Efficacy of acupuncture for 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. CONDITION: Postprandial distress syndrome (PDS) ; Digestive System ; Postprandial distress syndrome (PDS) PRIMARY OUTCOME: 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. SECONDARY OUTCOME: 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 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