ارزیابی نقادانه کارآزمایی‌های بالینی منتشر شده در زمینه تأثیر طب مکمل و جایگزین بر میزان بارداری در زنان نابارور

نوع مقاله : مروری

نویسندگان

1 دانشجوی دکترای تخصصی بهداشت باروری، مرکز تحقیقات مراقبت‌های پرستاری و مامایی، دانشگاه علوم پزشکی مشهد، مشهد، ایران.

2 استاد گروه مامایی، مرکز تحقیقات مراقبت‌های پرستاری و مامایی، دانشگاه علوم پزشکی مشهد، مشهد، ایران. استاد گروه مامایی، دانشکده پرستاری و مامایی، دانشگاه علوم پزشکی مشهد، مشهد، ایران.

چکیده

مقدمه: کارآزمایی­های بالینی در پزشکی مبتنی بر شواهد حائز اهمیت هستند و تصمیمات درمان بر اساس نتایج این مطالعات اتخاذ می­گردند. به‌دلیل فراوانی این نوع پژوهش‌ها در بحث طب مکمل و تأثیر آن بر ناباروری، مطالعه حاضر با هدف ارزیابی نقادانه کارآزمایی­های بالینی در زمینه تأثیر طب مکمل و جایگزین بر میزان بارداری در زنان نابارور انجام شد.
روشکار: در این مرور نقادانه متون، جستجو در پایگاه‌های الکترونیکی Magiran، SID،Scopus ، PubMed، Embase و ‌ Web of Science بدون محدویت زمانی تا اواخر آبان 1399 با کلمات کلیدی طب مکمل، جایگزین و ناباروری انجام گردید. معیارهای ورود به مطالعه، کارآزمایی­های بالینی منتشر شده به زبان فارسی یا انگلیسی مربوط به مصرف طب مکمل و جایگزین در زنان نابارور و معیارهای خروج شامل: عدم دسترسی به متن کامل انگلیسی مقاله و عدم رعایت اصول انجام کارآزمایی کنترل شده تصادفی بود. در ارزیابی مقالات از چک‌لیست کانسورت 2017 برای درمان­های غیردارویی استفاده گردید. محدوده امتیازدهی مقالات 44-0 بود.
یافتهها: از 25 مقاله مورد بررسی، میزان انطباق کلی کیفیت گزارش مقالات با ابزار کانسورت حدود 50% برآورد شد. بیشترین نقص در قسمت عنوان و چکیده (726/0±88/0) و بحث (898/0± 16/1) مشاهده شد. میانگین کلی نمرات مقالات 176/6±68/22 با حداقل نمره  9 و حداکثر 33 بود.
نتیجهگیری: کیفیت مقالات بررسی شده در مطالعه حاضر در حد متوسط بود. کارآزمایی­های بالینی بایستی بر اساس اصول استاندارد انجام و گزارش شوند و قبل از انتشار با ابزارهای مرتبط بررسی نقادانه گردند. آموزش پژوهشگران در جهت ارتقاء کیفیت مقالات کمک‌کننده است.
کلمات کلیدی: ارزیابی نقادانه، بارداری، طب مکمل و جایگزین، کارآزمایی­های کنترل شده تصادفی، ناباروری

کلیدواژه‌ها


عنوان مقاله [English]

Critical appraisal of Published Clinical Trials on "The Effect of Complementary and Alternative Medicine on Infertile Women's Pregnancy Rate"

نویسندگان [English]

  • Farangis Sharifi 1
  • Maryam Kabardian 1
  • Robab Latifnejad Roudsari 2
1 PhD Student of Reproductive Health, Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
2 Professor, Department of Midwifery, Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Professor, Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.
چکیده [English]

