Functional Gastrointestinal Disorders
Conditions
Brief summary
The investigators will conduct a multicenter cross-sectional study to discover symptom characteristics, quality of life, severity of anxiety and depression, status of lactose intolerance and treatment satisfaction of current Chinese Medicine (CM) regimens of outpatients with FGIDs. In the meanwhile, the investigators will also analyze the characters of CM patterns and corresponding elements, then explore the potential relationship between CM patterns and FGIDs' subtypes.
Detailed description
This is a multicenter cross-sectional study to discover symptom characteristics, quality of life, severity of anxiety and depression, status of lactose intolerance and treatment satisfaction of current Chinese Medicine (CM) regimens of outpatients with FGIDs. Afterwards, the investigators will explore the potential relationship between CM patterns and FGIDs' subtypes based on collected information. It is estimated that 4,632 outpatients from 18 centers across China will be recruited. Various demographic and disease-related information will be documented, including name, gender, age, education level, marital status, job category, disease course, medical consultation experience, current CM regimens and rationale, and treatment satisfaction. Patients will also complete a series of scales, containing, Rome IV Diagnostic Questionnaire, Patient-Reported Outcome (PRO) scale, the 36-Item Short Form Survey (SF-36), Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), lactose food frequency questionnaire (Lactose FFQ) and CM pattern scale. The primary outcome will be the symptom characteristics of outpatients with FGIDs. Secondary outcomes include population characteristics of FGID patients (quality of life, emotional status, lactose intolerance status, and satisfaction level of CM interventions), and potential association between CM patterns and FGIDs' subtypes.
Interventions
None listed
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Jiangsu Province Hospital of Traditional Chinese Medicine
Higher Education Mega Center Branch of Guangdong Provincial Hospital of Chinese Medicine
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Wuhan Hospital of Traditional Chinese Medicine
Hospital of Shanxi University of Traditional Chinese Medicine
First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
The First Affiliated Hospital of Zhejiang Chinese Medical University
Liuzhou Traditional Chinese Medical Hospital
Shaanxi Hospital of Traditional Chinese Medicine
Shanghai University of Traditional Chinese Medicine
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing Hospital of Traditional Chinese Medicine Affiliated with Capital Medical University
Henan University of Traditional Chinese Medicine
Second Affiliated Hospital of Fujian Traditional Chinese Medical University
Inner Mongolia Autonomous Region Hospital of Traditional Chinese Medicine
Hong Kong Baptist University
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Symptoms onset at least 3 months * Meet the diagnostic criteria of FGIDs * Informed consent and ability to read and understand questionnaires
Exclusion criteria
* Combined with organic gastrointestinal diseases * Appearance of gastrointestinal alarm symptoms * Combined with mental disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of different subtypes with Functional gastrointestinal disorders (FGIDs) in China | 2 years | The percentage of the different subtypes with FGIDs by Rome IV Diagnostic Criteria |
| The health-related quality of life (HRQOL) of outpatients with FGIDs in China | 2 years | The HRQOL scale contains 36 questions scoring from 0 to 4. Higher score means a worse outcome. The highest total score is 144. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HAMA scoring of outpatients with FGIDs in China | 2 years | Hamilton Anxiety Scale (HAMA) contained and 14 questions scoring form 0 to 4. A high score means a worse anxiety state. |
| Demographic characteristics of outpatients with FGIDs in China | 2 years | Including age, gender, education level, marital status and job categories |
| Treatment satisfaction score of CM interventions in outpatients with FGIDs in China | 2 years | Treatment satisfaction will be evaluated using a single question scoring from 0 to 4. A higher score means worse satisfaction. |
| HAMD scoring of outpatients with FGIDs in China | 2 years | Hamilton Depression Scale (HAMD) contained and 17 questions scoring form 0 to 4. A high score means a worse depression state. |
| Quality of life of outpatients with FGIDs in China | 2 years | 36-Item Short Form Survey (SF-36) will be used. Thirty items are contained and each item is scored on a 0 to 100 range. A high score defines a more favorable health state. |
Countries
Hong Kong
Contacts
Primary ContactSonia Low, BNurse
Outcome results
None listed