Br J Nutr. 1996 Jan;75(1):129-38.
Oxymetholone promotes weight gain in patients with advanced human
immunodeficiency virus (HIV-1) infection.
Hengge UR, Baumann M, Maleba R, Brockmeyer NH, Goos M.
Department of Dermatology, University of Essen, Germany.
The effect of the testosterone derivative oxymetholone alone or in combination
with the H1-receptor antagonist ketotifen, which has recently been shown to block
tumour necrosis factor alpha (TNF alpha), on weight gain and performance status
in human immunodeficiency virus (HIV) patients with chronic cachexia was
evaluated in a 30-week prospective pilot study. Thirty patients were randomly
assigned to either oxymetholone monotherapy (n 14) or oxymetholone plus ketotifen
(n 16). Patients receiving treatment were compared with a group of thirty
untreated matched controls, who met the same inclusion criteria. Body weight and
the Karnofsky index, which assesses the ability to perform activities of daily
life, and several quality-of-life variables were measured to evaluate response to
therapy. The average weight gain at peak was 8.2 (SD 6.2) kg (+ 14.5% of body
weight at study entry) in the oxymetholone group (P < 0.001), and 6.1 (SD 4.6) kg
(+10.9%) in the combination group (P < 0.005), compared with an average weight
loss of 1.8 (SD 0.7) kg in the untreated controls. The mean time to peak weight
was 19.6 weeks in the monotherapy group and 20.8 weeks in the combination group.
The Karnofsky index improved equally in both groups from 56% before to 67% after
20 weeks of treatment (P < 0.05). The quality of life variables (activities of
daily life, and appetite/nutrition) improved in 68% (P < 0.05) and 91% (P < 0.01)
of the treated patients respectively. Oxymetholone was safe and promoted weight
gain in cachectic patients with advanced HIV-1 infection. The addition of
ketotifen did not further support weight gain. These results suggest the need for
a randomized, double-blind, placebo-controlled multicentre trial.
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