| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
From the Peripheral Neuropathy Research Center, Department of Neurology(Drs. Dyck and Litchy and Ms. Davies) and the Section of Biostatistics (Dr. O'Brien), Mayo Clinic and Mayo Foundation, Rochester, MN, and Health Partners(Dr. Litchy), Minneapolis, MN.
Address correspondence and reprint requests to Dr Dyck, Peripheral Neuropathy Research Center, Department of Neurology, Mayo Clinic, 200 First Street S.W., Rochester, MN 55905.
Because there are little satisfactory data on change in severity of diabetic polyneuropathy (DP) over time from study of population-based cohorts of diabetic patients in epidemiologic surveys of DP, it is difficult to predict outcome or morbidity or to identify risk factors; it is also difficult to estimate statistical power for use in controlled clinical trials. In this longitudinal study of almost 200 patients from the Rochester Diabetic Neuropathy Study (RDNS) cohort, we assess which symptoms, clinical examinations, tests, or combinations of examinations and tests (composite scores) are best used as minimal criteria for the diagnosis of DP and as a quantitative measure of severity of DP. An abnormality (
97.5th percentile) of a composite score that included the Neuropathy Impairment Score of the lower limbs plus seven tests (NIS(LL)+7 tests), was a better minimal criteria for DP than clinical judgment alone or previously published minimal criteria. First, it provided a more comprehensive assessment of neuropathic impairment. Second, it avoided the overestimated frequency of DP when the minimal criteria for DP was any one or two abnormalities from multiple measurements. Minimal criteria using nerve conduction and reduced heart beat response to deep breathing identified approximately twice as many patients with DP than did clinical examination and vibration detection threshold using CASE IV. This difference could be used to subclassify stage 1 DP. Although various individual measures of DP, for example, vibration detection threshold (as evaluated by CASE IV and the 4, 2, and 1 stepping algorithm [see text]), were good measures of worsening, the composite score NIS(LL)+7 tests (assessing neuropathic impairment) was much better at showing monotone worsening. Using this composite score, the average diabetic patient in the RDNS worsened by 0.34 points per year, whereas patients with diabetic polyneuropathy worsened by 0.85 points per year. On the assumption that a therapeutic agent may prevent worsening of DP but not cause improvement, controlled clinical trials of patients with DP would need to be conducted for a period of 3 years to achieve a meaningful change of 2 NIS points (the level of abnormality considered by a Peripheral Nerve Society consensus group to be clinically meaningful).
Supported in part by grants obtained from the National Institute of Neurological Diseases and Stroke (14304).
Received November 5, 1996. Accepted in final form December 24, 1996.
This article has been cited by other articles:
|
|
 |
|
  D. N. Herrmann and M. B. Bromberg Chili peppers, nerve regeneration, and clinical trial design Neurology, April 17, 2007; 68(16): 1247 - 1248. [Full Text] [PDF]
|
|
|
|
 |
|
 D. Selvarajah, I. D. Wilkinson, C. J. Emery, N. D. Harris, P. J. Shaw, D. R. Witte, P. D. Griffiths, and S. Tesfaye Early Involvement of the Spinal Cord in Diabetic Peripheral Neuropathy Diabetes Care, December 1, 2006; 29(12): 2664 - 2669. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 P. G. Richardson, H. Briemberg, S. Jagannath, P. Y. Wen, B. Barlogie, J. Berenson, S. Singhal, D. S. Siegel, D. Irwin, M. Schuster, et al. Frequency, Characteristics, and Reversibility of Peripheral Neuropathy During Treatment of Advanced Multiple Myeloma With Bortezomib J. Clin. Oncol., July 1, 2006; 24(19): 3113 - 3120. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. G. Smith, J. Russell, E. L. Feldman, J. Goldstein, A. Peltier, S. Smith, J. Hamwi, D. Pollari, B. Bixby, J. Howard, et al. Lifestyle Intervention for Pre-Diabetic Neuropathy. Diabetes Care, June 1, 2006; 29(6): 1294 - 1299. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 L. G. Goransson, A. B. Tjensvoll, A. Herigstad, S. I. Mellgren, and R. Omdal Small-diameter nerve fiber neuropathy in systemic lupus erythematosus. Arch Neurol, March 1, 2006; 63(3): 401 - 404. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 C. S. Andreassen, J. Jakobsen, and H. Andersen Muscle Weakness: A Progressive Late Complication in Diabetic Distal Symmetric Polyneuropathy Diabetes, March 1, 2006; 55(3): 806 - 812. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
