Discrepancies between upper GI symptoms described by those who have them and their identification by conventional medical terminology: a survey of sufferers in four countries.

OBJECTIVE: The objective of this study was to develop a self-administered questionnaire for upper gastrointestinal (GI) symptoms using lay vocabulary uninfluenced by established medical terminology or concepts and to conduct a survey of symptom occurrence among sufferers in four countries. METHODS: The questionnaire was designed by integrating information gained from the vocabulary used by 38 upper GI symptom sufferers. There was no medical input to its development. The questionnaire was then used, after appropriate translation, in Brazil, Russia, the UK and the USA. Details of 10 659 symptom episodes were obtained from 2665 individuals. RESULTS: Nine symptoms described in lay vocabulary were identified during questionnaire development. Of these, one corresponded to regurgitation, whereas two that were distinguished by survey participants might both be interpreted as heartburn. One chest symptom for which a corresponding medical term was uncertain occurred in ∼30% of the respondents. Five different 'stomach' or abdominal symptoms were identified. The predominant symptom and the pattern of concurrent symptoms often varied from one symptom episode to another. Use of the terms 'heartburn', 'reflux', 'indigestion' and 'burning stomach' to describe symptoms varied between countries. CONCLUSION: Some common upper GI symptoms described by those who suffer them have no clear counterpart in conventional medical terminology. Inadequacy of the conventional terminology in this respect deserves attention, first, to characterize it fully, and thereafter to construct enquiry that delivers more precise symptom identification. Our results suggest that improvement may require the use of vocabulary of individuals suffering the symptoms without imposing conformity with established symptom concepts.

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

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.

Evaluation of an Innovative Over-the-Counter Treatment for Symptoms of Reflux Disease: Quick-Dissolving Alginate Granules.

Traditional antacids and alginate-based reflux suppressants are OTC products commonly used to treat reflux symptoms. There has been a lack of innovation of new formulations in this therapy area despite consumers finding established products unpalatable. Here we evaluate a novel product formulation which takes the form of quick-dissolving alginate granules in single-dose sachets (Gaviscon Direct Powder (GDP)). Market research and taste evaluation confirmed that reflux sufferers considered GDP to have good flavour and taste, no chalky aftertaste and dissolved rapidly in the mouth with 68% noting so within 10 seconds. GDP was considered convenient and easy to use. The consumer-driven product development was also shown to form a strong alginate raft in standardised in vitro conditions that met the specifications of the BP monograph (raft strength > 7.5 g). Gastric retention of GDP and a test meal was investigated in healthy volunteers using gamma scintigraphy in comparison to Liquid Gaviscon. Both products formed an alginate raft in the stomach above the test meal and emptied after the meal. The gastric retention of the GDP product was found to be noninferior to Liquid Gaviscon. In conclusion, the innovative GDP product formed an effective raft and was well liked by consumers.