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

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dc.contributor.authorKUMAR, SANDEEP
dc.contributor.authorRAI, RUCHI
dc.contributor.authorAGARWAL, G G
dc.contributor.authorDWIVEDI, VARSHA
dc.contributor.authorKUMAR, SURENDER
dc.contributor.authorDAS, VINITA
dc.date.accessioned2015-02-25T04:07:46Z
dc.date.available2015-02-25T04:07:46Z
dc.date.issued2013-03
dc.description.abstractBackground. 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.en_US
dc.identifier.citationKUMAR 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.en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/156334
dc.language.isoenen_US
dc.source.urihttps://nmji.in/archives/Volume-26/Issue-2/Original-Article-I.pdfen_US
dc.subject.meshAdult
dc.subject.meshBenzopyrans --therapeutic use
dc.subject.meshBreast --pathology
dc.subject.meshDouble-Blind Method
dc.subject.meshFemale
dc.subject.meshHumans
dc.subject.meshMastodynia --drug therapy
dc.subject.meshMastodynia --pathology
dc.subject.meshSelective Estrogen Receptor Modulators --therapeutic use
dc.titleA randomized, double-blind, placebo-controlled trial of ormeloxifene in breast pain and nodularity.en_US
dc.typeArticleen_US
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