J Neurosci Res 2002 Feb 1;67(3):285-9



Quality of Life Assessment in Adults with Somatotropin (Growth Hormone) Deficiency: Response to Treatment with Symbiotropin® an Effervescent Growth Hormone Secretagogue.

MARK LADLEY, MD. JOHN SORTINO, MD. USA

Context Adults with growth hormone (GH) deficiency (GHD) often have a plethora of physical and psychological complaints, collectively referred to as low quality of life (QoL). There is a characteristic cluster syndrome in adult Somatotropin (GH) deficiency related to: decreased mood, reporting lower openness, less assertiveness, less energy, greater emotional liability, more difficulty with sexual relationships and a greater sense of social isolation. Evidence suggests that the severity of these psychological distresses correlate positively, with the duration of AGHD. Consistently, QoL studies have shown that adults with GHD are both psychologically and physically less healthy--than are their age-matched peers and that GH therapy results in both substantial and sustained benefits. The possibility that Somatotropin is involved in cognitive deficits has been recognized in many clinical trials. Recent findings from a 6-year follow-up of nearly 500 patients, found that impaired cognitive function is a risk factor for all-cause mortality in middle-aged adults, much as it is in elderly adults. More recent epidemiological data suggests that adults with GHD, have reduced life expectancy.

Objective To investigate the relationship between the administration of the effervescent growth hormone secretagogue, Symbiotropin® and changes in QoL via two standardized tests of analysis.

Design, Setting and Participants This was a prospective, open treatment design of twenty-five

patients, of which sixteen were female (64%) and nine (36%) were male. The mean age was 59 years, with a range from 41 to 78. All patients had baseline scores that were indicative of severely reduced QoL, due to Somatotropin deficiency.

Main Outcome Measures Does the oral administration of effervescent growth hormone secretagogue (GHS) Symbiotropin® significantly improve the baseline Quality of Life (QoL) in patients with AGHD?

Results A. Within this group of 25 patients, regardless of gender or age, results for both sexes and both age groups were statistically significant in demonstrating an overall marked improvement in QoL (P= .001). The degree of improvement in the women’s overall QoL, was greater than men.

B. The monitored patient variables… improved well-being (P = .002), increased energy (P = .011), increase in exercise endurance (P = .034), improved flexibility (P = .045) were all statistically significant. Of note were three additional variables, improved mental focus, increased strength and improved sleeping patterns, which were not statistically significant (P =.052; P = .076; P = .072; respectively), but had Effect Sizes of (.86; .77; .79; respectively) that were highly substantial, that will summon further clinical investigations.

C. There were no patient adverse effects, or patients who asked to be removed from the study.

Conclusions In as early as three months, the oral administration of the effervescent GHS, Symbiotropin,® resulted in a statistically significant improvement in: increased well-being, increased energy, increase in exercise endurance, improved flexibility and an overall marked improvement in QoL, in both men and women, irrespective of their chronological age or gender.

Additionally, women demonstrated a statistically significant greater improvement in overall QoL, than did men.

Improved mental focus, increased strength and improved sleeping patterns were not statistically significant, but they demonstrated practical significance based on substantial Effect Sizes.

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