تأثیر ترکیب گیاهی منوهلپ® بر نشانه‌های زودرس یائسگی: یک کارآزمایی بالینی تصادفی دوسوکور کنترل شده با دارونما

نوع مقاله : اصیل پژوهشی

نویسندگان

1 کارشناس ارشد مامایی، کمیته تحقیقات دانشجویان، دانشکده پرستاری و مامایی، دانشگاه علوم پزشکی تبریز، تبریز، ایران.

2 استاد گروه مامایی، مرکز تحقیقات تعیین‌کننده‌های اجتماعی سلامت، دانشکده پرستاری و مامایی، دانشگاه علوم پزشکی تبریز، تبریز، ایران.

3 پزشک عمومی، مرکز تحقیقات گیاهان دارویی باریج، کاشان، ایران.

چکیده

مقدمه: نشانه ­های زودرس یائسگی بسیار شایع و اغلب بسیار ناراحت­ کننده می ­باشند. با توجه به افزایش روزافزون تعداد زنان با تجربه این نشانه­ ها در جهان و ایران، نیاز فزاینده­ای به استفاده از روش ­هایی جهت کاهش این نشانه­ ها وجود دارد، لذا مطالعه حاضر با هدف تعیین تأثیر ترکیب گیاهی منوهلپ بر کاهش شدت نشانه ­های زودرس یائسگی و تعداد و شدت گرگرفتگی (پیامدهای اولیه) و ارتقای کیفیت خواب و کیفیت زندگی (پیامدهای ثانویه) زنان یائسه انجام شد.
روش‌کار: در این مطالعه کارآزمایی بالینی دوسوکور، 100 زن 59-50 ساله شهر تبریز که از نشانه­های یائسگی رنج می­ بردند، به‌صورت تصادفی به یکی از دو گروه دریافت­ کننده منوهلپ یا دارونما تخصیص یافتند. تصادفی­ سازی بلوک­ بندی شده طبقه ­ای (بر اساس مدت زمان یائسگی) با نسبت تخصیص 1:1 انجام گرفت. جهت بررسی پیامدها، مقیاس‌های کلیماکتریک گرین، کیفیت خواب پیتزبورگ و کیفیت زندگی ویژه یائسگی (MENQOL) و چک­لیست تعداد و شدت گرگرفتگی مورد استفاده قرار گرفت. تجزیه و تحلیل داده­ ها با استفاده از نرم‌افزار آماری SPSS (نسخه 21) و آزمون­ های آنووا با اندازه ­گیری تکراری، آنالیز کوواریانس و من­ ویتنی­ یو انجام شد. میزان p کمتر از 05/0 معنی­ دار در نظر گرفته شد.
یافته ­ها: از نظر میانگین نمرات گرین، 4 و 12 هفته پس از شروع مداخله، تفاوت آماری معنی­ داری بین دو گروه وجود نداشت (تفاوت میانگین تعدیل شده 60/0، فاصله اطمینان 95%: 9/2- تا 0/4)، ولی میانگین رتبه تعداد گرگرفتگی (به‌ترتیب 003/0=p و 008/0=p) و میانگین شدت (59/0، 3/0 تا 9/0) در گروه منوهلپ نسبت به گروه دارونما بیشتر بود. از نظر میانگین رتبه نمره پیتزبورگ (29/0=p) 4 هفته و میانگین نمره MENQOL (64/0=p) 12 هفته پس از شروع مداخله تفاوت معنی­ داری بین دو گروه وجود نداشت.
نتیجه­ گیری: نتایج این مطالعه نتوانست تأثیر مثبت کپسول گیاهی ترکیبی منوهلپ بر بهبود نشانه‌های زودرس یائسگی را نشان دهد.

کلیدواژه‌ها

عنوان مقاله [English]

The effect of combined herbal capsules (Menohelp®) on early symptoms of menopause: a randomized double-blind placebo-controlled trial

نویسندگان [English]

  • Fariba Mousavi 1
  • Sakineh Mohammad-Alizadeh-Charandabi 2
  • Mojgan Mirgafourvand 2
  • Reza Bekhradi 3
1 M.Sc. in Midwifery, Student Research Committee, School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.
2 Professor, Department of Midwifery, Social Determinants of Health Research Center, School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.
3 General Physician, Barij Medicinal Plants Research Center, Kashan, Iran.
چکیده [English]

Introduction: Early symptoms of menopause are very common and often very bothersome. Considering the increasing number of women experiencing these symptoms in the world and Iran, there is a growing need to use methods to reduce these symptoms. Therefore, this study was performed with aim to determine the effect of the combined herbal capsules (Menohelp) on reducing the early symptoms of menopause, number and intensity of hot flashes (primary outcomes), and improving sleep quality and quality of life (secondary outcomes) in menopausal women.
Methods: In this double-blind trial in Tabriz, 100 women aged 50 to 59 years suffering from early symptoms of menopause were randomly assigned into two groups of receiving capsules of either Menohelp or placebo. The randomization was done using blocked randomization stratifying by duration of menopause with allocation ratio of 1:1. The outcomes were assessed using the Green Climacteric Scale, a checklist including the number and severity of hot flashes, Pittsburgh sleep quality and the Menopause-Specific Quality of Life (MENQOL). Data were analyzed by SPSS statistical software (version 21) and repeated measures ANOVA, ANCOVA and Mann-Whitney U. P<0.05 was considered statistically significant.
Results: There were no statistically significant differences between the two groups in terms of mean score of Green at 4 and 12 weeks of intervention (adjusted mean difference 0.60, 95% CI -2.9 to 4.0), but, mean rank number (p = 0.003 and p = 0.008, respectively) and mean intensity (0.59, 0.3 to 0.9) of hot flashes were higher in the Menohelp group than the placebo group. The mean rank score of Pittsburgh (p = 0.29) at 4 weeks and mean score of MENQOL (p = 0.64) at 12 weeks of intervention were not significantly different between the two groups.
Conclusion: The results of the present study could show the positive effects of Menohelp herbal capsule on improving the early symptoms of menopause.

کلیدواژه‌ها [English]

  • Black cohosh
  • Herbal medicine
  • Hot flashes
  • Menopause
  • Quality of life

