Objective: To determine effects of raloxifene on lipid profile, breast tissue and endometrial thickness in postmenopausal women. Design: A longitudinal cohort study. Place and Duration of Study: The study was conducted at Department of Gynaecology and Obstetrics, PNS Shifa Hospital, Karachi over a period of one year. Patients and Methods: Fifty cases of postmenopausal women, aged 45–60 years, who had last menstrual period 2-8 years back, visiting Gynea OPD at PNS Shifa Hospital, Karachi, were included in the study. The subject received raloxifene (Evista) 60 mg once daily. The tests done at the start of study as baseline were serum lipid profile (HDL, LDL, total triglyceride and cholesterol levels), TVS (trans vaginal sonography) for endometrial thickness and mammography. The above tests were again done at the end of study after 12 months. The adverse effects were recorded. Results: Fifty women were enrolled for study out of which 48 completed the study that is 96%. Mean age was 54 years, SD = 3.95. The mean value of LDL, total triglyceride and cholesterol decreased by 15.2%, 1.2% and 10.2 % respectively. The change was statistically significant. (p<0.001) HDL change was 0.665% and was not statistically significant. TVS, for endometrial thickness, and mammography for breast density showed no change. Adverse effects reported were hot flushes, leg cramps and vaginal symptoms in few cases. Conclusion: Raloxifene therapy significantly decreases cardiovascular risk markers LDL, total triglyceride and cholesterol. No abnormal change in breast density and in endometrial thickness indicate good safety profile of this agent.
Although this is a relatively better article, the way it is presented has tremendously decreased its importance. All studies with a repeated measure design (Pre-post design) should report mean change (gain score) and the standard deviation of the change, or preferably 95% confidence intervals. We are clinicians, and we should be more concerned about the clinical benefit and not about the p (or "pee") value. Thus we should try to always give 95% confidence intervals. Now that authors have not given SD of the mean change (gain score) there is no way of knowing that whether the effect of the drug on the subjects was homogenous or heterogenous, and whether there was any treatment interaction with individual subjects. Thus authors have wasted all the strengths of the pre-post design while keeping all the inherent limitations of the pre-post design. ------ Moreover, changes in lipid profile should not let one to jump to the conclusion that there will be cardioprotection. After all, hormone therapy also improves lipid profile in post-menopausal women.
Posted by: rqayyum on May 2005
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