Key result
Placebo improves mild diabetic neuropathy symptoms despite declining nerve conduction and heart rate deep breathing.
Why the study?
How do neuropathy symptoms and disease progression change over 1 year in placebo-administered patients with mild diabetic peripheral neuropathy?
Population
262 placebo-administered patients with mild diabetic peripheral neuropathy from two identical phase 3…
Design
Cohort, double-blind (in original trials)
Follow-up
1 year
Authors
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Symptom improvement despite objective decline in mild DPN may reflect placebo effects; leaves open optimal endpoints for future progression trials.
RCT (n=262)
double-blind
randomized
How do neuropathy symptoms and disease progression change over 1 year in placebo-administered patients with mild diabetic peripheral neuropathy?
In placebo-treated patients with mild symptomatic DPN, symptoms progressively improve over 12 months despite declines in objective measures like nerve conduction and heart rate deep breathing.
Tesfaye et al. (2007) conducted an RCT in mild diabetic peripheral neuropathy (n=262). Ruboxistaurin (RBX) vs. Placebo was evaluated on Change in neuropathy symptoms and disease progression. In placebo-administered patients with mild diabetic peripheral neuropathy, symptoms improved over 1 year (NTSS-6 -3.73; P<0.001), whereas nerve conduction and heart rate deep breathing declined.
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