The Effect of Dracocephalum Extract on Sleep Quality in Post-Menopausal Women: A Randomized Placebo-Controlled Trial
-
Fatima Muhammad Ibrahim
,
Maryam Mohammad Ibrahim
,
Haniyeh Abbassinya
,
Faezeh Rostami Cheri
,
Samaneh Nazarpoy Shirehjini
,
Farnoosh Farahbod
,
Nasim Khademi
Abstract
Objective: Sleep disturbance is one of the most prevalent problems in post-menopausal females. The current research intended to evaluate the effects of Dracocephalum on sleep disorder in post-menopausal females.
Method: The current study is a randomized, double-blind controlled trial, in which 110 post-menopausal women were randomly allocated to Dracocephalum or placebo groups. The intervention group took Dracocephalum capsules containing 250 mg Dracocephalum extract twice daily for one month. While, the placebo group took the same capsule containing 250 mg of starch twice daily for one month. Pittsburgh Sleep Quality Index was completed by the participants of both groups before and after the treatment and the data obtained were analyzed with Chi-square, paired and independent t-test in SPSS (version 20).
Results: The mean score of sleep quality before and after the treatment was 12.69 ± 3.98 and 8.58 ± 1.97 in the treatment group, respectively. Also, the score of sleep quality in the placebo group was 13.48 ± 2.60 and 11.21 ± 2.74 at the beginning and end of the research, respectively. The symptoms of sleep disorder in the intervention group significantly improved after the treatment (P < 0.001), while this was not the case with the placebo group (P = 0.155). Besides, there was a significant difference between the two groups in the mean score of sleep quality after the treatment (P = 0.012).
Conclusion: Dracocephalum extracts are effective in reducing symptoms of sleep disorders in post-menopausal women.
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3. Asltoghiri M, Ghodsi Z. The effects of Reflexology on sleep disorder in menopausal women. Procedia Soc Behav Sci. 2012;31:242-6.
4. TAAVONI S, Nazem Ekbatani N, HAGHANI H. The Effect of lemon Balm on sleep disorder in menopausal women 60-50 years old. Complementary Medicine Journal. 2013;2(4):344-54.
5. Taavoni S, Ekbatani N, Kashaniyan M, Haghani H. Effect of valerian on sleep quality in postmenopausal women: a randomized placebo-controlled clinical trial. Menopause. 2011;18(9):951-5.
6. Bixler EO, Papaliaga MN, Vgontzas AN, Lin HM, Pejovic S, Karataraki M, et al. Women sleep objectively better than men and the sleep of young women is more resilient to external stressors: effects of age and menopause. J Sleep Res. 2009;18(2):221-8.
7. Fund N, Green A, Chodick G, Orin M, Koren G, Shalev V, et al. The epidemiology of sleep disorders in Israel: results from a population-wide study. Sleep Med. 2020;67:120-7.
8. Tao MF, Sun DM, Shao HF, Li CB, Teng YC. Poor sleep in middle-aged women is not associated with menopause per se. Braz J Med Biol Res. 2016;49(1):e4718.
9. Han KS, Kim L, Shim I. Stress and sleep disorder. Exp Neurobiol. 2012;21(4):141.
10. Venter RE. Role of sleep in performance and recovery of athletes: a review article. S. Afr. J. Res. Sport Phys. Educ. Recreat. 2012;34(1):167-84.
11. Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011;21(1):41-53.
12. Polo-Kantola P. Sleep problems in midlife and beyond. Maturitas. 2011;68(3):224-32.
13. Xu Q, Lang CP. Examining the relationship between subjective sleep disturbance and menopause: a systematic review and meta-analysis. Menopause. 2014;21(12):1301-18.
14. Ornat L, Martínez-Dearth R, Chedraui P, Pérez-López FR. Assessment of subjective sleep disturbance and related factors during female mid-life with the Jenkins Sleep Scale. Maturitas. 2014;77(4):344-50.
