Introduction: Functional Dysphagia (FD) is a syndrome in which patients report dysphagia without evidence of Gastroesophageal Reflux Disease (GERD) or a histopathology-based esophageal motility disorder. There are data that argue that Ineffective Esophageal Motility (IEM) is the manometric correlate of FD. IEM is defined as a High Resolution Esophageal Manometry (HREM) with 50% or more of the swallows having a Distal Contractile Index (DCI) of. Methods: We performed a prospective, double-blind, placebo-controlled, cross-over trial of 10 patients with both FD and IEM. Patients were randomized to one of two groups for a period of six total weeks. Group A patients were treated with buspirone for two weeks followed by a two-week washout period and subsequently treated with placebo. Patients in Group B were treated with placebo for the first two weeks and buspirone the last two weeks. Outcomes measured at baseline, end of week 2, and week 6 include the Mayo Dysphagia Questionnaire-14 (MDQ-14), the GERD-HRQL, and HREM. A sample size of 10 patients was found to have 80% power to detect a difference of 25% in the number of failed or weak swallows. Results: The mean age of our 10 patients was 53 +/- 9 years and 70% were female. While 70% of the patients treated with placebo had IEM, only 50% of those treated with buspirone had IEM. However, this difference was not statistically significant. Furthermore, when comparing those treated with placebo with those treated with buspirone, there was no statistically significant difference in resting lower esophageal sphincter pressure, median integrated residual pressure, mean DCI, or percentage of swallows weak, failed, or normal (Table 1). There was also no statistically significant difference in any of the questions in the MDQ-14 or the GERD-HRQL (Table and Figure 1). Of note, patients had a statistically significant decrease in the total GERD-HRQL total score when treated with placebo compared to baseline levels.Figure: Percentage of Patients with Dysphagia at Baseline, With Placebo, and After Buspirone.Table: Table. Buspirone versus Placebo in Functional Dysphagia and Ineffective Esophageal MotilityConclusion: Despite previous data showing improved motility in healthy volunteers, our study shows no difference in terms of HREM parameters or symptom scores in FD and IEM patients treated with buspirone compared to placebo. Further research is necessary to identify novel agents.
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