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

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.

Dor mamária: propedêutica e terapêutica / Breast pain: propaedeutic and therapeutic

Mastalgia é um dos sintomas mais comuns em mulheres, tendo uma prevalência de 41 a 69% e pode se apresentar como um leve desconforto até dor severa, que interfere na qualidade de vida. A principal preocupação das pacientes que consultam por este sintoma é o medo do câncer. Essa é classificada em mastalgia cíclica, acíclica ou extramamária. Cíclica quando se apresenta no período pré-menstrual; na acíclica não há relação com o ciclo e, geralmente, acomete pacientes na pós-menopausa. A extramamária é a dor referida na mama, porém usualmente é de origem musculoesquelética. Na presença de achados clínicos e radiológicos normais, aproximadamente 85% das pacientes melhoram apenas com orientação e tranquilização, não necessitando de medicação. Foi realizada uma revisão sistemática para avaliar as possibilidades terapêuticas e seus níveis de evidência. Os anti-inflamatórios não esteróides tópico, para mastalgia cíclica ou acíclica, e o fitoterâpico Agnus castus, para mastalgia cíclica, demonstraram boa eficácia e tolerabilidade e podem ser usados como medida inicial. O tamoxifeno e o danazol são medicamentos eficazes, porém apresentam mais efeitos colaterais. Para casos especiais, ainda há a alternativa de usar bromocriptina e goserelina. O manejo da dor mamária pode ser sintetizado em três itens: excluir câncer, orientar e tranquilizar ao máximo e medicar ao mínimo.(AU)

Breast pain or mastalgia is one of the most common symptoms in women, with a prevalence ranging from 41 to 69%. It presents as a mild discomfort to severe pain, that interferes with the quality of life. The main concern of patients consulting for this symptom is the fear of cancer. It is classified as cyclical, acyclical or extra-mammary. When presented during the premenstrual period, it is cyclical; acyclical, when not cycle-related and usually affects patients in post-menopausal. Extra-mammary is the breast referred pain, but it is usually of muscle-skeptical origin. In the presence of normal clinical and radiological findings, approximately 85% of patients improve only with reassurance, not requiring medication. A systematic review was performed to assess the therapeutic possibilities and their evidence levels. Topical non-steroidal anti-inflammatory drugs, for cyclic or acyclic mastalgia, and the phytotherapic Agnus castus, for cyclic mastalgia, showed good efficacy and tolerability and can be used as an initial measure. Tamoxifen and danazol are effective drugs, but they present more side effects. For special cases, there is the alternative of using bromocriptin and goserelin. Breast pain management can be summarized in three items: exclude cancer, maximum reassurance and minimum medication.(AU)