Alternative supplement for enhancement of reproductive health and metabolic profile among perimenopausal women: a novel role of Nigella sativa

Document Type: Original Article

Authors

1 Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Malaysia

2 Medicinal Plants Research Centre, Yasuj University of Medical Sciences,Yasuj, Iran

3 Department of Biomedicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Malaysia

4 Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Malaysia

Abstract

Objective(s):The aim of this open label crossover study was to investigate the effects of Nigella sativa on reproductive health and metabolic profile of perimenopausal women in Rawang, Malaysia.  
Materials and Methods:Sixty nine perimenopausal women aged 45 to 65 were allocated into the experimental group treated orally with 1600mg/day of encapsulated pure powdered N. sativa compared to control groups treated with placebo for 12 weeks. At the end of study, participants underwent washout period for fourteen days before being crossed over and continued for another cycle of treatment. Participants were abstained from taking any other drugs, herbal preparations or food supplements throughout the study. Body weight, height, waist circumference, blood pressure, biochemical parameters and hormonal levels were measured at baseline and at the end of experiment for both cycles. Face to face interview was carried out at baseline and every week to check for compliance, minimize dropouts and to record reproductive health and quality of life indicators using Greene climacteric and SF-36 instruments.
Results:The treatment groups in both cycles showed significant improvement with reference to low density lipoprotein cholesterol and blood glucose (P<0.05). There were no significant differences between groups in total cholesterol, high density lipoprotein and triglyceride concentration. Treatment with N. sativa induced a significant reduction of prevalence and severity of menopausal symptomsas well as significant improvement in some components of quality of life (P<0.05).
Conclusion: These results suggested that treatment with N. sativa exert a therapeutic and protective effect by modifying weight gain, improving lipid profile and blood glucose as well as hormonal level which is believed to play an important role in the pathogenesis of metabolic syndrome during menopause.

Keywords


1. Curcio JJ, Kim LS, Wollner D, Pockaj BA. The potential role of 5-hydroxytryptophan for hot flash reduction: a hypothesis.Altern Med Rev 2005; 10:216-221.

2. Teomana N, Özcana A, Acarb B. The effect of exercise on physical fitness and quality of life in postmenopausal women.Maturitas 2004; 47:71-77.

3. Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: A comprehensive review. Health Qual Life Out 2009; 3:39-48.

4. Speroff L, Gass M, Constantine G, Olivier S. Efficacy and tolerability of desvenlafaxinesuccinate treatment for menopausal vasomotor symptoms. ObstetGynaecol 2008; 111:77-87.

5. Roe EB, Chiu KM, Arnaud CD. Selective estrogen receptor modulators and postmenopausal health. Adv Intern Med 2000; 45:259–278.

6. Smolinski D,Wollner D, Orlowski J, Curcio J, Nevels J, Kim LS. A pilot study to examine a combination botanical for the treatment of menopausal symptoms. J Altern Complement Med 2005; 11:483-489.

7. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. JAMA 2002; 288:321–333.

8. Parhizkar S, Latiff AL, Dollah MA, Hassan STS, Rashid I, Hanachi P. A review of the menopausal symptoms management with herbal remedies.Eur J Sci Res 2008;21:46-63.

9.Schwartsmann G, Ratain MJ, Cragg GM, Wong JE, Saijo N, Parkinson D,et al.Anticancer drug discovery and development throughout the world.J ClinOncol2002; 20:47s-59s.

10.Boronditsky RS. Balancing safety and efficacy focuse on endometrial protection.J Reprod Med 2000; 45:273-84.

11. Taylor M.Alternatives to conventional hormone replacement therapy. ComprTher 1997; 23:514–532.

12.Lieberman S. A review of the effectiveness of Cimicifugaracemosa (black cohosh) for the symptoms of menopause.J Women’s Health 1998; 7:525–529.

13. Kronenberg F, Fugh-Berman A. Complementary and alternative medicine for menopausal symptoms: A review of randomized, controlled trials. Ann Intern Med 2002; 137:805–813.

14.  Haq A, Lobo PL, Al-Tufail M, Rama NR,Al-Sedairy S. Immunomodulatory effect of Nigella sativa proteins fractionated by ion exchange chromatography. J Immunopharmacol 1995; 21:283-295.

15. Bamosa AO, Ali BA, Sawayan SA. Effect of oral ingestion of Nigella sativa seed on some blood parameters.J Saudi Pharm 1997; 5:126-129.

16. Buriro MA, Tayyab M.Effect of Nigella sativa on lipid profile in albino rats. Gomal J Med Sci 2007; 5:28-31.

17. Parhizkar S,Latiff LA,Rahman SA, Dollah MA,Hanachi P. Assessing estrogenic activity of Nigella sativa in ovariectomized rats using vaginal cornification assay. Afr J Pharm Pharmacol 2011; 5:137-142.

