摘要:AIM To investigate the efficacy and safety of mineralwater with a high content of hydrogen carbonate inpatients with heartburn.METHODS: This open, single-center, single-armclinical pilot study enrolled 50 patients, 18-64 yearsold, who had been suffering from heartburn at leasttwice a week for at least 3 mo before entering thestudy. Pharmacological treatment of heartburn was notpermitted, and patients with severe organic diseaseswere excluded. After a run-in period of one week, theparticipants received 1.5 L of the test water for thefollowing 6 wk; 300 mL with meals t.i.d., the remainderto be drunk throughout the day. During the trial, therewere five visits at the study center (screening, baseline,two interim visits and the final visit). The efficacyendpoints included incidence and duration of heartburnepisodes per week by patient's self-assessment (heartburndiary) as well as changes in symptom severity asper symptom specific questionnaires [Reflux Disease Questionnaire (RDQ); Quality of Life in Reflux andDyspepsia (QOLRAD); Gastrointestinal Quality of LifeIndex] and overall health-related quality of life per SF-12(12-question short form) at each visit. At the end of thestudy, patients and investigators independently ratedthe overall efficacy of the test water on a 4-point Likertscale. Safety was assessed by evaluation of adverseevents (AEs), vital signs (heart rate, blood pressure)and laboratory parameters. Changes from initial to finalexaminations were assessed by the non-parametricWilcoxon test; categorical variables were comparedusing the χ 2 test, and for more than 5 categories, by theU-test.RESULTS: Twenty-eight participants were men, 22women. The mean age of the patients in the fullanalysis set/intention-to treat population (FAS/ITT) was40.6 years. Forty-two participants completed the studyaccording to the study protocol and formed the perprotocolset (PP population); 48 participants drank thewater at least once as requested and were analyzedas ITT population. The occurrence of heartburn wasstatistically significantly reduced at wk 6 in both the ITTand the PP populations. At wk 6, the mean number ofheartburn episodes/week decreased by 5.1 episodes(P 〈 0.001) and the mean duration of heartburnsymptoms by 19 min (ITT) (P = 0.002). The frequencyof heartburn symptoms was reduced in 89.6% of thepatients (P 〈 0.001), and the duration of symptoms in79.2% of patients (ITT) (P 〈 0.001). All dimensions ofthe RDQ (heartburn, regurgitation, gastro-esophagealreflux disease symptoms, dyspepsia) showed asignificant improvement at 6 wk. Likewise, diseasespecificquality of life improved significantly (QOLRAD,GIQLI). Overall, 89.4% of patients rated the efficacyof the test water as "good" or "very good", as did theinvestigators for 91.5% of the patients. There wereno serious AEs. After 6 wk, systolic and diastolic bloodpressure values decreased slightly but significantly [-3.5and -3.0 mmHg, respectively (P = 0.008 and P = 0,002)].Ninety-six percent of patients and investigators for thesame percentage of patients rated the tolerability of thewater as "good" or "very good".CONCLUSION: The data demonstrate effectiveness ofa hydrogen carbonate-rich mineral water in alleviatingheartburn frequency and severity, thereby improvingquality of life. The water has excellent tolerability.