بررسی تأثیر گل مغربی و ویتامین B6 بر علائم سندرم پیش از قاعدگی: کارآزمایی بالینی تصادفی‌سازی شده

نوع مقاله: اصیل پژوهشی

نویسندگان

1 مربی گروه مامایی، مرکز تحقیقات مراقبت‌های مادر و کودک، دانشکده پرستاری و مامایی، دانشگاه علوم پزشکی همدان، همدان، ایران.

2 دانشجوی دکترای آمار زیستی، دانشکده بهداشت، دانشگاه علوم پزشکی همدان، همدان، ایران.

3 دانشیار گروه مامایی، مرکز تحقیقات مراقبت‌های مادر و کودک، دانشکده پرستاری و مامایی، دانشگاه علوم پزشکی همدان، همدان، ایران.

4 استاد گروه مامایی، مرکز تحقیقات مراقبت‌های مادر و کودک، دانشکده پرستاری و مامایی، دانشگاه علوم پزشکی همدان، همدان، ایران.

5 دانشیار گروه فارماکولوژی، دانشکده داروسازی، دانشگاه علوم پزشکی همدان، همدان، ایران.

6 مربی گروه مامایی، دانشکده پرستاری و مامایی، دانشگاه علوم پزشکی همدان، همدان، ایران.

چکیده

مقدمه: سندرم پیش از قاعدگی، مجموعه‌ای از علائم فیزیکی و روانی است که به‌طور دوره‌ای در مرحله ترشحی دوره قاعدگی بروز می‌کند. مطالعه حاضر با هدف تعیین تأثیر کپسول گل مغربی، ویتامین B6 و دارونما بر شدت علائم سندرم پیش از قاعدگی انجام شد.
روش‌کار: این مطالعه کار‌آزمایی بالینی تصادفی شده دو سوکور در سال 1395 بر روی 120 نفر از دانشجویان دانشگاه علوم پزشکی همدان و مبتلا به سندرم پیش از قاعدگی انجام شد. افراد به‌صورت تصادفی به 3 گروه 40 نفری تقسیم شدند و به‌مدت دو سیکل متوالی، به گروه اول روزانه 2 عدد قرص 40 میلی‌گرمی ویتامین B6، به گروه دوم کپسول روغن گل مغربی دو بار در روز و به گروه سوم روزانه 2 عدد دارونما از 14 روز قبل از قاعدگی تا 5 روز بعد از شروع آن داده شد. شدت علائم سندرم پیش از قاعدگی در پایان هر سیکل به‌وسیله فرم ثبت وضعیت روزانه مورد مقایسه قرار گرفت. تجزیه و تحلیل داده‌ها با استفاده از نرم‌افزار آماری SPSS (نسخه 21) و آزمون‌های کای اسکوئر، آنووا، تی زوجی و آزمون تعقیبی توکی انجام گرفت. میزان p کمتر از 05/0 معنی‌دار در نظر گرفته شد.
یافته‌ها: قبل از مداخله، میانگین شدت علائم در گروه دریافت‌کننده ویتامین B6 17/22±54/62 و در گروه کپسول گل مغربی 25/21±45/61 بود که بعد از مداخله به 15/18±08/54 و 05/9±38/21 کاهش پیدا کرد، ولی در گروه دارونما شدت علائم قبل از مداخله 12/30±21/61 بود که بعد از مداخله شدت علائم افزایش یافت (17/19±48/62). شدت علائم سندرم پیش از قاعدگی تنها در گروه دریافت‌کننده کپسول گل مغربی کاهش معناداری یافت (01/0>p).
نتیجه‌گیری: کپسول گل مغربی در مقایسه با ویتامین B6 و دارونما به‌طور قابل ملاحظه‌ای علائم سندرم پیش از قاعدگی را کاهش می‌دهد؛ لذا با توجه به عوارض جانبی اندک مشاهده شده، مصرف آن در زنان دارای سندرم پیش از قاعدگی می‌تواند مفید باشد.

کلیدواژه‌ها


عنوان مقاله [English]

The Effect of Evening Primrose and vitamin B6 on premenstrual syndrome: a randomized clinical trial

نویسندگان [English]

  • Arezoo Shayan 1
  • Hassan Ahmadinia 2
  • Seyedeh Zahra Masoumi 3
  • Fatemeh Shobeiri 4
  • Shirin Moradkhani 5
  • Hadis Sourinezhad 6
1 Instructor, Department of Midwifery, Mother and Child Care Research Center, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.
2 PhD Student in Biostatistics, School of Health, Hamadan University of Medical Sciences, Hamadan, Iran.
3 Associate Professor, Department of Midwifery, Mother and Child Care Research Center, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.
4 Professor, Department of Midwifery, Mother and Child Care Research Center, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.
5 Associate Professor, Department of pharmacology, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan, Iran.
6 Instructor, Department of Midwifery, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.
چکیده [English]

Introduction: Premenstrual syndrome is a set of physical and psychological symptoms which occur periodically during the secretory phase of the menstrual period. This study was performed with aim to compare the effect of Evening Primrose Capsule and vitamin B6 and placebo on the severity of premenstrual syndrome symptoms.
Methods: This randomized double-blind clinical trial was conducted on 120 students with premenstrual syndrome at Hamadan University of Medical Sciences in 2016. The subjects were randomly divided into 3 groups of 40 cases and for two consecutive cycles, the first group received daily 2 tablets (40 mg) vitamin B6, the second group received evening primrose capsules (1000 mg) twice daily, and third group received daily 2 placebo, 14 days before menstruation up to 5 days after it. The severity of premenstrual syndrome symptoms was compared at the end of each cycle by daily status recording form. Data were analyzed by SPSS software (version 21) and Chi-square, ANOVA, paired t-test, and Tukey test. P<0.05 was considered statistically significant.
Results: Before intervention, the mean severity of symptoms in the group receiving vitamin B6 was 62.54±22.17 and in the group receiving evening primrose capsules was 61.45±21.25 that after the intervention decreased to 54.08±18.15 and 21.38±9.05, respectively, but in the placebo group, the severity of the symptoms before the intervention was 61.21 ± 30.12 and the severity of the symptoms increased after the intervention (62.48 ± 19.17). The severity of premenstrual syndrome symptoms had significant decrease only in the group of evening primrose capsule (P <0.01).
Conclusion: The evening primrose capsule significantly reduces the symptoms of premenstrual syndrome compared with vitamin B6 and placebo; therefore, due to the limited side effects observed, it can be useful in women with premenstrual syndrome

کلیدواژه‌ها [English]

  • Evening primrose capsule
  • Premenstrual Syndrome
  • Tablet Vitamin B6
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