Peter Beitsch, MD/

Placebo Side Effects similar to Tamoxifen in Prevention Trial

The International Breast Cancer Invention Study (IBIS-I) was a randomized controlled trial that enrolled pre- and post-menopausal women deemed to be at increased risk of breast cancer. Patients were assigned 1:1 to receive tamoxifen or placebo for 5 years.  Interesting numbers

  1. only 16% of patients offered prophylaxis started the study
  2. side effects in the first 6 months led to increased discontinuation
  3. nausea was side effect most likely leading to non-adherence
  4. overall rate of adherence for at least 4.5 years was about 70% (tamoxifen: 65.2% vs placebo: 74.0%; P < .001) 

    So placebo causes almost the same level of non-compliance as tamoxifen!      http://www.cancertherapyadvisor.com/breast-cancer/breast-cancer-prophylactics-tamoxifen-placebo-symptoms-similar-adherence/article/672235/?DCMP=EMC-CTA_WeeklyHighlights_DMD20170629&cpn=onc_all&hmSubId=&hmEmail=JdPiYjVYOztVXhLI4XxCARpwAZUt9yyvMhkOjt7-LyE1&NID=1336187731&spMailingID=17562559&spUserID=MzQ0NTg1NjM1NDMyS0&spJobID=1042266561&spReportId=MTA0MjI2NjU2MQS2

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