بررسی تأثیر داروی ارملوکسیفن بر ماستالژی (درد پستان): مروری نظام‌مند و متاآنالیزی از کارآزماییهای بالینی

نوع مقاله : مروری

نویسندگان

1 استادیار گروه بهداشت باروی، دانشکده پرستاری و مامایی رازی، دانشگاه علوم پزشکی کرمان، کرمان، ایران.

2 کارشناس ارشد آموزش مامایی، دانشکده پرستاری و مامایی، دانشگاه علوم پزشکی ایران، تهران، ایران.

3 دانشجوی دکتری آموزش پزشکی، دانشکده پزشکی، دانشگاه علوم پزشکی تهران، تهران، ایران.

4 دانشیار گروه گوارش اطفال، دانشکده پزشکی، دانشگاه علوم پزشکی مشهد، مشهد، ایران.

5 استادیار گروه بهداشت باروی، مرکز تحقیقات مادر و کودک، دانشکده پرستاری و مامایی، دانشگاه علوم پزشکی هرمزگان، بندرعباس، ایران.

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

چکیده

مقدمه: علی‌رغم مطالعات انجام شده به‌صورت مروری ساده یا سیستماتیک، بررسی تأثیر ارملوکسیفن بر ماستالژی به‌خوبی روشن نشده است، لذا مطالعه حاضر با هدف تعیین تأثیر ارملوکسیفن بر ماستالژی در مرور کارآزمایی­های بالینی انجام گرفت.
روش‌کار: جهت انجام این مطالعه مروری، منابع الکترونیکی لاتین از جمله Cochrane Library، ISI Web of Science، Scopus و PubMed و پایگاه­های اطلاعات علمی SID و Magiran به‌صورت سیستماتیک بدون محدودیت زمانی تا تاریخ 1 ژانویه 2021 با استفاده از کلید واژه‌های Mastalgia یا  Mastalgiasیا Mastodynia یا  Mastodyniasیا  Mammalgiaیا  Mammalgiasو  Breast Painیا  Breast Painsو Breast و  pain و  Centchromanیا  Selective Estrogen Receptor Modulators (SERM)و Systematic Review وMeta-Analysis  مورد جستجو قرار گرفتند.
یافته‌ها: 12 مطالعه به مرور نظام‌مند وارد شدند و نتایج 9 مطالعه در یک متاآنالیز ترکیب شدند. اختلاف درصد قبل و بعد از درمان با اورملوکسیفن معنی‌دار بود (001/0p<) و بهبودی 87 درصدی درد پستان را نشان داد (90/0-83/0:CI؛ 87%). بر اساس نتیجه آزمون Q، ناهمگنی بین مطالعات در حد متوسط و غیرمعنی‌دار بود (33%=I2، 14/0=p). همچنین، یافته­های دو مطالعه اثربخشی معنی‌داری از داروی اورملوکسیفن را گزارش کردند.
نتیجه‌گیری: نتایج این متاآنالیز از اثربخشی داروی ارملوکسیفن در تسکین درد پستان حمایت کردند. البته تحلیل یافته­های این مطالعات در این متاآنالیز به‌دلیل ناهمگونی بالای بین مطالعات، حجم کوچک نمونه و تعداد کم آنها باید با احتیاط تفسیر گردد.

کلیدواژه‌ها


عنوان مقاله [English]

The Effect of ormeloxifene on mastalgia: A systematic review and meta-analysis of clinical trials

نویسندگان [English]

  • Masumeh Ghazanfarpour 1
  • Zari Dolatabadi 2
  • Masumeh Saeidi 3
  • Mohammad Ali Kiani 4
  • Nasibeh Roozbeh 5
  • Farzaneh Ashrafinia 6
1 Assistant Professor, Department of Reproductive Health, Razi School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.
2 Assistant Professor, Department of Reproductive Health, Razi School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.
3 M.Sc. in Midwifery Education, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.
4 PhD Student in Medical Education, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.
5 Assistant professor, Department of Reproductive Health, Mother and Child Research Center, School of Nursing and Midwifery, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
6 Instructor, Department of Midwifery, Razi School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.
چکیده [English]

