Conference Report From the 10th World Congress on the Menopause

Professor Lorraine Dennerstein, AO MBBS, PHD, DPM, FRANZCP

July 03, 2002

Trial Design and Its Role in the Study of Menopause

There has been much controversy over which health problems can be truly linked to the hormonal changes of the menopause rather than to the effects of chronologic aging or other lifestyle or psychosocial factors. Clinical experience is known to be based on a small proportion of self-selecting women who may not be representative of most women's experience.^[1] In a plenary lecture at the 10th World Congress on the Menopause, Professor Leon Speroff, Health Sciences University, Portland, Oregon,^[2] indicated that randomized, placebo-controlled trials were subject to a number of biases that greatly limit the generalizability of their findings. These include selection bias that results from particular inclusion and exclusion criteria. The effects of selection bias are to create a homogenous group of individuals who may bear little resemblance to the majority of those who would approach their general practitioner about a particular health problem.

Professor Goran Samsioe, University of Lund, Sweden,^[3] reported that inclusion and exclusion criteria can lead to selection of a group of individuals with lower cardiovascular risk, for example, who may then have a lower number of events, which may prejudice the power needed for statistical analysis of the effect of an intervention on cardiovascular risk. Professor Speroff further pointed out that only a limited number of hypotheses and end points can be explored in any one randomized controlled trial. He presented an extensive proforma to assist the clinician or researcher in evaluating epidemiologic reports.^[2] It was concluded that both randomized controlled trials and cohort studies are needed to provide complementary information, as they provide different aspects of the problem under investigation.

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