title: Meaningful degrees of prevention or improvement of nerve conduction in controlled clinical trials of diabetic neuropathy.
abstract: 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.
authors.affiliation: Peripheral Neuropathy Research Laboratory, Mayo Clinic, Rochester, Minnesota 55905.
authors.forename: P J
authors.initials: PJ
authors.lastname: Dyck
authors.forename: P C
authors.initials: PC
authors.lastname: O'Brien
mesh_terms: 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