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
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