| Background and AimThe degree of depression, anxiety and somatization in patients with functional dyspepsia (FD) is much higher compared to the ordinary population. Flupentixol and Melitracenacen can significantly improve the mental and somatic symptoms in FD patients. Foe now, however, there is few research on the efficacy of Flupentixol and Melitracenacen in FD patients with different types of anxiety and depression state.Therefore, the aim of the study was to observe and identify the clinical efficacy of Flupentixol and Melitracenacen in patients of functional dyspepsia with different types of anxiety and depression state by a randomized, controled trial.Subjects & MethodsSubjects, seleced accoding to the criteria, were randomly divided into study group and control group. The patients in study group were treated with Flupentixol and Melitracenacen 10.5mg qd (before breakfast), except for routine treatment; while the patients in control group were merely given routine treatment. The treatment course lasted 8 weeks. The dyspepsia symptom questionnaire, the Somatic Self-rating Scale(SSS), Self-Rating Anxiety Scale(SAS) and Self-Rating Depression Scale(SDS) scores were collected along with the treatment, which were separated accomplished during the follow-up in 0,2nd,4th,8th weekend. Data analysis of these scores concerning the different types(Type I Depression; Type II Anxiety; Type â…¢ Depression & Anxiety) were performed after the 8-week treatment.ResultsA total of 74 patients were included:39 cases in study group(Type 1:9; Type II:7; Type 111:23) and 35 cases in control group(Type 1:9; Type II:11; Type III:15). The differences of age, sex, course, dyspepsia symptom questionnaire scores, SAS/SDS scores in the two groups were not statistically significant at the baseline (p>0 .05).1. After the treatment, Flupentixol and Melitracenacen could improve the efficacy rate as well as decline the scores of dyspepsia symptom questionnaire in FD patients with different types of anxiety and depression state, opposed to the routine treatment, and there was a significant difference between these two therapies(T< 0.05). Subgroup analysis:in the Type I & Type II FD patients, Flupentixol and Melitracenacen could decline the scores of dyspepsia symptom questionnaire, but could not improve the efficacy rate(P>0.05). In the Type III FD patients, Flupentixol and Melitracenacen could both improve the efficacy rate and decline the scores of dyspepsia symptom questionnaire(P<0.05).2. After the treatment, Flupentixol and Melitracenacen could decrease the SSS scores in FD patients with different types of anxiety and depression state, in comparison with the routine treatment, and it showed a remarkable difference between these two therapies(P< 0.05). Subgroup analysis:in the Type I & Type II & Type III FD patients, Flupentixol and Melitracenacen could decline the SSS scores (P < 0.05),and a dramatic difference between these two therapies could be proven(P< 0.05).3. After the treatment, Flupentixol and Melitracenacen could reduce the SDS/SAS scores in FD patients with different types of anxiety and depression state, contrust to the routine treatment, these two therapies indicated a marked difference(P < 0.05).Subgroup analysis:in the Type I, Type II, Type III FD patients, Flupentixol and Melitracenacen could decline the SDS/SAS scores (P< 0.05), and there was a demonstrable difference between these two therapies(P< 0.05).4. The safety of the medicine:there were no serious adverse events arised in both group.Conclusion1. After treatment, when opposed to the routine treatment, Flupentixol and Melitracenacen can improve the efficacy rate and decline the scores of dyspepsia symptom questionnaire, SSS scores, SDS/SAS scores on FD patients with different types of anxiety and depression state.2. Subgroup analysis:compared to the routine treatment, Flupentixol and Melitracenacen has different effect on functional dyspepsia in patients with different type of anxiety and depression. In the FD patients with depression(Type I) or anxiety(Type II) state, although Flupentixol and Melitracenacen can not improve the efficacy rate, but it can improve somatization symptoms and also the depression and anxiety state. In the FD patients with depression and anxiety state, Flupentixol and Melitracenacen can improve the effective rate, somatization symptoms and depression and anxiety state.3. Flupentixol and Melitracenacen is a relatively safe drug of the FD with anxiety and depression state. |