Vascular events in healthy older women receiving calcium supplementation: randomised controlled trial

The title should have been: "A preliminary randomized controlled trial" rather than just "a randomized controlled trial"

4 April 2012

It seems the results of this secondry analysis has raised many eyebrows. There has been much argument and controversy on the results of the study (20 Rapid Responses). Without repeating those points, I have certain additional comments to make:

1. Sample size is not sufficient to make a conclusion on association of cardiovascular events with calcium as the women of older age groups (postmenopausal) as such are prone to myocardial infarction and other vascular events. And the difference between intervention arm and plecebo controlled arm may be just by chance and not real. So the title may, at the most be named as a "preliminary" randomized trial rather than a randomized controlled trial.

2. Vascular events in elderly include the thrombo-embolic phenomenon also which is not discussed here.

3. Treatment history of women is not taken, e.g. HRT, aspirin analogues etc.
Though other diseases like diabetes, hypertension have been asked and major diseases are excluded.

Competing interests: None declared

Neeru Gupta, Scientist E

KK Jani

Indian Council of Medical Research, Ansari Nagar, New Delhi-110029

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