Functional Dyspepsia
Conditions
Brief summary
The aim of this study was to prove that press needle (PN) and medication are more effective in reducing symptoms and improving quality of life in people with functional dyspepsia compared to sham press needle (Sham PN) and medication. The main questions this study aims to answer are: * Does the press needle and medication group reduce symptoms in people with functional dyspepsia as assessed by the Short Form-Leeds Dyspepsia Questionnaire (SF-LDQ) compared to the sham press-needle and medication group on days 7 and 14, compared to before therapy? * Does the press-needle and medication group improve quality of life in people with functional dyspepsia as assessed by the Short-Form Nepean Dyspepsia Index (SF-NDI) compared to the sham press-needle and medication group on days 7 and 14, compared to before therapy? A total of 38 participants were randomly allocated into two groups, either PN or Sham PN needle groups Participants will: * Receive PN or Sham PN for 14 days and replaced on day 7. * Complete the SF-LDQ and SF-NDI questionnaires before therapy, on day 7, and day 14.
Interventions
DEVICEThe press needle and medication
Press needles using the needle sizes 0.17mm x 0.9mm on auricular acupuncture points (MA-IC6 (Stomach) bilaterally) and the needle sizes 0.20 mm x 1.5mm on body acupuncture points (ST36 bilaterally). After that, apply an adhesive patches on top of the press needle. The press needle is attached for 14 days (on the 7th day the press needle is replaced). Medication using proton pump inhibitor drugs
DEVICEThe sham press needle and medication
Sham press needle uses adhesive patches without needles on auricular acupuncture points (MA-IC6 (Stomach) bilateral) and body acupuncture points (ST36 bilateral). The sham press needle is attached for 14 days (on the 7th day the sham press needle is replaced). Medication using proton pump inhibitor drugs
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participants and the outcome asssesors will be blinded to group allocation
Intervention model description
The intervention group received press needles and medication, while the control group received sham press needles and medication.
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18-59 years * Patients with functional dyspepsia * Esophagogastroduodenoscopy (EGD) results show no significant structural abnormalities or no structural abnormalities. * Willing to participate in the research until completion and sign a letter of consent for medical action (informed consent).
Exclusion criteria
* At the acupuncture point location there is inflammation, malignancy, and scar tissue. * Deformity of the earlobe. * History of allergies to stainless steel and plaster. * Medical emergencies, impaired consciousness, pregnancy, history of diabetes mellitus, and history of keloid formation. * History of digestive tract cancer, history of hepatobiliary cancer, history of chronic kidney failure stage 4 and 5, history of hyperthyroidism or hypothyroidism.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) | Before therapy, day 7, day 14 | Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) is a questionnaire consisting of 4 questions A and B. The total score ranges from 0 to 32. |
| Short-Form Nepean Dyspepsia Index (SF-NDI) | Before therapy, day 7, day 14 | Short-Form Nepean Dyspepsia Index (SF-NDI) is a questionnaire consisting of 10 questions. The total score ranges from 10 to 50 (higher score indicate worst quality of life) |
Countries
Indonesia
Contacts
Primary ContactMaria Anastasia Darmawan, MD
Outcome results
None listed