Growth hormone treatment for sustained pain reduction and improvement in quality of life in severe fibromyalgia
Cuatrecasas G et al. – In this largest and longest placebo–controlled trial performed in FM (NCT00933686), addition of growth hormone (GH) to the standard treatment is effective in reducing pain, showing sustained action over time.Methods
- A total of 120 patients were enrolled in a multicenter, placebo–controlled study for 18months.
- They were randomly assigned to receive either 0.006mg/kg/day of GH subcutaneously (group A, n=60) or placebo (group B, n=60) for 6months (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).