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Sunday, 21 February 2016

Effect of a traditional syrup from Citrus medica L. fruit juice on migraine headache: A randomized double blind placebo controlled clinical trial


Volume 179, 17 February 2016, Pages 170-176


Department of Phytopharmaceuticals (Traditional Pharmacy), School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran
Department of Pharmaceutics, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran
Center for Nanotechnology in Drug Delivery, Shiraz University of Medical Sciences, Shiraz, Iran

Abstract

Ethnopharmacological relevance In Persian ethnomedicine several herbal remedies and functional foods have been used to treat migraine headache which are mostly summarized in Qarabadin-e-kabir (Aghili-Shirazi MH, 1773). One of them is Citron syrup (Sharbat-e-Balang) containing edible Citrus medica L. fruit juice and sugar. The present study was designed to assess the efficacy and safety of Citron syrup on patients with migraine headache. Materials and methods Citron syrup was prepared as described in Qarabadin-e-kabir. In this double blind randomized placebo-controlled clinical trial, ninety patients with migraine headache were allocated to three parallel groups (Citron syrup, propranolol or placebo). Patients received 15 ml of Citron syrup, placebo syrup or 20 mg of propranolol tablet three times daily after a meal for 4 weeks. Primary outcomes were obtained from three measures: the frequency (per month), mean duration (hour) and mean intensity (visual analogue scale "VAS" 0-10 score) of headache attacks evaluated prior to and following 4 weeks of the intervention. Results Citron syrup was superior to placebo in reduction of headache attacks intensity (P<0.01) and duration (p<0.0001) and as effective as propranolol in patients with migraine headache (P>0.05). However, unlike propranolol, Citron syrup could not significantly reduce the frequency of attacks compared to placebo. No indication of any serious side effects from Citron syrup was observed. Conclusion According to obtained results, Citron syrup as a traditional Persian remedy can be suggested as an effective treatment for decreasing pain intensity and duration of attacks in migraine headache and the effectiveness is comparable to propranolol. However, the syrup did not show significant effect on frequency of attacks. © 2015 Elsevier Ireland Ltd. All rights reserved.

Author keywords

Citron; Citrus medica; Clinical trial; Juice syrup; Migraine headache; Persian Traditional Medicine

Indexed keywords

EMTREE drug terms: antimigraine agent; citrus medica extract; placebo; plant extract; propranolol; unclassified drug
EMTREE medical terms: adult; Article; citron; comparative study; controlled study; demography; disease duration; dizziness; double blind procedure; drug design; drug effect; drug efficacy; drug safety; female; fruit juice; human; major clinical study; male; migraine; nausea; outcome assessment; randomized controlled trial; syrup; tablet; traditional medicine; visual analog scale
Chemicals and CAS Registry Numbers: propranolol, 13013-17-7, 318-98-9, 3506-09-0, 4199-09-1, 525-66-6