A randomized, double-blind, placebo-controlled study of growth hormone in the treatment of fibromyalgia (FM)

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.

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