This article is a summary/review of the following article:
Ong, T. G., Gordon, M., Banks, S. S., Thomas, M. R., & Akobeng, A. K. (2019). Probiotics to prevent infantile colic. The Cochrane Database of Systematic Reviews, 3, CD012473. doi:10.1002/14651858.CD012473.pub2
Background
The clinical presentation of infantile colic (IC) has changed very little since Wessel and Cobb's 1954 definition of "unexplained episodes of crying for more than three hours per day for three days per week for at least three weeks" (Wessel, Cobb, Jackson, Harris, & Detwiler, 1954). Drossman and Hasler (2016) expanded the definition to include fussiness and paroxysms of irritability in an infant for at least 1 week, with no failure to thrive. Ong and Banks updated the scholarly evidence in their 2019 Cochrane Review of infantile colic (IC). They noted that "probiotics are cheap and readily available," and explored the scientific research for evidence of the possible prevention of IC using probiotics (Ong, Gordon, Banks,, Thomas, & Akobeng, 2019).
Objective/s
The objective of the Cochrane review was to determine the efficacy and safety of prophylactic probiotics in infants and/or their mothers to reduce or prevent IC.
Intervention/Methods
The review comprised six randomized control trials (RCTs) with inclusion of cluster and crossover studies. Participants in these studies included newborn infants free of diagnosed IC younger than 1 month, pregnant women from 32 weeks to term, and breastfeeding mothers. A comprehensive electronic database and trial registry search was conducted in January 2018 in the CENTRAL, MEDLINE Ovid, EMBASE Ovid, CINAHL EBSCO Host, PsycINFO Ovid, Cochrane Database of Systematic Reviews, and WHO International Clinical Trials Registry Platform.
The interventions included administration of a single probiotic or a combination of probiotic with a prebiotic versus no intervention, another intervention(s), or placebo. The systematic review was designed to study the effect of the intervention to the onset of IC.
The primary outcome measures were to identify any occurrence of new cases of colic and any life-threatening or adverse effects such as bacterial infection, choking, and parental depression. The secondary outcome measures included the duration of crying time in minutes per day and frequency of episodes in a 24-hour time period in comparison with post-treatment interventions.
Authors evaluated the risk of bias in each study using Cochrane-recommended criteria and determined it to be low for all six studies. Overall, certainty of evidence was assessed using the GRADE approach. Studies were funded by industry in terms of supply of interventional product (probiotic) and/or authors' salary.
Results
Six RCT studies were included from the 3,257 records retrieved through electronic database searches resulting in 1,886 participants. The duration of interventions was from 30 days to 6 months; the control was placebo in all studies.
There was low evidence to support the use of probiotics to prevent IC. No significant difference to the occurrence of new cases of IC (risk ratio [RR] = 0.46; 95% CI [0.18, 1.19]) between the intervention groups with probiotics to placebo in a random-effects meta-analysis of three studies with 1,148 participants was noted. In contrast, there was a significant difference in the groups in favor of probiotics (RR = 0.58; 95% CI [0.38, 0.90]) in a sensitivity analysis with a fixed-effects model. There was no difference in adverse effects (RR = 1.02; 95% CI [0.14, 7.21]) between the intervention groups with probiotics vs placebo in the meta-analysis of all six studies with 1,851 participants.
Random-effects meta-analysis of three studies including 707 participants showed differences in crying time between the intervention groups in favor of probiotics (mean difference [MD] = -32.57 minutes per day; 95% CI [-55.60, -9.54]). Similar results were found in a sensitivity analysis with a fixed-effects model (MD = -32.57; 95% CI [-55.6, -9.54]).
Conclusions
Low-certainty evidence supports probiotics in comparison with placebo to prevent IC, as 40% less cases of IC were discovered in the probiotic group in three studies. In one meta-analysis, a reduction in crying time was identified with the use of probiotics-particularly Lactobacillus-although this also had low-certainty evidence. Fortunately, no serious adverse effects of probiotic administration were noted in any study, and the authors noted that probiotics are safe and cost-effective. This study does not advise a change in practice. Further research studies focusing on specific probiotic strains for infants with abnormal gut flora are warranted.
Implications for Practice
Nurses are uniquely positioned to help new parents cope with IC, providing reassurance and support that colic is self-limited and benign. Johnson, Cocker, and Chang (2015) also supported that IC resolves by around 3-6 months of age without any intervention.
Managing IC is relevant to nursing practice, as nurses work in close collaboration with new parents and infants. Reassuring parents of babies with inconsolable crying promotes parent's well-being and essential bonding with their infant. Gordon, Gohil, and Banks (2019) showed that parent training programs that promote education, psychological interventions, and support to parents helped reduce parents' anxiety levels and their infant's symptoms too.
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