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At week 24, serum IGF-1 levels increased and body weight was reduced by an average of 6.5% from baseline.
An orally administered amino acid-based test supplement was shown to increase insulin-like growth factor 1 (IGF-1) in patients with fibromyalgia and stress-associated low-normal human growth hormone (hGH), which improved the clinical symptoms, including stress-related weight gain, according to a study published in Frontiers in Endocrinology.1 IGF-1 is a common indicator of hGH levels caused by stress-related stimulation of the hormone somatostatin.
Although results of previous studies showed that patients with fibromyalgia receiving recombinant human growth hormone (rhGH) had improvements in tender points and fatigue, there are currently no US Food and Drug Administration (FDA)-approved treatments for increasing hGH levels in those who do not have hGH deficiency.2
“Several studies indicate that reduced production of human growth hormone (hGH) is evident in approximately 30% of individuals with fibromyalgia and may play a role in its pathophysiology,” wrote a team of investigators led by Susan Pekarovics, MD, attending physician and clinical instructor at Cedars-Sinai Medical Center. “Impaired hGH production in these individuals is hypothesized to contribute to common fibromyalgia symptoms and comorbidities, such as fatigue, disordered sleep, impaired cognition, decreased lean body mass, increased adipose tissue, muscle weakness, and poor general health.”
The prospective, observational, single-center, single-arm cohort study evaluated the effects of a daily administration of the test supplement, which consisted of a blend of L-lysine, L-arginine, oxo-proline, N-acetyl-l-cysteine, L-glutamine, and Schizonepeta tenuifolia, in patients with fibromyalgia, stress-related weight gain, and stress-related low-normal hGH production on IGF-1. Stress-related low-normal hGH was defined as the 15 – 30th percentile for age-appropriate levels.
Investigators enrolled 84 adult patients (56 female, 28 male) with fibromyalgia and low-normal age-adjusted IGF-1 serum levels at Pekarovics’ private practice between 2018 and 2020. Patients continued to receive standard care during the 24-week period, with follow-up appointments scheduled at 0, 6, 12, 18, and 24 weeks.
The primary endpoint was changes in IGF-1 from baseline to week 24. Changes in clinical symptoms, changes in body weight, fasting cardiometabolic markers, tolerability, and safety were also evaluated. Clinical symptoms were assessed using the Perceived Stress Scale (PSS) and the Revised Fibromyalgia Impact Questionnaire (FIQR).
IGF-1 levels peaked at week 12 and remained elevated throughout the course of the study. At week 24, serum IGF-1 levels increased with a mean ± Standard Error (SE) change of 28.4 ± 3.0 ng/mL (P <.001). Body weight was reduced with a mean ± SE change of -5.5 ± 0.3 kg (P <.001), indicating an average 6.5% weight loss from baseline.
Significant changes in FIQR and PSS scores were reported at week 24 (-29.1 ± 1.1 and -20.0 ± 0.8, respectively; P <.001). Systolic and diastolic blood pressure, cholesterol (HbA1c, LDL, and HDL), and triglycerides all showed statistically significant improvements from baseline (P <.001). The test supplement was well tolerated, no adverse events were reported, and no patients withdrew from the study.
Investigators noted that the lack of a placebo comparator group may be considered a limitation of the study.
“The hGH enhancing effects of the test supplement represents a potential low-risk and cost-effective treatment to amplify endogenous hGH and improve clinical symptoms, benefitting individuals with low-normal hGH such as fibromyalgia, especially as this population includes elderly patients where the risk/benefit ratio is of substantial concern,” investigators concluded. “Future studies should be conducted for repurposing sustained augmentation of IGF-1 with the supplement in weight control, and to assess its benefits in otherwise healthy individuals with obesity and low-normal hGH,” investigators concluded.