18. Parhizkar S,Latiff AL, Rahman SA, Dollah MA. Evaluation of estrogen-like activity of Nigella sativa inovariectomized rats.Afr J Pharm Pharmacol 2011; 5:1006-1011.

19. WeeCC,DavisRB,Hamel MB. Comparing the SF-12 and SF-36 health status questionnaires in patients with and without obesity.Health Qual Life Out 2008; 6:11.

20. Michalak EE, Yatham LN, Lam RW. Quality of life in bipolar disorder: a review of the literature. Health Qual Life Out2005; 3:72.

21. Brazier JE, Harper R, Jones NM, O’Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ 1992; 305:160-164.

22. Ryan N, Rosner A. Quality of life and costs associated with micronized progesterone and medroxyprogesterone acetate in hormone replacement therapy for nonhysterectomized, postmenopausal women. ClinTher 2001; 23:1099-1115.

23. Tinker LF, Perri MG, Patterson RE, Bowen DJ, McIntosh M, Parker LM, Sevick MA, Wodarski LA. The effects of physical and emotional status on adherence to a low-fat dietary pattern in the Women’s Health Initiative. J Am Diet Assoc 2002; 102:789-800.

24. Elit L, Esplen MJ, Butler K, Narod S. Quality of life and psychosexual adjustment after prophylactic oophorectomy for a family history of ovarian cancer. Fam Cancer 2001; 1:149-156.

25. Mishra GD, Brown WJ, Dobson AJ. Physical and mental health: Changes during menopause transition. Qual Life Res 2003; 12:405-412.

26. Schneider HP, Heinemann LA, Rosemeier HP, Potthoff P, Behre HM. The menopause rating scale (MRS): comparison with Kupperman index and quality-of-life scale SF-36. Climacteric 2000; 3:50-58.

27. Guo R, Canter PH, Ernst E. A systematic review of

randomised clinical trials of individualised herbal medicine in any indication. Postgrad Med J 2007; 83:633-637.

28. Kessel B, KronenbergF. The role of complementary and alternative medicine in management of menopausal symptoms.EndocrinolMetabClin N Am 2004; 33:717–739.

29. Lioyd KB, Hornsby LB.  Complementary and alternative medications for women’s health issues. NutrClinPract2009; 24:589-608.

30. Tissera  MHA, Serasinghe P, Karunarathna C. Preliminary Study on the effect of Baraka Oil on Cholesterol in Human Blood. Baraka 2014 .Available from: http://www.baraka.lk/research/clinical-trials-of-black-seed/

31. El Dakhakhny M, Mady NL, Halim MA. Nigella sativa L. Oil protects against induced hepatotoxicity and improves serum lipid profile in rats. Arzneimittelforschung 2000; 50:832-836.

32. Zandi PR, Carlson MC, Plassman BL, Welsh-bohmer KA, Mayer LS, Steffens DC, et al. Hormone replacement therapy and incidence of Alzheimer disease in older women. The cache county study. JAMA 2002; 288:2123-2129.

33. Houcher Z, BoudiafKh, Benboubetra M,Houcher B. Effects of Methanolic Extract and Commercial Oil of Nigella sativa L. on Blood Glucose and Antioxidant Capacity in Alloxan-Induced Diabetic Rats.Pteridines 2007; 18:8-18.

34. Najmi A, Haque SF, Khan RA, Nasiruddin M. Therapeutic Effect ofNigella sativa Oil on different clinical andbiochemical parameters inmetabolic syndrome. Inter J Pharmacol 2008; 5:1531-2976.

35. Qidwai W, Hamza HB, Qureshi R, Gilani A.Effectiveness, Safety, and Tolerability of powdered Nigella sativa (Kalonji) seed in capsules on serum lipid levels, blood sugar, blood pressure, and body weight in adults: Results of a randomized, double-blind controlled trial. J Altern Complement Med 2009; 15:639-644.

36. El-Bagir NM, Farah ITO, Alhaidary A, Mohamed HE, Beynen AC. Clinical loboratory serum values in rabbits fed diets containing black cumin seed. J Anim Vet Adv 2010; 9:2532-2536.

37. Parhizkar S, Latiff AL, Rahman SA, Dollah MA. Preventive effect of Nigella sativa on metabolic syndrome in menopause induced rats. J Med Plants Res 2011; 5:1478-1484.

38. Ibrahim RM, Hamdan NS, Ismail M, Saini SM, Rashid SNA, Latiff LA, et al. Protective effect of Nigella sativa on metabolic syndrome in menopausal women.Adv Pharm Bull 2014; 4:29-33.