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FM Journal Club

This study evaluates the efficacy of Lactobacillus Reuteri in reducing crying time in colicky infants. Results show a significant reduction in crying time after 21 days of treatment. However, the study has limitations and requires further investigation to validate the findings.

joshuafields
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FM Journal Club

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  1. FM Journal Club February, 2011

  2. Background • 3 - 28 % of babies, • All babies cry most in the first 3 mo • No standard definition • Rule of Threes, ≥ 3 hrs, ≥ 3 d/ wk, ≥ 3 wk • 6 wk peak •  60% by 3 mo, 90% by 4 mo • Most treatment works in 1/3 of babies

  3. Background • Social phenomenon: • “Caretakers perception of what is excessive or prolonged (crying) and caretakers ultimate response to the perception defines it as a problem.” Up to Date

  4. Colic and Probiotics • Just in Case • Journal of Family Practice • Search: • Dynamed: No mention under colic tx • UpToDate: 2 RCT’s, good synopsis • 2010 Double blind, pacebo controlled RCT • 2007 Prospective randomized, no placebo, open, simethacone vs probiotic • Google Scholar: 1st reference

  5. The Reference • Lactobacillus Reuteri DSM in Infantile Colic: A Randomized, Double-Blind Placebo-Controlled Trial. • Sevino et at. Pediatrics 2010; 126; e526-e533. Online August 16, 2010.

  6. Methods • 50 term breast fed babies, recruited from general practice and outpatient clinics, randomly assigned to receive Lactobacillus reuteri or placebo and evaluated for 21 days, for crying time and gut flora. • 5 drops of suspension, once a day before the feed in the morning for 21 days. (108 colony forming units)

  7. Were the patients randomized? Was Allocation Concealed? • Page e 527: Study design • Randomized, using random digit method, computer generated numbers. Two treatment randomization, with random block of varying size. The pediatrician allocated the next available product entry into the trial, each patient received it directly from the department.

  8. Were patients similar? • Table 1 • Probiotics slightly older by 4 days • No sig differences according to P values • Page e529 • There were no significant differences between the groups regarding type of delivery, gender, age, family history or GI, atopy, or growth or median crying time.

  9. Blinding • Method of blinding • Active study product: suspension of freeze dried L. Reuteri in sunflower oil in dark bottle. Placebo: Identical w/o L. Reuteri. • Patients/Clinicians/Assessors: p. e528: • The bottles were coded and blinded by the study statistician for both participants and pediatricians, and code was revealed to the investigators once recruitment, data collection, and all … analysis complete

  10. How Complete Was Follow – Up? Intention to Treat? • Follow-up • None “lost”, 46 completed the trial • Intention to Treat • 4 excluded from analysis • 1 fever • 2 failure to complete daily forms • 1 GERD • The 4 treated as responders as they were all in the placebo group. (p. 528)

  11. Was the study stopped early? • No

  12. Results: Continuous Variable • Day 21: Reduction in daily crying time • Placebo: 35 min • L. Reuteri: 90 min • P = 0.022 • Days 7, 14 not statistically significant. Noted in discussion and in Table 2. Not in main text. • Reporting bias?

  13. Results: Dichotomous: Reduction in crying time by 50%(ITT) p. 529

  14. Error • Type II? • Power Calculation p. 528 • 80% power to detect a difference of 50 min of crying with a dropout rate of 20% • Type I? • Possible with tiny sample size

  15. Other results • No differences in Growth parameters, GI symptoms, • Adverse events: • Not powered for adverse events • Rhinitis, ezcema, fever, otalgy, GERD • “unrelated”

  16. Application: Similar to my patients? • Solely breast fed • Italian • Full term, otherwise healthy • Recruited from general and outpatient practices

  17. Application: All relevant outcomes considered? • Real or Surrogate: minutes of crying time?, flora? • Adverse outcomes? • Long term outcomes?

  18. Application: Will my patient benefit? Risks,harms and costs • NNT: 4. You need to treat approximately 4 infants for 3 weeks with L. Reuteri, to have 1 additional infant display a 50% reduction in crying time. • 72% responders to placebo at 21 days • 96% responders to L. Reuteri at d. • Effect is decreasing over time

  19. Application • 90% are better at 4 months of age • Remember in treatments studied “Most treatments works in 1/3 of babies” • 50 minutes less crying time may be very important to families • Tiny study, need replication • Many studies can’t be replicated

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