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
  1. Seedhom AE, Mohammed ES, Mahfouz EM. Life style factors associated with premenstrual syndrome among El-Minia University students, Egypt. ISRN Public Health 2013; 2013:617123.
  2. Brahmbhatt S, Sattigeri BM, Shah H, Kumar A, Parikh D. A prospective survey study on premenstrual syndrome in young and middle aged women with an emphasis on its management. Int J 2013; 1(2):69-72.
  3. Marrif HI. Premenstrual syndrome, pharmaceuticals and alternative management. Eur J Soc Sci 2011; 21:2.
  4. Pearlstein T, Steiner M. Premenstrual dysphoric disorder: burden of illness and treatment update. FOCUS 2012; 10(1):90-101.
  5. Shooshtari MH, Hosseinpoor S, Tirandaz F, Mirhosseini M. Prevalence of premenstrual dysphoric disorder in female students of medical sciences. ISRN Public Health Am Based Res J 2013; 2:19-24.
  6. Fritz MA, Speroff L. Clinical gynecologic endocrinology and infertility. 8th ed. Philadelphia: Lippincott Williams & Wilkins; 2011.
  7. Direkvand Moghadam A, Kaikhavani S, Sayehmiri K. The worldwide prevalence of premenstrual syndrome: a systematic review and meta-analysis study. Iran J Obstet Gynecol Infertil 2013; 16(65):8-17. (Persian).
  8. Kroll AR. Recreational physical activity and premenstrual syndrome in college-aged women. [Master Thesis]. Massachusetts: University of Massachusetts Amherst; 2010.
  9. Samadi Z, Taghian F, Valiani M. The effects of 8 weeks of regular aerobic exercise on the symptoms of premenstrual syndrome in non-athlete girls. Iran J Nurs Midwifery Res 2013; 18(1):14-9.
  10. Farajnia S, Hosseinian S, Shahidi S, Sadeghi MS. Codifying and examine psychometric properties of Marital Sexual Function Scale (MSFS). Biannual J Appl Counsel 2014; 4(1):85-102.
  11. Cheng SH, Shih CC, Yang YK, Chen KT, Chang YH, Yang YC. Factors associated with premenstrual syndrome–a survey of new female university students. Kaohsiung J Med Sci 2013; 29(2):100-5.
  12. Rad M, Sabzevary MT, Dehnavi ZM. Factors associated with premenstrual syndrome in female high school students. J Educ Health Promot 2018; 7:64.
  13. Pinar G, Colak M, Oksuz E. Premenstrual syndrome in Turkish college students and its effects on life quality. Sex Reprod Healthc 2011; 2(1):21-7.
  14. Mazza D. Women's health in general practice. Australia: Elsevier; 2011.
  15. Mohebbi Dehnavi Z, Jafarnejad F, Mojahedy M, Shakeri M, Sardar M. The relationship between temperament warm and cold with symptoms of premenstrual syndrome. Iran J Obstet Gynecol Infertil 2016; 18(179):17-24. (Persian).
  16. Charles RB, Herbert W, Laube D, Ling F, Smith R. Obstetrics and gynecology. Philadelphia: Lippincott Williams & Wilkins; 2013. P. 380-5.
  17. Johnson SR. Premenstrual syndrome, premenstrual dysphoric disorder, and beyond: a clinical primer for practitioners. Obstet Gynecol 2004; 104(4):845-59.
  18. Speroff L, Fritz MA. Clinical gynecologic endocrinology and infertility. 7th ed. Philadelphia: Lippincott Williams & Wilkins; 2005. P. 531-47.
  19. Wyatt KM, Dimmock PW, Frischer M, Jones PW, O'Brien SP. Prescribing patterns in premenstrual syndrome. BMC Womens Health 2002; 2(1):4.
  20. Zargari A. Medicinal plants. 7th ed. Tehran: Tehran University Publication; 1998. P. 319. )Persian).
  21. Fallah Huseini H, Fakhrzadeh H, Larijani B, Shikh Samani AH. Review of anti-diabetic medicinal plant used in traditional medicine. J Med Plants 2006; 1(17):1-8.
  22. Emtiazy M, Keshavarz M, Khodadoost M, Kamalinejad M, Gooshahgir SA, Bajestani HS, et al. Relation between body humors and hypercholesterolemia: an Iranian traditional medicine perspective based on the teaching of Avicenna. Iran Red Crescent Med J 2012; 14(3):133-8.
  23. Masoumi SZ, Shayan AR, Ahmadinia HA, Ebrahim R, Niyatabesh RA, Moradkhani SH, et al. Effects of fenugreek seeds on the severity and duration of pain in primary dysmenorrhea in the students at Hamadan University of Medical sciences, Iran (2016). Iran J Obstet Gynecol Infertil 2018; 21(4):25-33. (Persian).
  24. Shayan A, Masoumi SZ, Shobeiri F, Tohidi S, Khalili A. Comparing the effects of agnugol and metformin on oligomenorrhea in patients with polycystic ovary syndrome: a randomized clinical trial. J Clin Diagn Res 2016; 10(12):QC13.
  25. Abdnejad R, Simbar M. A review on herbal medicines effective of premenstrual syndrome in Iran. Iran J Obstet Gynecol Infertil 2016; 19(11):18-30. (Persian).
