Condition category
Digestive System
Date applied
16/02/2017
Date assigned
31/03/2017
Last edited
31/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Postprandial distress syndrome (PDS) is a form of indigestion that causes an unpleasant sense of fullness in the stomach after a eating a meal. PDS is related to pain and burning in the throat and stomach. Although PDS is not a life-threatening condition, people who suffer from PDS have higher rates of depression and anxiety. PDS is usually treated by prokinetics/antacids (tablets that are chewed or swallowed that control the acid in the stomach). However, there are very few studies that have looked at how these treatments actually work in treating PDS. Therefore, treatments by other methods should be examined. Some studies have shown that acupuncture therapy (an ancient Chinese treatment that inserts small needles into the skin) has been found to have helped relieve symptoms from other stomach disorders and could be successful in helping those with PDS. The aim of this study is to determine how well acupuncture works at treating PDS.

Who can participate?
Adults aged 18-65 who have PDS

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive verum acupuncture which consists of needles inserted into the skin at specific locations until a specific sensation is felt by the participant. Those in the second group receive minimal acupuncture which includes needles inserted lightly in the skin at nonspecific spots. Both groups receive 12 sessions that last 20 minutes over four weeks. Participants are followed up at four, six, eight and 12 weeks to see if the treatments affected their PDS symptoms.

What are the possible benefits and risks of participating?
Participants may benefit from a reduction in their symptoms. There are no notable risks with participating, however participants may feel some discomfort and temporary pain due to the acupuncture treatment.

Where is the study run from?
Beijing Hospital of Traditional Chinese Medicine (China)

When is the study starting and how long is it expected to run for?
June 2016 to September 2019

Who is funding the study?
Beijing Municipal Science & Technology Commission (China)

Who is the main contact?
Prof Cun-Zhi Liu
lcz623780@126.com

Trial website

Contact information

Type

Public

Primary contact

Prof Cun-Zhi Liu

ORCID ID

Contact details

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing
100010
China
+86 10 52176043
lcz623780@126.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Z161100000516007

Study information

Scientific title

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

Acronym

APDS-RCT

Study hypothesis

Acupuncture will produce a significant improvement in symptoms of PDS compared to minimal acupuncture

Ethics approval

Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 02/12/2016, ref: 2016BL-073-02

Study design

Two-arm multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No specific participant information sheet available, please use the contact details below to request a further information.

Condition

Postprandial distress syndrome (PDS)

Intervention

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 acupuncture group): Participants in this group receive acupuncture (insertion of small needles in the skin) at selected acupoints: Baihui (DU20), Zhongwan (RN12), Tianshu (ST25), Qihai (RN6), Neiguan (PC6), Danzhong (RN17), Zusanli (ST36) and Gongsun (SP4). In addition, according to participants symptoms, different needling points are inserted. These include needling for weakness of the qi of the spleen and stomach (Taibai SP3), depression of the qi of the liver (Taichong LR3), damp-heat in the stomach (Neiting ST44). Needles are stimulated by the clinician until patients feel a deqi sensation. Each session takes 20 minutes. Participant receive 12 treatment sessions in total over four weeks (three sessions per week).

Group two (control/minimal acupuncture group): Participants in this group receive acupuncture at non-acupoints with a superficial puncture (2mm in depth) in order to avoiding deqi sensation. The location of non-acupoints as following: NP1 Middle of Touwei (ST8) and Yuyao (EX-HN4) points, NP2 2.0 cun above the anterior superior iliac spine, NP3 2.0 cun below the umbilicus and 1.0 cun lateral to the anterior midline, NP4 Middle of the medial epicondyle of the humerus and the styloid process of ulna, NP5 3.0 cun below Yanglingquan (GB34) between the gallbladder and bladder meridian and NP6: Middle of Qiuxu (GB40) and Jiexi (ST41) points. Treatments consist of twelves sessions that take 20 minutes over four weeks (three sessions per week).

Participants are followed up after 12 weeks to see if they have any improvements with their PDS symptoms.

Intervention type

Device

Phase

Drug names

Primary outcome measures

The Overall Treatment Evaluation (OTE) (severity ratings of individual symptoms) is evaluated using a seven-point Likert scale at 4 weeks.

Secondary outcome measures

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

Overall trial start date

10/06/2016

Overall trial end date

20/09/2019

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

280

Participant 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

Recruitment start date

10/04/2017

Recruitment end date

15/03/2019

Locations

Countries of recruitment

China

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
23 Meishuguanhou Street Dongcheng District
Beijing
100010
China

Trial participating centre

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
5 Haiyuncang Hutong Dongcheng Qu
Beijing
100700
China

Sponsor information

Organisation

Beijing Municipal Science & Technology Commission

Sponsor details

Building 2
No. 7
Evergreen Road
Haidian District
Beijing
100195
China
+86 10 66153395
xxgk@mail.bsti.ac.cn

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Beijing Municipal Science & Technology Commission

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

IPD sharing plan:
The datasets generated during and/or analysed during the current study is not expected to be made available due to confidentiality reasons.

Intention to publish date

20/09/2020

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes