no significant differences between the two groups were observed. Finally, applying syndrome differentiation model, the mean score of migraine headache pain intensity turned out to be significantly lower in patients with “hot” type migraine syndrome at in 30, 45, 60, 90, and 120 min after R. damascena oil application compared to “cold” types (P values: 0.001, 0.001, <0.001, <0.001, and 0.02; respectively).ConclusionIt seems that syndrome differentiation can help in selection of patients who may benefit from the topical R. damascena oil in short-term relief of pain intensity in migraine headache. Further studies of longer follow-up and larger study population, however, are necessitated for more scientifically rigorous judgment on efficacy of R. damascena oil for patients with migraine headache.
Keywords:Migraine disorders  Headache  Rose  Traditional Persian medicine  Medicinal plants
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