Effect of clinician-patient communication on compliance with flupentixol-melitracen in functional dyspepsia patients

Table 1 Demographic and baseline clinical characteristics of the enrolled functional dyspepsia patients

	Groups
	1	2	3	4
n	65	66	65	66
Age (yr)
mean ± SD	46.69 ± 10.74	44.16 ± 9.26	45.72 ± 10.35	46.81 ± 9.82
range	29-65	27-64	26-65	28-64
Sex ratio, M/F	1.17	1.2	1.32	1.13
Symptom duration (mo)	10.15 ± 3.96	10.34 ± 3.81	9.95 ± 3.72	10.23 ± 4.03
LDQ score	11.85 ± 4.94	12.88 ± 4.26	12.44 ± 4.91	12.33 ± 4.75
HADS score
Anxiety	11.38 ± 3.35	11.75 ± 3.26	11.12 ± 3.10	11.33 ± 3.25
Depression	12.67 ± 3.30	12.45 ± 3.12	12.80 ± 3.31	12.90 ± 3.03

The values are presented as the mean ± SD. LDQ: Leeds dyspepsia questionnaire; HADS: Hospital anxiety and depression scale; M: Male; F: Female.

Table 2 Flow of the patients in each part of the trial

	Groups				Total
	1	2	3	4
Study entry	65	66	65	66	262
Did not receive study medication	2	5	3	0	10
Lost to follow-up	3	4	2	3	12
Compliance analysis of FM	65	66	65	-	196
ITT population	60	57	60	63	240

ITT: Intent-to-treat; FM: Flupentixol melitracen.

Table 3 Pearson r values for the correlations between the compliance index and the reduction in leeds dyspepsia questionnaire and hospital anxiety and depression scale scores in functional dyspepsia patients treated with flupentixol-melitracen plus omeprazole

Groups	Reduction in LDQ score	Reduction in HADS anxiety subscale	Reduction in HADS depression subscale
1	0.671	0.671	0.601
2	0.651	0.571	0.691
3	0.731	0.531	0.511

¹The P value is < 0.01. LDQ: Leeds dyspepsia questionnaire; HADS: Hospital anxiety and depression scale.

Table 4 Adverse events during the study

	Groups
	1 (n = 60)	2 (n = 57)	3 (n = 60)	4 (n = 63)
Insomnia	3	4	4	0
Dizziness	1	1	0	0
Dry mouth	1	2	1	0
Nausea	1	1	0	1
Skin rash	0	1	0	1