Qualifying Statements
- This document consists of recommendations for the clinical use of growth hormone (GH). These guidelines should be used by physicians in conjunction with their best clinical judgment. Periodically, these guidelines will be revised to reflect the latest developments in the use of GH in patients with non-GH-deficient conditions such as Turner syndrome, a clinical condition that is not associated with GH deficiency (GHD) but is improved by use of GH. As expanded indications and new indications (approved by the US Food and Drug Administration [FDA]) for the use of GH arise, the guideline will be updated.
- Considerable interest exists in using GH therapy in various other patients, including those with chronic fatigue syndrome, fibromyalgia, battered-wife syndrome, or obesity. Moreover, GH has been of interest as a means to enhance athletic performance or as an antiaging treatment. These applications have not been approved by the FDA, and further studies are needed to evaluate the use of GH in other disorders. Indeed, the prescribing of GH for off-label indications is a matter of major concern. Because third-party payers (sometimes reluctant to cover patients with documented pituitary disease) may be asked to provide coverage, misuse of GH might ultimately endanger patients who genuinely require GH therapy.
- Because most of the early studies of GH treatment for GHD in adults were done in Europe, publications cited dosing in IU or mU (international units), and early recommendations were often on a weight-adjusted (IU/kg) or square meter-adjusted (IU/m2) basis. More recently, studies have recommended beginning with single low doses in IU/day. The conversion of IU or mU to mg is 3:1. For example, a mean starting dose of 0.6 IU is equivalent to 0.2 mg/day. Mean maintenance dosages of 0.15 to 0.25 mU/kg per week are equivalent to 0.05 to 0.08 mg/kg per week, which, for a 70-kg man, would be 0.35 to 0.56 mg/day.
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