Current Thoughts on The Safety of HRT            - Page 2 The WHI study showed an increase in heart attacks, strokes, and breast cancer although confirming the decrease in colon cancer, hip fractures and spinal fractures. These complications were enough for many regulatory bodies to suggest that HRT was less safe, should be used in the lowest dose for the shortest possible time and only for severe vasomotor symptoms. It was claimed that oestrogens were no longer indicated for prevention of heart attacks and strokes and should not be first-line treatment for the prevention of osteoporosis. These directives were issued in spite of protest that the WHI used the wrong population of the wrong age treated with the wrong oestrogens and come to the wrong conclusions even from their own data. There were not enough patients in the 50-55 age group to make any comment about the effect on heart attacks. In a subsequent WHI publication, it was clear that the increase cardiovascular complications occurred in women over the age of 70 and in women who started HRT even in this population had a non-significant 11% decrease in cardiovascular events if oestrogen/progestogen therapy was started within 10 years of the menopause. One of the fundamental errors in this study is that one dose is not appropriate for all patients. They used a combination of Premarin with continuous progestogen as a non-bleeding preparation. The epidemiologists were not clinicians and were not aware that different women require different doses by different routes of different combinations of different hormones for different symptoms with different surgical status and for different ages. Although the Premarin/Provera combination was a totally inappropriate treatment for these older women, it was not possible to determine whether the increase in complications in older women were due to the oestrogen or the progestogen component or a combination of both. Thus the oestrogen-only study was awaited with great interest particularly as it had not been stopped. On 3rd March 2003 it was discontinued with a mid-week Press conference which led to the newspapers reporting that the oestrogen-only arm of the WHI study was stopped because of an increase in strokes. The data did not support that judgement. Once again if we look at the patients aged 50-59, we can see there was a decrease in heart attacks of 42%, a decrease in breast cancer of 28%, a decrease in colon cancer of 41%, a decrease in deaths of 27%. There was a slight non-significant increase in strokes of 8% which was 19 patients in the control group and 19 patients in the active group. This was hardly a reason to stop the study which, with a few more patients, could have shown a significant decrease in the incidence of breast cancer.    There were so many faults in the design of the WHI study that I believe it will be mostly discredited within another 2-3 years, particularly as most of the patients and most of the data from this study are inappropriate for our practice. They used a treatment we don't use on a group of patients we don't treat who had no symptoms. Their conclusions are similar to the statement that we should not perform an appendicectomy for gallbladder disease. We know that. Page 3 >> John STUDD, DSc, MD, FRCOG Professor of Gynaecology 18th January 2005  . www.studd.co.uk Back to top