Introduction: Randomize controlled trials (RCTs) are important in evidence-based medicine, and treatment decisions are made based on the results of these studies. Due to the frequency of this type of research on complementary and alternative medicine (CAM) and its effect on infertility, this study was performed with aim of critical appraisal of the effect of CAM on infertile women's pregnancy rate.
Methods: In this critical review, searching was made on electronic scientific databases including Scopus, PubMed, Embase, Web of Science, SID and Magiran without time limitation until November 2020 using the keywords of CAM and infertility. Inclusion criteria was Persian or English published RCTs related to the use of CAM in infertile women and exclusion criteria was lack of access to the full text of the article and non-compliance of the study method with the principles of RCTs. In the evaluation of the articles, the 2017 CONSORT checklist was used for non-pharmacological treatments. The scoring range was 0-44.
Results: Out of the 25 articles reviewed, the overall quality compliance rate with the CONSORT checklist was estimated about 50%. The greatest weakness in reporting was observed in the title and abstract (0.88 ± 0. 726) and the discussion section (1.16 ± 0.898). The total mean score of the articles was 22.68 ± 6.176 with a minimum of 9 and a maximum of 33.
Conclusion: The appraised articles in the present study had an average quality. It is required that RCTs be conducted and reported in accordance with standard principles and be thoroughly reviewed critically with relevant checklists before publication. Training of researchers helps improving the quality of articles.

کلیدواژه‌ها [English]

