Objectives: Conflicting data of the benefits of GH replacement improving psychological and physical well being is available, though open GH studies generally agree on an overall improvement. For growth hormone deficient patients to continue on therapy after evaluation there should be a 7 point improvement in their QoL-AGHDA, as documented in the NICE guidelines. The aim of this study was to determine the impact of 0.4 mg of GH on QoL in severe GH deficient patients in a double blind placebo controlled study.
Methods: Seventeen patients (10 males and 7 females) with confirmed severe GH deficiency secondary to hypopituitarism were randomised to subcutaneous recombinant GH (Lilly rGH®, dose 0.004 mg/kg/day) versus placebo (sterile diluent containing glycerol and m-cresol) of 12 weeks duration per arm and then crossed over. Thereafter, patients continued open GH therapy for a further 6 months. QoLAGHDA questionnaires were completed and assessed at the end of each study phase.
Results: All patients completed the questionnaires and compliance was more than 95% for GH administration. All patients had restoration of their IGF-1 to the normal range.Two patients had an AGHDA score in the normal range at baseline (1 & 2 respectively), so were excluded from further analysis. When compared with baseline, only 1/15 patients over the initial three months period improved their scores with rGH by more than 7 points which was no significantly different to placebo scores (P=0.73). However, 6/15 patients improved their scores by more than 7 points after 6 months of continuous rGH replacement in the open phase compared with placebo values (P=0.47).
Conclusions: Three months rGH treatment was insufficient to affect the QoL-AGHDA of seven points or more and a minimum evaluation period of 6 months treatment appeared to be required to effect a change.