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

Document Type : Review Article


1 Assistant Professor, Department of Reproductive Health, Razi School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.

2 M.Sc. in Midwifery Education, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.

3 PhD Student in Medical Education, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.

4 Assistant professor, Department of Reproductive Health, Mother and Child Research Center, School of Nursing and Midwifery, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.

5 Instructor, Department of Midwifery, Razi School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.


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.


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