Comparative Efficacy of Zolpidem and Nigella Sativa in Treatment of Sleep Disorder and Vasomotor Symptoms in Menopausal Women of Women’s General Hospital
Abstract
Objective: To evaluate the efficacy of Zolpidem and Nigella sativa compared to placebo in treatment of sleep disturbance in healthy postmenopausal women. Menopause is a period that diagnosed after 12 months of amenorrhea and is characterized by a group of symptoms that include irregular menses; vasomotor and urogenital symptoms. The effects of non-hormonal therapies are being widely researched on menopause symptoms. There has been no study to compare Zolpidem and Nigella sativa versus placebo.
Materials and methods: In this double-blind, placebo controlled trial, we compared the effect of Zolpidem with Nigella sativa and placebo in reducing sleep quality in 60 menopausal women. The prior and the later results were compared. We divided the patients into three groups after history taking and physical examination and filling the Pittsburgh questionnaire. Each group received their medication as the following order: Group A: Zolpidem, Group B: Nigella sativa, Group C: placebo. The first group received Zolpidem with the dose of 5 mg for 8 weeks. The second group received Nigella sativa with the dose of 600 mg for 8 weeks. The third group received placebo for 8 weeks. After two months, the Pittsburg questionnaire was filled again.
Results: In the nigella sativa group, we had not significant improvement in sleep quality (p =0.07), hot flashes (p =0.15), palpitation (p =0.56) and night sweets (p =0.08). In zolpidem group, we have seen lack of improvement of hot flashes (p =0.73), and palpitation (p =0.36), which are nonsignificant statistically according to p values, but in zolpidem group, we had significant improvement in sleep quality (p =0.01), and night sweats (p =0.049).
Conclusion: It seems that zolpidem has some effect on improving the quality of sleep in postmenopausal women. zolpidem also is good for night sweats. Nigella sativa was not effective in vasomotor symptoms and sleep quality.
2. Im EO, Lee BI, Chee W, Dormire S, Brown A. A national multiethnic online forum study on menoposaul symptom experiences. Nurs Res 2010; 59: 26-33.
3. Gibbs RS, Karlan BY, Haney AF, Nygaald IE.Danforth’s obstetrics and gynecology. Philadephia. Lippincott Williams & Wilkins; 10th Ed 2008: 1063-72.
4. North American Menopause Society. Available at www.menopause.org.
5. National Institutional for Complementary and alternative medicine. Complementary, Alternative, or Integrative Health: What’s In a Name? 2005.
6. Souls MR, Sherman S, Parrott E, Rebar E,Santoro N,Utian W,et al . Executive summary: stages of reproductive aging workshop. (STRAW). Park city, Utah, july 2001. Menopause 2001; 8:402-7.
7. Davari-Tanha F, Soleimani-Farsani M, Asadi M , Shariat M,Shirazi M,Hadizadeh H. Comparison of citalopram and venlafaxine’s role in treating sleep disturbances in menopausal women, a randomized, double-blind, placebo-controlled trial. Arch Gynecol Obstet 2016; 293: 1007-13.
8. Labbate, LA, Fava, M, Rosenbaum, JF, Arana JW. Drugs for the treatment of depression. In: Handbook of Psychiatric Drug Therapy, 6th ed, Lippincott Williams & Wilkins, Philadelphia. 2010: 54.
9. Padmaa M Paarakh. Nigella Sativa Linn_A Comprehensive review, Indian journal of Natural Products and Resources 2010; 4: 409-29.
10. Seidi MM, Stewart DE. Alternative treatment for menopause symptoms. Can FAM Physician 1998; 44; 1271-6.
11. Rossouw J, Anderson GL, Prentice RL, Lacroix AZ, Kooperberg C,Stefanick M, et al . Risks and benefits of estrogen plus progestin in healthy postmenopausal women; principle results from the women’s health initiative randomized controlled trial. JAMA 2002; 288: 321-33.
12. Hiirata JD, Swiersz LM, Small R, Ettinger B. Does Dong-Quai have estrogenic effects in post menopausal women? A double blind placebo controlled trial, Fertil Steril 1997; 68; 981-6.
13. Mantyranta T, Hemminki E, Kangas I, Topo P, Uutela A. Alternative drug used for the climacteric in Finaland, Maturitas 1997; 27:5-11.
14. Women’s nutritional Advisory Service (WNAS). Menopause survey 2002-interim results. 2002.
15. Stadberg E, Mattsson LA, Milsom I. The prevalence and severity of climartic symptoms and the use of different treatment regimens in a Swedish population, Acta Obstet Gynecol Scand 1997; 76; 442-8.
16. Duthie FJ. Flora of the Upper Gangetic Plain and of the Adjacent Siwalik and Sub-Himalayan Tracts. National government publication, Calcutta: Botanical Survey of India 1960.
17. Sandhu KS, Rana AC. A Review of plant nigella sativa: A brief consideration of its pharmacognostic characters, chemical constituents and therapeutic benefits. Pharma science Monitor 2013; 4: 323-43.
18. Rajsekhar S, Kuldeep B. Pharmacognosy and Pharmacology of Nigella sativa - A review. International Research Journal of Pharmacy 2011; 2: 36-9.
19. Dorsey CM, Lee KA, Scharf MB. Effect of zolpidem on sleep in women with perimenopausal insomnia: a 4 week randomized multicenter double-blind, placebo controlled study. Clinical Therapeutics 2004; 26: 1578-86.
20. Kravitz HM,Ganz PA, Bromberger J, Powell LH, Sutton-Tyrrell K, Meyer PM. Sleep difficulty in women at midlife: a community survey of sleep and menopausal transition. Menopause 2003; 10: 19-28.
21. Timur S, Sahin NH. Effects of sleep disturbance on the quality of life of Turkish menopausal women: a population- based study. Maturitas 2009; 64: 177-81.
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Issue | Vol 14, No 3 (September 2020) | |
Section | Original Articles | |
DOI | https://doi.org/10.18502/jfrh.v14i3.4672 | |
Keywords | ||
Zolpidem Nigella Sativa Sleep Disorder Menopause |
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