  • Complementary and Alternative Medicine
  • Critical appraisal
  • Infertility
  • Pregnancy
  • Randomized Controlled Trials
  1. Mbuagbaw L, Thabane M, Vanniyasingam T, Debono VB, Kosa S, Zhang S, et al. Improvement in the quality of abstracts in major clinical journals since CONSORT extension for abstracts: a systematic review. Contemporary clinical trials 2014; 38(2):245-50.
  2. Falagas ME, Grigori T, Ioannidou E. A systematic review of trends in the methodological quality of randomized controlled trials in various research fields. Journal of clinical epidemiology 2009; 62(3):227-31.
  3. Joukar F, Heidarzadeh A, Asgharnezhad M, Soltanipour S, Jalali MM, Moradi M. Evaluation of clinical trial abstracts of scientific journal using the CONSORT checklist. Journal of Guilan University of Medical Sciences 2015; 24(95):40-51.
  4. Sarveravan P, Astaneh B, Shokrpour N. Adherence to the CONSORT Statement in the reporting of randomized controlled trials on pharmacological interventions published in iranian medical journals. Iranian journal of medical sciences 2017; 42(6):532.
  5. Li JY, Zhang YF, Smith GS, Xue CJ, Luo YN, Chen WH, et al. Quality of reporting of randomized clinical trials in Tai Chi interventions—a systematic review. Evidence-Based Complementary and Alternative Medicine 2011; 2011.
  6. Al-Jundi A, Sakka S. Critical appraisal of clinical research. Journal of clinical and diagnostic research: JCDR 2017; 11(5):JE01.
  7. Shakeri MT, Taghipour A, Tanbakouchi D, Sharifi Moghadam Bajestani M, Sadeghi R, Hadianfar A, et al. Assessment of Randomized Controlled Clinical Trials articles in Iranian Journal of Obstetrics, Gynecology and Infertility: 2009-2019. Iran J Obstet Gynecol Infertil 2021; 24(4):25-34.
  8. Uetani K, Nakayama T, Ikai H, Yonemoto N, Moher D. Quality of reports on randomized controlled trials conducted in Japan: evaluation of adherence to the CONSORT statement. Internal medicine 2009; 48(5):307-13.
  9. Smith BA, Lee HJ, Lee JH, Choi M, Jones DE, Bausell RB, et al. Quality of reporting randomized controlled trials (RCTs) in the nursing literature: application of the consolidated standards of reporting trials (CONSORT). Nursing outlook 2008; 56(1):31-7.
  10. Tharyan P, George AT, Kirubakaran R, Barnabas JP. Reporting of methods was better in the Clinical Trials Registry-India than in Indian journal publications. Journal of clinical epidemiology 2013; 66(1):10-22.
  11. Turner L, Shamseer L, Altman DG, Schulz KF, Moher D. Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review a. Systematic reviews 2012; 1(1):1-7.
  12. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. Jama 1996; 276(8):637-9.
  13. Moher D, Schulz KF, Altman DG; CONSORT. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Med Res Methodol 2001; 1:2.
  14. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340:c332.
  15. Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Annals of internal medicine 2008; 148(4):295-309.
  16. Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P. CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Annals of internal medicine 2017; 167(1):40-7.
  17. Chen Y, Li J, Ai C, Duan Y, Wang L, Zhang M, et al. Assessment of the quality of reporting in abstracts of randomized controlled trials published in five leading Chinese medical journals. PloS one 2010; 5(8):e11926.
  18. Wang L, Li Y, Li J, Zhang M, Xu L, Yuan W, et al. Quality of reporting of trial abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine. Trials 2010; 11(1):1-6.
  19. Schulz KF, Chalmers I, Grimes DA, Altman DG. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals. Jama. 1994; 272(2):125-8.
  20. Tabatabaei-Malazy O, Shadman Z, Ejtahed HS, Atlasi R, Abdollahi M, Larijani B. Quality of reporting of randomized controlled trials of herbal medicines conducted in metabolic disorders in Middle East countries: A systematic review. Complementary therapies in medicine 2018; 38:61-6.
  21. Linde K, Jonas WB, Melchart D, Willich S. The methodological quality of randomized controlled trials of homeopathy, herbal medicines and acupuncture. International journal of epidemiology 2001; 30(3):526-31.
  22. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Controlled clinical trials 1996; 17(1):1-12.
  23. Moher D, Soeken K, Sampson M, Ben-Porat L, Berman B. Assessing the quality of reports of systematic reviews in pediatric complementary and alternative medicine. BMC Pediatr 2002; 2:3.
  24. Salesi M, Maghari A, Mohammadi E, Yekaninejad MS, Ghanbari A. Quality assessment of published randomized controlled trials in the journal of military medicine during 1999-2015. Journal of Military Medicine 2017; 19(2):106-25.
  25. Dhillon RK, McLernon DJ, Smith PP, Fishel S, Dowell K, Deeks JJ, et al. Predicting the chance of live birth for women undergoing IVF: a novel pretreatment counselling tool. Human Reproduction 2016; 31(1):84-92.
