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More KEEPS confusion

April 16, 2013

I was off target this morning (click here), wondering why an open sub-study paper had appeared before the main KEEPS trial results. But not in a good way.

The KEEPS main trial has still not appeared in a peer-reviewed journal. No raw data or clinical endpoints have been published anywhere, not even the raw data for the primary endpoint, carotid intimal medial thickness (CIMT) at four years.

But since October 3rd 2102, press releases, websites, interviews with health journalists, and at least one conference presentation have leaked out the authors’ conclusions. These were always positive. Here are a couple of examples:

“researchers concluded that estrogen/progesterone treatment started soon after menopause appears to be safe; relieves many of the symptoms of menopause; and improves mood, bone density, and several markers of cardiovascular risk.”  Here

“Hormone Therapy Has Many Favorable Effects in Newly Menopausal Women: Initial Findings of the Kronos Early Estrogen Prevention Study (KEEPS)” and “Estrogen /progesterone treatment started soon after menopause appears safe and relieves many of the symptoms menopausal women face as well as improving mood and markers of cardiovascular risk, according to a multicenter randomized study” Here

Google “KEEPS HRT” to find dozens more.  But read the details.  This is from the North American Menopause Society meeting abstract (click here).

“The carotid ultrasound studies showed similar rates of progression of arterial wall thickness in all three treatment groups over the four years of study. These changes were generally small, limiting the statistical power to detect any differences among the groups.”

i.e. the trial was negative.  Neither estrogen nor estrogen & progestagen improved CIMT, the chosen surrogate marker for cardiovascular disease. But anyone who had not checked the trial registration site for the primary outcome would never realise this.

It’s difficult to criticise this sort of thing properly until the full trial report is published. But this looks like drug marketing masquerading as research.

The KEEPS study itself is funded by grants from the Auroroa Foundation, an outfit largely funded by the billionaire John Spurling. The study drugs were supplied by Bayer Health Care and Abbott Pharmaceuticals. The KEEPS chief investigator Howard R Hodis does not list any conflicts in his papers but has appeared on HT marketing videos sponsored by Wyeth (click here). Another Rogerio Lobo is on my name and shame list (click here).

Look out for the trial report.

Jim Thornton

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