eCAM Advance Access originally published online on December 9, 2006
eCAM 2007 4(3):381-391; doi:10.1093/ecam/nel100
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Thermal Care of Functional Dyspepsia Based on Bicarbonate-Sulphate-Calcium Water: A Sequential Clinical Trial
1Direzione Scientifica of Fondazione Ospedale Maggiore Policlinico Mangiagalli e Regina Elena Milan, 2Gastroenterology and Hepatology Unit, Dipartimento di Gastroenterologia e Malattie Infettive, University Hospital of Pisa Italy and 3Department of Internal Medicine, University of Pisa Italy
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°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.
Keywords: balneotherapy – functional dyspepsia – functional gastrointestinal disorders – hydrotherapy – sequential methods – spa – thermal care
For reprints and all correspondence: Giuseppe Rocca, Direzione Scientifica, Fondazione Policlinico Milano, Italy. Tel: +39-333-2693227; Fax: +39-2-5503-8331; E-mail: bepperocca{at}policlinico.mi.it
Received June 26, 2006; accepted October 30, 2006