A randomized, double-blind, placebo-controlled trial of ormeloxifene in breast pain and nodularity.

Abstract

BACKGROUND:

Breast pain and non-discrete breast nodularity are common in women.

METHODS:

We did a randomized, double-blind, placebocontrolled trial of oral ormeloxifene 30 mg, a selective oestrogen receptor modulator (SERM) or placebo twice a week for 3 months in 20-50-year-old women with breast pain with or without lumpiness. Women with a discrete benign lump or cancer were excluded from the study. Serial assessments of pain on a visual analogue scale and nodularity grade on a 5-point ordinal Lucknow-Cardiff scale were done. A total of 151 patients were randomly allocated to two interventions using a block size of 4.

RESULTS:

Of the 151 patients, 121 (active 57, placebo 64) were available for efficacy analysis. The mean pain level showed a systematic downward trend over five visits (F=105.23, p<0.0001) that significantly reduced in the active group compared to that in the placebo group (F=18.66, p<0.0001). The patterns of variation in pain over time for the individual groups differ from the overall mean pattern for the two groups and thus from one another (F=44.43, p<0.0001). Cumulative frequencies of breast nodularity grades during successive visits showed significant improvement (p=0.001) compared to placebo at the end of the third month. The effect of the active drug persisted till the completion (6 months) of treatment (p<0.001). At the last visit, 93.3% of women in the active group had grade 2 or lower nodularity as compared to 71.1% in the placebo group. Oligomenorrhoea alone was reported by 12 patients.

CONCLUSION:

Ormeloxifene showed significant efficacy for treating breast pain and nodularity.

• Authors: Sandeep Kumar, Ruchi Rai, G G Agarwal, Varsha Dwivedi, Surender Kumar, Vinita DAS
• Journal: The National medical journal of India (Natl Med J India) 2013 Mar-Apr Vol. 26 Issue 2 Pg. 69-74 ISSN: 0970-258X [Print] India
• PMID: 24093978 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2013, NMJI.

Chemical References

• Benzopyrans
• Selective Estrogen Receptor Modulators
• ormeloxifene

Topics

• Adult
• Benzopyrans (therapeutic use)
• Breast (pathology)
• Double-Blind Method
• Female
• Humans
• Mastodynia (drug therapy, pathology)
• Selective Estrogen Receptor Modulators (therapeutic use)