title: Thermal care of functional dyspepsia based on bicarbonate-sulphate-calcium water: a sequential clinical trial.
abstract: Drug treatment of functional dyspepsia is often unsatisfactory. We assessed the efficacy of a bicarbonate-sulphate-calcium thermal water cycle of 12 days, in patients with functional dyspepsia. Patients with functional dyspepsia were sent by their general practitioners to 12 days of treatment with thermal water, 200-400 ml in the morning, at temperature of 33 degrees C (91.4 F) and were evaluated on a strict intention to treat basis. Four efficacy endpoints were analyzed as follows: (i) reduction of the global symptoms score, (ii) reduction of intensity to a level not interfering with everyday activities, (iii) specific efficacy on ulcer-like or dysmotility-like dyspepsia and (iv) esophageal or abdominal-associated symptoms. Statistical significance was reached for all three primary outcomes after the first 29 consecutive patients. Thermal water reduced the global symptom score, reduced intensity of symptoms to a level not interfering with everyday activity, but was unable to completely suppress all symptoms. A parallel effect emerged for ulcer-like and dyspepsia-like subgroups. The effect on heartburn and abdominal symptoms was not significant, suggesting a specific effect of the water on the gastric and duodenal wall. The Roma II criteria identify a natural kind of dyspepsia that improves with thermal water. Ulcer-like and dysmotility-like are not therapeutically distinguishable subgroups. Patients with dominant esophageal or abdominal symptoms should receive a different therapy. Sequential methods are very effective for the evaluation of traditional care practices and should be considered preliminary and integrative to randomized controlled trials in this context.
authors.affiliation: Direzione Scientifica of Fondazione Ospedale Maggiore Policlinico Mangiagalli e Regina Elena Milan, Italy. bepperocca@policlinico.mi.it
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Rocca
authors.forename: Federico
authors.initials: F
authors.lastname: Dioni
authors.forename: Nadia
authors.initials: N
authors.lastname: Rocca
authors.forename: Filippo
authors.initials: F
authors.lastname: Oliveri
authors.forename: Maurizia R
authors.initials: MR
authors.lastname: Brunetto
authors.forename: Ferruccio
authors.initials: F
authors.lastname: Bonino