Introduction: Despite the studies have been published as review or systematic, the effect of ormeloxifene on mastalgia has not been well elucidated. Therefore, this study was performed with aim to determine the effect of ormeloxifene on mastalgia in clinical trial studies.
Methods: To perform this review study, the English electronic databases including ISI Web of Science, PubMed, Scopus, and Cochrane Library; also, Magiran and Scientific Information Database (SID) were searched without time limitation until January 1, 2021, by using the keywords of Mastalgia or Mastalgias or Mastodynia, or Mastodynias or Mammalgia or Mammalgias, and Breast Pain, Breast, pain, and Centchroman or Selective Estrogen Receptor Modulators (SERM), and Systematic Review, and Meta-Analysis.  
Results: Twelve studies were included in this systematic review, and the results of nine studies were combined in the meta-analysis. The percentage difference before and after treatment with ormeloxifene was significant (p<0.001), and ormeloxifene resulted in 86% improvement in breast pain relief (87%; CI:0.83-0.90). The result of the Q test showed moderate and insignificant heterogeneity between the studies (P=0.14; I2=33%). Also, the findings of the two studies have indicated significant efficacy of ormeloxifene.
Conclusion: The results of the meta-analysis supported the efficacy of ormeloxifene in relieving breast pain. However, the analysis of the findings in this meta-analysis should be interpreted with caution due to the high heterogeneity between the studies, small sample size, and the limited number of studies.

کلیدواژه‌ها [English]

