Assessment of the Safety and Efficacy of a Raft-Forming Alginate Reflux Suppressant (Liquid Gaviscon) for the Treatment of Heartburn during Pregnancy

Abstract

Gastro-oesophageal reflux (GER) and the symptoms of heartburn and regurgitation are common in pregnancy. These symptoms are transient and mostly resolve postpartum but have a negative impact on quality of life. Here, we present a prospective clinical evaluation of the safety and efficacy of an alginate raft-forming oral suspension that is licensed for use in pregnancy. The study was a multicentre, prospective, open-label, and baseline-controlled study of Liquid Gaviscon (LG) in the treatment of heartburn in pregnant women with current symptoms of heartburn and/or reflux requiring treatment (recruited 144). The efficacy of the study medication was rated by the investigator (primary endpoint) and patient. Treatment was deemed to be a success in 91% of patients as judged by the investigator (95% CI 85.0–95.3) and 90% (95% CI 84.1–94.8) when assessed by the patient themselves. Very few adverse events or serious adverse events were reported that were considered to be related to the study medication, and these were consistent with the normal population incidences. Serum sodium levels remained unchanged. This prospective open-label study in a large number of pregnant women has shown that LG is both safe and highly efficacious in the treatment of heartburn and GER symptoms in pregnancy.

Efficacy of alginate-based reflux suppressant and magnesium-aluminium antacid gel for treatment of heartburn in pregnancy: a randomized double-blind controlled trial

“…This confirmed the safety of alginate-based reflux suppressant use in pregnancy as reported from previous studies1112. Alginate-based reflux suppressants are licensed for use by pregnant women to combat the frequent symptoms of heartburn and regurgitation.…”

Alginates in the Treatment of Gastroesophageal Reflux Disease

“…В открытом многоцентровом исследовании применение альгината в течение более четырех недель приводило к купированию симптомов рефлюкса, тогда как дистресс плода наблюдался только в трех случаях [50]. В другом проспективном исследовании с участием двух центров (Южная Африка и Соединенное Королевство) показатели перинатальной заболеваемости и смертности плода были сопоставимы с таковыми в нормальной популяции при приеме альгината в максимальной дозе 80 мл/сут в течение четырех недель [51]. В более позднем исследовании 100 беременных были поровну разделены на две группы.…”

Treatment of reflux disease during pregnancy and lactation

“…In another multi-centered (South Africa and United Kingdom) prospective study, a total of 144 women were given alginate therapy at a maximum dose of 80 mL/day for 4 weeks during their pregnancies. While side effects directly related to the drug, such as diarrhea and nausea, were observed only in 3 of the mothers using alginate, fetus-related perinatal morbidity and mortality rates were found to be similar to normal population incidences (10).…”