  26. Aelion A, Barbieri E, Shastri S, Grill E, Chung P, Rosenwaks Z. The use of complementary medical therapies (CMT) in infertility patients. Fertility and Sterility 2009; 92(3):S33-4.
  27. Coulson C, Jenkins J. Complementary and alternative medicine utilisation in NHS and private clinic settings: a United Kingdom survey of 400 infertility patients. Journal of Experimental & Clinical Assisted Reproduction 2005; 2(1):1-3.
  28. Rayner JA, Willis K, Burgess R. Women's use of complementary and alternative medicine for fertility enhancement: a review of the literature. The Journal of Alternative and Complementary Medicine 2011; 17(8):685-90.
  29. Fischer FH, Lewith G, Witt CM, Linde K, von Ammon K, Cardini F, et al. High prevalence but limited evidence in complementary and alternative medicine: guidelines for future research. BMC complementary and alternative medicine 2014; 14(1):1-9.
  30. Vickers AJ. Bibliometric analysis of randomized trials in complementary medicine. Complementary Therapies in Medicine 1998; 6(4):185-9.
  31. Sharifi F, Jamali J, Larki M, Roudsari RL. Domestic Violence against Infertile Women: A Systematic Review and Meta-Analysis. Sultan Qaboos University Medical Journal [SQUMJ] 2021.
  32. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. Bmj 2021; 372.
  33. Smith CA, De Lacey S, Chapman M, Ratcliffe J, Norman RJ, Johnson NP, et al. Effect of acupuncture vs sham acupuncture on live births among women undergoing in vitro fertilization: a randomized clinical trial. Jama 2018; 319(19):1990-8.
  34. Wanting X, Yanmei Z, Ying Z, Huarong X, Jinzhu H, Zhen W, et al. Curative effect of assisted reproduction technology by Traditional Chinese Medicine multi-channel interventional therapy on 95 cases of in vitro fertilization and embryo transfer failure. Journal of Traditional Chinese Medicine 2017; 37(5):681-7.
  35. Morin SJ, Frattarelli JL, Franasiak JM, Juneau CR, Scott Jr RT. Laser acupuncture before and after embryo transfer improves in vitro fertilization outcomes: a four-armed randomized controlled trial. Medical Acupuncture 2017; 29(2):56-65.
  36. Arentz S, Smith CA, Abbott J, Fahey P, Cheema BS, Bensoussan A. Combined lifestyle and herbal medicine in overweight women with polycystic ovary syndrome (PCOS): A randomized controlled trial. Phytotherapy research 2017; 31(9):1330-40.
  37. Wu XK, Stener-Victorin E, Kuang HY, Ma HL, Gao JS, Xie LZ, et al. Effect of acupuncture and clomiphene in Chinese women with polycystic ovary syndrome: a randomized clinical trial. Jama 2017; 317(24):2502-14.
  38. Chen J, Feng S, Zeng J, Wu X, Yang M, Tang H, et al. Effectiveness of electroacupuncture for polycystic ovary syndrome: study protocol for a randomized controlled trial. Trials 2016; 17(1):1-6.
  39. Zheng Y, Feng X, Mi H, Yao Y, Zhao Y, Li J, et al. Effects of transcutaneous electrical acupoint stimulation on ovarian reserve of patients with diminished ovarian reserve in in vitro fertilization and embryo transfer cycles. Journal of Obstetrics and Gynaecology Research 2015; 41(12):1905-11.
  40. Zheng CH, Zhang J, Wu J, Zhang MM. The effect of transcutaneous electrical acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization: a study protocol for a randomized controlled trial. Trials 2014; 15(1):1-7.
  41. Guo J, Li D, Liu C, Ji X, Li R, Du X. Effects of Chinese herbs combined with in vitro fertilization and embryo transplantation on infertility: a clinical randomized controlled trial. Journal of Traditional Chinese Medicine 2014; 34(3):267-73.
  42. Kuang H, Li Y, Wu X, Hou L, Wu T, Liu J, et al. Acupuncture and clomiphene citrate for live birth in polycystic ovary syndrome: study design of a randomized controlled trial. Evidence-Based Complementary and Alternative Medicine 2013; 2013.
  43. Rashidi BH, Tehrani ES, Hamedani NA, Pirzadeh L. Effects of acupuncture on the outcome of in vitro fertilisation and intracytoplasmic sperm injection in women with polycystic ovarian syndrome. Acupuncture in Medicine 2013; 31(2):151-6.
  44. di Villahermosa DI, dos Santos LG, Nogueira MB, Vilarino FL, Barbosa CP. Influence of acupuncture on the outcomes of in vitro fertilisation when embryo implantation has failed: a prospective randomised controlled clinical trial. Acupuncture in Medicine 2013; 31(2):157-61.
  45. Smith CA, De Lacey S, Chapman M, Ratcliffe J, Norman RJ, Johnson N, et al. Acupuncture to improve live birth rates for women undergoing in vitro fertilization: a protocol for a randomized controlled trial. Trials 2012; 13(1):1-6.
  46. Moy I, Milad MP, Barnes R, Confino E, Kazer RR, Zhang X. Randomized controlled trial: effects of acupuncture on pregnancy rates in women undergoing in vitro fertilization. Fertility and Sterility 2011; 95(2):583-7.
