Randomized Controlled Trial of Intravenous Immunoglobulin for Autoimmune Postural Tachycardia Syndrome (iSTAND)
Bibliographic record
Abstract
Abstract Objective: Assess response to intravenous immunoglobulin (IVIG) in presumed autoimmune postural orthostatic tachycardia syndrome (POTS) Background: POTS predominantly affects young women and may be associated with systemic autoimmune disorders, serum autoantibodies or recent infection. Uncontrolled case studies suggest that IVIG is beneficial for treating autoimmune POTS. However, no previous randomized controlled trials have been conducted. Methods: This single site randomized controlled clinical trial compared IVIG to intravenous albumin infusions. Albumin comparator ensured blinding and control for effects of volume expansion. Eligible POTS patients had COMPASS-31 score ≥ 40 and met pre-determined criteria suggesting autoimmunity. Over 12 weeks, participants received 8 infusions (0.4gm/kg each). Four infusions were given weekly followed by four infusions every other week. Primary outcome measure was improvement in COMPASS-31 two weeks after final infusion. Results: 50 participants consented; 30 met inclusion criteria and received study drug (16 IVIG and 14 albumin; 29 female). Group baseline characteristics were well matched. 27 participants completed treatment protocol. Change in COMPASS-31 did not differ between groups (median change [IQR]; IVIG: -5.5 [-23.3, 2.5] vs. Albumin: -10.6 [-14.1, -4.7]; p-value = 0.629). Response rate was also not different between groups. Adverse events were common but usually mild and did not differ between treatment groups. Conclusions: This first randomized controlled trial of IVIG in POTS found no difference in symptom response compared to albumin infusion. Both groups showed improvement possibly related to volume expansion obscuring other benefits. Future clinical trials may benefit from the use of POTS-specific clinical outcome measures sensitive to symptoms other than orthostatic intolerance.
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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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.010 | 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".