Abstract
BackgroundThere are limited long-term randomized controlled trials of growth hormone (GH) supplementation to adult height and few published reports of the health-related quality of life (HRQOL) following treatment. The present follow-up study of young adults from a long-term controlled trial of GH treatment in patients with Turner syndrome (TS) yielded data to examine whether GH supplementation resulted in a higher HRQOL (either due to taller stature or from the knowledge that active treatment and not placebo had been received) or alternatively a lower HRQOL (due to medicalization from years of injections).MethodsThe original trial randomized 154 Canadian girls with TS aged 7-13 years from 13 centres to receive either long-term GH injections at the pharmacologic dose of 0.3 mg/kg/week or to receive no injections; estrogen prescription for induction of puberty was standardized. Patients were eligible for the follow-up study if they were at least 16 years old at the time of follow-up. The instrument used to study HRQOL was the SF-36, summarized into physical and mental component scales (PCS and MCS); higher scores indicate better HRQOL.ResultsThirty-four of the 48 eligible participants (71%) consented to participate; data were missing for one patient. Both groups (GH and no treatment) had normal HRQOL at this post-treatment assessment. The GH group had a (mean ± SD) PCS score of 56 ± 5; the untreated group 58 ± 4; mean score for 16-24 year old females in the general population 53.5 ± 6.9. The GH group had a mean MCS score of 52 ± 6; the untreated group 49 ± 13; mean score for 16-24 year old females in the general population 49.6 ± 9.8. Secondary analyses showed no relationship between HRQOL and height.ConclusionsWe found no benefit or adverse effect on HRQOL either from receiving or not receiving growth hormone injections in a long-term randomized controlled trial, confirming larger observational studies. We suggest that it remains ethically acceptable as well as necessary to maintain a long-term untreated control group to estimate the effects of pharmacological agents to manipulate adult height. Young adult women with TS have normal HRQOL suggesting that they adjust well to their challenges in life.Trial RegistrationClinicalTrials.gov Identifier NCT00191113.
Highlights
There are limited long-term randomized controlled trials of growth hormone (GH) supplementation to adult height and few published reports of the health-related quality of life (HRQOL) following treatment
The primary results of the original trial were that growth hormone supplementation increased adult height in women with Turner Syndrome by 7.2 cm on average with high individual variability in the magnitude of response
Thirty-four of the 48 eligible participants (71%) consented to participate in the present follow-up study; data were missing for one patient
Summary
There are limited long-term randomized controlled trials of growth hormone (GH) supplementation to adult height and few published reports of the health-related quality of life (HRQOL) following treatment. Busschbach et al surveyed twenty-five short adult women with Turner syndrome not treated with growth hormone who were the first to respond to their request to participate [9] They found normal scores on the six dimensions of the Nottingham Health Profile, an earlier measure of health-related quality of life. Naess et al surveyed 80 relatively older women with Turner syndrome, mean age 34 years; mean height 152.8 cm, 50% response rate from one specialty clinic and one voluntary registry [11] They reported significantly lower scores in two SF-36 subscales: “physical functioning” and “general health”. They suggested these significant findings may be related to the older age at testing compared with the other studies using the SF-36
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