High Dose Intravenous Immunoglobulin is Effective in Painful Diabetic Polyneuropathy Resistant to Conventional Treatments. Results of a Double Blind, Randomized, Placebo-Controlled, Multicenter Trial. (P2.268)
Bibliographic record
Abstract
Objective: To assess the efficacy and safety of high dose intravenous immunoglobulin (IVIg) as pain therapy in treatment resistant diabetic painful polyneuropathy. Background: Overexpression of proinflammatory cytokines is involved in the pathogenesis of neuropathic pain. Design/Methods: Randomized, double blind, placebo-controlled, multicenter trial, involving diabetic patients with a painful polyneuropathy resistant to antidepressants and atiepileptics alone or in combination and who reported baseline severity of pain more than 60 units (mm) on a VAS scale at enrollment. Results: 26 diabetic patients with a painful polyneuropathy according to the Toronto Diabetic Neuropathy Expert Group and resistant to conventional therapies were enrolled and followed up for 12 weeks. Eleven patients in the IVIg arm and 12 patients in the placebo arm completed the study. There were no significant differences concerning age, sex and pain severity. The mean value of pain intensity in the IVIg group dropped from 87.3mm at baseline to 48.4 at the end of the first week and to 47.5 after 4 weeks, while in the placebo group changed from 92.9 to 75.8 after one week and to 85.8 after 4 weeks (p=0.0001). At the end of the study pain severity in patients in the IVIg arm was 54.1 while in the placebo arm was 86.7 (p=0.001). The mean Neuropathic Pain Symptom Inventory (NPSI) total score in the IVIg group dropped from 86 at baseline to 50 after one week and to 40 after 4 weeks while in the placebo group changed from 89 to 80 and then to 86 (p=0.000001 comparing baseline and the fourth week in the 2 groups). The therapy was well tolerated without significant side effects along the follow up. Conclusions: The present study confirms previous data concerning a significant pain relief with IVIg in diabetic patients with a painful neuropathy resistant to conventional treatments.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".