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Planta Med 2016; 82(04): 285-288
DOI: 10.1055/s-0035-1558208
Biological and Pharmacological Activity
Original Papers
Georg Thieme Verlag KG Stuttgart · New York

Effectiveness of Topical Nigella sativa Seed Oil in the Treatment of Cyclic Mastalgia: A Randomized, Triple-Blind, Active, and Placebo-Controlled Clinical Trial

Hasan Fallah Huseini
1   Medicinal Plants Research Center, Institute of Medicinal Plants, ACECR, Karaj, Iran
,
Saeed Kianbakht
1   Medicinal Plants Research Center, Institute of Medicinal Plants, ACECR, Karaj, Iran
,
Mohammad Hossein Mirshamsi
2   Department of Surgery, Faculty of Medicine, Yazd University of Medical Sciences, Yazd, Iran
,
Ali Babaei Zarch
3   Department of Pharmacology, Faculty of Pharmacy, Yazd University of Medical Sciences, Yazd, Iran
› Author Affiliations
Further Information

Publication History

received 07 July 2015
revised 27 September 2015

accepted 05 October 2015

Publication Date:
19 November 2015 (online)

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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.

Key words

Nigella sativa - Ranunculaceae - mastalgia - Diclofenac - pain
 

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