Evaluation of the effect of topical chamomile (Matricaria chamomilla L.) oleogel as pain relief in migraine without aura: a randomized, double-blind, placebo-controlled, crossover study.

Neurol Sci. 2018 May 28. doi: 10.1007/s10072-018-3415-1. [Epub ahead of print] Zargaran A1,2, Borhani-Haghighi A3,4, Salehi-Marzijarani M5, Faridi P6, Daneshamouz S7, Azadi A7, Sadeghpour H8, Sakhteman A8, Mohagheghzadeh A9,10. Author information 1 Pharmaceutical Sciences Research Center, and Department of Phytopharmaceuticals (Traditional Pharmacy), School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran. 2 Department of Traditional Pharmacy, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran. 3 Clinical Neurology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. 4 Department of Neurology, Shiraz University of Medical Sciences, Shiraz, Iran. 5 Department of Biostatistics, Faculty of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. 6 Research Office for the History of Persian Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. 7 Department of Pharmaceutics, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran. 8 Department of Medicinal Chemistry, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran. 9 Pharmaceutical Sciences Research Center, and Department of Phytopharmaceuticals (Traditional Pharmacy), School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran. mohaghegh@sums.ac.ir. 10 Research Office for the History of Persian Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. mohaghegh@sums.ac.ir. Abstract Phytotherapy is a source of finding new remedies for migraine. Traditional chamomile oil (chamomile extraction in sesame oil) is a formulation in Persian medicine (PM) for pain relief in migraine. An oleogel preparation of reformulated traditional chamomile oil was prepared and then standardized based on chamazulene (as a marker in essential oil) and apigenin via gas chromatography (GC) and high-performance liquid chromatography (HPLC) methods, respectively. A crossover double-blind clinical trial was performed with 100 patients. Each patient took two tubes of drug and two tubes of placebo during the study. Visual analog scale (VAS) questionnaires were filled in by the patients and scores were given, ranging from 0 to 10 (based on the severity of pain) during 24 h. Other complications like nausea, vomiting, photophobia, and phonophobia were also monitored. There was 4.48 ± 0.01 μl/ml of chamazulene and 0.233 mg/g of apigenin in the preparation (by correcting the amount with extraction ratio). Thirty-eight patients in the drug-placebo and 34 patients in the placebo-drug groups (a total number of 72 patients as per protocol) completed the process in the randomized controlled trial (RCT). Adapted results from the questionnaires showed that pain, nausea, vomiting, photophobia, and phonophobia significantly (p < 0.001) decreased by using chamomile oleogel on the patients after 30 min. Results supported the efficacy of chamomile oleogel as a pain relief in migraine without aura. KEYWORDS: Chamomile; Migraine; Neurological sciences; Persian medicine PMID: 29808331 DOI: 10.1007/s10072-018-3415-1