Abstract:
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. CONCLUSION: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).
journal_name
BMC Musculoskelet Disordjournal_title
BMC musculoskeletal disordersauthors
Cuatrecasas G,Riudavets C,Güell MA,Nadal Adoi
10.1186/1471-2474-8-119subject
Has Abstractpub_date
2007-11-30 00:00:00pages
119issn
1471-2474pii
1471-2474-8-119journal_volume
8pub_type
杂志文章,随机对照试验abstract:BACKGROUND:Open dislocations are infrequent, often associated with damage to the neuro vascular structures. We present an unusual case of an open antero-lateral dislocation of the elbow, which was not associated with any vascular or neural injury. CASE PRESENTATION:A 34 year female dance instructor sustained an open d...
journal_title:BMC musculoskeletal disorders
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pub_type: 临床试验,杂志文章
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pub_type: 杂志文章,随机对照试验
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