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Centchroman regresses mastalgia: a randomized comparison with danazol.

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We conducted a randomized trial to evaluate effectiveness of Centchroman in control of mastalgia and compared it with Danazol. Research Question- Is proportion of pain relief achieved by Centchroman similar to or inferior to that achieved by Danazol? In a randomized controlled trial of Centchroman vs. Danazol in mastalgia, 81 patients with mastalgia were studied. Thirty-nine patients were randomized to Danazol arm and 42 in Centchroman arm. The treatment was given for 12 weeks, followed by observation for 12 weeks. The pain was measured by visual analogue scale (VAS) of 0-10. At 12 weeks 89.7% women achieved reduction in pain score to ?3 in Centchroman group (pvalue 0.001). In Danazol group 69.44% women achieved reduction in pain score to ? 3 (p?=?0.001). Three months after stopping therapy, Centchroman was more effective in pain score reduction at 24 weeks as compared to Danazol (p?=?0.019). Centchroman is an effective, safe and inexpensive alternative to Danazol for treatment of mastalgia.

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The online version of this article (doi:10.1007/s12262-010-0216-z) contains supplementary material, which is available to authorized users.

SUBMITTER: Tejwani PL

PROVIDER: S-EPMC3087062 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature

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Centchroman regresses mastalgia: a randomized comparison with danazol.

Tejwani Prakash Lakhmichand PL Srivastava Anurag A Nerkar Hrishikesh H Dhar Anita A Hari Smriti S Thulkar Sanjay S Chumber Sunil S Kumar Sunesh S

The Indian journal of surgery 20101130 3

<h4>Unlabelled</h4>We conducted a randomized trial to evaluate effectiveness of Centchroman in control of mastalgia and compared it with Danazol. Research Question- Is proportion of pain relief achieved by Centchroman similar to or inferior to that achieved by Danazol? In a randomized controlled trial of Centchroman vs. Danazol in mastalgia, 81 patients with mastalgia were studied. Thirty-nine patients were randomized to Danazol arm and 42 in Centchroman arm. The treatment was given for 12 weeks ...[more]

PMID: 22654331

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Project description:BackgroundGenetic defects in telomere maintenance and repair cause bone marrow failure, liver cirrhosis, and pulmonary fibrosis, and they increase susceptibility to cancer. Historically, androgens have been useful as treatment for marrow failure syndromes. In tissue culture and animal models, sex hormones regulate expression of the telomerase gene.MethodsIn a phase 1-2 prospective study involving patients with telomere diseases, we administered the synthetic sex hormone danazol orally at a dose of 800 mg per day for a total of 24 months. The goal of treatment was the attenuation of accelerated telomere attrition, and the primary efficacy end point was a 20% reduction in the annual rate of telomere attrition measured at 24 months. The occurrence of toxic effects of treatment was the primary safety end point. Hematologic response to treatment at various time points was the secondary efficacy end point.ResultsAfter 27 patients were enrolled, the study was halted early, because telomere attrition was reduced in all 12 patients who could be evaluated for the primary end point; in the intention-to-treat analysis, 12 of 27 patients (44%; 95% confidence interval [CI], 26 to 64) met the primary efficacy end point. Unexpectedly, almost all the patients (11 of 12, 92%) had a gain in telomere length at 24 months as compared with baseline (mean increase, 386 bp [95% CI, 178 to 593]); in exploratory analyses, similar increases were observed at 6 months (16 of 21 patients; mean increase, 175 bp [95% CI, 79 to 271]) and 12 months (16 of 18 patients; mean increase, 360 bp [95% CI, 209 to 512]). Hematologic responses occurred in 19 of 24 patients (79%) who could be evaluated at 3 months and in 10 of 12 patients (83%) who could be evaluated at 24 months. Known adverse effects of danazol--elevated liver-enzyme levels and muscle cramps--of grade 2 or less occurred in 41% and 33% of the patients, respectively.ConclusionsIn our study, treatment with danazol led to telomere elongation in patients with telomere diseases. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01441037.).

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Centchroman regresses mastalgia: a randomized comparison with danazol.

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Electronic supplementary material

Publications

Centchroman regresses mastalgia: a randomized comparison with danazol.

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