Electro-acupuncture for Irritable Bowel Syndrome With Constipation: a Pilot, Randomized, Double-blinded, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Responders have a decrease in the weekly average of worst abdominal pain scores of ≥30% compared with baseline and a weekly increase of ≥1 CSBM
研究概览
简要总结
The aim of the clinical trial is to evaluate the efficacy and safety of electro-acupuncture for irritable bowel syndrome with constipation (IBS-C) patients. 60 IBS-C patients will be randomized and allocated to either the electro-acupuncture arm or the sham acupuncture arm. We hypothesize that electro-acupuncture would result in superior symptom improvement compared to sham acupuncture. In addition, biological samples (blood, urine, and stool) will be collected during the trial for future exploratory studies. These samples will be used to investigate changes in gut microbiota composition and related metabolites. These analyses aim to explore potential mechanistic links between electro-acupuncture interventions and clinical outcomes in subsequent research. Apart from the IBS-C participants, 30 healthy volunteers aged 21 to 65 years (inclusive) will be recruited to provide blood, urine, and stool samples. These samples will serve as a reference for comparative analyses with those from IBS-C patients before and after electro-acupuncture treatment. The healthy controls will not receive any interventions.
详细描述
I) Study period:
14 weeks, including 2 weeks of run-in (wash-out), 6 weeks of treatment, and 6 weeks of follow-up. 15 visits will be scheduled for each participant, comprising 2 visits during recruitment and the wash-out period, 12 visits during the treatment period, and 1 visit at the end of the follow-up period.
II) Coding of data:
The trial uses patient-blind technique, which means needles for acupuncture and sham acupuncture will be of identical looking and use same package, conduct blinding according to randomization codes. The study will only be unblinded at final statistical analysis and in final report. In case of emergency code breaking, before code breaking, the investigator should well inform the principal investigator of the corresponding participating site. Investigators who break the codes need to explain the reasons and document on patients' notes. The following circumstances can be considered for an emergency breaking, including, but not limited to: (1) When a SAE happens and is considered to be relevant to experimental medication or placebo; (2) When a serious complication happens.
III) AE/SAE reporting:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
After a participant's eligibility is confirmed, a randomization number which corresponds to the group allocation will be provided to the acupuncturist. The clinical assessor and participants will be blinded to the allocation.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fulfilment of the Rome IV criteria for IBS-C;
- •Age of 21 to 65 years (inclusive);
- •Weekly average of worst daily abdominal pain score of ≥3 (0-10 scale) for at least 12 weeks before the first visit and during screening period;
- •<3 complete spontaneous bowel movements (CSBMs) per week for at least 12 weeks before the first visit and during screening period;
- •Written informed consent.
排除标准
- •Pregnancy or breast-feeding;
- •Medical history of inflammatory bowel diseases, carbohydrate malabsorption, hormonal disorder, known allergies to food additives, and/or any other serious diseases;
- •History of gastrointestinal tract segment removal or bariatric surgery for obesity;
- •Appendectomy or cholecystectomy within the past 2 months, or other abdominal surgeries within the past 6 months prior to trial enrollment;
- •Unstable medical conditions that could be associated with abdominal pain or discomfort and could potentially influence the assessments in this trial (e.g., chronic kidney disease, endometriosis, lactose intolerance);
- •Diagnosed with primary severe mental illness;
- •Patients who have received acupuncture treatment in last three months, or took concomitant medication with affect gastrointestinal motility or visceral sensation, such as antidiarrheal agent, antidepressant, narcotic analgesic, and anticholinergic;
- •Alcoholism or drug abuse in past 1 year;
- •Having needle phobia or allergy to acupuncture needle materials;
- •Antibiotics and probiotics/prebiotics usage in the previous month;
- •Participating in other clinical studies.
研究组 & 干预措施
Sham-Acupuncture group
Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted (actual penetration of the skin) at the same way as in the acupuncture group but on sham-acupuncture points (Sham-Baihui, Sham-Toulinqi, Sham-Taichong, Sham-Zhangmen, Sham-Sanyinjiao, Sham-Zhongwan, Sham-Guanyuan, Sham-Tianshu, Sham-Zusanli. The sham points aren't acupuncture points nor located on meridians. Both the electroacupuncture and sham acupuncture groups follow the same procedures, including connection to the stimulator device for the same duration. In the sham group, although no electrical current is delivered, the power switch is turned on and the knobs are manipulated to produce audible clicking sounds, mimicking auditory cues of active treatment.
