Efficacy of acupuncture for postprandial distress syndrome (PDS)

Efficacy of Acupuncture for Postprandial Distress Syndrome (PDS): a multi-centre, Randomized, Controlled Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12511434

Enrollment

280

Registered

2017-03-31

Start date

2017-04-10

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postprandial distress syndrome (PDS) Digestive System Postprandial distress syndrome (PDS)

Interventions

Participants are randomly allocated to one of two groups using stratified block randomisation (generated by PROC PLAN in SAS, using the study site as the stratification factor). Group one (Verum acup

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 06/02/2018: 1. 18-65 years old 2. If they have epigastric pain syndrome symptoms (epigastric pain or epigastric burning), then the symptoms that are causing distress have to be one of the following meal-related symptoms: postprandial fullness, upper abdominal bloating or early satiation 3. Normal esophagogastroduodenoscopy results within a year 4. No acupuncture treatment in previous 1 month 5. Never joined any other study in process in previous 2 months Previous inclusion criteria: 1. 18-65 years old 2. If they have epigastric pain syndrome symptoms (epigastric pain or epigastric burning), then the symptoms that are causing distress have to be one of the following meal-related symptoms: postprandial fullness, upper abdominal bloating or early satiation 3. Normal esophagogastroduodenoscopy results within a year 4. No acupuncture treatment in previous 1 month 5. No use of medicine for PDS during two weeks before enrollment 6. Never joined any other study in process in previous 2 months

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 06/02/2018: 1. Functional dyspepsia (FD) symptoms caused by any serious or malignant disease 2. Surgery related with the gastrointestinal tract 3. Taking drugs which might affect dyspepsia, such as anti-secretary drugs, antacids, prokinetics, non-steroidal anti-inflammatory drugs and antidepressant drugs before 1 month participating in the trial 4. Drug or alcohol abuse 5. Pregnant women or women in lactation period Previous exclusion criteria as of 11/01/2018: 1. Functional dyspepsia (FD) symptoms caused by any serious or malignant disease 2. Surgery related with the gastrointestinal tract 3. Drug or alcohol abuse 4. Pregnant women or women in lactation period Previous exclusion criteria: 1. Functional dyspepsia (FD) symptoms caused by any serious or malignant disease 2. Surgery related with the gastrointestinal tract 3. Taking drugs which might affect dyspepsia, such as anti-secretary drugs, antacids, prokinetics, non-steroidal anti-inflammatory drugs and antidepressant drugs before 1 month participating in the trial 4. Drug or alcohol abuse 5. Pregnant women or women in lactation period

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 11/01/2018: The overall treatment evaluation (OTE) and elimination rate of three meal-related symptoms (postprandial fullness, upper abdominal bloating and early satiation) are combined primary outcomes measured at four weeks. Previous primary outcome measure: The Overall Treatment Evaluation (OTE) (severity ratings of individual symptoms) is evaluated using a seven-point Likert scale at four weeks.	—

Measure

Time frame

Current primary outcome measure as of 11/01/2018: The overall treatment evaluation (OTE) and elimination rate of three meal-related symptoms (postprandial fullness, upper abdominal bloating and early satiation) are combined primary outcomes measured at four weeks. Previous primary outcome measure: The Overall Treatment Evaluation (OTE) (severity ratings of individual symptoms) is evaluated using a seven-point Likert scale at four weeks.

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Secondary

Measure	Time frame
1. Symptoms and global assessment are measured using a four-rate scale questionnaire-asymptomatic (0 point), mild (1 point), moderate (2 points) or severe (3 points) that evaluated eight symptoms including postprandial distension, early satiety, epigastric pain, epigastric burning, upper abdominal bloating, belching, nausea and vomiting at baseline, once every week in treatment period and at 8, 12, 16 weeks 2. Quality of life is measured using the 25-item Nepean Dyspepsia Index (NDI) at baseline, 4, 8 and 16 weeks after the first treatment. 3. Severity of anxiety and depression is measured using the Hospital Anxiety Depression Scale (HADS) at baseline, 4, 8 and 16 weeks 4. Number of participants with adverse events related to acupuncture is measured by safety assessment during the treatment at baseline, 4, 8 and 16 weeks	—

Measure

Time frame

1. Symptoms and global assessment are measured using a four-rate scale questionnaire-asymptomatic (0 point), mild (1 point), moderate (2 points) or severe (3 points) that evaluated eight symptoms including postprandial distension, early satiety, epigastric pain, epigastric burning, upper abdominal bloating, belching, nausea and vomiting at baseline, once every week in treatment period and at 8, 12, 16 weeks 2. Quality of life is measured using the 25-item Nepean Dyspepsia Index (NDI) at baseline, 4, 8 and 16 weeks after the first treatment. 3. Severity of anxiety and depression is measured using the Hospital Anxiety Depression Scale (HADS) at baseline, 4, 8 and 16 weeks 4. Number of participants with adverse events related to acupuncture is measured by safety assessment during the treatment at baseline, 4, 8 and 16 weeks

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Countries

China

Contacts

Public ContactCun-Zhi Liu

lcz623780@126.com+86 10 52176043

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026