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Journal Club

This article examines a randomized trial comparing sublingual buprenorphine with oral morphine for the treatment of neonatal abstinence syndrome, focusing on the duration of treatment. The results show that buprenorphine led to a significantly shorter duration of treatment and hospital stay compared to morphine.

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Journal Club

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  1. Journal Club Alcohol, Other Drugs, and Health: Current Evidence September-October, 2017

  2. Featured Article Buprenorphine for the treatment of the neonatal abstinence syndrome. Kraft WK, et al. N Engl J Med.2017;376(24):2341–2348.

  3. Study Objectives • To “compare sublingual buprenorphine with oral morphine with respect to the duration of treatment in infants with the neonatal abstinence syndrome.” www.aodhealth.org

  4. Study Design • Randomized, double-blind, double-dummy trial at a single site in the US. • Of 121 eligible infants, 63 were enrolled. • Buprenorphine group: 33 • Morphine group: 30 www.aodhealth.org

  5. Assessing Validity of an Article about Therapy • Are the results valid? • What are the results? • How can I apply the results to patient care? www.aodhealth.org

  6. Are the Results Valid? • Were participants randomized? • Was randomization concealed? • Were participants analyzed in the groups to which they were randomized? • Were participants in the intervention and control groups similar? www.aodhealth.org

  7. Are the Results Valid?(cont‘d) • Were participants aware of group allocation? • Were outcome assessors aware of group allocation? • Was follow-up complete? www.aodhealth.org

  8. Were participants randomized? • Yes. • Infants “were randomly assigned in a 1:1 ratio to receive either sublingual buprenorphine or oral morphine and the corresponding placebo. Randomization was stratified according to maternal exposure to methadone or buprenorphine and the maternal intention to breast-feed or bottle-feed.” www.aodhealth.org

  9. Was randomization concealed? • Yes. www.aodhealth.org

  10. Were participants analyzed in the groups to which they were randomized? • Yes. www.aodhealth.org

  11. Were the participants in the intervention and control groups similar? • Yes. www.aodhealth.org

  12. Were participants aware of group allocation? • No, the study used a double dummy design. www.aodhealth.org

  13. Were outcome assessors aware of group allocation? • Not stated. www.aodhealth.org

  14. Was follow-up complete? • No. • 5 infants withdrew from the study after randomization but were included in the intention-to-treat analysis. They were excluded from the per-protocol analysis. • Overall, 13 adverse events occurred. There were no differences between the 2 groups with regard to adverse events. www.aodhealth.org

  15. What Are the Results? • How large was the treatment effect? • How precise was the estimate of the treatment effect? www.aodhealth.org

  16. How large and precise was the treatment effect? • Using an intent-to-treat analysis, the median duration of treatment was significantly shorter with buprenorphine than with morphine (15 days versus 28 days, 95% confidence interval [CI], 7 to 21; P<0.001). • Median length of hospital stay was shorter in the buprenorphine group (21 days versus 33 days, 95% CI, 7 to 22; P<0.001). www.aodhealth.org 16

  17. How Can I Apply the Results to Patient Care? • Were all clinically important outcomes considered? • Are the likely treatment benefits worth the potential harm and costs? www.aodhealth.org

  18. Were all clinically important outcomes considered? • Preterm infants and those with in utero exposure to benzodiazepines were excluded. • Longer term outcomes were not assessed. www.aodhealth.org

  19. Are the likely treatment benefits worth the potential harm and costs? • Although there were adverse events in both groups, there was no difference found between groups in respect to harm. • Shortened hospital stays for neonatal abstinence syndrome treatment could translate to a reduction in overall treatment cost. www.aodhealth.org

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