Topiramate vs placebo in painful diabetic neuropathy: analgesic and metabolic effects.

BACKGROUND: Using identical methods, three simultaneous placebo-controlled trials of topiramate for painful diabetic neuropathy (PDN) did not reach significance. This independent yet concurrent placebo-controlled trial used different methods to assess topiramate efficacy and tolerability in PDN. METHODS: This 12-week, multicenter, randomized, double-blind trial included 323 subjects with PDN and pain visual analog (PVA) score of at least 40 on a scale from 0 (no pain) to 100 (worst possible pain). Topiramate (n = 214) or placebo (n = 109) was titrated to 400 mg daily or maximum tolerated dose. Short-acting rescue analgesics were permitted only during the first 6 weeks. RESULTS: Baseline characteristics were comparable between groups except for mean body weight (topiramate, 101.4 kg; placebo, 95.7 kg; p = 0.028). Twelve weeks of topiramate treatment reduced PVA scale score (from 68.0 to 46.2 mm) more effectively than placebo (from 69.1 to 54.0 mm; p = 0.038). Fifty percent of topiramate-treated subjects and 34% of placebo-treated subjects responded to treatment, defined as >30% reduction in PVA scale score (p = 0.004). Topiramate monotherapy also reduced worst pain intensity (p = 0.003 vs placebo) and sleep disruption (p = 0.020 vs placebo). Diarrhea, loss of appetite, and somnolence were the most commonly reported adverse events in the topiramate group. Topiramate reduced body weight (-2.6 vs +0.2 kg for placebo; p < 0.001) without disrupting glycemic control. CONCLUSIONS: Topiramate monotherapy reduced pain and body weight more effectively than placebo in patients with painful diabetic neuropathy.

Preliminary results of a pilot program on depression in patients with congestive heart failure.

While the sample size is too small to warrant conclusions, these preliminary results suggest that assessment of depression would be worthwhile for patients diagnosed with congestive heart failure. 32 out of 54 patients with congestive heart failure scored positive for depression. When psychiatric treatment was given, there was a decrease in depressive symptoms for four of the six patients at the 6-mo, retest. A decrease in depressive symptoms was found for two of the six untreated patients, and the remaining four patients had worse scores on the Zung Depression Inventory. Primary care physicians, who typically meet with such patients regularly, are encouraged to screen for depression, as their clinical assessments in this study were associated with scores on the Zung Depression Inventory. These observations support a full scale investigation with a much larger sample size and a requisite medical cost comparison.

Detection of Lawsonia intracellularis in swine using polymerase chain reaction methodology.

The polymerase chain reaction (PCR) was evaluated for its usefulness as a diagnostic tool to detect Lawsonia (ileal symbiont) intracellularis. Porcine ilea were collected from swine cases submitted to the Iowa State University Veterinary Diagnostic Laboratory between December 1, 1994, and June 30, 1995. Sampling was random, with no regard to health status. There were 621 ileum scrapings evaluated using the PCR technique. Thirty-five of the samples were positive, either by PCR or conventional diagnostic methods such as histology and Warthin-Starry silver stain. These 35 samples were further evaluated by Warthin-Starry silver stain and indirect immunofluorescent antibody test (IFAT) to confirm the presence of L. intracellularis in the tissue sections. Of the 26 samples positive by PCR, 22 were positive by IFAT. Sixteen of the 22 were also positive when stained with Warthin-Starry and evaluated microscopically for typical bacteria. Nine of the original samples were negative by all 3 techniques. PCR appears more sensitive and specific for L. intracellularis detection than Warthin-Starry stain and IFAT. This study provides evidence that PCR may be useful as a reference standard for the detection of L. intracellularis. PCR may be an appropriate monitoring tool for swine herds because it is a rapid procedure that could be applied to batch testing. Although the test is currently too laborious and expensive for routine diagnostic use, there may be situations in which it is justified because of the advantages of greater sensitivity and specificity.

Evaluation of antemortem polymerase chain reaction and serologic methods for detection of Lawsonia intracellularis-exposed pigs.

