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Hypertonic saline for treatment of bronchiolitis remains debatable
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Negative results from a study on the efficacy of hypertonic saline in bronchiolitis in the ED may not accurately represent the treatment’s ability to reduce the disease’s severity, according to comments published in Archives of Pediatrics and Adolescent Medicine.
“Grewal et al should be congratulated for their recent study concerning the use of 3% hypertonic saline in the treatment of bronchiolitis. We would, however, make several points regarding the methodology of the study and raise concerns about the ultimate message,” wrote Daniel Horner, MBBS, BSc, MRCP, MCEM, of Manchester Royal Infirmary in England, and colleagues.
Horner et al noted that the observation period after treatment of 120 minutes did not provide sufficient time for researchers to determine whether hypertonic saline improved cases of mild to moderate bronchiolitis. They also said that the Respiratory Assessment Change Score (RACS) — which was used to evaluate changes in the disease — was “an overcomplicated tool to assess treatment benefit, based on its multiple variables, subjective criteria, and lack of nonrespiratory data.” The small study sample may also have affected results, according to Horner et al.
Avidor Mandelberg, MD, of the Edith Wolfson Medical Center, and Israel Amirav, MD, of R. Sieff Hospital in Israel agreed with Horner et al, noting that clinical scores, like those yielded by RACS, are subjective. Additionally, research assistants, as opposed to physicians collected the data, and Mandelberg and Amirav questioned whether their experience played a role in the study’s outcomes.
“Furthermore, only 2.5 mL of hypertonic saline was used (in only 1.5 inhalations on average), and the CS was measured for only up to 120 minutes postinhalation, in contrast to 4 mL in the hypertonic saline group and 3 to 12 inhalations per day for several days in the previous positive studies,” wrote Mandelberg and Amirav.
“The purpose of our study was to determine if hypertonic saline had an immediate effect on patients’ clinical status during their ED visit, hence our choice of two hours as a study period and up to 2 doses of hypertonic saline as the number of study doses,” wrote Grewal et al in reply.
Grewal et al also said that no gold standard test exists for measuring bronchiolitis severity, so their choice in using RACS based on high reliability and validity was warranted. Additionally, the research assistants were registered pediatric nurses who were trained in the clinical scoring system to ensure accuracy and standardization, according to the researchers.
Grewal et al also noted that 2.5 mL of saline solution was the standard treatment in their hospital and therefore was an appropriate dosage to be used in the study.
“We feel that our study highlights the fact that immediate clinical benefits may not be seen with hypertonic saline. This does not contradict current evidence that suggests a beneficial role for hypertonic saline over the complete clinical course of bronchiolitis. Rather, this highlights the importance of conducting future research in the optimal treatment of bronchiolitis in the ED,” wrote Grewal et al. – by Melissa Foster
For more information:
- Horner D. Arch Pediatr Adolesc Med. 2010;164(4):395.
- Mandelberg A. Arch Pediatr Adolesc Med. 2010;164(4):395-396.
- Grewal S. Arch Pediatr Adolesc Med. 2010;164(4):396-397.
These letters highlight the restrictions of good clinical trials – consistent and rigorous adherence to the methods, trained personnel and adaption to busy medical settings, none of which mimic “the real world.” Determination of clinical usefulness may require, even for clinical transitional studies, a further “T5 Trial” – the Tincture of Time.
– Caroline B. Hall, MD
Infectious
Diseases in Children Editorial Board