Sediflù may relieve cough in children Original paper

In this randomized controlled trial, an herb-containing cough syrup improved cough and cough-related outcomes in children with dry or productive cough.

This Study Summary was published on April 17, 2024.

Quick Summary

In this randomized controlled trial, an herb-containing cough syrup improved cough and cough-related outcomes in children with dry or productive cough.

What was studied?

The effect of Sediflù (a syrup containing eucalyptus honey and dry extracts of horehound flowers, sundew flowers, ivy leaves, and plantain leaves) on cough and cough-related outcomes in the context of pediatric cough.

The primary outcomes were daytime and nighttime cough severity assessed using the Cough Symptom Score (CSS). The secondary outcomes, which were assessed using Paul’s Night Cough Questionnaire, were nighttime cough frequency, nighttime cough severity, nighttime cough bothersome score, child sleep quality, and parental sleep quality.

Who was studied?

56 children (average age of 9) with dry or productive cough, who were recruited from two primary care centers in Madrid, Spain.

How was it studied?

A 7-day randomized controlled trial was conducted, in which the participants took 10 mL of either Sediflù or a placebo syrup twice per day (in the morning and evening) for a total daily dose of 20 mL. All outcomes were assessed at baseline and every day thereafter until the end of the trial.

What were the results?

The daytime CSS improvement was greater in the Sediflù group than in the placebo group on days 3 (18% higher), 4 (28% higher), 5 (36% higher), 6 (44% higher), and 7 (71% higher). The nighttime CSS improvement was greater in the Sediflù group than in the placebo group on nights 4 (36% higher), 5 (43% higher), 6 (58% higher), and 7 (71% higher).

At the end of the trial, the improvement in all secondary outcomes was greater in the Sediflù group than in the placebo group.

No adverse effects were observed in either group.

Anything else I need to know?

The trial was exploratory in nature (it was not preregistered, and multiple outcomes were tested at several time points with no adjustments for multiple comparisons, which increases the risk of false-positive results), so the findings should be considered preliminary.

The trial was funded by Cinfa Laboratories (the manufacturer of Sediflù). Moreover, some of the trial authors worked as scientific advisors for Cinfa Laboratories at the time the trial was conducted.

This Study Summary was published on April 17, 2024.