Results of Double Blind Placebo Controlled Trial to Assess the Effect of Vitamin B6 on Managing of Nausea and Vomiting In Pediatrics with Acute Gastroenteritis
Bibliographic record
Abstract
BACKGROUND: Gastroenteritis and respiratory tract infections are the most common childhood diseases. Despite the common use of vitamin B6 to control vomiting in children with gastroenteritis, no study has been performed in this field. This study aimed to assess the value of vitamin B6 in the prevention of vomiting in patients with mild to moderate gastroenteritis. METHODOLOGY: This study was a double blind controlled clinical trial on 96 children with mild to moderate gastroenteritis with age range of 6 months to 12 years admitted in Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Patients were randomly assigned to two groups of 48 subjects matched for age, sex and symptoms of dehydration. Vitamin B6 was given in case group and control group was given placebo. The severity of dehydration and vomiting in patients before and after treatment were evaluated by a physician. All data were recorded in the questionnaire and results in the two treatment groups were compared by using SPSS software (Version 15, Chicago, IL, USA). RESULTS: The mean ± SD age of patients whom underwent Vitamin B6 treatment was 2.9±2.4 versus 2.5±2 in placebo group. Significant difference between mean age, gender, and severity of dehydration in children of two groups wasn't observed. After treatment in both treatment groups, 40 patients (83.3%) had mild dehydration, and 8 patients (16.7%) had moderate dehydration. Vomiting was noted in 28 patients (58.3%) after treatment with vitamin B6 and in 37 patients (77.1%) after treatment with placebo. The mean frequency of vomiting after treatment with vitamin B6 was 1.7±1.3 times and in the control group (treated with distilled water) was 1.5±0.77 time, but no significant difference between the severity of dehydration, controlling vomiting and the mean frequency of vomiting was observed in both groups (P>0.05). CONCLUSION: It seems that the use of oral vitamin B6 treatment has no benefit and impact compared with the placebo. Thus, use of vitamin B6 in the prevention of vomiting due to acute mild to moderate gastroenteritis is not only scientifically, but in the present study it was proved to be ineffective. This work was done on a comparative basis and further researches are recommended.
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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 | 0.004 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 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) | 0.009 | 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".