15. Sarris J, Byrne GJ. A systematic review of insomnia and complementary medicine. Sleep Med Rev. 2011;15(2):99-106.
16. Cases J, Ibarra A, Feuillère N, Roller M, Sukkar SG. Pilot trial of Melissa officinalis L. leaf extract in the treatment of volunteers suffering from mild-to-moderate anxiety disorders and sleep disturbances. Med J Nutrition Metab. 2011;4(3):211-8.
17. Lange T, Dimitrov S, Born J. Effects of sleep and circadian rhythm on the human immune system. Ann N Y Acad Sci. 2010;1193:48-59.
18. Gooneratne NS. Complementary and alternative medicine for sleep disturbances in older adults. Clin Geriatr Med. 2008;24(1):121-38, viii.
19. Haybar H, Javid AZ, Haghighizadeh MH, Valizadeh E, Mohaghegh SM, Mohammadzadeh A. The effects of Melissa officinalis supplementation on depression, anxiety, stress, and sleep disorder in patients with chronic stable angina. Clin Nutr ESPEN. 2018;26:47-52.
20. Leach MJ, Page AT. Herbal medicine for insomnia: A systematic review and meta-analysis. Sleep Med Rev. 2015;24:1-12.
21. Khadivzadeh T, Abdolahian S, Ghazanfarpour M, Kargarfard L, Dizavandi FR, Khorsand I. A Systematic Review and Meta-analysis on the Effect of Herbal Medicine to Manage Sleep Dysfunction in Peri- and Postmenopause. J Menopausal Med. 2018;24(2):92-9.
22. Farrahi J, Nakhaee N, Sheibani V, Garrusi B, Amirkafi A. Psychometric properties of the Persian version of the Pittsburgh Sleep Quality Index addendum for PTSD (PSQI-A). Sleep Breath. 2009;13(3):259-62.
23. Mohammadbeigi A, Absari R, Valizadeh F, Saadati M, Sharifimoghadam S, Ahmadi A, et al. Sleep Quality in Medical Students; the Impact of Over-Use of Mobile Cell-Phone and Social Networks. J Res Health Sci. 2016;16(1):46-50.
24. Farrahi Moghaddam J, Nakhaee N, Sheibani V, Garrusi B, Amirkafi A. Reliability and validity of the Persian version of the Pittsburgh Sleep Quality Index (PSQI-P). Sleep Breath. 2012;16(1):79-82.
25. Mohammadi MR, Ahmadi N, Khaleghi A, Mostafavi SA, Kamali K, Rahgozar M, et al. Prevalence and Correlates of Psychiatric Disorders in a National Survey of Iranian Children and Adolescents. Iran J Psychiatry. 2019;14(1):1-15.
26. Taavoni, S., Ekbatani, N., & Haghani, H. (2015). Effect of Valerian and Lemon Balm Combined Capsules, On Postmenopausal Sleep Disorder, a Triple Blind Randomized Placebo Control Clinical Trial. Eur Psychiatry .30(S1), 1-1.
27. Taavoni S, Nazem Ekbatani N, Haghani H. Valerian/lemon balm use for sleep disorders during menopause. Complement Ther Clin Pract. 2013;19(4):193-6.
28. Heydari N, Dehghani M, Emamghoreishi M, Akbarzadeh M. Effect of Melissa officinalis capsule on the mental health of female adolescents with premenstrual syndrome: a clinical trial study. Int J Adolesc Med Health. 2018;31(3).
29. Miladi-Gorji H, Vafaei AA, Bageri A. To investigate the effect of Portulaca oleracea L. and Melissa officinalis L. extract on sleeping time in mice. Journal of Medicinal Plants. 2011;10(38):95-101.
30. Hepsomali P, Groeger JA, Nishihira J, Scholey A. Effects of Oral Gamma-Aminobutyric Acid (GABA) Administration on Stress and Sleep in Humans: A Systematic Review. Front Neurosci. 2020;14:923.
