CURRENT MANAGEMENT OF THE NEONATAL ABSTINENCE SYNDROME - A CRITICAL ANALYSIS OF THE EVIDENCE

Objective: To systematically and critically analyse and summarise the published evidence for the rational choice of pharmacologic treatment of the neonatal abstinence syndrome (NAS), a frequently observed condi tion in neonates born to mothers who are dependent on physically addic ting drugs. Design: Studies comparing different pharmacological agents for the treatment of NAS were identified utilising MEDLINE(R) and add itionally the references cited in pertinent articles. The identified s tudies were critically analysed regarding their study designs and outc ome measures. The reported data for the comparative efficacy of the dr ugs were summarised and evaluated. Results: Fourteen studies were iden tified, most of them comparing treatment of NAS with phenobarbital, pa regoric or diazepam. However, none of these studies was conducted in a double-blind fashion. Frequently, treatment allocations were not prop erly randomised. Prenatal drug exposure varied and was often not suffi ciently verified. Outcome measures and their evaluations differed wide ly. Due to the different study objectives and flaws in study design, a combined analysis of the published data in the form of a meta-analysi s was not deemed possible. When attempting to compare efficacy, diazep am appears to be less efficacious in treating NAS than phenobarbital o r paregoric. The relative efficacy of paregoric and phenobarbital appe ars to depend upon the antenatal exposure of the neonate and on the ou tcome measure of the study. Only two studies evaluate the efficacy of pure opioids, none of them in direct comparison to paregoric. It remai ns questionable whether paregoric, which contains the central stimulan t camphor and a large amount of alcohol, should be the opioid of choic e for the treatment of NAS. Conclusion: Most published studies were co nducted prior to the development of clinical epidemiology and modem st udy design and thus yielded only very limited comparative data on the benefits of different treatment protocols. There is very little eviden ce regarding the efficacy of different pharmacological therapy regimen s to treat NAS. More studies are required to produce the evidence need ed to allow a rational choice between treatment modalities of NAS and thus to ensure optimal care of the neonates suffering from this condit ion.