Stroke: hormone replacement therapy does not clearly increase the risk

Clinical bottom line (level 1b-)

  1. Postmenopausal women with a history of coronary heart disease who received hormone replacement therapy compared with placebo were not clearly more likely to have a stroke.
Simon et al: Circulation 2001; 103 : 638-642
Expires November 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 20 clinical centres, USA

2763 patients (aged mean 67, 100% female) postmenopausal and previous coronary heart disease
Control Group: (n = 1383, 1383 analysed): placebo
Experimental Group: (n = 1380, 1380 analysed): conjugated equine estrogen 0.625 mg per day and methoxyprogestreon acetate 2.5 mg per day

100% followed for 4.1 years
Outcome notes:
  • stroke or TIA : strokes were confirmed on CT scan

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
stroke or TIA 4 years 112
(8.10%)		 103
(7.46%)		 8%
(-19% to 29%)		 0.63%
(-1.36% to 2.63%)		 160
(NNT = 38 to infinity;
NNH = 73 to infinity)

Citation

  1. Simon JA, Hsia J, Cauley JA, et al: postmenopausal hormone therapy and risk of stroke: the heart and estrogen-progestin replacement study (HERS). Circulation 2001; 103 : 638-642
Search Terms: from ACP Journal Club other articles noted
Contributor: Chris Ball, November 2001
Reviewer:

Clinical Question.
Patient postmenopausal and previous ischaemic heart disease
Intervention or Exposure hormone replacement therapy
Comparison placebo
Outcome stroke