Fibromyalgia & HGH^® Reference Information

Edward Lichten, M.D.,PC
180 East Brown Street
Birmingham, MI 48009 
248.593.9999

Human Growth Hormone is the
Treatment that May Do the Most!

Bennett RM, Clark SC, Walczyk J. A randomized, double-blind, placebo-controlled study of growth hormone in the treatment of fibromyalgia. Am J Med 1998 Mar;104(3):227-31 Department of Medicine, Oregon Health Sciences University, Portland 97201, USA.

PURPOSE: The cause of fibromyalgia (FM) is not known. Low levels of insulin-like growth factor 1 (IGF-1), a surrogate marker for low growth hormone (GH) secretion, occur in about one third of patients who have many clinical features of growth hormone deficiency, such as diminished energy, dysphoria, impaired cognition, poor general health, reduced exercise capacity, muscle weakness, and cold intolerance. To determine whether suboptimal growth hormone production could be relevant to the symptomatology of fibromyalgia, we assessed the clinical effects of treatment with growth hormone. METHODS: Fifty women with fibromyalgia and low IGF-1 levels were enrolled in a randomized, placebo-controlled, double-blind study of 9 months' duration. They gave themselves daily subcutaneous injections of growth hormone or placebo. Two outcome measures--the Fibromyalgia Impact Questionnaire and the number of fibromyalgia tender points-were evaluated at 3-monthly intervals by a blinded investigator. An unblinded investigator reviewed the IGF-1 results monthly and adjusted the growth hormone dose to achieve an IGF-1 level of about 250 ng/mL. RESULTS: Daily growth hormone injections resulted in a prompt and sustained increase in IGF-1 levels. The treatment (n=22) group showed a significant improvement over the placebo group (n=23) at 9 months in both the Fibromyalgia Impact Questionnaire score (P <0.04) and the tender point score (P <0.03). Fifteen subjects in the growth hormone group and 6 subjects in the control group experienced a global improvement (P <0.02). There was a delayed response to therapy, with most patients experiencing improvement at the 6-month mark. After discontinuing growth hormone, patients experienced a worsening of symptoms. Carpal tunnel symptoms were more prevalent in the growth hormone group (7 versus 1); no other adverse events were more common in this group. CONCLUSIONS: Women with fibromyalgia and low IGF-1 levels experienced an improvement in their overall symptomatology and number of tender points after 9 months of daily growth hormone therapy. This suggests that a secondary growth hormone deficiency may be responsible for some of the symptoms of fibromyalgia.

These Patients Do Not Improve with Standard Therapy!

Wolfe F, Anderson J, Harkness D, Bennett RM, Caro XJ, Goldenberg DL, Russell IJ, Yunus MB.: Arthritis Rheum 1997 Sep;40(9):1571-9 Health status and disease severity in fibromyalgia: results of a six-center longitudinal study. Arthritis Rheum. 1997 Sep;40(9):1553-5 Arthritis Research Center, and University of Kansas School of Medicine, Wichita 67214, USA.

OBJECTIVE: To determine the intermediate and long-term outcomes of fibromyalgia in patients seen in rheumatology centers in which there is special interest in the syndrome. METHODS: We conducted a longitudinal outcome study by mailed comprehensive Health Assessment Questionnaire administered every 6 months to 538 patients, from 6 rheumatology centers, whose median duration of disease at first assessment was 7.8 years. The final assessment took place after 7 years. In addition, there was study followup of 85 patients who had attended the Wichita center for > 10 years. RESULTS: Although functional disability worsened slightly and health satisfaction improved slightly, measures of pain, global severity, fatigue, sleep disturbance, anxiety, depression, and health status were markedly abnormal at study initiation and were essentially unchanged over the study period. Correlations between first and last assessment values were as high as r = 0.82. For some variables, abnormalities were 3 times greater at one center compared with another. CONCLUSION: Patients with established fibromyalgia, seen in rheumatology centers in which there a special interest in the disease and followed up for as long as 7 years, have markedly abnormal scores for pain, functional disability, fatigue, sleep disturbance, and psychological status, and these values do not change substantially over time. Half the patients are dissatisfied with their health, and 59% rate their health as fair or poor. There are marked differences in disease severity among the various centers, but < 14% of the variance in outcomes can be explained by demographic or center factors. Values at the first assessment are predictive of final values

Bennett RM, Cook DM, Clark SR, Burckhardt CS, Campbell SM. Department of Medicine, Oregon Health Sciences University, Portland 97201, USA. Hypothalamic-pituitary-insulin-like growth factor-I axis dysfunction in patients with fibromyalgia. J Rheumatolo 1997 Jul; 24(7): 1384-9

OBJECTIVE: To investigate the serum levels of insulin-like growth factor-I (IGF-I) in patients with fibromyalgia (FM) compared to healthy controls and patients with other rheumatic diseases, and to explore possible etiologic mechanisms of low IGF-I levels inpatients with FM. METHODS: Five hundred patients with FM and 152 controls (74 healthy blood donors, 26 myofascial pain patients and 52 patients with other rheumatic diseases) were studied. All had measurements of acid extracted serum IGF-I. A subset of 90 patients with FM were evaluated for clinical features that might explain low IGF-I levels. Twenty-five patients with FM underwent growth hormone (GH) provocation testing with l-dopa and clonidine. RESULTS: The mean serum IGF-I level in patients with FM was 138 +/- 56 ng/ml and in controls 215 +/- 86 ng/ml (p = 0.00000000001). Low levels of IGF-I were not due to depression, tricyclic medications, nonsteroidal antiinflammatory drugs, poor aerobic conditioning, obesity, or pain level. Patients with focal myofascial pain syndromes had normal IGF-I levels (236 +/- 68), as did most patients with other rheumatic disorders, unless they had concomitant FM. Patients with FM with initially normal levels often had a rapid decline of IGF-I over 1 to 2 years. Most patients with FM with low IGF-I levels failed to secrete GH after stimulation with clonidine and l-dopa. CONCLUSION: Many, but not all, patients with FM have low levels of IGF-I that cannot be explained by clinical associations. These results suggest that low IGF-I levels in patients with FM are a secondary phenomenon due to hypothalamic-pituitary-GH axis dysfunction.

New References

1. Bennett RM, Clark, SC, Walczyk, J. A randomized, double-blind, placebo-controlled study of growth hormone in the treatment of fibromyalgia. American Journal of Medicine 1998, 104(3): 227-231.
2. Bennett, RM. Fibromyalgia, chronic fatigue, and myopascial pain. Current Opinion in Rhematology 1998, 10(2):95-103.
3. Bennett, RM. Fibromyalgia Review. Journal of Musculoskeletal Pain 2001, 9(2): 91-106.
4. Bennett, RM. Fibromyalgia Review. Journal of Musculoskeletal Pain 2001, 9(1): 95-110.
5. Bennett, RM. Fibromyalgia Review. Journal of Musculoskeletal Pain 2000, 8(4): 89-104.
6. Bennett, RM. Fibromyalgia Review. Journal of Musculoskeletal Pain 1999, 7(3): 95-108.
7. Bennett, RM. Disordered growth hormone secretion in fibromyalgia: a review of recent findings. Zeitschrift fr Rheumatologie. 1998;57(2): 72-76.
8. Bennett, RM. Fibromyalgia and Pain Management. Mayo Clinic Proceedings 2000; 75(3): 316.