Management of gastrointestinal complaints in differentiated thyroid cancer patients treated with 131I: Comparison of the efficacy of pantoprazole, metoclopra-mide, and ondansetron – a randomized clinical trial [Behandlung gastrointestinaler beschwerden unter 131I-therapie bei patienten mit differenzier-tem schilddrüsenkarzinom: Vergleich der wirksamkeit von pantoprazol, meto-clopramid und ondansetron – eine randomisierte klinische prüfung]
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Objective: To compare safety and efficacy of pantoprazol, metoclopramide, ondansetron, as compared to placebo, in controlling gastrointestinal (GI) complaints of thyroid cancer patients treated with I-131these patients. Design: Four-armed, parallel group, single blind, randomized controlled clinical trial, setting: A university hospital, registration: database for clinical trials IRCT2013061713705N1. Patients: 85 patients with differentiated thyroid cancer who received131I. Main outcome measures: Post-radioiodine nausea and vomiting within three days of therapy (primary endpoint); occurrence of adverse reaction. Results: The patients’ characteristics were similar within the study groups. Among the study variables, age, sex, administered dosage, history of previous GI complaints, and history of hyper -emesis gravidarum in female patients were not statistically different among the groups (p > 0.05). The results revealed that only ond-ansetron shows a therapeutic benefit over the placebo in controlling nausea (p < 0.05); however, it does not prevent vomiting (p > 0.05). The other two drugs, pantoprazole and meto-clopramide, did not control nausea (p > 0.05) or vomiting (p > 0.05). Conclusions: This study may demonstrate that the therapeutic dose of ondansetron could be an effective prophylactic agent in controlling GI complaints in differential thyroid carcinoma (DTC) patients following RAI therapy; however, these pre -liminary findings should be validated in larger studies. © Schattauer 2014.
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