  47. So EW, Ng EH, Wong YY, Yeung WS, Ho PC. Acupuncture for frozen–thawed embryo transfer cycles: a double-blind randomized controlled trial. Reproductive biomedicine online 2010; 20(6):814-21.
  48. Andersen D, Løssl K, Andersen AN, Fürbringer J, Bach H, Simonsen J, et al. Acupuncture on the day of embryo transfer: a randomized controlled trial of 635 patients. Reproductive biomedicine online 2010; 21(3):366-72.
  49. Madaschi C, Braga DP, Figueira RD, Iaconelli Jr A, Borges Jr E. Effect of acupuncture on assisted reproduction treatment outcomes. Acupuncture in Medicine 2010; 28(4):180-4.
  50. Kong S, Hughes A. Acupuncture as an adjunct to in vitro fertilization: a randomized trial. Medical Acupuncture 2009; 21(3):179-82.
  51. Domar AD, Meshay I, Kelliher J, Alper M, Powers RD. The impact of acupuncture on in vitro fertilization outcome. Fertility and Sterility 2009; 91(3):723-6.
  52. So EW, Ng EH, Wong YY, Lau EY, Yeung WS, Ho PC. A randomized double blind comparison of real and placebo acupuncture in IVF treatment. Human Reproduction 2009; 24(2):341-8.
  53. Smith C, Coyle M, Norman RJ. Influence of acupuncture stimulation on pregnancy rates for women undergoing embryo transfer. Fertility and sterility 2006; 85(5):1352-8.
  54. Westergaard LG, Mao Q, Krogslund M, Sandrini S, Lenz S, Grinsted J. Acupuncture on the day of embryo transfer significantly improves the reproductive outcome in infertile women: a prospective, randomized trial. Fertility and sterility 2006; 85(5):1341-6.
  55. Dieterle S, Ying G, Hatzmann W, Neuer A. Effect of acupuncture on the outcome of in vitro fertilization and intracytoplasmic sperm injection: a randomized, prospective, controlled clinical study. Fertility and sterility 2006; 85(5):1347-51.
  56. Stener‐Victorin E, Waldenström U, Wikland M, Nilsson L, Hägglund L, Lundeberg T. Electro‐acupuncture as a peroperative analgesic method and its effects on implantation rate and neuropeptide Y concentrations in follicular fluid. Human Reproduction 2003; 18(7):1454-60.
  57. Paulus WE, Zhang M, Strehler E, El-Danasouri I, Sterzik K. Influence of acupuncture on the pregnancy rate in patients who undergo assisted reproduction therapy. Fertility and sterility 2002; 77(4):721-4.
  58. Sarayloo K, Latifnejad Roudsari R. Critical evaluation of the published clinical trials regarding the effect of complementary medicine on menopausal symptoms. Iran J Obstet Gynecol Infertil 2018; 21(4):87-98.
  59. Mehrazmay A, Karambakhsh A, Salesi M. Reporting quality assessment of randomized controlled trials published in nephrology urology monthly journal. Nephro-urology monthly 2015; 7(4).
  60. Irani M, Maleki N, Latifnejad Roudsari R. Assessing the Quality of randomized controlled trials published in relation to the Efficacy of Massage Therapy on Labor Pain Intensity Using CONSORT criteria. Iran J Obstet Gynecol Infertil 2017; 20:56-67.‎
  61. Manouchehri E, Alirezaei S, Roudsari RL. Compliance of Published Randomized Controlled Trials on the Effect of Physical Activity on Primary Dysmenorrhea with the Consortium’s Integrated Report on Clinical Trials Statement: A Critical Appraisal of the Literature. Iranian Journal of Nursing and Midwifery Research 2020; 25(6):445.
  62. Cao H, Han M, Ng EH, Wu X, Flower A, Lewith G, et al. Can Chinese herbal medicine improve outcomes of in vitro fertilization? A systematic review and meta-analysis of randomized controlled trials. PLoS One 2013; 8(12):e81650.
  63. Ghojazadeh M, Tavananezhad N, Karkhanee M, Naghavi Behzad M, Azami Aghdash S. Quality of randomized clinical trial reports published by iranian researchers in the obstetrics and gynecology level 1 journals: Using consort. Iran J Obstet Gynecol Infertil 2013; 16(78):7-15.
  64. Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials. New England journal of medicine 1987; 317(7):426-32.
  65. Ayatollahi M, Jafari P, Ghaem H. Assessment of Quality randomized controlled trials published in Iran during 2000-2002. Babol University of Medical Journal 2004; 7(4):64-70.
  66. Talachi H, Orak RJ, Ravaghi H, Amanollahi A. Assessment of the quality of methodology reporting in the randomized trials. Journal of Health Administration (JHA) 2012; 15(48).
  67. Turpen RM, Fesperman SF, Smith WA, Vieweg J, Dahm P. Reporting quality and information consistency of randomized, controlled trials presented as abstracts at the American Urological Association annual meetings. The Journal of urology 2010; 184(1):249-53.
  68. Bahri N, Latifnejad Roudsari R. A critical appraisal of research evidence on Iranian women’s attitude towards menopause. Iran J Obstet Gynecol Infertil 2015; 18(178):1-11.
  69. Bayrami R, Latifnejad Roudsari R. Quality of Reporting of Cohort Studies Investigating Preconception Risk Factors of Gestational Diabetes According to the STROBE Statement. Iranian Journal of Epidemiology 2020; 16(3):248-57.