title: Effectiveness of Topical Nigella sativa Seed Oil in the Treatment of Cyclic Mastalgia: A Randomized, Triple-Blind, Active, and Placebo-Controlled Clinical Trial.
abstract: Cyclic mastalgia is common in women and has no optimal therapy. Analgesic effects of Nigella sativa have been reported. Thus, the effect of a standardized N. sativa seed oil (600 mg applied to the site of pain bis in die for 2 months) on the 10-centimeter visual analog scale scores of pain severity in 52 women with cyclic mastalgia was compared to that of topical diclofenac (20 mg bis in die) (n = 51) and placebo (n = 53). There was no significant difference between the 1- and 2-month pain scores in the active treatment groups (p > 0.05). The pain scores of the active treatment groups did not differ significantly at 1 and 2 months (p > 0.05). The endpoint pain scores of the active treatment groups decreased significantly compared with the baseline (both p < 0.001). The pain scores of the active treatment groups at 1 and 2 months were significantly smaller than those of the placebo group (both p < 0.001). The pain scores of the placebo group at 1 and 2 months were not significantly different from the baseline (p > 0.05). No adverse effect was observed. In conclusion, topical N. sativa seed oil is safe, more effective than placebo, and has clinical effectiveness comparable to topical diclofenac in the treatment of cyclic mastalgia.
authors.affiliation: Medicinal Plants Research Center, Institute of Medicinal Plants, ACECR, Karaj, Iran.
authors.forename: Hasan Fallah
authors.initials: HF
authors.lastname: Huseini
authors.affiliation: Medicinal Plants Research Center, Institute of Medicinal Plants, ACECR, Karaj, Iran.
authors.forename: Saeed
authors.initials: S
authors.lastname: Kianbakht
authors.affiliation: Department of Surgery, Faculty of Medicine, Yazd University of Medical Sciences, Yazd, Iran.
authors.forename: Mohammad Hossein
authors.initials: MH
authors.lastname: Mirshamsi
authors.affiliation: Department of Pharmacology, Faculty of Pharmacy, Yazd University of Medical Sciences, Yazd, Iran.
authors.forename: Ali Babaei
authors.initials: AB
authors.lastname: Zarch
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D004008:Diclofenac / Q000627:therapeutic use; D004311:Double-Blind Method; D015340:Epidemiologic Research Design; D005260:Female; D006801:Humans; D059373:Mastodynia / Q000188:drug therapy*; D031881:Nigella sativa / Q000737:chemistry*; D010938:Plant Oils / Q000627:therapeutic use*; D012639:Seeds / Q000737:chemistry
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010938:Plant Oils; D004008:Diclofenac