Recombinant human nerve growth factor in the treatment of diabetic polyneuropathy. NGF Study Group.
BACKGROUND
Preclinical studies have demonstrated that nerve growth factor may prevent or reverse peripheral neuropathy. We have therefore tested the effects of recombinant human nerve growth factor in patients with diabetic polyneuropathy.


METHODS
A total of 250 patients with symptomatic diabetic polyneuropathy randomly received either placebo or one of two doses of recombinant human nerve growth factor for 6 months. Patients were assessed for symptoms and signs of polyneuropathy before and after treatment.


RESULTS
Compared with placebo, recombinant human nerve growth factor led to significant improvement after 6 months of treatment, as measured by the sensory component of the neurologic examination, two quantitative sensory tests, and the impression of most subjects that their neuropathy had improved. Three prospectively identified multiple endpoint analyses indicated improvements in the nerve growth factor treatment groups over the placebo group in all three analyses (p = 0.032; p = 0.008; p = 0.005). Recombinant human nerve growth factor was well tolerated, with injection site discomfort reported as the most frequent adverse event.


CONCLUSIONS
Recombinant human nerve growth factor appears to be safe and shows preliminary evidence of efficacy in patients with symptomatic diabetic polyneuropathy.
Apfel
S C
SC
Department of Neurology, Albert Einstein College of Medicine, Bronx, NY 10461, USA.
Kessler
J A
JA
Adornato
B T
BT
Litchy
W J
WJ
Sanders
C
C
Rask
C A
CA
D000293:Adolescent; D000328:Adult; D003929:Diabetic Neuropathies / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009414:Nerve Growth Factors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009431:Neural Conduction / Q000187:drug effects; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012677:Sensation / Q000187:drug effects; D016896:Treatment Outcome
D009414:Nerve Growth Factors; D011994:Recombinant Proteins