Peanut Oral Immunotherapy With or Without H1 and H2 Antihistamine Premedication for Peanut Allergy (PISCES): A Placebo-Controlled Randomized Clinical Trial
Bibliographic record
Abstract
BACKGROUND: Current forms of peanut oral immunotherapy (OIT) are associated with side effects, and there is a lack of evidence addressing how to mitigate them. OBJECTIVE: To determine whether premedication with desloratadine and ranitidine results in fewer side effects during peanut OIT/desensitization. METHODS: antihistamine blockade, or double-placebo. Patients, study staff/investigators, and statisticians were blinded. The primary outcomes were the frequency and severity of OIT-induced adverse events. The secondary outcomes were quality of life and eliciting doses to blinded food challenge. RESULTS: Adverse reactions occurred more in the OIT groups compared with the double-placebo group (OIT with antihistamines vs double-placebo hazard ratio, 3.75 [95% CI, 2.79-4.72]; OIT with placebo antihistamines vs double-placebo, hazard ratio, 4.62 [95% CI, 3.61-5.62]). Patients given antihistamines cotreatment with OIT had a similar risk of adverse events compared with those who did not use antihistamines with OIT (hazard ratio, 1.23 [95% CI, 0.49-1.97]). OIT with and without antihistamines accelerated the incidence rate of adverse events compared with double-placebo (4.8 and 6.4 events per patient vs 3.5 per patient, incidence rate ratio, 2.49 [95% CI, 1.36-4.56] and 2.04 [95% CI, 1.01-4.15], respectively). Antihistamines pretreatment modestly reduced the frequency of moderate to severe adverse reactions among OIT-treated groups (1.9 per patient vs 4.2 per patient, incidence rate ratio, 0.46 [95% CI, 0.24-0.89]), primarily urticaria (0.6 vs 2.1 per patient) followed by abdominal pain (2.6 vs 4.2 per patient), but increased neuropsychiatric adverse events (primarily tiredness and sedation, 2.3 vs 0.7 per patient). Eliciting doses after treatment were similar in all groups. Quality of life improved similarly regardless of treatment with peanut OIT or placebo OIT. CONCLUSIONS: Peanut OIT with antihistamines modestly reduce the skin and gastrointestinal components of the high incidence of adverse reactions during OIT, and there are no clear differences in improvement in quality of life whether treated with OIT, OIT with antihistamines, or placebo OIT despite OIT being effective in inducing desensitization. Safer food allergy treatment approaches that importantly improve quality of life need to be proved in future robust randomized trials.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.009 | 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".