Sunday, October 26, 2003 - 10:20 AM

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

D. Mark Ladley, MD and John Sortino, MD.

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). Adults with Somatotropin deficiency report lower openness, less assertiveness, less energy, greater emotional liability, more difficulty with sexual relationships and a greater sense of social isolation.The somatotroph cells of the anterior pituitary gland produce GH, which is also commonly known as Somatotropin in the scientific literature. Daily release of Somatotropin from the anterior pituitary averages approximately 500 mcg at age 20, then declines to 200 mcg at age 40 and 25 mcg at age 80.

The objective of this study was to investigate the relationship between the administration of Symbiotropin,® an effervescent growth hormone secretagogue (GHS), against two standardized clinical assessment measures of QoL.The subject population consisted of a sample of twenty-five patients who participated in the study,of which sixteen were female (64%) and nine (36%) were male. Subjects were chosen to participate in this clinical study, based on their degree of baseline GHD impairment.

There were two methods of QoL assessment evaluated in our clinical trial.The reliability of both means of assessment, were in the high level.The first instrument was the Assessment of Growth Hormone Deficiency in Adults Questionnaire (QoL~AGHDA) which was used to quantify the degree of patient QoL impairment at baseline,and also at three-months post-therapy with Symbiotropin.® In analyzing the patient QoL~AGHDA scores from our study, there were statistically significant mean differences within the whole group, between the baseline scores and the three-month reassessment scores, where (P=.001).That is,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 improvement in QoL. Interestingly, the baseline QoL~ AGHDA scores were higher in women compared to men, indicating women had a higher degree of QoL impairment. However, the women's total gain in mean score improvement,during this three-month analysis,was greater than men (i.e.,male mean decrease = 5.00 and female mean decrease = 6.81). Thus, the degree of improvement in overall QoL for women, was greater than men in our study.

The second means of QoL assessment in our clinical trial, was a modified version of the instrument,The General Growth Hormone Patient Self-Assessment Questionnaire (GGHPSAQ) (modified).This questionnaire was administered at 3 months post-baseline,following Symbiotropin® therapy. In regards to particular variables of this questionnaire, improved well-being was statistically significant (P =.002). Improved well-being also demonstrated practical importance,which was indicated via its very large Effect Size (ES) of 1.48. Increased energy was another variable that was statistically significant (P =.011). When looking at the mean differences by age, the variable increase in exercise endurance was statistically significant (P =.034), as was also, improved flexibility (P =.045). More importantly, these beneficial changes occurred, in the absence of any patient side-effects.

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 an ES of (.86;.77;.79; respectively) that were substantial, that will summon further clinical investigations.

IN CONCLUSION, in this prospective clinical trial, in as early as three months, the 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 importance based on a substantial ES.

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