Growth hormone treatment for sustained pain reduction and improvement in quality of life in severe fibromyalgia

Abstract

Functional 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.

Challenges in drug discovery for overcoming ‘dysfunctional pain’: an emerging category of chronic pain

“…Exploration of trace (biomarker) associated with the pathophysiology is ongoing using various methodologies. For example, deficiencies in the growth hormone insulin-like growth factor cascade are associated with chronic pain at least in subgroup of patients with fibromyalgia [15]. A recent study using rectal biopsy samples has suggested that densities of rectal peptide YY and somatostatin cells are significantly altered in IBS patients [16].…”

Fibromiyaljide Farmakolojik Tedavi

“…Ancak yüksek maliyet ve olası yan etkiler (metabolik değişiklikler, karpal tünel sendromu ve anemi) kullanım konusunda endişe yaratmaktadır 85 .…”

Growth Hormone: The Body Knows when to Quit

“…The most recent clinical trial in this area was conducted under rigorous, randomized, doubleblinded, controlled conditions which showed that fibromyalgia patients, who were concomitantly receiving stable doses of amitriptyline, selective serotonin reuptake inhibitors and tramadol as part of their treatment regimen, and who also presented with the lowest levels of HGH and IGF-1, were most responsive clinically to supplemental HGH therapy [21]. However, a recent analysis by Blumenthal and Malemud [22] re-evaluated the data from that clinical trial [21] where the primary end-point measured in response to treatment with exogenous HGH was a reduction in the number of fibromyalgia tender points and concluded that, in fact, no statistically significant difference could be found between the HGH-treated and the placebo arm of the clinical trial in either primary or secondary end-points. Therefore, it can be concluded that the administration of HGH or supplemental HGR to alleviate the chronic pain of fibromyalgia remains controversial, to say the least.…”