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Medical Affairs Manager and Scientific Service Manager, Novartis CH, Italy
The prevalence of gastroesophageal reflux disease (GERD) symptoms in pregnancy is very high, up to 80%, with a maximum peak during the third trimester. Together with lifestyle modifications, antacids and antisecretive agents, such as proton pump inhibitors (PPIs) and histamine H2receptor antagonists (H2RAs), are commonly prescribed in non-pregnant, adult population. In certain Countries these drugs are not allowed in or are allowed only during the late stages of pregnancy. Alginate-based formulations have been used for the symptomatic treatment of heartburn for decades, as they usually contain sodium or potassium bicarbonate. In the presence of gastric acid, a foamy raft is created above the gastric contents. The alginate raft moves into the esophagus in place or ahead of acidic gastric contents during reflux episodes physically preventing reflux of gastric contents into the esophagus. Alginate-based formulations are allowed with no restrictions also in pregnancy: their safety profile make them a very valid option taking into account the risk/benefit ratio for both parturient and unborn baby. This systematic review paper aims to explore the use of medications for treating GERD in pregnancy, including alginate raft-forming-agents, highlighting the benefits for both the mother and the fetus. Electronic search in databases was conducted on databases such as Medline, PubMed, Ovid retrieving data concerning the reflux treatments in pregnancy, with a special focus on alginate raft forming antireflux agents. From the literature on alginate use in pregnancy, no particular risks have been shown to date for both parturient and unborn baby when alginate had been administered during all the pregnancy trimesters. The physical mode of action ensures the maximum esophageal protection by the neutral foam floating in the stomach, maintaining physiological pH values at stomach level, without interfering with the digestive processes. The symptoms’ healing has been markedly improved during the weeks of observation; the symptoms monitored in all studies were: heartburn, regurgitation, pain (chest). After four weeks of treatment little or no change was observed in maternal mean sodium or potassium concentrations. No sodium restriction diet has been adopted. No edema of lower limbs or weight gain occurred. No adverse reactions related to the testing drug had been reported and all the authors concluded that alginate was safe for the unborn baby. Nowadays pharmacological treatments for GER are available as OTC drugs, including antacids, antisecretive agents, PPIs and H2RAs, and as medical devices, such as alginate raft forming antireflux agents (i.e.: Reflubloc™, Novartis NCH Italy). On this last product, considering the specific indication in pregnancy and the safety profile, without restrictions of administration during the whole pregnancy period, furthermore the physical mode of action, it gives the gynecologists a very important option in treating GER in pregnancy, taking care of both pregnant and fetus. Raft-forming-antireflux agents are safe and effective in GER treatment during pregnancy.