Background: Dyspepsia and heartburn are among the most frequent complaints of the upper gastrointestinal tract impacting quality of life. The present study aimed to investigate the impact of drinking a natural mineral...Background: Dyspepsia and heartburn are among the most frequent complaints of the upper gastrointestinal tract impacting quality of life. The present study aimed to investigate the impact of drinking a natural mineral water (medicinal product category “Heilwasser” in Germany) high in hydrogen carbonate (Staatl. Fachingen STILL) on functional dyspeptic complaints and heartburn. Methods: 56 men and women with self-reported heartburn were enrolled to this one-arm pilot study. They had to drink 1.5 L of a hydrogen carbonate rich mineral water each day over a course of six weeks. Participants reported the number and duration of heartburn episodes in a daily dairy. The Reflux Disease Questionnaire (RDQ), Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) and the Gastrointestinal Quality of Life Index (GILQI) were used to assess the therapeutic course of the treatment and the Short Form Health Survey (SF-12) to assess general quality of life. Mean ± standard deviation were calculated and pre- and post-treatment changes were compared using the Wilcoxon test. Results: The consumption of a hydrogen carbonate rich mineral water decreased the number of heartburn episodes per week significantly by 4.8 ± 8.2 at the end of the study (p < 0.001). The duration of episodes was also significantly reduced by 25.7 minutes after six weeks of intervention (p < 0.001). Accordingly, the subjectively perceived severity of heartburn, regurgitation and dyspeptic complaints as well as the GERD dimension as assessed by Reflux Disease Questionnaire improved significantly. There was a significant improvement in the disease-specific quality of life as measured by the Gastrointestinal Quality of Life Index (p < 0.001) and by the Quality Of Life in Reflux and Dyspepsia (p < 0.001) questionnaires and the general health-related quality of life as assessed by SF-12 (p < 0.007). Conclusions: The present pilot study provides evidence that supplementation with natural mineral water rich in hydrogen carbonate may improve heartburn and dyspeptic symptoms, which finally resulted in an improvement of the subjectively perceived quality of life. Drinking mineral water rich in hydrogen carbonate may be an alternative remedy for the treatment of dyspeptic symptoms and heartburn. Trial Registration: Eudra CT No 2013-001256-36.展开更多
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, 1...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.展开更多
文摘Background: Dyspepsia and heartburn are among the most frequent complaints of the upper gastrointestinal tract impacting quality of life. The present study aimed to investigate the impact of drinking a natural mineral water (medicinal product category “Heilwasser” in Germany) high in hydrogen carbonate (Staatl. Fachingen STILL) on functional dyspeptic complaints and heartburn. Methods: 56 men and women with self-reported heartburn were enrolled to this one-arm pilot study. They had to drink 1.5 L of a hydrogen carbonate rich mineral water each day over a course of six weeks. Participants reported the number and duration of heartburn episodes in a daily dairy. The Reflux Disease Questionnaire (RDQ), Quality of Life in Reflux and Dyspepsia questionnaire (QOLRAD) and the Gastrointestinal Quality of Life Index (GILQI) were used to assess the therapeutic course of the treatment and the Short Form Health Survey (SF-12) to assess general quality of life. Mean ± standard deviation were calculated and pre- and post-treatment changes were compared using the Wilcoxon test. Results: The consumption of a hydrogen carbonate rich mineral water decreased the number of heartburn episodes per week significantly by 4.8 ± 8.2 at the end of the study (p < 0.001). The duration of episodes was also significantly reduced by 25.7 minutes after six weeks of intervention (p < 0.001). Accordingly, the subjectively perceived severity of heartburn, regurgitation and dyspeptic complaints as well as the GERD dimension as assessed by Reflux Disease Questionnaire improved significantly. There was a significant improvement in the disease-specific quality of life as measured by the Gastrointestinal Quality of Life Index (p < 0.001) and by the Quality Of Life in Reflux and Dyspepsia (p < 0.001) questionnaires and the general health-related quality of life as assessed by SF-12 (p < 0.007). Conclusions: The present pilot study provides evidence that supplementation with natural mineral water rich in hydrogen carbonate may improve heartburn and dyspeptic symptoms, which finally resulted in an improvement of the subjectively perceived quality of life. Drinking mineral water rich in hydrogen carbonate may be an alternative remedy for the treatment of dyspeptic symptoms and heartburn. Trial Registration: Eudra CT No 2013-001256-36.
基金Supported by Deutsche Heilbrunnen im Verband Deutscher Mineralbrunnen e.V.,Kennedyallee 28,53175 Bonn,Germany,www.vdm-bonn.de
文摘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.
