Progesterone cream for cyclic breast pain.

Abstract

erythrocytes. It is partly explained by acute phase increases in plasma fibrinogen concentration and viscosity. In particular, however, we found that the filterability of both polymorphonuclear and mononuclear leucocytes is reduced in acute cerebral infarction. This may not only explain the reduced filterability of blood but also promote malperfusion of the microcirculation and infarction.Reduced filterability of leucocytes may be part of the acute phase response to injury, as suggested by the correlation with fibrinogen concentration in the patients with stroke and by similar findings in the controls with chest infection. Preceding infection is an important risk factor for cerebral infarction.5 The risk of infarction also increases with age, and we observed decreased filterability of leucocytes in controls aged over 40. We suggest that mechanisms by which increasing age and infections increase the risk of cerebral infarction include increased plasma fibrinogen concentration and viscosity and decreased filterability of leucocytes, each of which tends to reduce capillary flow. Women attending our breast clinic with cyclic breast pain of at least two months' duration were included in the study. Women not menstruating regularly, taking the contraceptive pill, or with breast abnormalities were excluded. The women were asked to record their pain on a linear analogue scale from one to 100 daily from the first day of menstruation.2 The nodularity of the breasts was assessed by palpation on one day of the luteal phase of the cycle each month.Patients who kept full records during a control month were randomised into the six month trial. They were asked to apply 5 g of cream each evening from the tenth day of one menstrual cycle to the first day of the next. Two different preparations in identical containers labelled first or second were used; one contained 1% natural progesterone and the other was without the active hormone. The active and placebo creams were applied for three months, each in random order, and only the statistician knew the order of the treatments. For each patient a mean pain score was calculated from the seven worst daily pain scores during the premenstrual phase each month. The seven worst days were usually consecutive and most often the days before the next period. The pain and nodularity scores for each patient were analysed by non-parametric tests, which compared differences within patients.Thirty two women were entered into the study; 17 were randomised to use the active drug first and 15 the placebo. Seven did not return for their monthly appointments (usually after the first month). Thus complete data were available for 25 of the women, 14 of whom used the active treatment first and 11 the placebo.The data were first analysed for trends in the pain and nodularity scores over time, but no evidence of any such trends was found. To compare the drugs a mean pain score and a total nodularity score were calculated for each patient's three month exposure to each drug. The results (table) showed a small...

Evaluation and Management of Breast Pain

“…175 Progesterone cream applied to the breast was not better than placebo for cyclic breast pain in another small randomized study. 176 Danazol and Gestrinone.-Danazol, the only medication approved by the Food and Drug Administration for treatment of mastalgia, is a derivative of 17-α-ethinyl testosterone that suppresses gonadotropin secretion, prevents luteinizing hormone surge, and inhibits ovarian steroid formation. Danazol relieves breast pain and tenderness in controlled clinical trials.…”

The Influence of Progesterone Gel Therapy in the Treatment of Fibrocystic Breast Disease

“…Recently this type of fibrocystic breast disease and mastalgia treatment was very common in France. Some random control "cross-over" studies did not find such a significant improvement with this type of the therapy versus placebo group [32]. However, in double blind study in Italy it was noted that the use of micronized progesterone vaginal cream decreased breast pain by 64.9% in patients with mastalgia versus 22% in control group [33].…”

Mastalgia: A narrative literature review of current understanding and management

“…McFadyen et al found that progesterone cream applied locally was no better than placebo cream in relieving mastalgia. 63 Along similar lines, a small, randomized, double-blind crossover study (N = 26) by Maddox et al concluded that the therapeutic response of 20 mg/day of oral medroxyprogesterone acetate during the luteal phase was no better than a placebo in the management of cyclic mastalgia. 64 However, in a randomized, double-blind, placebo-controlled study conducted in Italy by Nappi et al, a vaginal cream of micronized progesterone was found to be effective in reducing pain in 64.9% of cases, compared with 22.2% of controls.…”