Meaningful degrees of prevention or improvement of nerve conduction in controlled clinical trials of diabetic neuropathy.
Use of nerve conduction in assessing therapy in preventing or ameliorating neuropathy is desirable because abnormalities of nerve conduction are associated with severity of neuropathic symptoms and deficits. Assuming that a therapy is associated with a statistically significant improvement of nerve conduction, what degree of nerve conduction change is clinically meaningful? We suggest that in controlled clinical trials, a mean change of 2 points on the neurologic disability score is clinically detectable and meaningful. Based on our previously published cross-sectional epidemiological data, this corresponds to a change of motor nerve conduction velocity of the average ulnar median and peroneal nerves of 2.9 m/s and peroneal nerve of 2.2 m/s. The corresponding changes of amplitude were 1.2 and 0.7 mV, respectively. Smaller degrees of nerve conduction change were found when only insulin-dependent patients were evaluated.
Dyck
P J
PJ
Peripheral Neuropathy Research Laboratory, Mayo Clinic, Rochester, Minnesota 55905.
O'Brien
P C
PC
D002986:Clinical Trials as Topic; D003929:Diabetic Neuropathies / Q000175:diagnosis* / Q000517:prevention & control / Q000628:therapy; D006801:Humans; D009431:Neural Conduction; D010543:Peroneal Nerve / Q000503:physiopathology; D012044:Regression Analysis