  26. Beckmanne CR, Herbert W. Obstetrics and gynecology. 7th ed. Philadelphia: Lippincott Williams & Wilkins; 2013.
  27. Bordoni A, Biagi PL, Turchetto E, Serroni P, De Jaco AP, Orlandi C. Treatment of premenstrual syndrome with essential fatty acids (evening primrose oil). J Clin Med 1987; 68(1):23-8.
  28. Saki M, Jariani M, Saki K, Delfan B, Tarahi M, Gholami M. Effects of evening primrose oil on depression disorders on patients at the psycho-neurological clinic of Khoramabad. J Ilam Univ Med Sci 2009; 16(4):46-54. (Persian).
  29. Alvandipour M, Tayebi P, Alizadeh NR, Khodabakhshi H. Comparison between effect of evening primrose oil and Vitamin E in treatment of cyclic mastalgia. J Babol Univ Med Sci 2011; 13(2):7-11. (Persian).
  30. Babazadeh R, Keramat A. Premenstrual syndrome and complementary medicine in Iran: a systematic review. Feyz 2011; 15(2):174-87. (Persian).
  31. Dante G, Facchinetti F. Herbal treatments for alleviating premenstrual symptoms: a systematic review. J Psychosom Obstet Gynecol 2011; 32(1):42-51.
  32. Jarvis CI, Lynch AM, Morin AK. Management strategies for premenstrual syndrome/premenstrual dysphoric disorder. Ann Pharmacother 2008; 42(7-8):967-78.
  33. Bendich A. The potential for dietary supplements to reduce premenstrual syndrome (PMS) symptoms. J Am Coll Nutr 2000; 19(1):3-12.
  34. Kiani F, Sayehmiri K, Sayehmiri F, Naghdi N, Ghafari M, Asadi-Samani M, et al. Effects of vitamin B6 on premenstrual syndrome: a systematic review and meta-Analysis. J Chem Pharm Sci 2016; 9(3):1346-53.
  35. Salehi L, Salehi F. The effect of pyridoxine (vit B6) on premenstrual syndrome. J Kordestan Univ Med Sci 2007; 2(15):32-9.
  36. Sepehrirad M, Bahrami H, Noras M.The role of complementary medicine in control of premenstrual syndrome evidence based (Regular Review Study). Iran J Obstet Gynecol Infertil 2016; 19(24):11-22. (Persian).
  37. Chocano-Bedoya PO, Manson JE, Hankinson SE, Johnson SR, Chasan-Taber L, Ronnenberg AG, et al. Intake of selected minerals and risk of premenstrual syndrome. Am J Epidemiol 2013; 177(10):1118-27.
  38. Salimi S, Nokhostin B, Alijahan R, Hazrati S. Investigating the relationships between maternal hemoglobin concentration and maternal body mass index in pregnancy and neonatal birth weight. Iran J Obstet Gynecol Infertil 2012; 15(14):14-20. (Persian).
  39. Khajehei M, Abdali K, Parsanezhad ME, Tabatabaee HR. Effect of treatment with dydrogesterone or calcium plus vitamin D on the severity of premenstrual syndrome. Int J Gynecol Obstet 2009; 105(2):158-61.
  40. Fallah LT, Najafi A, Fathizadeh N, Khaledian Z. The effect of evening primrose oil on premenstrual syn. Sci J Hamadan Nurs Midwifery Facul 2008; 16(1):35-45
  41. Whelan AM, Jurgens TM, Naylor H. Herbs, vitamins and minerals in the treatment of premenstrual syndrome: a systematic review. Can J Clin Pharmacol 2009; 16(3):e407-29.
  42. Masumi Z, Khalili A, Delforooz F, Faradmal J, Shayan A. Comparison the effect of evening primrose oil and vitamin E on premenstrual syndrome. Complement Med J Facul Nurs Midwifery 2017; 7(2):1931-43. (Persian).
  43. Henshaw CA. PMS: diagnosis, aetiology, assessment and management. Adv Psych Treat 2007; 13(2):139-46.
  44. Ghasemnezhad A, Honermeier B. Yield, oil constituents, and protein content of evening primrose (Oenothera biennis L.) seeds depending on harvest time, harvest method and nitrogen application. Ind Crops Prod 2008; 28(1):17-23.
  45. Watanabe S, Sakurada M, Tsuji H, Matsumoto S, Kondo K. Efficacy of γ-linolenic acid for treatment of premenstrual syndrome, as assessed by a prospective daily rating system. J Oleo Sci 2005; 54(4):217-24.
  46. Kashanian M, Mazinani R, Jalalmanesh S. Pyridoxine (vitamin B6) therapy for premenstrual syndrome. Int J Gynecol Obstet 2007; 96(1):43-4.
  47. Hassani N, Kazemi M, Karimi Afshar H, Kazemi M, Tavakoli M. Comparison of the effects of relaxation and vitamin b6 on emotional and physical symptoms in premenstrual syndrome. Evid Based Care 2015; 5(2):75-83. (Persian).
  48. Sharma P, Kulshreshtha S, Singh G, Bhagoliwal A. Role of bromocriptine and pyridoxine in premenstrual tension syndrome. Indian J Physiol Pharmacol 2007; 51(4):368-74.
  49. Dickerson LM, Mazyck PJ, Hunter MH. Premenstrual syndrome. Am Fam Physician 2003; 67(8):1743-52.