title: Carpal tunnel syndrome and gynaecomastia during growth hormone treatment of elderly men with low circulating IGF-I concentrations.
abstract: OBJECTIVE
  We studied the relationship between plasma level of insulin-like growth hormone I (IGF-I), changes in lean body mass and in adipose mass, and adverse side-effects during human growth hormone (hGH) treatment of elderly men who had low IGF-I levels.
  
  
  METHODS
  The first six months was a period of baseline observation. The subjects were then randomized into two groups so that during months 7-18, men in group I received hGH, and men in group II served as untreated controls.
  
  
  METHODS
  Eighty-three overtly healthy elderly men, who were selected because their plasma IGF-I level was less than 0.35 units/ml. The men were randomly assigned in a ratio of three to one into group I (n = 62) or into group II (n = 21).
  
  
  METHODS
  Plasma IGF-I level was measured monthly. Lean body mass and adipose mass were measured every six months.
  
  
  RESULTS
  Fifteen men left the study during the baseline period because of personal reasons or intercurrent medical events. In those who received drug (group I), there were a number of adverse reactions which could have been related to the hGH therapy: carpal tunnel syndrome 10, gynaecomastia 4, and hyperglycaemia 3. In total there were 27 dropouts from group I and two dropouts from group II after the six-month point, for a variety of medical and non-medical reasons, the majority probably not related to hGH therapy. During the hGH treatment of group I, plasma IGF-I increased from the range 0.10-0.35 units/ml into the range 0.5-2.2 units/ml. Among the 18 men who completed 12 months of hGH treatment without experiencing one of the three above-noted presumed hGH side-effects, mean and peak plasma IGF-I during treatment were significantly lower than among the 13 men who experienced carpal tunnel syndrome or gynaecomastia (one subject had both) while on hGH. With one exception, neither carpal tunnel syndrome nor gynaecomastia occurred in any individual with a mean IGF-I level less than 1.0 units/ml during hGH treatment. Twelve months of hGH treatment (group I) caused an increase in lean body mass to 106% of the initial baseline (month one of the protocol), and a reduction in adipose mass to 84% of the baseline. Meanwhile, the lean body mass of the untreated men in group II declined to 97% of the initial baseline. The body composition responses after 12 months of treatment in group I were larger in the men whose mean intra-treatment IGF-I level was 0.5-1.0 units/ml, than in the men whose mean intra-treatment IGF-I level was 1.0-1.5 units/ml.
  
  
  CONCLUSIONS
  These observations show that when elderly men with low circulating IGF-I concentrations are treated continuously with hGH, elevation of plasma IGF-I above 1.0 units/ml is associated with a substantial frequency of carpal tunnel syndrome or gynaecomastia. It may be that the effects of the hormone in expanding lean body mass and reducing adipose mass can be achieved, and the side-effects avoided, by maintaining the mean IGF-I level in the range 0.5-1.0 units/ml.
authors.affiliation: Department of Medicine, Medical College of Wisconsin, Milwaukee.
authors.forename: L
authors.initials: L
authors.lastname: Cohn
authors.forename: A G
authors.initials: AG
authors.lastname: Feller
authors.forename: M W
authors.initials: MW
authors.lastname: Draper
authors.forename: I W
authors.initials: IW
authors.lastname: Rudman
authors.forename: D
authors.initials: D
authors.lastname: Rudman
mesh_terms: D000273:Adipose Tissue / Q000187:drug effects; D000368:Aged; D001823:Body Composition / Q000187:drug effects; D015992:Body Mass Index; D002349:Carpal Tunnel Syndrome / Q000139:chemically induced*; D013006:Growth Hormone / Q000009:adverse effects* / Q000494:pharmacology; D006177:Gynecomastia / Q000139:chemically induced*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000032:analysis* / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000009:adverse effects / Q000494:pharmacology
chemical_list: D011994:Recombinant Proteins; D007334:Insulin-Like Growth Factor I; D013006:Growth Hormone