• Guillem Cuatrecasas, C Alegre, J Fernandez-Solà, M J Gonzalez, F Garcia-Fructuoso, V Poca-Dias, A Nadal, Gabriel Cuatrecasas, F Navarro, A Mera, M Lage, R Peinó, F Casanueva, C Liñan, G Sesmilo, M J Coves, J P Izquierdo, I Alvarez, E Granados, and M Puig-Domingo.
• Endocrinology Department Centro Médico Teknon and Clinica Sagrada Familia, Barcelona, Spain. gcuatrecasas@cpen.cat
• Pain. 2012 Jul 1;153(7):1382-9.

AbstractFunctional defects in growth hormone (GH) secretion and its efficacy as a complementary treatment have been suggested for fibromyalgia. This study investigated the efficacy and safety of low-dose GH as an add-on therapy in patients with both severe FM and low insulin-like growth factor 1 levels. A total of 120 patients were enrolled in a multicenter, placebo-controlled study for 18 months. They were randomly assigned to receive either 0.006 mg/kg/day of GH subcutaneously (group A, n=60) or placebo (group B, n=60) for 6 months (blind phase). The placebo arm was switched to GH treatment from month 6 to month 12 (open phase), and a follow-up period after GH discontinuation was performed until month 18. Standard treatment for fibromyalgia (selective serotonin re-uptake inhibitors, opioids, and amitriptyline) was maintained throughout the study. Number and intensity of tender points, Fibromyalgia Impact Questionnaire (FIQ) with its subscales, and EuroQol 5 dimensions test (EQ5D) with visual analogue scale (VAS) were assessed at different time points. At the end of the study, 53% of group A patients obtained fewer than 11 positive tender points, vs 33% of group B patients (P<.05). 39.1% vs 22.4% reached more than 50% improvement in VAS (P<.05). Group A patients showed significantly improved FIQ scores (P=.01) compared with group B. Although GH discontinuation worsened all scores in both groups during follow-up, impairment in pain perception was less pronounced in the GH-treated group (P=.05). In this largest and longest placebo-controlled trial performed in FM (NCT00933686), addition of GH to the standard treatment is effective in reducing pain, showing sustained action over time.Copyright © 2012 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

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