Research - Nigella sativa
Topical Black Cumin as Effective as NSAID Gel in Treating Cyclic Mastalgia
Reviewed: 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 [published online November 19, 2015].Planta Med. doi: 10.1055/s-0035-1558208.
Mastalgia, or breast pain, may interfere with quality of life and can occur as a non-cyclic phenomenon or as cyclic mastalgia, which occurs during the premenstrual phase of the cycle. Although there are a few standard treatments for severe mastalgia, including nonsteroidal anti-inflammatory drugs (NSAIDs), these common therapies can cause adverse side effects. Traditionally, black cumin (Nigella sativa, Ranunculaceae) seed and preparations thereof have been used both internally and externally as an analgesic, galactagogue, digestive stimulant, and antibacterial for a variety of ailments, including gastrointestinal problems, bacterial infections, dysmenorrhea, and hypertension. In Iranian traditional medicine, black cumin seed oil is used topically for mastalgia. This randomized, triple-blind, placebo-controlled trial compared the topical use of black cumin seed gel with diclofenac gel (an NSAID) and placebo.
The study included Iranian women (aged 25-45 years) with regular menstrual cycles who had cyclic mastalgia during at least three previous consecutive menstrual cycles, who experienced pain for at least seven days per month, and who had mastalgia severity scores greater than 4 on a visual analog scale (VAS; 0 = no pain to 10 = severe pain), requiring medical treatment. Those taking NSAIDs, hormones, or a hormone-based contraceptive, and those who had irregular menstrual cycles, cancer, a hysterectomy, or an oophorectomy (the surgical removal of ovaries) in the past were excluded. Patients who were pregnant, lactating, planning to become pregnant, or had severe health issues also were excluded.
Treatments consisted of cold-pressed black cumin seed oil gel (30% seed oil by weight; Barij Essence Pharmaceutical Company; Mashhad-e Ardahal, Iran), diclofenac gel (1% diclofenac by weight; Darou Pakhsh Pharmaceutical Company; Tehran, Iran), and placebo gel. The same gel base was used for all three treatments. Patients applied 2 g black cumin seed oil gel (equivalent to 600 mg of black cumin seed oil), 2 g diclofenac gel (equivalent to 20 mg of diclofenac), or 2 g placebo gel topically at the mastalgia site twice daily for two menstrual cycles.
The study’s primary endpoint was pain improvement based on VAS scores during three baseline cycles and two treatment cycles at the late luteal phase (post-ovulation). Patients also reported any adverse side effects (the secondary endpoint). 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 gel, diclofenac gel, or placebo gel (n = 53 for each). In the black cumin seed oil and diclofenac groups, one and two patients, respectively, were lost to follow-up for “personal reasons,” leaving a total of 156 for the analysis. Patients reportedly “fully complied” with the study protocol.
No significant differences were noted in baseline pain scores between groups. Following the second treatment cycle, those in the black cumin seed oil group experienced a significant decrease in pain scores compared to baseline (P < 0.001). A significant decrease in pain scores was also seen in those using diclofenac (P < 0.001). A nonsignificant reduction in pain scores between baseline and endpoint was observed in the placebo group (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 those 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 after either treatment cycle. Patients (98% of the black cumin seed oil group and 95% of the diclofenac group) reported more than 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 (58.24%), oleic acid (22.58%), and palmitoleic acid (0.28%) were prominent fixed compounds in the black cumin seed oil. The phytochemicals -cymene (51.62%), thymoquinone (14.48%) and carvacrol (0.96%) were detected as volatile components.
In this study, both black cumin seed oil gel and diclofenac gel were effective in treating mastalgia compared with placebo. The data suggest that black cumin seed oil may be as effective as diclofenac, since no significant differences were noted between pain scores in treatment cycles of these groups. Since there were no adverse side effects reported during the treatment period, black cumin seed oil appears safe for use.
Thymoquinone and carvacrol have previously been shown to have analgesic effects, and may contribute to the pain-reducing effects seen with the topical application of black cumin seed oil gel. However, since 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.
The results of this trial suggest that topical black cumin may be a candidate for the list of evidence-based natural therapies for cyclic mastalgia, which includes chaste tree (Vitex agnus-castus, Lamiaceae) berry, evening primrose (Oenothera biennis, Onagraceae) seed oil, vitamin E, and molecular iodine.
—Amy C. Keller, PhD
Source : American Botanical Council
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Turmeric/Nigella Combination Improves Metabolic Syndrome Parameters
Amin F, Islam N, Anila N, Gilani AH. Clinical efficacy of the co-administration of turmeric and black seeds (Kalongi) in metabolic syndrome – a double blind randomized controlled trial – TAK-MetS trial. Complement Ther Med. 2015;23(2):165-174.