31. Jie F, Yin G, Yang W, Yang M, Gao S, Lv J, et al. Stress in Regulation of GABA Amygdala System and Relevance to Neuropsychiatric Diseases. Front Neurosci. 2018;12:562.
32. Gottesmann C. GABA mechanisms and sleep. Neuroscience. 2002;111(2):231-9.
33. Yamatsu A, Yamashita Y, Pandharipande T, Maru I, Kim M. Effect of oral γ-aminobutyric acid (GABA) administration on sleep and its absorption in humans. Food Sci Biotechnol. 2016;25(2):547-51.
34. Luppi PH, Peyron C, Fort P. Not a single but multiple populations of GABAergic neurons control sleep. Sleep Med Rev. 2017;32:85-94.
35. Lipovac M, Chedraui P, Gruenhut C, Gocan A, Kurz C, Neuber B, et al. Effect of Red Clover Isoflavones over Skin, Appendages, and Mucosal Status in Postmenopausal Women. Obstet Gynecol Int. 2011;2011:949302.
36. Shamshad Begum S, Jayalakshmi HK, Vidyavathi HG, Gopakumar G, Abin I, Balu M, et al. A Novel Extract of Fenugreek Husk (FenuSMART™) Alleviates Postmenopausal Symptoms and Helps to Establish the Hormonal Balance: A Randomized, Double-Blind, Placebo-Controlled Study. Phytother Res. 2016;30(11):1775-84.
37. Kamalifard M, Farshbaf-Khalili A, Namadian M, Ranjbar Y, Herizchi S. Comparison of the effect of lavender and bitter orange on sleep quality in postmenopausal women: A triple-blind, randomized, controlled clinical trial. Women Health. 2018;58(8):851-65.
38. Yang HM, Liao MF, Zhu SY, Liao MN, Rohdewald P. A randomised, double-blind, placebo-controlled trial on the effect of Pycnogenol on the climacteric syndrome in peri-menopausal women. Acta Obstet Gynecol Scand. 2007;86(8):978-85.
39. Liu ZM, Ho SC, Woo J, Chen YM, Wong C. Randomized controlled trial of whole soy and isoflavone daidzein on menopausal symptoms in equol-producing Chinese postmenopausal women. Menopause. 2014;21(6):653-60.
40. Park JY, Kim KH. A randomized, double-blind, placebo-controlled trial of Schisandra chinensis for menopausal symptoms. Climacteric. 2016;19(6):574-80.
2. Khaleghi A, Mohammadi MR, Zandifar A, Ahmadi N, Alavi SS, Ahmadi A, et al. Epidemiology of psychiatric disorders in children and adolescents; in Tehran, 2017. Asian J Psychiatr. 2018;37:146-53.
3. Asltoghiri M, Ghodsi Z. The effects of Reflexology on sleep disorder in menopausal women. Procedia Soc Behav Sci. 2012;31:242-6.
4. TAAVONI S, Nazem Ekbatani N, HAGHANI H. The Effect of lemon Balm on sleep disorder in menopausal women 60-50 years old. Complementary Medicine Journal. 2013;2(4):344-54.
5. Taavoni S, Ekbatani N, Kashaniyan M, Haghani H. Effect of valerian on sleep quality in postmenopausal women: a randomized placebo-controlled clinical trial. Menopause. 2011;18(9):951-5.
6. Bixler EO, Papaliaga MN, Vgontzas AN, Lin HM, Pejovic S, Karataraki M, et al. Women sleep objectively better than men and the sleep of young women is more resilient to external stressors: effects of age and menopause. J Sleep Res. 2009;18(2):221-8.
7. Fund N, Green A, Chodick G, Orin M, Koren G, Shalev V, et al. The epidemiology of sleep disorders in Israel: results from a population-wide study. Sleep Med. 2020;67:120-7.
8. Tao MF, Sun DM, Shao HF, Li CB, Teng YC. Poor sleep in middle-aged women is not associated with menopause per se. Braz J Med Biol Res. 2016;49(1):e4718.
