associated with low IGF-1 serum levels. A pilot study.
BMC Musculoskelet Disord. 2007 Nov 30;8(1):119 [Epub ahead of print]
Cuatrecasas G, Riudavets C, Guell MA, Nadal A.
BACKGROUND: There is evidence of functional growth hormone (GH)
deficiency, expressed by means of low insulin-like growth factor 1
(IGF-1) serum levels, in a subset of fibromyalgia patients. The
efficacy of GH versus placebo has been previously suggested in this
population. We investigated the efficacy and safety of low dose GH as
an adjunct to standard therapy in the treatment of severe, prolonged
and well-treated fibromyalgia patients with low IGF-1 levels.
METHODS: Twenty-four patients were enrolled in a randomized,
open-label, best available care-controlled study. Patients were
randomly assigned to receive either 0.0125 mg/kg/d of GH
subcutaneously (titrated depending on IGF-1) added to standard
therapy or standard therapy alone during one year. The number of
tender points, the Fibromyalgia Impact Questionnaire (FIQ) and the
EuroQol 5D (EQ-5D), including a Quality of Life visual analogic scale
(EQ-VAS) were assessed at different time-points.
RESULTS: At the end of the study, the GH group showed a 60% reduction
in the mean number of tender points (pairs) compared to the control
group (p<0.05; 3.25+/-0.8 vs. 8.25+/-0.9). Similar improvements were
observed in FIQ score (p<0.05) and EQ-VAS scale (p<0.001). There was
a prompt response to GH administration, with most patients showing
improvement within the first months in most of the outcomes. The
concomitant administration of GH and standard therapy was well
tolerated, and no patients discontinued the study due to adverse events.
CONCLUSIONS: The present findings indicate the advantage of adding a
daily GH dose to the standard therapy in a subset of severe
fibromyalgia patients with low IGF-1 serum levels.
Trial Registration: NCT00497562 (ClinicalTrials.gov).