Metabolic syndrome (MetS) is characterized by abdominal obesity and the co-occurrence of at least 3 of the following: high blood pressure (BP), elevated fasting blood glucose (FBG), high serum triglyceride (TG) levels, and low concentrations of high-density lipoprotein cholesterol (HDL-C). Medicinal plants may be used along with exercise and dietary modification to treat and prevent MetS as they contain bioactive phytochemicals with diverse metabolic effects. Experimental and clinical studies have shown that turmeric (Curcuma longa, Zingiberaceae) rhizome and nigella (Nigella sativa, Ranunculaceae) seed have hypolipidemic, hypoglycemic, and antioxidant effects. These authors followed up their 2014 study1 showing the synergistic effects of these herbs by conducting a randomized, double-blind, placebo-controlled, clinical trial to evaluate the effect of these herbs alone and in combination among patients with MetS.
Patients were recruited from "a small community, Hijrat Colony, an urban-slum located at Mai-Kolachi, Karachi, Pakistan." Male residents of the colony with a waist circumference (WC) ˃90 cm (35.4 inches), along with 3 or more features of MetS, and who were not on regular medications were recruited. The exclusion criteria were as follows: hypertension or coronary heart disease; taking herbal supplements; on medications for hyperlipidemia, obesity, or chronic disease; and debilitation. The sample size was calculated for a 5% level of significance and a power of 80%. Assuming a 20% non-participation rate, at least 62 patients in each group were required.
A total of 250 patients (mean age, 44 ± 13.3 years) were randomly assigned to receive 1 of the following treatments daily for 8 weeks:
- 1.5 g powdered nigella (3 capsules of 500 mg each) (n = 62)
- 2.4 g powdered turmeric (3 capsules of 800 mg each) (n = 63)
- 900 mg nigella and 1.5 g turmeric (3 capsules, each containing 300 mg of nigella and 500 mg of turmeric) (n = 62)
- 1.5 g powdered psyllium (Plantago ovata, Plantaginaceae) seed husk (3 capsules of 500 mg each) (n = 63)
At baseline and at the end of the study, the patients completed diet and physical activity questionnaires. Blood samples were drawn at baseline and after 4 and 8 weeks; they were analyzed to determine plasma levels of FBG, C-reactive protein (CRP), cholesterol, low-density lipoprotein cholesterol (LDL-C), HDL-C, and TGs. BP, WC, hip circumference (HC), and body mass index (BMI) were assessed at baseline and every 2 weeks.
At baseline, there were no significant differences among the groups in clinical characteristics. There were 6-9 withdrawals in each group. One patient in the nigella group quit due to nausea and 1 patient in the combination group dropped out due to excessive weakness, while in the turmeric group, 3 patients withdrew due to nausea and 1 due to skin pruritus (itching).
Compared to baseline, BMI, body fat percentage, and BP improved in all groups, but there were no significant differences among the groups. The authors attributed these improvements to lifestyle modifications.
After 8 weeks, TGs (P=0.001), cholesterol (P=0.02), FBG (P=0.02), LDL-C (P<0.001), and HDL-C (P=0.02) were significantly improved in the nigella group compared with placebo; however, when compared with baseline values, only cholesterol (P<0.001) and TGs (P<0.001) were significantly improved.
Compared with placebo, turmeric alone was more effective in reducing total cholesterol (P=0.009), LDL-C (P<0.001), and CRP (P<0.001), but had no significant effect on blood glucose. However, the effect on lipids was not significant compared to baseline.
In the combination group, improvements were observed in all clinical parameters compared with baseline values. Compared with the placebo group, greater improvements were seen in CRP (P=0.007), body fat percentage (P=0.04), total cholesterol (P=0.02), FBG (P<0.001), TGs (P=0.03), LDL-C (P<0.001), and HDL-C (P=0.04). Compared with the nigella group, the combination group showed greater improvements in HC (P=0.001), body fat percentage (P=0.008), weight (P<0.001), TGs (P=0.02), and CRP (P<0.001).
Although the occurrence of mild adverse effects was the highest in the turmeric group, there was no significant difference among groups. One patient in the nigella group and 3 patients in the turmeric group reported nausea, but there were no reports of nausea in the combination group. The authors suggest that this may be due to the lower dose of turmeric in the combination or the presence of nigella in the combination.
In summary, nigella alone improved lipid profiles and FBG and turmeric alone reduced LDL-C and CRP levels compared to placebo. However, the combination of nigella and turmeric (at 60% lower doses) improved several MetS parameters; the combination reduced body fat percentage, FBG, CRP, and improved lipid profiles. The study is limited by the failure to characterize the botanicals. These results need to be confirmed in longer-duration studies of larger and more ethnically diverse populations using herbs that have been chemically profiled.
