A randomized, double-blind, placebo-controlled trial of ormeloxifene in breast pain and nodularity.
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Date
2013-03
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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.
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KUMAR SANDEEP, RAI RUCHI, AGARWAL G G, DWIVEDI VARSHA, KUMAR SURENDER, DAS VINITA. A randomized, double-blind, placebo-controlled trial of ormeloxifene in breast pain and nodularity. National Medical Journal of India. 2013 Mar-Apr ; 26 (2): 69-74.