Clinical Studies
A Randomized, Double-Blind, Placebo-controlled Study of Growth Hormone in the Treatment of Fibromyalgia 1

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Abstract

PURPOSE: The cause of fibromyalgia (FM) is not known. Low levels of insulin-like growth factor 1 (IGF-1), a surrogate marker for low growth hormone (GH) secretion, occur in about one third of patients who have many clinical features of growth hormone deficiency, such as diminished energy, dysphoria, impaired cognition, poor general health, reduced exercise capacity, muscle weakness, and cold intolerance. To determine whether suboptimal growth hormone production could be relevant to the symptomatology of fibromyalgia, we assessed the clinical effects of treatment with growth hormone.

METHODS: Fifty women with fibromyalgia and low IGF-1 levels were enrolled in a randomized, placebo-controlled, double-blind study of 9 months’ duration. They gave themselves daily subcutaneous injections of growth hormone or placebo. Two outcome measures—the Fibromyalgia Impact Questionnaire and the number of fibromyalgia tender points—were evaluated at 3-monthly intervals by a blinded investigator. An unblinded investigator reviewed the IGF-1 results monthly and adjusted the growth hormone dose to achieve an IGF-1 level of about 250 ng/mL.

RESULTS: Daily growth hormone injections resulted in a prompt and sustained increase in IGF-1 levels. The treatment (n = 22) group showed a significant improvement over the placebo group (n = 23) at 9 months in both the Fibromyalgia Impact Questionnaire score (P <0.04) and the tender point score (P <0.03). Fifteen subjects in the growth hormone group and 6 subjects in the control group experienced a global improvement (P <0.02). There was a delayed response to therapy, with most patients experiencing improvement at the 6-month mark. After discontinuing growth hormone, patients experienced a worsening of symptoms. Carpal tunnel symptoms were more prevalent in the growth hormone group (7 versus 1); no other adverse events were more common in this group.

CONCLUSIONS: Women with fibromyalgia and low IGF-1 levels experienced an improvement in their overall symptomatology and number of tender points after 9 months of daily growth hormone therapy. This suggests that a secondary growth hormone deficiency may be responsible for some of the symptoms of fibromyalgia.

Section snippets

Methods

This study was approved by the ethics committee of the Oregon Health Sciences University and performed according to their guidelines. All subjects gave their informed written consent.

Results

Fifty patients were enrolled according to the protocol guidelines. Forty-five patients completed all 9 months of study. The two treatment groups were similar in all major demographic features (Table 1). Eighteen subjects in the placebo group and 11 patients in the growth hormone group fulfilled modified criteria for the chronic fatigue syndrome [22]. Three patients in the growth hormone group were discontinued, 2 for medical reasons and 1 for noncompliance. Two patients receiving placebo were

Discussion

We assessed the efficacy of recombinant human growth hormone in the treatment of fibromyalgia patients. The treated group experienced significant improvement after 9 months of treatment in symptoms, as measured by the Fibromyalgia Impact Questionnaire, and signs, as measured by the tender point score. No patient had a complete remission of symptoms, although several patients experienced an impressive improvement in their functional ability. In general there was a lag of about 6 months before

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    Supported in part by a research grant from Genentech, Inc., San Francisco.

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