ارزیابی نقادانه کارآزمایی‌های بالینی منتشر شده در رابطه با تأثیر طب مکمل بر روی علائم یائسگی

نوع مقاله : مروری

نویسندگان

1 دانشجوی دکترای تخصصی بهداشت باروری، کمیته تحقیقات دانشجویی، دانشکده پرستاری و مامایی، دانشگاه علوم پزشکی مشهد، مشهد، ایران.

2 دانشیار گروه مامایی، مرکز تحقیقات مراقبت مبتنی بر شواهد، دانشگاه علوم پزشکی مشهد، مشهد، ایران.

چکیده

مقدمه: مطالعات کارآزمایی بالینی در حیطه یائسگی، به دلیل نقش بسیار حیاتی سلامت زنان در خانواده و جامعه، از جایگاه ویژه‌ای در تولید شواهد برخودار هستند. شرط استفاده از نتایج کارآزمایی‌های بالینی در پزشکی مبتنی بر شواهد، کیفیت مطلوب کارآزمایی بالینی و صحت متدولوژیک آن است. مطالعه حاضر با هدف بررسی نقادانه کیفیت کارآزمایی‌های بالینی منتشر شده توسط پژوهشگران ایرانی، در زمینه تأثیر طب مکمل بر روی علائم یائسگی انجام شد.
روش‌کار: در این مطالعه توصیفی، مطالعات کارآزمایی بالینی منتشر شده در حیطه تأثیر طب مکمل بر روی علائم یائسگی در یک بازه زمانی (10 ساله) سال‌های 94-1384 در مجلات ایرانی نمایه شده در پایگاه‌های اطلاعاتی معتبر SID، Iranmedx، Irandoc، Magiran و Google scholar و با استفاده از کلید‌واژه‌های یائسگی، طب مکمل، ماساژ، طب فشاری، طب گیاهی و کارآزمایی بالینی مورد بررسی قرار گرفتند. از مجموع 238 مقاله بازیابی شده، تعداد 47 مقاله با استفاده از چک لیستConsort 2010 مورد ارزیابی نقادانه قرار گرفت. حداکثر و حداقل امتیازی که هر مقاله می‌توانست کسب کند به ترتیب 37 و صفر بود. تجزیه و تحلیل داده­ها با استفاده از روش­های آمار توصیفی و نرم‌افزار آماری SPSS (نسخه 16) صورت گرفت.
یافته‌ها: میانگین کیفیت کلی مقالات بررسی شده برابر با 94/3±93/23 از حداقل و حداکثر کسب شده 33-16 بود. به‌علاوه از 47 کارآزمایی بالینی منتشر شده، محاسبه حجم نمونه در 21 مورد (68/44%)، شیوه تصادفی‌سازی در 20 مورد (5/46%)، نوع کورسازی و چگونگی انجام آن در 19 مورد (42/40%) و روش مورد استفاده برای تولید توالی تخصیص در 35 مقاله (46/74%) ذکر شده بود. در 46 مقاله (87/97%) نیز به روش‌های آماری استفاده شده اشاره شده بود. در بین بخش‌های اصلی مقاله، قسمت "پیشینه و هدف" بیشترین و "روش‌کار" کمترین میانگین را در ارزیابی کیفی به خود اختصاص دادند.
نتیجه‌گیری:کارآزمایی‌های بالینی منتشر شده در مجلات علوم پزشکی ایران از طراحی و شیوه گزارشی در حد متوسط برخوردارند، بنابراین پیشنهاد می‌شود که سردبیران مجلات، داوران و پژوهشگران کارآزمایی‌های بالینی از یک دستورالعمل استاندارد به‌منظور طراحی و گزارش کارآزمایی‌ها استفاده نموده و آموزش‌های لازم در این خصوص در نظر گرفته شود.

کلیدواژه‌ها

عنوان مقاله [English]

Critical Evaluation of the Published Clinical Trials Regarding the Effect of Complementary Medicine on Menopausal Symptoms

نویسندگان [English]

  • Khadijeh Sarayloo 1
  • Robab Latifnejad Roudsari 2
1 PhD Student of Reproductive Health, Student Research Committee, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.
2 Associate Professor, Department of Midwifery, Evidence-Based Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
چکیده [English]

Introduction: Clinical trials in the field of menopause play a critical role in producing valid evidence due to the importance of women’s health in the family and society. The results of clinical trials could be used in the evidence-based medicine in case they have a good quality and precise methodology. Therefore, this study aimed to evaluate the quality of clinical trials published by Iranian authors regarding the effects of complementary medicine on menopausal symptoms.
Materials and Methods: This descriptive study assessed the clinical trials published during 2007-2016 concerning the impact of complementary medicine on menopausal symptoms. The articles of Iranian journals indexed in SID, Iranmedex, Irandoc, Magiran, and Google Scholar were selected. Several keywords were utilized for searching, including menopause, complementary medicine, massage therapy, acupressure, herbal medicine, and clinical trials. Finally, 47 out of 238 retrieved articles were critically appraised using the  Consolidated Standards of Reporting Trials (CONSORT) checklist 2010. The maximum and minimum score that each article could obtain was 37 and zero, respectively. All the data were analyzed using descriptive statistics by SPSS version 16.
Results: The findings of present study demonstrated that the mean score of overall quality for the reviewed articles was 23.93±3.94 with the maximum and maximum scores of 16 and 33, respectively. It was revealed that among the 47 clinical trials, sample size calculation, randomization method, type and method of blinding, and the method for generating a random allocation sequence were mentioned in 21 (44.68%), 20 (46.5), 19 (40.42), and 35 (74.46%) studies, respectively. In addition, the used statistical methods were also noted in 46 (97.87%) studies. In the qualitative assessment, the highest mean score was obtained for the introduction and the least for the materials and methods parts.
Conclusion: According to the results of this study, the clinical trials published in Iranian medical journals are moderate in terms of study design and reporting method. Consequently, it is recommended that the editors, referees, and researchers of clinical trials, apply a standard guideline for designing and reporting the results of clinical trials. Moreover, the necessary steps for trainings in this regard should be considered.

کلیدواژه‌ها [English]

  • Acupressure
  • Acupuncture
  • Complementary Medicine
  • CONSORT
  • Herbal Medicine
  • Menopause
  • Randomized controlled trial

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مجله زنان، مامایی و نازایی ایران
دوره 21، شماره 4
تیر 1397
صفحه 87-98

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