Source : American Botanical Council - Herbclip
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Radioprotective Potential of Nigella Sativa Extract in Swiss Albino Mice Exposed to Whole Body
Ganesh Chandra Jagetia and Ravikiran PB
The radioprotective activity of Nigella sativa extract (NSE) was ascertained by administering mice orally with 25, 50, 100, 150, 200, 400 or 500 mg/kg b. wt. of NSE, once daily for five consecutive days prior to 10 Gy γ-irradiation. One hour after the last administration of NSE on fifth day, the animals were whole body exposed to 10 Gy radiation. The exposure of animals to 10 Gy irradiation resulted in the death of all irradiated animals within 16 days post-irradiation, whereas administration of mice with different doses of NSE reduced the radiation-induced mortality and increased the animal survival significantly (p<0.05). The maximum number of survivors (60%) was observed in the group of animals treated with 150 mg/kg NSE. A further increase in the NSE dose up to 500 mg/kg did not significantly elevate the animal survival when compared to 150 mg/kg. Since maximum number of survivors was observed with 150 mg/kg of NSE, it was considered as an optimum dose for radioprotection and further experiments were performed using this dose. In another set of experiments the animals were administered with 150 mg/kg b. wt. of NSE orally once daily for five consecutive days before exposure to 7, 8, 9, 10 or 11 Gy γ-radiation, where the animals were monitored daily up to thirty days post-irradiation for the development of symptoms of radiation sickness and mortality. Treatment of mice with NSE before irradiation delayed the onset of mortality and reduced the symptoms of radiation sickness when compared with the double distilled water (DDW) treated irradiated controls. The LD50/30 was found to be 8 Gy for DDW + irradiation group, whereas the NSE treatment increased LD50/30 up to 9.6 Gy with a dose reduction factor (DRF) of 1.2. The in vitro studies in cell free system revealed that NSE inhibited the generation of various free radicals including 2,2-diphenyl-2-picryl hydrazyl (DPPH), 3-ethyl benzothiazoline-6-sulphonic acid (ABTS•+), hydroxyl (OH•) and superoxide (O2•-) in a concentration dependent manner. The radioprotective effect of NSE may be due to free radical scavenging and increased antioxidant status
Source : Journal Alternative and Integrative Medicine
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A systematic review of anti-obesity medicinal plants - an update
Shirin Hasani-Ranjbar 1,2, Zahra Jouyandeh2 and Mohammad Abdollahi3*
1 Obesity & Eating Habits Research Center, Endocrinology & Metabolism Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
2 Endocrinology & Metabolism Research Center, Endocrinology & Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran
3 Faculty of Pharmacy, and Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran
Obesity is the most prevalent health problem affecting all age groups, and leads to many complications in the form of chronic heart disease, diabetes mellitus Type 2 and stroke. A systematic review about safety and efficacy of herbal medicines in the management of obesity in human was carried out by searching bibliographic data bases such as, PubMed, Scopus, Google Scholar, Web of Science, and IranMedex, for studies reported between 30th December 2008 to 23rd April 2012 on human or animals, investigating the beneficial and harmful effects of herbal medicine to treat obesity. Actually we limited our search to such a narrow window of time in order to update our article published before December of 2008. In this update, the search terms were “obesity” and (“herbal medicine” or “plant”, “plant medicinal” or “medicine traditional”) without narrowing or limiting search items. Publications with available abstracts were reviewed only. Total publications found in the initial search were 651. Total number of publications for review study was 33 by excluding publications related to animals study.
Studies with Nigella Sativa, Camellia Sinensis, Crocus Sativus L, Seaweed laminaria Digitata, Xantigen, virgin olive oil, Catechin enriched green tea, Monoselect Camellia, Oolong tea, Yacon syrup, Irvingia Gabonensi, Weighlevel, RCM-104 compound of Camellia Sinensis, Pistachio, Psyllium fibre, black Chinese tea, sea buckthorn and bilberries show significant decreases in body weight. Only, alginate-based brown seaweed and Laminaria Digitata caused an abdominal bloating and upper respiratory tract infection as the side effect in the trial group. No other significant adverse effects were reported in all 33 trials included in this article.
In conclusion, Nigella Sativa, Camellia Synensis, Green Tea, and Black Chinese Tea seem to have satisfactory anti-obesity effects. The effect size of these medicinal plants is a critical point that should be considered for interpretation. Although there was no report for side effect in these trials, we believe that safety of these plants still remains to be elucidated by further long-term studies.
Source : BMC Complementary and Alternative Medicine
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