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Letter to the Editor |
Department of Psychiatry, College of Physicians & Surgeons, Columbia University, New York, New York 10032
Address correspondence to: Stuart Seidman, M.D., Assistant Professor, Department of Psychiatry, College of Physicians & Surgeons of Columbia University, 1051 Riverside Drive, Unit 98, New York, New York 10032. E-mail: sns5{at}columbia.edu.
To the editor:
We write to highlight a relevant underreporting in an article reported in JCEM. Specifically, in the report by Steidle et al. (1) describing a large testosterone replacement study, the mood effects, which were clearly envisioned as a primary outcome measure, were given short shrift. Allow us to place this in context.
There is a clinical consensus among endocrinologists and andrologists that testosterone replacement enhances mood in hypogonadal men (2, 3). We have been especially interested in looking at systematically collected data that can establish such effects empirically. Counterintuitively, in a randomized clinical trial conducted by one of us (S.N.S.) in men with major depression and mild hypogonadism, antidepressant effects of testosterone replacement and placebo were large (approximately 40%), but indistinguishable from each other (4).
We reviewed published data from clinical trials of testosterone replacement for frankly hypogonadal men in which mood was systematically assessed. In studies with at least 10 subjects, we found only one placebo-controlled trial of testosterone replacement that reported mood (5). In this study, the lack of a mood effect was reported in just one sentence, and the data were not shown.
Most authors who reference improved mood with testosterone replacement use the influential study by Wang et al. (6, 7). In this and a similarly designed trial by McNicholas et al. (8), mood assessments after testosterone replacement were compared with prereplacement baseline. Both studies demonstrated large improvements in positive moods and reduction in negative moods (6, 7, 8). Notably, Wang et al. (6) have recently reported that in the 123 men in this study whom they were able to follow on testosterone for 3 yr, the improvements in mood persisted. Yet, importantly, no placebo controls (or placebo substitutions) were included in these studies, leaving the question open as to whether such enhanced mood might have been equally detectable in a placebo group of hypogonadal men who thought they might be receiving testosterone.
Steidle et al. (1) performed a useful study that could address these questions: 99 hypogonadal men who were randomized to placebo could be compared with the 307 hypogonadal men randomized to testosterone replacement. Mood was considered a primary outcome, and patients rated positive moods (alert, full of energy, friendly, well, or good) and negative moods (angry, irritable, sad or blue, tired, nervous) on a 0–7 Likert scale. Yet, in the nine-page report, only one sentence describes the mood results: "Although all treatments resulted in mean improvements from baseline in both positive and negative mood scores, no significant differences among the treatment groups were observed" (1). The data collected for every other a priori outcome of interest was reported in meticulous detail using text, figures, and tables; for mood, it was limited to just this one sentence.
Admirably, this was the largest placebo-controlled testosterone replacement study ever done. Because mood is the least studied of the presumed hypogonadal symptoms, missing this opportunity to better detail the mood effects of testosterone replacement is a loss for science and the public health (9, 10). Delineating mood effects of testosterone replacement illuminates contentious issues in the field, such as "andropause" and its treatment (9) and testosterone use in depressed men (10). These public health issues have proponents who advocate testosterone replacement for mood. Data bearing on these issues helps clinicians make well-informed clinical decisions, rather than expose men to unwarranted treatment. To avoid even the appearance of conflict of interest, it would be good editorial practice to ensure that studies supported by a pharmaceutical company gave proper attention to unwelcome findings.
Footnotes
A response to this letter was invited, but the authors of the original article chose not to provide one.
Received June 18, 2004.
References
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