Abstract
The aim of this study was to compare the therapeutic efficacy of alginate-based reflux suppressant and magnesium-aluminium antacid gel for treatment of heartburn in pregnancy. A double-blinded, randomized, controlled trial was conducted. One hundred pregnant women at less than 36 weeks gestation with heartburn at least twice per week were randomized to either alginate-based reflux suppressant or to magnesium-aluminium antacid gel. Details of heartburn were recorded before beginning the treatment and the second week of study. Primary outcome measure was the improvement of heartburn frequency after treatment and secondary outcome were the improvement of heartburn intensity, quality of life, maternal satisfaction, maternal side effects, pregnancy and neonatal outcomes. There was no difference between treatment and control groups in improvement of heartburn frequency (80% vs 88%, p = 0.275), 50% reduction of frequency of heartburn (56% vs 52%, p = 0.688), improvement of heartburn intensity (92% vs 92%, p = 1.000) and 50% reduction of heartburn intensity (68% vs 80% cases, p = 0.075). There were also no significant differences in quality of life, maternal satisfaction, maternal side effects, pregnancy and neonatal outcomes. Alginate-based reflux suppressant was not different from magnesium-aluminium antacid gel in the treatment of heartburn in pregnancy.
Highlights
For the treatment of heartburn in pregnancy[2]
Fifty women were assigned to the alginate-based reflux suppressant group and 50 women were assigned to the magnesium-aluminium antacid gel group
There were no significant differences between the groups with respect to maternal age, gestational age when heartburn present, pre-pregnancy body mass index (BMI), parity, twin pregnancy, and history of heartburn/dyspepsia before pregnancy (Table 1)
Summary
For the treatment of heartburn in pregnancy[2]. The Cochrane review in 2015, which includes nine small studies (which involved data from only four small studies), indicates that there are limited data suggesting that heartburn in pregnancy could be completely relieved by pharmaceutical treatment[2]. Antacids have no teratogenic effect in animal studies and considered safe to use in pregnancy[8]. Alginate-based reflux suppressants are licensed for use in pregnant women to combat the frequent symptoms of heartburn and regurgitation. The advantage of alginate-based reflux suppressants over antacids alone is that they provide rapid and longer lasting symptom relief 9. There has been one multicenter, prospective, open-label, and baseline-controlled study of liquid alginate-based reflux suppressants in the treatment of heartburn in pregnant women. There has been no randomized controlled trial to compare the efficacy of alginate-based reflux suppressants to magnesium-aluminium antacid gel for treatment of heartburn in pregnancy. The primary aim of this study was to compare the reduction of heartburn frequency after treatment. Secondary aims were to compare the reduction of heartburn intensity, quality of life, maternal satisfaction, maternal side effects, pregnancy and neonatal outcomes
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