Electronic Letters to:

Endocrine Care: Catherine Beauregard, Andrea L. Utz, Amber E. Schaub, Lisa Nachtigall, Beverly M. K. Biller, Karen K. Miller, and Anne Klibanski Growth Hormone Decreases Visceral Fat and Improves Cardiovascular Risk Markers in Women with Hypopituitarism: A Randomized, Placebo-Controlled Study J Clin Endocrinol Metab 2008; 93: 2063-2071 [Abstract] [Full text] [PDF]

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Have we learnt nothing from the early trials of HRT?

S.E Zac-Varghese, Daniel Morganstein, Karim Meeran   (5 August 2008)

Have we learnt nothing from the early trials of HRT? 5 August 2008
S.E Zac-Varghese, Endocrinology Specialist Registrar Imperial College, Daniel Morganstein, Karim Meeran Send letter to journal: Re: Have we learnt nothing from the early trials of HRT? s.zac-varghese{at}imperial.ac.uk S.E Zac-Varghese, et al.	Beuregard et al. (1) present data showing the effects of growth hormone replacement in growth hormone deficient women. There would appear to be a number of flaws in their study. First, there is a significant difference in the rate of hypoadrenalism between the two groups, with potentially profound metabolic consequences. Second, the treatment group starts with approximately three times greater visceral adipose mass. In this context, the apparent reduction in the treatment group and rise in the placebo group may simply represent regression to the mean. In any case, it seems hard to attribute any biological significance to these results when the treatment arm ended the study with a greater amount of visceral adipose tissue. Finally, the emphasis of the paper on surrogate markers of cardiovascular health seems reminiscent of the extensive literature on postmenopausal estrogen therapy showing apparently favorable changes in a range of markers (2, 3). Sadly this has not been shown to transfer into a benefit in hard clinical end points (4-6). It is disappointing that the same mistakes may be being made again with growth hormone therapy. This underlies the need for a robust randomized trial of growth hormone replacement assessing clinical outcomes. References 1. Beauregard C, Utz AL, Schaub AE, Nachtigall L, Biller BMK, Miller KK, Klibanski A. 2008 Growth Hormone Decreases Visceral Fat and Improves Cardiovascular Risk Markers in Women with Hypopituitarism: A Randomized, Placebo-Controlled Study. J Clin Endocrinol Metab 2008; 93:2063-2071 2. Barrett-Connor E, Slone S, Greendale G, Kritz-Silverstein D, Espeland M, Johnson SR, Waclawiw M, Fineberg SE. 1997 The Postmenopausal Estrogen/Progestin Interventions Study: Primary Outcomes in Adherent Women. Maturitas 27:261-274 3. Grodstein F, Manson JE, Colditz GA, Willett WC, Speizer FE, Stampfer MJ. 2008 A Prospective, Observational Study of Postmenopausal Hormone Therapy and Primary Prevention of Cardiovascular Disease. Ann Intern Med. 133:933-941 4. Writing Group for the Women's Health Initiative Investigators. 2002 Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women, Principal Results From the Women's Health Initiative Randomized Controlled Trial. JAMA 288:321-333 5. HERS Research Group. 2002 Cardiovascular disease outcomes during 6.8 years of hormonal therapy: Heart and Estrogen/ Progestin Replacement study follow-up (HERS II). JAMA 88:49-57 6. Salpeter SR, Walsh JM, Greyber E, Salpeter EE. 2006 Coronary Heart Disease Events Associated with Hormone Therapy in Younger and Older Women: a Meta-analysis. J. Gen. Intern. Med. 21:363-366