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| Date: 02-15-2016 | HC# 011661-538 |
Huseini HF, Kianbakht S, Mirshamsi MH, Zarch AB. Effectiveness of topical Nigella sativa seed oil in the treatment of cyclic mastalgia: a randomized, triple-blind, active, and placebo-controlled clinical trial. Planta Med.November 19, 2015; [epub ahead of print]. doi: 10.1055/s-0035-1558208.
Mastalgia, or breast pain, may interfere with the quality of life of women and can occur with the menstrual cycle. Although there are many standard treatments for mastalgia, including nonsteroidal anti-inflammatory drugs (NSAIDs), these common therapies can cause adverse side effects. Black cumin (Nigella sativa, Ranunculaceae) seed has been used traditionally for a variety of ailments, including gastrointestinal problems, bacterial infections, and for hypertension. In Iranian traditional medicine, black cumin seed oil is used for mastalgia. This randomized, triple-blind, placebo-controlled trial compared the topical use of black cumin seed gel with diclofenac gel and placebo.
This study was carried out at Shahid Rahnemoon Hospital in Yazd, Iran. Iranian women from 25-45 years old with regular menstrual cycles, cyclic mastalgia for 3 or more menstrual cycles, and mastalgia for 7 days a month were included. Those included scored greater than 4 for pain using a visual analog scale from 0 (pain absent) to 10 (pain severe), necessitating treatment. Those taking NSAIDs, hormones, or a hormone-based contraceptive, or those who had irregular menstrual cycles, cancer, a hysterectomy, or an oophorectomy in the past, were excluded. Patients who were pregnant, lactating, planning pregnancy, or had other severe health issues were also excluded.
Treatments consisted of 30% per weight gel of cold-pressed black cumin seed oil (Barij Essence Pharmaceutical Company; Mashhad-e Ardahal, Iran), 1% per weight gel of diclofenac (Darou Pakhsh Pharmaceutical Company; Tehran, Iran), and placebo. The same gel base was used for all 3. Patients used 2 g of black cumin seed oil gel (equivalent to 600 mg of black cumin seed oil), diclofenac gel (equivalent to 20 mg of diclofenac), or placebo gel topically at the mastalgia site twice daily for 2 menstrual cycles. Patients used the visual analogue scale (VAS) to rate pain (primary endpoint) of 3 baseline cycles and 2 treatment cycles at the late luteal phase (post-ovulation), and any adverse side effects (secondary endpoint) were reported. Returned treatment containers and patient self-reporting were used to measure compliance. Fatty acid concentrations, as well as fixed and volatile compounds in the black cumin seed oil, were measured using gas chromatography-mass spectrometry.
From a total of 181 patients screened, 159 were randomly assigned to black cumin seed oil treatment, diclofenac, or placebo (53 to each). In the black cumin seed oil and diclofenac groups, 1 and 2 patients respectively, were lost to follow up for "personal reasons," leaving a total of 156 analyzed. It is mentioned that patients "fully complied" with the study protocol, and no significant differences were noted in baseline pain scores of patients. Following the second treatment cycle, those in the black cumin seed oil group experienced a significant decrease in pain scores as compared to baseline scores (7.23 ± 1.25 vs. 1.33 ± 1.09, P<0.001). This was also seen in those using diclofenac (7.35 ± 1.51 vs. 1.25 ± 1.21, P<0.001). A nonsignificant decline in pain scores between baseline and endpoint was observed in the placebo group (7.26 ± 1.34 vs. 5.91 ± 1.19, P>0.05).
The pain scores of those in the black cumin seed oil and diclofenac groups during both treatment cycles were significantly less than scores of the placebo group (P<0.001 for both comparisons). Additionally, no significant differences were noted between scores of the black cumin seed oil and diclofenac groups at either treatment cycle. Patients (98% of the black cumin seed oil group and 95% of the diclofenac group) reported 50% pain relief, with relief occurring 10-15 minutes following topical application. None of the patients reported any adverse side effects. In the phytochemical analysis, the unsaturated fatty acids linoleic acid (58.42%), oleic acid (22.58%), and palmitoleic acid (0.28%) were prominent fixed compounds in the black cumin seed oil. Both thymoquinone (14.48%) and carvacrol (0.96%) were detected as volatile components.
In this study, both black cumin seed oil and diclofenac were efficacious in treating mastalgia compared with placebo. The data suggest that black cumin seed oil may be as effective as diclofenac, as no significant differences were noted between pain scores in treatment cycles of these groups. As there were no adverse side effects reported in this population during the treatment period, black cumin seed oil appears safe for use. Unsaturated fatty acids, thymoquinone, and carvacrol may contribute to the pain-reducing bioactivity observed in black cumin seed oil; however, as these compounds were not directly tested, no conclusion can be drawn as to their bioactivity, and the pain modulation may be due to other undetected compounds. Further studies should investigate the potential mechanisms of action of black cumin seed oil.
—Amy C. Keller, PhD