9. Han KS, Kim L, Shim I. Stress and sleep disorder. Exp Neurobiol. 2012;21(4):141.
10. Venter RE. Role of sleep in performance and recovery of athletes: a review article. S. Afr. J. Res. Sport Phys. Educ. Recreat. 2012;34(1):167-84.
11. Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011;21(1):41-53.
12. Polo-Kantola P. Sleep problems in midlife and beyond. Maturitas. 2011;68(3):224-32.
13. Xu Q, Lang CP. Examining the relationship between subjective sleep disturbance and menopause: a systematic review and meta-analysis. Menopause. 2014;21(12):1301-18.
14. Ornat L, Martínez-Dearth R, Chedraui P, Pérez-López FR. Assessment of subjective sleep disturbance and related factors during female mid-life with the Jenkins Sleep Scale. Maturitas. 2014;77(4):344-50.
15. Sarris J, Byrne GJ. A systematic review of insomnia and complementary medicine. Sleep Med Rev. 2011;15(2):99-106.
16. Cases J, Ibarra A, Feuillère N, Roller M, Sukkar SG. Pilot trial of Melissa officinalis L. leaf extract in the treatment of volunteers suffering from mild-to-moderate anxiety disorders and sleep disturbances. Med J Nutrition Metab. 2011;4(3):211-8.
17. Lange T, Dimitrov S, Born J. Effects of sleep and circadian rhythm on the human immune system. Ann N Y Acad Sci. 2010;1193:48-59.
18. Gooneratne NS. Complementary and alternative medicine for sleep disturbances in older adults. Clin Geriatr Med. 2008;24(1):121-38, viii.
19. Haybar H, Javid AZ, Haghighizadeh MH, Valizadeh E, Mohaghegh SM, Mohammadzadeh A. The effects of Melissa officinalis supplementation on depression, anxiety, stress, and sleep disorder in patients with chronic stable angina. Clin Nutr ESPEN. 2018;26:47-52.
20. Leach MJ, Page AT. Herbal medicine for insomnia: A systematic review and meta-analysis. Sleep Med Rev. 2015;24:1-12.
21. Khadivzadeh T, Abdolahian S, Ghazanfarpour M, Kargarfard L, Dizavandi FR, Khorsand I. A Systematic Review and Meta-analysis on the Effect of Herbal Medicine to Manage Sleep Dysfunction in Peri- and Postmenopause. J Menopausal Med. 2018;24(2):92-9.
22. Farrahi J, Nakhaee N, Sheibani V, Garrusi B, Amirkafi A. Psychometric properties of the Persian version of the Pittsburgh Sleep Quality Index addendum for PTSD (PSQI-A). Sleep Breath. 2009;13(3):259-62.
23. Mohammadbeigi A, Absari R, Valizadeh F, Saadati M, Sharifimoghadam S, Ahmadi A, et al. Sleep Quality in Medical Students; the Impact of Over-Use of Mobile Cell-Phone and Social Networks. J Res Health Sci. 2016;16(1):46-50.
24. Farrahi Moghaddam J, Nakhaee N, Sheibani V, Garrusi B, Amirkafi A. Reliability and validity of the Persian version of the Pittsburgh Sleep Quality Index (PSQI-P). Sleep Breath. 2012;16(1):79-82.
25. Mohammadi MR, Ahmadi N, Khaleghi A, Mostafavi SA, Kamali K, Rahgozar M, et al. Prevalence and Correlates of Psychiatric Disorders in a National Survey of Iranian Children and Adolescents. Iran J Psychiatry. 2019;14(1):1-15.
26. Taavoni, S., Ekbatani, N., & Haghani, H. (2015). Effect of Valerian and Lemon Balm Combined Capsules, On Postmenopausal Sleep Disorder, a Triple Blind Randomized Placebo Control Clinical Trial. Eur Psychiatry .30(S1), 1-1.
27. Taavoni S, Nazem Ekbatani N, Haghani H. Valerian/lemon balm use for sleep disorders during menopause. Complement Ther Clin Pract. 2013;19(4):193-6.