OBJECTIVE: To evaluate polymerase chain reaction (PCR) for detection of Lawsonia intracellularis DNA in feces and an indirect fluorescent antibody test (IFAT) for detecting serum IgG antibodies in pigs exposed to L intracellularis. ANIMALS: 15 seven-week-old pigs and 42 three-week-old pigs. PROCEDURE: During 3 experiments, 23 pigs were inoculated with a pure culture of L intracellularis, 31 pigs served as noninoculated controls, and 3 pigs were used as sentinels. Fecal shedding of L intracellularis was monitored by use of PCR analysis at 7-day intervals. At euthanasia, the ileum was obtained for PCR and histologic analyses. Serum was obtained at 7-day intervals for use in the IFAT. RESULTS: Polymerase chain reaction analysis detected L intracellularis DNA in the feces of 39% of the inoculated pigs; by postinoculation days 21 to 28, 90% of inoculated pigs developed IgG antibodies detected by IFAT. Neither L intracellularis DNA nor IgG antibodies were detected in any of the noninoculated control pigs at euthanasia. Sera from pigs inoculated with enteric pathogens other than L intracellularis did not contain detectable antibodies that reacted with L intracellularis by use of the IFAT. CONCLUSION: The IFAT for L intracellularis IgG antibody detection appeared to be a more sensitive antemortem test for detecting pigs experimentally infected with L intracellularis than was a PCR method for direct detection of the organism in the feces. CLINICAL RELEVANCE: Not all animals that are infected with L intracellularis shed the organism in feces at detectable amounts.

Effect of light-tip distance on polymerization of resin composite.

The inability to place a light tip in close approximation to a resin restoration may affect the resultant polymerization and clinical durability of the restoration. This research measured light intensity at the surface of a resin composite, as well as 2 mm within its bulk, as the tip-to-resin distance is moved from 0 to 10 mm. The polymerization of the resin composite at both locations was measured for the various tip distances using exposure durations of 10, 20, 40, and 60 seconds. Light intensity did not decrease with the inverse square of the tip distance. The polymerization on the surface was greatly dependent upon the duration of exposure. The extent of polymerization 2 mm below the surface was still dependent primarily upon exposure duration, but intensity had a significant affect. For exposure durations of 10, 20, and 40 seconds, a tip distance greater than 4 mm demonstrated a significant decrease in resin polymerization 2 mm below the resin composite surface.

Multispectral magnetic resonance image analysis.

Multiecho magnetic resonance (MR) scanning produces tomographic images with approximately equal morphologic information but varying gray scales at the same anatomic level. Multispectral image classification techniques, originally developed for satellite imaging, have recently been applied to MR tissue characterization. Statistical assessment of multispectral tissue classification techniques has been used to select the most promising of several alternative methods. MR examinations of the head and body, obtained with a 0.35, 0.5, or 1.5T imager, comprised data sets with at least two pulse sequences yielding three images at each anatomical level: (1) TR = 0.3 sec, TE = 30 msec, (2) TR = 1.5, TE = 30, (3) TR = 1.5, TE = 120. Normal and pathological images have been analyzed using multispectral analysis and image classification. MR image data are first subjected to radiometric and geometric corrections to reduce error resulting from (1) instrumental variations in data acquisition, (2) image noise, and (3) misregistration. Training regions of interest (ROI) are outlined in areas of normal (gray and white matter, CSF) and pathological tissue. Statistics are extracted from these ROIs and classification maps generated using table lookup, minimum distance to means, maximum likelihood, and cluster analysis. These synthetic maps are then compared pixel by pixel with manually prepared classification maps of the same MR images. Using these methods, the authors have found that: (1) both supervised and unsupervised classification techniques yielded theme maps (class maps) which demonstrated tissue characteristic signatures and (2) tissue classification errors found in computer-generated theme maps were due to subtle gray scale changes present in the original MR data sets arising from radiometric inhomogeneity and spatial nonuniformity.