Evaluation of effect of isoflavone on thyroid economy & autoimmunity in oophorectomised women: A randomised, double-blind, placebo-controlled trial.

Background and objectives: The potential of soy isoflavones to interfere with thyroid function has been reported. However, there are limited data regarding their effect on thyroid function and autoimmunity in surgical menopausal women. The present study aimed to evaluate the effect of isoflavones on thyroid function and autoimmunity, menopausal symptoms, serum follicle stimulating hormone (FSH) and estradiol levels in oophorectomised women. Methods: A randomized, double blind, placebo-controlled trial was conducted in 43 oophorectomised women to evaluate the effect of soy isoflavones (75 mg/day for 12 wk) on serum thyroid profile (free T3 , free T4 , TSH, TBG and anti-TPO antibody titres) assessed at baseline, 6 and 12 wk after randomization. Assessment was also done for menopause symptom score (MSS) three weekly, and FSH and estradiol levels at baseline and at study completion. Results: There was a significant alteration in free T 3 levels in the group receiving isoflavones (4.05 ± 0.36, 4.12 ± 0.69 and 3.76 ± 0.55 pmol/l at baseline, 6 and 12 wk, respectively; P=0.02). However, the mean change in various thyroid parameters at 12 wk from baseline was not significantly different between the two groups. MSS was also significantly decreased at 9 and 12 wk from baseline with isoflavones (12.47 ± 8.15, 9.35 ± 5.23 and 9 ± 5.14 at baseline, 9 and 12 wk respectively; P=0.004) with significant improvement in urogenital symptoms compared to placebo. Isoflavones did not significantly affect other parameters during study period. There were no serious adverse events reported and the proportion of patients experiencing adverse events was similar between the two groups. Interpretation and conclusions: Modest reduction in serum free T3 levels in the isoflavone group in the absence of any effect on other thyroid parameters might be considered clinically unimportant.

Changing chronobiology of cardiovascular outcome following prophylaxis.

Cardiovascular events like angina, myocardial infarction and stroke have shown an increasing occurrence in the morning hours. We did this pilot nested case control study to see for any change in the time pattern of occurrence of cardiovascular events among patients on prophylaxis. A pilot study was done and the demographic characters, history of cardiovascular diseases, time of occurrence of cardiovascular event, history of drug intake and compliance were noted. Eighty four patients on prophylaxis and 135 patients presenting for the first time reported during the study period. Age did not show any significant difference. More males were getting prophylaxis for stroke and for the combined cardiovascular events. Time distribution of events showed peak occurrence between 8 to 12 hr followed by 20 to 24 hr among those who were not on prophylaxis and reverse in those on secondary prophylaxis. Odds of developing cardiovascular events though was not significantly different, was higher between 16-20 hr (1.26), 20-24 hr (1.48) and 0-4 hr (1.22) among those on prophylaxis. Seventy eight patients were taking antihypertensives. This observation demands further studies to determine the cause of evening increase in cardiovascular event especially since very little is known regarding evening exaggeration of risk factors which is becoming relevant especially in those getting prophylaxis.