干预措施: Acupuncture needles (Device)
Electro-Acupuncture group
Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into scalp acupuncture points (Baihui, Toulinqi) or straightly into body acupuncture points (Taichong, Zhangmen, Sanyinjiao, Zhongwan, Guanyuan, Tianshu, Zusanli). Electroacupuncture will be applied to the abdominal points at fast and dispersed waves through electric needle stimulator (ES-160 6-Channel Programmable Electro-acupuncture) for 30 min. The intensity is adjusted to a level at which patients feel comfortable. The alternating stimulation is believed to produce maximal biochemical responses in the brain.
干预措施: Acupuncture needles (Device)
结局指标
主要结局
Responders have a decrease in the weekly average of worst abdominal pain scores of ≥30% compared with baseline and a weekly increase of ≥1 CSBM
时间窗: Baseline (week 2), after treatment period (week 8), end of follow-up (week 14)
Proportion of patients with a decrease in the weekly average of worst abdominal pain scores of ≥30% and a weekly increase of ≥1 CSBM as compared with the baseline.
次要结局
- Median time to the first spontaneous bowel movements, complete spontaneous bowel movements after electro-acupuncture(From first session of electro-acupuncture up to the end of follow-up, approximately 12 weeks)
- Average number of bisacodyl tablets or enemas used per week(Baseline, week 8, week 14)
- Global assessment of efficacy of treatment with Likert scale(Week 5, week 8, week 14)
- Proportion of patients with an improvement of ≥30% in abdominal pain scores(Baseline, week 8, week 14)
- Proportion of patients with an average increase of 1 or more spontaneous, complete bowel movements per week(Baseline, week 8, week 14)
- Average number of spontaneous bowel movements, complete spontaneous bowel movements per week(Baseline, week 8, week 14)
- Percentage of bowel movements with normal consistency(Baseline, week 8, week 14)
- Percentage of bowel movements with severe or very severe straining during defecation(Baseline, week 8, week 14)
- Change from baseline in the IBS-C symtoms using IBS Symptom Severity Scale (IBS-SSS)(Baseline, week 5, week 8, week 14)
- Change from baseline in the IBS-C symtoms using IBS Quality of Life (IBS-QOL)(Baseline, week 5, week 8, week 14)
- Change from baseline in the IBS-C symtoms using Patient Assessment of Constipation Symptoms (PAC-SYM)(Baseline, week 5, week 8, week 14)
- Change from baseline in the IBS-C symtoms using Constipation Quality of Life (PAC-QOL)(Baseline, week 5, week 8, week 14)
- Change from baseline in the IBS-C symtoms using Patient Health Questionnaire-15 (PHQ-15)(Baseline, week 5, week 8, week 14)
- Change from baseline in the psychological conditions using Hamilton Depression Scale (HAMD)(Baseline, week 8, week 14)
- Change from baseline in the psychological conditions using Self-rating Depression Scale (SDS)(Baseline, week 8, week 14)
- Change from baseline in the psychological conditions using Patient Health Questionnaire (PHQ-9)(Baseline, week 8, week 14)
- Change from baseline in the psychological conditions using General Anxiety Disorder (GAD-7)(Baseline, week 8, week 14)
- Change from baseline in the psychological conditions using Hospital Anxiety and Depression Scale (HADS)(Baseline, week 8, week 14)
- Change from baseline in the psychological conditions using Visceral Sensitivity Index (VSI)(Baseline, week 8, week 14)
- Change from baseline in the psychological conditions using Perceived Stress Scale (PSS)(Baseline, week 8, week 14)
- Patient expectancy and trust in treatment with Likert scale(Week 2, week8, week 14)
- Recruitment rate(Baseline)
- Retention rate(Baseline to week 14)
- Adherence to treatment protocols(Baseline to week 14)
- Completeness and quality of symptom diaries and questionnaire responses(Baseline, week 5, week 8, week 14)
- Number and type of adverse events documented(Baseline to week 14)
研究者
Linda Zhong
Assoc Prof
Nanyang Technological University