28. Heydari N, Dehghani M, Emamghoreishi M, Akbarzadeh M. Effect of Melissa officinalis capsule on the mental health of female adolescents with premenstrual syndrome: a clinical trial study. Int J Adolesc Med Health. 2018;31(3).
29. Miladi-Gorji H, Vafaei AA, Bageri A. To investigate the effect of Portulaca oleracea L. and Melissa officinalis L. extract on sleeping time in mice. Journal of Medicinal Plants. 2011;10(38):95-101.
30. Hepsomali P, Groeger JA, Nishihira J, Scholey A. Effects of Oral Gamma-Aminobutyric Acid (GABA) Administration on Stress and Sleep in Humans: A Systematic Review. Front Neurosci. 2020;14:923.
31. Jie F, Yin G, Yang W, Yang M, Gao S, Lv J, et al. Stress in Regulation of GABA Amygdala System and Relevance to Neuropsychiatric Diseases. Front Neurosci. 2018;12:562.
32. Gottesmann C. GABA mechanisms and sleep. Neuroscience. 2002;111(2):231-9.
33. Yamatsu A, Yamashita Y, Pandharipande T, Maru I, Kim M. Effect of oral γ-aminobutyric acid (GABA) administration on sleep and its absorption in humans. Food Sci Biotechnol. 2016;25(2):547-51.
34. Luppi PH, Peyron C, Fort P. Not a single but multiple populations of GABAergic neurons control sleep. Sleep Med Rev. 2017;32:85-94.
35. Lipovac M, Chedraui P, Gruenhut C, Gocan A, Kurz C, Neuber B, et al. Effect of Red Clover Isoflavones over Skin, Appendages, and Mucosal Status in Postmenopausal Women. Obstet Gynecol Int. 2011;2011:949302.
36. Shamshad Begum S, Jayalakshmi HK, Vidyavathi HG, Gopakumar G, Abin I, Balu M, et al. A Novel Extract of Fenugreek Husk (FenuSMART™) Alleviates Postmenopausal Symptoms and Helps to Establish the Hormonal Balance: A Randomized, Double-Blind, Placebo-Controlled Study. Phytother Res. 2016;30(11):1775-84.
37. Kamalifard M, Farshbaf-Khalili A, Namadian M, Ranjbar Y, Herizchi S. Comparison of the effect of lavender and bitter orange on sleep quality in postmenopausal women: A triple-blind, randomized, controlled clinical trial. Women Health. 2018;58(8):851-65.
38. Yang HM, Liao MF, Zhu SY, Liao MN, Rohdewald P. A randomised, double-blind, placebo-controlled trial on the effect of Pycnogenol on the climacteric syndrome in peri-menopausal women. Acta Obstet Gynecol Scand. 2007;86(8):978-85.
39. Liu ZM, Ho SC, Woo J, Chen YM, Wong C. Randomized controlled trial of whole soy and isoflavone daidzein on menopausal symptoms in equol-producing Chinese postmenopausal women. Menopause. 2014;21(6):653-60.
40. Park JY, Kim KH. A randomized, double-blind, placebo-controlled trial of Schisandra chinensis for menopausal symptoms. Climacteric. 2016;19(6):574-80.
| Files | ||
| Issue | Vol 17 No 4 (2022) | |
| Section | Original Article(s) | |
| DOI | https://doi.org/10.18502/ijps.v17i4.10695 | |
| Keywords | ||
| Dracocephalum Herbal Medicine Post-Menopausal Period Randomized Controlled Trial Sleep Quality | ||
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How to Cite
1.
Muhammad Ibrahim F, Mohammad Ibrahim M, Abbassinya H, Rostami Cheri F, Nazarpoy Shirehjini S, Farahbod F, Khademi N. The Effect of Dracocephalum Extract on Sleep Quality in Post-Menopausal Women: A Randomized Placebo-Controlled Trial. Iran J Psychiatry. 2022;17(4):455-461.
