Compliance, Depression, Dyspepsia
Conditions
Keywords
functional dyspepsia, depression, compliance
Brief summary
The study hypothesis is appropriate clinician-patient communication that provides explanations of the reasons for psychoactive drug prescriptions based on the generation of FD symptoms and the drugs' effects might improve compliance with psychoactive agent regimens among FD patients.
Detailed description
Antidepressive agents have been proved to be effective in the treatment of functional dyspepsia (FD) patients. However, one of the factors that limit therapeutic benefit is the poor compliance with prescribed drugs. The possible reasons for lack of compliance include the patient's health beliefs (e.g., that people who took such agents is possibly considered insane in China), lack of knowledge about antidepressants (that they are addictive or can be stopped on recovery), and aversion to side effects. The investigators propose to examine whether different clinician-patient communication methods could affect adherence to antidepressant drugs in functional dyspepsia patients.
Interventions
DRUGOmeprazole
Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).
DRUGFlupentixol-Melitracen(psychological and GI) + Omeprazole
Prescribe Flupentixol and Melitracen Tablets(one tablet, po, qd, 1 hour after breakfast) and Omeprazole (20mg, po, qd, 30min before breakfast).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
DRUGFlupentixol-Melitracen(psychological) + Omeprazole
Prescribe Flupentixol and Melitracen Tablets(one tablet, po, qd, 1 hour after breakfast) and Omeprazole (20mg, po, qd, 30min before breakfast). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
DRUGFlupentixol-Melitracen(without explanation) + Omeprazole
Prescribe Flupentixol and Melitracen Tablets(one tablet, po, qd, 1 hour after breakfast) and Omeprazole (20mg, po, qd, 30min before breakfast). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* met the ROME III criteria for FD; * education level no lower than high school; * Hospital Anxiety and Depression Scale (HADS) score \> 8 respectively; * absence of abnormalities in physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), abdominal ultrasonography and upper GI endoscopy within 6 months; * absence of H. pylori infection
Exclusion criteria
* known allergy to omeprazole, flupenthixol or melitracen; * any evidence of organic digestive diseases; * reflux-related symptoms only (e.g., retrosternal pain, burning and regurgitation) or predominantly reflux-related symptoms; * severe psychological symptoms that affected life and work; * pregnancy or breastfeeding; * recent myocardial infarction or cardiac arrhythmias; * previous gastric surgery; * use of PPIs, psychoactive drugs or other drugs that might affect gastric function within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance of Flupentixol-Melitracen | weeks 1, 2, 4, 8 | The patients were asked to keep a diary to record their medication intake. At each visit (weeks 1, 2, 4, 8), the patient bring back the drug bottle and the diary, then the physician recorded the number of pills remaining in the bottle. Pills remained more than 20% at any visit or seven days of consecutive abstinence were adopted as the criterion for identifying therapy noncompliance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8 | week 0 and 8 | The severity of patients' dyspeptic symptoms were assessed using the Leeds Dyspepsia Questionnaire (LDQ) at week 0 and 8. The LDQ contains eight items about epigastric pain, retro-sternal pain, regurgitation, nausea, vomiting, belching, early satiety and dysphagia with six grades for each item and a sum of the eight symptom scores make the LDQ score.LDQ scores of 0 - 4 were classified as very mild dyspepsia, 4 - 8 as mild dyspepsia, 9 -15 as moderate dyspepsia, and \> 15 as severe or very severe dyspepsia. The change of LDQ scores was calculated by LDQ scores of 8 weeks minus baseline, with lower values represent a better outcome. |
| Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8 | week 0 and 8 | Each patient was surveyed using the Hospital Anxiety and Depression Scale to assess the psychiatric symptom at week 0 and 8.The HADS consists of 14 items, seven of which assess anxiety, and seven assess depression. The anxiety and depression subscales were calculated independently. The patients were asked to answer each item on a four-point (0 - 3) scale. Scores of 0 to 7 on either subscale can be regarded as within the normal range, scores of 8 to 10 are suggestive of the presence of the respective state, and scores of 11 or higher indicate the probable presence of the respective mood disorder. The change of HADS scores was calculated by HADS anxiety and depression scores of 8 weeks minus baseline, with lower values indicate better outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Reaction | 8 weeks | Number of participants with adverse reactions were recorded to analyze the safety profile of treatment. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Deanxit(Psychological and GI) + Omeprazole Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms. | 65 |
| Deanxit(Psychological) + Omeprazole Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition. | 66 |
| Deanxit(Without Explanation) + Omeprazole Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace. | 65 |
| Proton Pump Inhibitor Prescribe Omeprazole.
Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast). | 66 |
| Total | 262 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Did not receive study medication | 2 | 5 | 3 | 0 |
| Overall Study | Lost to Follow-up | 3 | 4 | 2 | 3 |
Baseline characteristics
| Characteristic | Deanxit(Psychological and GI) + Omeprazole | Deanxit(Psychological) + Omeprazole | Deanxit(Without Explanation) + Omeprazole | Proton Pump Inhibitor | Total |
|---|---|---|---|---|---|
| Age, Continuous | 46.69 years STANDARD_DEVIATION 10.74 | 44.16 years STANDARD_DEVIATION 9.26 | 45.72 years STANDARD_DEVIATION 10.35 | 46.81 years STANDARD_DEVIATION 9.82 | 45.91 years STANDARD_DEVIATION 10.24 |
| Region of Enrollment China | 65 participants | 66 participants | 65 participants | 66 participants | 262 participants |
| Sex: Female, Male Female | 35 Participants | 36 Participants | 37 Participants | 35 Participants | 143 Participants |
| Sex: Female, Male Male | 30 Participants | 30 Participants | 28 Participants | 31 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 65 | 9 / 66 | 5 / 65 | 2 / 66 |
| serious Total, serious adverse events | 0 / 65 | 0 / 66 | 0 / 65 | 0 / 66 |
Outcome results
Primary
Compliance of Flupentixol-Melitracen
The patients were asked to keep a diary to record their medication intake. At each visit (weeks 1, 2, 4, 8), the patient bring back the drug bottle and the diary, then the physician recorded the number of pills remaining in the bottle. Pills remained more than 20% at any visit or seven days of consecutive abstinence were adopted as the criterion for identifying therapy noncompliance.
Time frame: weeks 1, 2, 4, 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deanxit(Psychological and GI) + Omeprazole | Compliance of Flupentixol-Melitracen | 44 participants |
| Deanxit(Psychological) + Omeprazole | Compliance of Flupentixol-Melitracen | 28 participants |
| Deanxit(Without Explanation) + Omeprazole | Compliance of Flupentixol-Melitracen | 31 participants |
Secondary
Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8
The severity of patients' dyspeptic symptoms were assessed using the Leeds Dyspepsia Questionnaire (LDQ) at week 0 and 8. The LDQ contains eight items about epigastric pain, retro-sternal pain, regurgitation, nausea, vomiting, belching, early satiety and dysphagia with six grades for each item and a sum of the eight symptom scores make the LDQ score.LDQ scores of 0 - 4 were classified as very mild dyspepsia, 4 - 8 as mild dyspepsia, 9 -15 as moderate dyspepsia, and \> 15 as severe or very severe dyspepsia. The change of LDQ scores was calculated by LDQ scores of 8 weeks minus baseline, with lower values represent a better outcome.
Time frame: week 0 and 8
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Deanxit(Psychological and GI) + Omeprazole | Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8 | -3.85 units on LDQ scale |
| Deanxit(Psychological) + Omeprazole | Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8 | -2.51 units on LDQ scale |
| Deanxit(Without Explanation) + Omeprazole | Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8 | -2.49 units on LDQ scale |
| Proton Pump Inhibitor | Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8 | -1.31 units on LDQ scale |
Secondary
Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8
Each patient was surveyed using the Hospital Anxiety and Depression Scale to assess the psychiatric symptom at week 0 and 8.The HADS consists of 14 items, seven of which assess anxiety, and seven assess depression. The anxiety and depression subscales were calculated independently. The patients were asked to answer each item on a four-point (0 - 3) scale. Scores of 0 to 7 on either subscale can be regarded as within the normal range, scores of 8 to 10 are suggestive of the presence of the respective state, and scores of 11 or higher indicate the probable presence of the respective mood disorder. The change of HADS scores was calculated by HADS anxiety and depression scores of 8 weeks minus baseline, with lower values indicate better outcome.
Time frame: week 0 and 8
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Deanxit(Psychological and GI) + Omeprazole | Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8 | HADS anxiety score | -4.46 units on HADS score |
| Deanxit(Psychological and GI) + Omeprazole | Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8 | HADS depression score | -4.82 units on HADS score |
| Deanxit(Psychological) + Omeprazole | Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8 | HADS anxiety score | -2.29 units on HADS score |
| Deanxit(Psychological) + Omeprazole | Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8 | HADS depression score | -2.25 units on HADS score |
| Deanxit(Without Explanation) + Omeprazole | Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8 | HADS depression score | -2.86 units on HADS score |
| Deanxit(Without Explanation) + Omeprazole | Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8 | HADS anxiety score | -2.78 units on HADS score |
| Proton Pump Inhibitor | Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8 | HADS depression score | -1.88 units on HADS score |
| Proton Pump Inhibitor | Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8 | HADS anxiety score | -1.68 units on HADS score |
Other Pre-specified
Number of Participants With Adverse Reaction
Number of participants with adverse reactions were recorded to analyze the safety profile of treatment.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Deanxit(Psychological and GI) + Omeprazole | Number of Participants With Adverse Reaction | 6 participants |
| Deanxit(Psychological) + Omeprazole | Number of Participants With Adverse Reaction | 9 participants |
| Deanxit(Without Explanation) + Omeprazole | Number of Participants With Adverse Reaction | 5 participants |
| Proton Pump Inhibitor | Number of Participants With Adverse Reaction | 2 participants |