Clinical experience with Somatonorm.

A total of 21 patients with hGH deficiency was included in a double-blind, randomized, comparative multicentre trial of somatrem (Somatonorm) and pituitary hGH. Owing to the withdrawal of the latter product, only 6 months follow-up can be evaluated. Growth velocities on both preparations were similar, and patients with complete hGH deficiency responded better than those with only partial deficiency. No specific side-effects were noted, but antibodies to hGH were noted in two patients on Somatonorm. Antibodies to Escherichia coli polypeptide (ECP) were found in both groups. In an open study of 14 children treated with Somatonorm, growth velocity increased from a mean of 3.26 +/- 0.42 cm/year to 7.1 +/- 0.47 cm/year during the 1 year of follow-up; in this time, bone age increased by 10 months. No clinical or biological abnormalities were detected, though 50% of the children developed anti-hGH antibodies and 13 out of 14 developed Z scores greater than 0.1 for ECP antibodies, compared with 5 out of 14 before treatment.

RCT Entities:   Population Interventions Outcomes