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. 2015 Sep 19;2015(9):CD011379. doi: 10.1002/14651858.CD011379.pub2

Kovacs 1990.

Methods RCT. Women recruited from 4 private obstetric practices, May 1985–June 1987, Australia.
Participants 50 pregnant women aged 20‐40, more than 20 weeks pregnant and having experienced moderately severe heartburn at least once a day in the previous week. Women with known gastrointestinal disorders, systemic medication or chronic respiratory diseases, emphysema or recurrent pneumonia were excluded. Women had moderate and severe degree of heartburn at study entry.
Interventions Intervention groups: mucaine with oxethazaine, mucaine. Data for these women have been combined for analysis. N = 32.
Comparison group: placebo. N = 18.
Study duration: 1 week.
Intervention and treatment were provided in identical bottles. Women were allowed to take an antacid if treatment was not successful after 15 minutes of the drug dose. Women were asked to record the severity of heartburn before the trial and after the 7 day study period, as well as the number of doses used each day and antacids taken. Side effects were also recorded at the end of the week.
Outcomes Relief of heartburn, symptoms severity and relief, use of medication, willingness to use the medication again. All outcomes were analysed using mean and standard deviation
Notes This study was supported by Wyeth Pharmaceuticals. Heartburn relief data were not used in the analysis as it were presented as a mean.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation not described. Study described as randomised.
Allocation concealment (selection bias) Low risk Women allocated to trial number in sequence. Identical treatments and placebo prepared, so that staff and women would not have been aware of the next allocation.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Treatment and placebo identical.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Treatment and placebo identical.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Data for all women recruited.
Selective reporting (reporting bias) Low risk All relevant outcomes appear to have been reported.
Other bias Unclear risk This study was supported by Wyeth Pharmaceuticals.