RANDOMIZED CONTROLLED TRIAL
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Heterogeneity in responsiveness of perceived quality of life to body composition changes between adult- and childhood-onset Japanese hypopituitary adults with GH deficiency during GH replacement.

OBJECTIVE: To examine the responsiveness of quality of life (QoL) associated with changes in clinical indices relevant to GH deficiency (GHD) in Japanese hypopituitary adults.

DESIGN AND METHODS: QoL was determined using the Short Form (SF)-36 in Japanese adults with adult-(AO; n = 27) or childhood- (CO; n = 37) onset GHD in a 24-week double-blind placebo-controlled study with a fixed GH dose, and a subsequent 48-week open-label extension study with GH doses individualized using serum IGF-I levels.

RESULTS: Baseline QoL was significantly decreased from the Japanese national reference in both onset types, more so in AO patients. Throughout the study, AO patients showed a trend for an increase in physical functioning and general health (P = 0.0564 and 0.0999 respectively), whereas CO patients showed no changes in these domains. Fat mass changes negatively correlated with the changes in physical functioning and general health in AO patients (r = -0.42 and -0.64 respectively), but to a lesser degree in CO patients (r = -0.36 and -0.32 respectively). CO patients displayed significant decreases in social functioning (P = 0.0305) and mental health (P = 0.0442) and a decreasing trend in bodily pain (P = 0.0769), although no correlation between these decreases and any measured clinical index was observed, except between changes in bodily pain and IGF-I levels (r = -0.43).

CONCLUSIONS: QoL impairment was evident in Japanese adults with GHD, particularly in AO patients. In AO patients, general health and physical functioning domains were responsive to fat mass changes during GH treatment; this association was not evident in CO patients. These relationships between QoL and body composition warrant verification.

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