Plain English Summary
Background and study aims
Functional dyspepsia (FD) is a long-term condition of the digestive system, that causes discomfort in the upper belly, near the ribs. Although FD is not a life-threatening disease, it has considerable impact on quality of life. There are various available drug treatments for FD which neutralize stomach acid or stop the stomach from producing so much, but many FD patients turn to complementary and alternative therapies as often medications do not provide enough relief. Acupuncture is a popular alternative therapy, derived from ancient Chinese medicine. Although it has been frequently used to treat symptoms of FD, evidence of its effectiveness is lacking. The Rome III consensus subdivided FD into two subgroups: postprandial distress syndrome (an unpleasant feeling of fullness after eating) and epigastric pain syndrome (upper abdominal pain and burning). However, few studies have been conducted to examine the treatment responses of different FD subgroups. The aim of this study is to assess the effectiveness of acupuncture in the treatment of postprandial distress syndrome (PDS) patients.
Who can participate?
Male and female patients aged 18-65 diagnosed with PDS
What does the study involve?
Patients are randomly allocated to one of two groups: a verum acupuncture group or a minimal acupuncture group. The verum acupuncture sessions involve placing needles in specific points on the body, which are stimulated by hand for at least 30 seconds to achieve the typical acupuncture sensation. The minimal acupuncture sessions involve the placement of needles in non-acupoints (places not intended to cause an effect). Both verum acupuncture and minimal acupuncture treatments consist of 12 sessions of 20 minutes duration over 4 weeks (three sessions per week). Participants in both groups are followed up 4, 8 and 16 weeks after first acupuncture.
What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their symptoms and general quality of life. The risks of receiving acupuncture are minimal. Acupuncture is a relatively safe treatment when given by properly trained clinicians. Occasionally, acupuncture can make people feel nauseous or faint. Participants are warned of these potential side-effects before receiving acupuncture.
Where is the study run from?
1. Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (China)
2. Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine (China)
3. Beijing Friendship Hospital Affiliated to the Capital Medical University (China)
When is the study starting and how long is it expected to run for?
March 2016 to January 2017
Who is funding the study?
Beijing Municipal Science & Technology Commission (China)
Who is the main contact?
Dr Liu Cun-Zhi
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Z161100000516007
Study information
Scientific title
Acupuncture for postprandial distress syndrome (APDS): a pilot randomized controlled trial
Acronym
APDS
Study hypothesis
The efficacy of verum acupuncture on postprandial distress syndrome (PDS) is superior to minimal acupuncture.
Ethics approval
Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 14/03/2016, ref: 2016BL-011-01
Study design
Two-arm multi-centre randomized controlled pilot 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 to request a further information.
Condition
Postprandial distress syndrome (PDS)
Intervention
Participants will be randomly assigned to verum acupuncture at acupoints or minimal acupuncture at non-acupoints in a 1:1 ration
Verum acupuncture group: Participants in the verum acupuncture group will receive a standardized 20-minute acupuncture session needling at selected points: Baihui(DU20), zhongwan(RN12), Tianshu(ST25), Qihai(RN6), Neiguan(PC6), Danzhong(RN17), Zusanli(ST36), Gongsun(SP4). Needles will be stimulated manually at least 30 seconds to achieve the typical acupuncture sensation (deqi). Treatments consist of 12 sessions of 20 minutes duration over 4 weeks (three sessions per week).
Minimal acupuncture group: Participants in the minimal acupuncture group will receive 20-minute acupuncture at non-acupoints. Needles will be placed at non-acupoints with a superficial puncture (2 mm in depth) to avoid de qi and manual stimulation. The location of non-acupoints as following:
1. In the middle of Jiaosun(SJ20) and Shuaigu(GB8) points
2. 2.0 cun above the anterior superior iliac spine
3. 2.0 cun below the umbilicus, and 1.0 cun lateral to the anterior midline
4. In the middle of the medial epicondyle of the humerus and the styloid process of ulna
5. 3.0 cun below Yanglingquan(GB34), between the gallbladder and bladder meridian
6. In the middle of Qiuxu(GB40) and Jiexi(ST41) points
Treatments consist of 12 sessions of 20 minutes duration over 4 weeks (three sessions per week).
The use of other treatments related to PDS will not be allowed for participans in either group. The study will include 4 weeks treatment and 12 weeks follow-up.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Overall treatment effect (OTE) is measured using patient interviews using a Likert scale at baseline, once a week for the four week treatment period and then at 4, 8 and 16 weeks after first acupuncture.
Secondary outcome measures
1. Symptoms and global assessment of PDS patients are measured using a four-item questionnaire-asymptomatic (0 point), mild (1 point), moderate (2 points) or severe (3 points)-including eight symptoms: postprandial distension, early satiety, epigastric pain, epigastric burning, upper abdominal bloating, nausea. Assessment will be conducted at baseline, twice a week in treatment period and 8, 16 weeks after first acupuncture.
2. Quality of life is evaluated using the 25-item Nepean Dyspepsia Index (NDI) at baseline, 4, 8 and 16 weeks after first acupuncture
3. Severity of anxiety and depression will be graded using the Hospital Anxiety Depression Scale (HADS) at baseline, 4, 8 and 16 weeks after first acupuncture
Overall trial start date
01/03/2016
Overall trial end date
31/01/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged between 18 and 65 years
2. Normal esophagogastroduodenoscopy results within a year
3. Not allowed drug: anti-secretory drugs, antacids, prokinetics, non-steroidal anti-inflammatory drugs and antidepressant drugs during the treatment period
4. No other treatments received during the study
5. Willing to sign written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
42
Participant exclusion criteria
1. Presence of serious structural disease(disease of heart, lung, liver or kidney), malignant or mental disease
2. Signs of irritable bowel syndrome
3. Surgery related with the gastrointestinal tract
4. Severe coagulopathy
5. Drug or alcohol abuse
6. Pregnant or breastfeeding
Recruitment start date
15/07/2016
Recruitment end date
31/10/2016
Locations
Countries of recruitment
China
Trial participating centre
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing
100010
China
Trial participating centre
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing
100700
China
Trial participating centre
Beijing Friendship Hospital Affiliated to the Capital Medical University
Beijing
100069
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.
Intention to publish date
31/03/2017
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29132415