The Use of Recombinant Human Growth Hormone to Protect Against Muscle Weakness in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Pilot, Randomized Placebo-Controlled Trial

Mendias CL, Enselman ERS, Olszewski AM, Gumucio JP, Edon DL, Konnaris MA, Carpenter JE, Awan TM, Jacobson JA, Gagnier JJ, Barkan AL, Bedi A · The American Journal of Sports Medicine

Circulating IGF-1 was 2.1 times higher over the treatment window. At 26 weeks normalised isokinetic knee extension torque was 29 percent higher on growth hormone than on placebo (p equal to 0.05, Cohen d 0.80), the trial's primary outcome, with no difference at any earlier point and no difference in quadriceps volume on MRI, which both groups lost about 20 percent of by five weeks. Serum matrix metalloproteinase-3, taken as an indirect marker of cartilage breakdown, was 36 percent lower on growth hormone across the treatment window. Patient-reported scores did not differ except the KOOS symptoms subscale, which was consistently lower on growth hormone. Adverse events were similar (8 of 10 against 7 of 9), with one dose halved for sweating.

Population

Men aged 18 to 35 with a unilateral complete anterior cruciate ligament tear undergoing reconstruction at one centre; 20 randomised, one placebo withdrawal

Intervention

Recombinant human growth hormone 0.5 mg per square metre of body surface twice daily by subcutaneous injection from one week before surgery to five weeks after

Comparator

Bacteriostatic saline on the same schedule, double-blind

Limitations

Nineteen men at one centre, significance set at p under 0.10 for a pilot, and the safety committee stopped the trial on the strength difference rather than at a planned size of 17 a group. Strength was measured only to six months, MMP-3 is a serum marker rather than a cartilage measurement, and the growth hormone group had 17 percent more quadriceps volume at baseline. Funded by the Mark Cuban Foundation; several authors report payments from device and drug companies. The drug tested was recombinant growth hormone itself, not a secretagogue.