L. Vileikyte, H. Leventhal, J. S. Gonzalez, M. Peyrot, R. R. Rubin, J. S. Ulbrecht, A. Garrow, C. Waterman, P. R. Cavanagh, and A. J.M. Boulton Diabetic Peripheral Neuropathy and Depressive Symptoms: The association revisited Diabetes Care, October 1, 2005; 28(10): 2378 - 2383. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. J. Dyck, P. C. O'Brien, W. J. Litchy, C. M. Harper, C. J. Klein, and P. J. B. Dyck Monotonicity of Nerve Tests in Diabetes: Subclinical nerve dysfunction precedes diagnosis of polyneuropathy Diabetes Care, September 1, 2005; 28(9): 2192 - 2200. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 G A Suarez, V M Clark, J E Norell, T E Kottke, M J Callahan, P C O'Brien, P A Low, and P J Dyck Sudden cardiac death in diabetes mellitus: risk factors in the Rochester diabetic neuropathy study J. Neurol. Neurosurg. Psychiatry, February 1, 2005; 76(2): 240 - 245. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
P. A. Low, L. M. Benrud-Larson, D. M. Sletten, T. L. Opfer-Gehrking, S. D. Weigand, P. C. O'Brien, G. A. Suarez, and P. J. Dyck Autonomic Symptoms and Diabetic Neuropathy: A population-based study Diabetes Care, December 1, 2004; 27(12): 2942 - 2947. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A. Dispenzieri, A. Moreno-Aspitia, G. A. Suarez, M. Q. Lacy, G. Colon-Otero, A. Tefferi, M. R. Litzow, V. Roy, W. J. Hogan, R. A. Kyle, et al. Peripheral blood stem cell transplantation in 16 patients with POEMS syndrome, and a review of the literature Blood, November 15, 2004; 104(10): 3400 - 3407. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
D. Ziegler, C. G.H. Sohr, and J. Nourooz-Zadeh Oxidative Stress and Antioxidant Defense in Relation to the Severity of Diabetic Polyneuropathy and Cardiovascular Autonomic Neuropathy Diabetes Care, September 1, 2004; 27(9): 2178 - 2183. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
A. J.M. Boulton, R. A. Malik, J. C. Arezzo, and J. M. Sosenko Diabetic Somatic Neuropathies Diabetes Care, June 1, 2004; 27(6): 1458 - 1486. [Full Text] [PDF]
|
|
|
|
|
|
J-P Lefaucheur and A Creange Neurophysiological testing correlates with clinical examination according to fibre type involvement and severity in sensory neuropathy J. Neurol. Neurosurg. Psychiatry, March 1, 2004; 75(3): 417 - 422. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
N. I. Spielholz, P. J. Dyck, P. C. O'Brien, M. E. Shy, and E. M. Frohman Quantitative sensory testing: Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology Neurology, December 9, 2003; 61(11): 1628 - 1630. [Full Text] [PDF]
|
|
|
|
|
|
M.E. Shy, E.M. Frohman, Y.T. So, J.C. Arezzo, D.R. Cornblath, M.J. Giuliani, J.C. Kincaid, J.L. Ochoa, G.J. Parry, and L.H. Weimer Quantitative sensory testing: Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology Neurology, March 25, 2003; 60(6): 898 - 904. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 S. C. Apfel, S. Schwartz, B. T. Adornato, R. Freeman, V. Biton, M. Rendell, A. Vinik, M. Giuliani, J. C. Stevens, R. Barbano, et al. Efficacy and Safety of Recombinant Human Nerve Growth Factor in Patients With Diabetic Polyneuropathy: A Randomized Controlled Trial JAMA, November 1, 2000; 284(17): 2215 - 2221. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
M. I. Periquet, V. Novak, M. P. Collins, H. N. Nagaraja, S. Erdem, S. M. Nash, M. L. Freimer, Z. Sahenk, J. T. Kissel, and J. R. Mendell Painful sensory neuropathy: Prospective evaluation using skin biopsy Neurology, November 1, 1999; 53(8): 1641 - 1641. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
G. I. Wolfe, N. S. Baker, A. A. Amato, C. E. Jackson, S. P. Nations, D. S. Saperstein, C. H. Cha, J. S. Katz, W. W. Bryan, and R. J. Barohn Chronic Cryptogenic Sensory Polyneuropathy: Clinical and Laboratory Characteristics Arch Neurol, May 1, 1999; 56(5): 540 - 547. [Abstract] [Full Text] [PDF]
|
|
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
