The treatment of symptomatic benign breast disease with danazol. 1988

G Ramsey-Stewart
Royal Prince Alfred Hospital Medical Centre, Sydney.

A prospective randomized double blind trial, using danazol in a dose of 200 mg twice a day, was carried out on 80 women presenting with severe cyclical symptomatic benign mammary dysplasia. Standardized scores for 4 parameters of disease severity (breast pain, breast tenderness, breast nodularity and breast cysts) were defined and measured monthly on all patients admitted to the trial. Using nonparametric statistical analysis, significant improvement in breast pain, tenderness and nodularity, was found in both the double blind and crossover arms of the trial. An insufficient number of patients presented with breast cysts to draw any conclusions regarding the efficacy of danazol on cysts. Six months of treatment may produce a more sustained response, than 3 months of treatment. Danazol appears to be efficacious in managing patients with severe breast symptoms due to benign disease.

UI MeSH Term Description Entries
D010146 Pain An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS. Suffering, Physical,Ache,Pain, Burning,Pain, Crushing,Pain, Migratory,Pain, Radiating,Pain, Splitting,Aches,Burning Pain,Burning Pains,Crushing Pain,Crushing Pains,Migratory Pain,Migratory Pains,Pains, Burning,Pains, Crushing,Pains, Migratory,Pains, Radiating,Pains, Splitting,Physical Suffering,Physical Sufferings,Radiating Pain,Radiating Pains,Splitting Pain,Splitting Pains,Sufferings, Physical
D011245 Pregnadienes Pregnane derivatives containing two double bonds anywhere within the ring structures.
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D011897 Random Allocation A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects. Randomization,Allocation, Random
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D003613 Danazol A synthetic steroid with antigonadotropic and anti-estrogenic activities that acts as an anterior pituitary suppressant by inhibiting the pituitary output of gonadotropins. It possesses some androgenic properties. Danazol has been used in the treatment of endometriosis and some benign breast disorders. Azol,Cyclomen,Danatrol,Danazant,Danazol-Ratiopharm,Danocrine,Danol,Danoval,Ladogal,Norciden,Panacrine,Danazol Ratiopharm
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D005348 Fibrocystic Breast Disease A common and benign breast disease characterized by varying degree of fibrocystic changes in the breast tissue. There are three major patterns of morphological changes, including FIBROSIS, formation of CYSTS, and proliferation of glandular tissue (adenosis). The fibrocystic breast has a dense irregular, lumpy, bumpy consistency. Breast Dysplasia,Fibrocystic Mastopathy,Mammary Dysplasia,Adenosis of Breast,Chronic Cystic Mastitis,Cystic Breast Disease,Cystic Disease of Breast,Fibrocystic Changes of Breast,Fibrocystic Disease of Breast,Microglandular Adenosis,Adenoses, Microglandular,Adenosis, Microglandular,Breast Adenosis,Breast Cystic Disease,Breast Cystic Diseases,Breast Disease, Cystic,Breast Disease, Fibrocystic,Breast Fibrocystic Change,Breast Fibrocystic Changes,Breast Fibrocystic Disease,Cystic Mastitis, Chronic,Disease, Cystic Breast,Disease, Fibrocystic Breast,Dysplasia, Breast,Dysplasia, Mammary,Mastopathy, Fibrocystic,Microglandular Adenoses
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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