مراجع

  1. Berek JS. Berek & Novak's Gynecology. 16th ed. Wolters Kluwer; 2019.
  2. InterLACE Study Team. Variations in reproductive events across life: a pooled analysis of data from 505 147 women across 10 countries. Human Reproduction 2019; 34(5):881-93.
  3. Monteleone P, Mascagni G, Giannini A, Genazzani AR, Simoncini T. Symptoms of menopause—global prevalence, physiology and implications. Nature Reviews Endocrinology 2018; 14(4):199-215.
  4. Bacon JL. The menopausal transition. Obstetrics and Gynecology Clinics 2017; 44(2):285-96.
  5. Islam MR, Gartoulla P, Bell RJ, Fradkin P, Davis SR. Prevalence of menopausal symptoms in Asian midlife women: a systematic review. Climacteric 2015; 18(2):157-76.
  6. Dicker D, Nguyen G, Abate D, Abate KH, Abay SM, Abbafati C, et al. Global, regional, and national age-sex-specific mortality and life expectancy, 1950–2017: a systematic analysis for the Global Burden of Disease Study 2017. The lancet 2018; 392(10159):1684-735.
  7. Hill K. The demography of menopause. Maturitas 1996; 23(2):113-27.
  8. Shou C, Li J, Liu Z. Complementary and alternative medicine in the treatment of menopausal symptoms. Chinese journal of integrative medicine 2011; 17:883-8.
  9. Kim N, Gross C, Curtis J, Stettin G, Wogen S, Choe N, et al. The impact of clinical trials on the use of hormone replacement therapy: a population-based study. Journal of general internal medicine 2005; 20:1026-31.
  10. Hill DA, Crider M, Hill SR. Hormone therapy and other treatments for symptoms of menopause. American Family Physician 2016; 94(11):884-9.
  11. Vinogradova Y, Coupland C, Hippisley-Cox J. Use of hormone replacement therapy and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases. bmj 2019; 364.
  12. Peng W, Adams J, Sibbritt DW, Frawley JE. Critical review of complementary and alternative medicine use in menopause: focus on prevalence, motivation, decision-making, and communication. Menopause 2014; 21(5):536-48.
  13. Swiss Natural. Natural HRT Extra Strength. Available from https://www.nationalnutrition.ca/swiss-natural-natural-hrt-extra-strength-50-caps-50-caps-2-for-deal.html. Accessed 20 Apr 2023.
  14. Kenda M, Glavač NK, Nagy M, Sollner Dolenc M. Herbal products used in menopause and for gynecological disorders. Molecules 2021; 26(24):7421.
  15. Erem S, Özçelik AÖ. Alternative Treatments in Menopausal Period. Health Sciences Research in the Globalizing World; 2018:371.
  16. Taylor M. Complementary and alternative approaches to menopause. Endocrinology and Metabolism Clinics 2015; 44(3):619-48.
  17. Van Die MD, Burger HG, Teede HJ, Bone KM. Vitex agnus-castus (Chaste-Tree/Berry) in the treatment of menopause-related complaints. The Journal of Alternative and Complementary Medicine 2009; 15(8):853-62.
  18. Chan YS, Cheng LN, Wu JH, Chan E, Kwan YW, Lee SM, et al. A review of the pharmacological effects of Arctium lappa (burdock). Inflammopharmacology 2011; 19(5):245-54.
  19. Jiang K, Jin Y, Huang L, Feng S, Hou X, Du B, et al. Black cohosh improves objective sleep in postmenopausal women with sleep disturbance. Climacteric. 2015 Jul 4;18(4):559-67.
  20. Rattanatantikul T, Maiprasert M, Sugkraroek P, Bumrungpert A. Efficacy and safety of nutraceutical on menopausal symptoms in post-menopausal women: A randomized, double-blind, placebo-controlled clinical trial. Journal of dietary supplements 2022; 19(2):168-83.
  21. Tanmahasamut P, Vichinsartvichai P, Rattanachaiyanont M, Techatraisak K, Dangrat C, Sardod P. Cimicifuga racemosa extract for relieving menopausal symptoms: a randomized controlled trial. Climacteric 2015; 18(1):79-85.
  22. Komesaroff PA, Black CV, Cable V, Sudhir K. Effects of wild yam extract on menopausal symptoms, lipids and sex hormones in healthy menopausal women. Climacteric 2001; 4(2):144-50.
  23. Mohammad-Alizadeh-Charandabi S, Shahnazi M, Nahaee J, Bayatipayan S. Efficacy of black cohosh (Cimicifuga racemosa L.) in treating early symptoms of menopause: a randomized clinical trial. Chinese medicine 2013; 8(1):1-7.
  24. Askari F, Basiri Mk, Basiri Mm, Torabi S, Gholamfarkhani S, Mohareri M, et al. Age of natural menopause and the comparison of incidence of its early complications in menopause transition stages in women from Gonabad city. Horizon of Medical Sciences 2012; 17(4):42-8.
  25. Greene JG. Constructing a standard climacteric scale. Maturitas 2008; 61(1-2):78-84.
  26. Buysse DJ, Reynolds III CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry research 1989; 28(2):193-213.
  27. Amsterdam JD, Yao Y, Mao JJ, Soeller I, Rockwell K, Shults J. Randomized, double-blind, placebo-controlled trial of Cimicifuga racemosa (black cohosh) in women with anxiety disorder due to menopause. Journal of clinical psychopharmacology 2009; 29(5):478-83.
  28. Lee H, Choue R, Lim H. Effect of soy isoflavones supplement on climacteric symptoms, bone biomarkers, and quality of life in Korean postmenopausal women: a randomized clinical trial. Nutrition Research and Practice 2017; 11(3):223-31.
  29. Tayebi N, Emamghoreishi M, Akbarzadeh M. Effect of vitex agnus-castus on depression of postmenopausal women: A randomized clinical trial. Shiraz E-Medical Journal 2021; 22(6).
  30. Peng CC, Liu CY, Kuo NR, Tung TH. Effects of phytoestrogen supplement on quality of life of postmenopausal women: a systematic review and meta-analysis of randomized controlled trials. Evidence-Based Complementary and Alternative Medicine 2019; 2019.
  31. Djapardy V, Panay N. Alternative and non-hormonal treatments to symptoms of menopause. Best Practice & Research Clinical Obstetrics & Gynaecology 2022; 81:45-60.
  32. Naseri R, Farnia V, Yazdchi K, Alikhani M, Basanj B, Salemi S. Comparison of vitex agnus-castus extracts with placebo in reducing menopausal symptoms: a randomized double-blind study. Korean journal of family medicine 2019; 40(6):362-7.
  33. Abbaspoor Z, Hajikhani NA, Afshari P. Effect of Vitex agnus-castus on menopausal early symptoms in postmenopausal women: a randomized, double blind, placebo-controlled study. British Journal of Medicine and Medical Research 2011; 1(3):132-40.
  34. Ferrari A. Soy extract phytoestrogens with high dose of isoflavones for menopausal symptoms. Journal of Obstetrics and Gynaecology Research 2009; 35(6):1083-90.
  35. Castelo-Branco C, Navarro C, Beltrán E, Losa F, Camacho M, the Natural Products Study Group of the Spanish Menopause Society. Black cohosh efficacy and safety for menopausal symptoms. The Spanish Menopause Society statement. Gynecological Endocrinology 2022; 38(5):379-84.
مجله زنان، مامایی و نازایی ایران
دوره 26، شماره 3
خرداد 1402
صفحه 66-77

فایل ها

هم رسانی

ارجاع به این مقاله

آمار