SOMATOMED CLINICAL TRIAL - CHRONIC FATIGUE SYNDROME

 

VESPRO SOMATOMED GHS GROWTH HORMONE SECRETAGOGUE -- IN PERSONS WITH CHRONIC FATIGUE SYNDROME

Salvato, P., Thompson, C., Bayou City Medical Center Hospital, Houston, Texas, U.S.A.

Objective: To determine if a growth hormone secretagogue called SomatoMed (VesPro GHS Growth Hormone) was safe and efficacious in patients with CDC define Chronic Fatigue Syndrome (CFS).

Methods: Body cell mass measured by BIA (BCM), natural killer number (NK#), and Insulin growth factor-1 (IgF-1) levels were evaluated in 200 CFS patients. These measures were assessed at study initiation and every month for three months. Subjective measures of symptoms, cognitive function, activities of daily living and sleep disturbance were also assessed monthly for three months.

Results:

Objective

BCM: 126 (63%) of the patients had increase in BCM of 1 lb or more; 103 (82%) lost weight due to decrease in fat body mass; 23 (18%) gained from 5-11 lbs.;

IgF-1: 118 (59%) patients had increase in their IgF-1 level of 20% or more NK#: 129 (65%) had increase of their NK# of 30% or more;

Subjective

 

  • Sleep: 158 (79%) had marked improvement in their sleep;
  • Cognitive: 156 (78%) had marked improvement in cognitive function;
  • Muscle Pain: 104 (52%) had improvement in muscle pain;
  • Fatigue: 135 (68%) had improvement in fatigue;

Side effects:

 

  • 56 (28%) had transient muscle and joint pain during initiation of therapy;
  • 61 (31%) of the patients had mild edema;

Conclusion

An oral secretagogue, Somatomed, has been found to be a safe and efficacious therapy, capable of improving many of the clinical signs and symptoms associated with the Chronic Fatigue Syndrome. Clinically, the efficacy of Somatomed has been verified through IgF-1 measurements and patient assessment, as well as improvement in immune function and body cell mass. It is of interest to note that even in patients who did not raise IgF-1 levels, significant improvement in sleep and cognition were still noted. This product deserves further study in patients with Chronic Fatigue Syndrome.