  • Breast pain
  • Mastalgia
  • Ormeloxifene
  • Systematic review
  1. Mirghafourvand M, Ahmadpour P, Rahi P, Salehiniya H. Relationship between depression and anxiety with the severity and length of cyclic mastalgia in women. Iran J Obstet Gynecol Infertil 2016; 18(179):1-7.
  2. Aminimoghadam Z. Mastalgia. EBNESINA 2006; 9(1):26-31.
  3. Fakhravar S, Bahrami N, Olfati F. Effect of individual counseling on pain quality in the women with cyclic mastalgia: a clinical trial. Journal of Inflammatory Disease 2018; 22(4):22-30.
  4. Sharami SH, Sobhani AR, Asgharnia M, Shabaani M. Prevalence of Cyclic Mastalgia and It’s Relation With Age, Marriage and Employment Outside the House. Journal Of Guilan University of Medical Sciences 2000; 9(33):111-6.
  5. Ahmadinezhad M, Delfan B, Tarahi M, Pouria A, Hashemi SM, Taheri TM, et al. Comparison of Efficacy of Local Piroxicam and Diclofenac in Benign Mastalgia; 2007.
  6. Singh MM. Centchroman, a selective estrogen receptor modulator, as a contraceptive and for the management of hormone‐related clinical disorders. Medicinal research reviews 2001; 21(4):302-47.
  7. Kamboj VP, Ray S, Anand N. Centchroman a safe reversible postcoital contraceptive with curative and prophylactic activity in many disorders. Frontiers in Bioscience 2018; 10:1-14.
  8. Lal J. Clinical pharmacokinetics and interaction of centchroman—a mini review. Contraception. 2010; 81(4):275-80.
  9. Shrivastava A. Efficacy and Safety of Ormeloxifene in Regression of Mastalgia Associated with Fibrocystic Disease of Breast. Int J Sci Res 2017;6(8):1–2
  10. Rajswaroob U, Kannan R, Kannan NS, Tirouaroul T. Effectiveness of centchroman on regression of fibroadenosis and mastalgia. Journal of clinical and diagnostic research: JCDR 2016; 10(10):PC10.
  11. Dhar A, Srivastava A. Role of centchroman in regression of mastalgia and fibroadenoma. World journal of surgery 2007; 31(6):1180-6.
  12. Mohakul SK, Guttala S, Tiru P. Role of ormeloxifene (centchroman) in benign mastalgia of diverse origin. Women’s Health Gynecol 2017; 3:1-8.
  13. Khadka S, Adhikary S, Rajbanshi S, Khaniya S, Agrawal CS, Niraula S, et al. Effective regression of mastalgia with centchroman and tamoxifen: a randomised comparison. Indian Journal of Surgery 2019; 81(3):271-6.
  14. Jain BK, Bansal A, Choudhary D, Garg PK, Mohanty D. Centchroman vs tamoxifen for regression of mastalgia: a randomized controlled trial. International Journal of Surgery 2015; 15:11-16.
  15. Dhar D, Anand S, Sarkar D. kumar Paira S, Mukherjee R. A comparative study of Centchroman vs tamoxifen in the management of mastalgia and fibroadenoma. Int J Sci Res 2018.
  16. Hafiz SP, Barnes NL, Kirwan CC. Clinical management of idiopathic mastalgia: a systematic review. Journal of primary health care 2018; 10(4):312-23.
  17. Kataria K, Dhar A, Srivastava A, Kumar S, Goyal A. A systematic review of current understanding and management of mastalgia. Indian Journal of Surgery 2014; 76(3):217-22.
  18. Ghassab-Abdollahi N, Mirghafourvand M, Osouli Tabrizi S. The effect of centchroman on mastalgia: a systematic review. The European Journal of Contraception & Reproductive Health Care 2019; 24(1):71-9.
  19. Moher D, Liberati A, Tetzlaff J, Altman DG. Group P. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS 2009; 6(7):2-9.
  20. Kumar S, Rai R, Agarwal GG, Dwivedi V, Kumar S, Das V. A randomized, double-blind, placebo-controlled trial of ormeloxifene in breast pain and nodularity. Natl Med J India 2013; 26(2):69-74.
  21. 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.
  22. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta‐ Statistics in medicine 2002; 21(11):1539-58.
  23. Neogi P, Manwatkar S, Singh SK, Kola A, Imran Q, Katyayan I, et al. A comparative study of Centchroman, Tamoxifen and Danazol in management of cyclical mastalgia. International Surgery Journal 2019; 6(2):365-8.
  24. Bansal V, Bansal A, Bansal AK. Efficacy of Sevista (Ormeloxifene) in treatment of mastalgia and fibrocystic breast disease. Int J Reprod Contracept Obstetr Gynecology 2015; 4(4):1057-60.
  25. Tejwani PL, Srivastava A, Nerkar H, Dhar A, Hari S, Thulkar S, et al. Centchroman regresses mastalgia: a randomized comparison with danazol. Indian Journal of Surgery 2011; 73(3):199-205.
  26. Kumar VK, Hasan A. Observation on role of centchroman versus danazol in treatment of benign breast disorder. Int J Sci Res 2017; 6:683-5.
  27. Rathi J, Chawla I, Singh K, Chawla A. Centchroman as First‐line Treatment for Mastalgia: Results of an Open‐label, Single‐arm Trial. The breast journal 2016; 22(4):407-12.
  28. Kontostolis E, Stefanidis K, Navrozoglou I, Lolis D. Comparison of tamoxifen with danazol for treatment of cyclical mastalgia. Gynecological Endocrinology 1997; 11(6):393-7.
  29. Samami M, Bahmani N, Alaee M, Honar BN. Determining the effect of mood disorders treatment as a nonsurgical approach in the elimination of mastalgia in women with breast pain 2020; 2(3):11-20.
  30. Stachs A, Stubert J, Reimer T, Hartmann S. Benign breast disease in women. Deutsches Ärzteblatt International 2019; 116(33-34):565.
  31. Groen JW, Grosfeld S, Bramer WM, Ernst MF, Mullender MM. Cyclic and non-cyclic breast-pain: A systematic review on pain reduction, side effects, and quality of life for various treatments. European Journal of Obstetrics & Gynecology and Reproductive Biology 2017; 219:74-93.