A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms
There is growing interest in measuring quality of life (QoL) in medicine. Together with objective variables such as healing rate, as recorded with endoscopy, this is believed to give a better basis for evaluation of treatment regimens in patients with upper gastrointestinal diseases. A strategy for the assessment of QoL in patients with upper gastrointestinal symptoms is presented here. The QoL evaluation was based on a battery of questionnaires, covering both general and specific aspects of life. General well-being was evaluated with the Psychological General Well-being Index (PGWB), and subjective symptoms with two specific questionnaires, the Gastrointestinal Symptom Rating Scale (GSRS) and the Ulcus Esophagitis Subjective Symptoms Scale (UESS). This new strategy was applied clinically in a study including 146 outpatients with suspected peptic ulcer. Initially, the patients reported a low degree of general well-being as evaluated with the PGWB, but the values returned to those found in normal populations within 4 weeks. Evaluation of the GSRS and UESS with regard to internal consistency, construct validity, and the ability to detect changes showed them to be satisfactory. The psychometric documentation of the measures indicates that they may give reliable and clinically valid information when used for evaluation of medical treatments in upper gastrointestinal disease. Further documentation of the methods is, however, needed to establish a generally acceptable QoL assessment in gastroenterology.