None listed
Conditions
Brief summary
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder in which abdominal discomfort or pain is associated with disordered defecation. It has been one of the most frequent clinical problems in gastroenterology, with an estimated prevalence globally of 7%-21%, which is comparable to that in New Zealand. IBS has no structural or biochemical basis, and its current treatment mainly targets the most troublesome symptom the patient experiences rather than its underlying pathophysiology. The high prevalence of the disease and the poor responses of patients to the established treatments have substantially impacted the healthcare system and individuals, family, and society. The health-related quality of life in IBS patients has been reported to be reduced to similar levels or even worse than individuals with diabetes and end-stage renal failure. Therefore, there is an urgent need to explore other effective solutions for this disease. The application of acupuncture for treating IBS has a long history in traditional Chinese medicine discipline and is still practised in TCM clinics and hospitals worldwide. The effectiveness of acupuncture for treating IBS has also been reported in many clinical studies within the biomedical research frame. However, there are no studies on this topic that have been reported in New Zealand. Our research team postulates that the quality of life may be enhanced when traditional Chinese acupuncture is used as an addition to the standard care for patients suffering from IBS-diarrhoea. Therefore, we propose a pilot study to test this hypothesis as a proof of concept, which may lead to a larger randomised controlled trial. To achieve this, 40 participants with diarrhoea predominant IBS will be recruited and randomised into two intervention groups: standard of care vs standard of care plus traditional Chinese acupuncture, for effectiveness comparison.
Interventions
Participants in the interventional group will receive both the standard care from a specialist gastroenterologist who has about 20 years of working experience as a medical practitioner and 10 years as a specialist in internal medicine and gastroenterology and acupuncture treatment from a registered acupuncturist who has over 36 years of clinical experience in Chinese medicine, including acupuncture and Chinese herbal medicine.
The standard care includes reassurance and medication targeting the
Participants in the interventional group will receive both the standard care from a specialist gastroenterologist who has about 20 years of working experience as a medical practitioner and 10 years as a specialist in internal medicine and gastroenterology and acupuncture treatment from a registered acupuncturist who has over 36 years of clinical experience in Chinese medicine, including acupuncture and Chinese herbal medicine. The standard care includes reassurance and medication targeting the most troublesome symptoms (including fibre supplementation, anti-depressants, antispasmodics and anti-diarrhoeal medications for symptom control). The gastroenterologist will justify the frequency and duration of consultation according to individual participant’s needs as routine clinical visits; therefore, the participant’s irritable bowel symptoms will be monitored throughout the 8-week treatment period (at least two visits at Week 1 and Week 8). A set of acupoints (Ren4 GuanYuan, Ren6 QiHai, Ren10 XiaWan, Ren12 ZhongWan, ST24 HuaRouMen and ST26 WaiLing) are selected based on traditional Chinese medicine (TCM) abdominal acupuncture theory. The frequency of acupuncture treatment will be twice per week for 8 weeks, in total, 16 sessions. Acupuncture needles are with diameters of 0.2-0.3 mm and lengths of 25-60 mm. The selection of needle size and the deepness of the needle insertion will base on the location of the acupoints, the body condition and body shape of each individual participant, especially the abdominal wall thickness of the individual participant and the expected function of needling. The needles are typically left in place for 25-30 minutes after insertion, but for severe cases, needles can be left up to 55 minutes. The interventions will occur in either the specialist clinic or the acupuncture clinic. A follow-up period of 24 weeks post-treatment is designed to evaluate the effectiveness of the interventions. During the follow-up period, participants are expected to continually follow the dietary and lifestyle advice from the acupuncturist or the gastroenterologist. The lifestyle and dietary advice provided by the acupuncturist will follow TCM principles and be based on each individual body constitution, and those provided by the gastroenterologist will follow the 2018 American College of Gastroenterology (ACG) monograph on the management of irritable bowel syndrome, the National Institute for Health and Care Excellence (NICE) guidelines and the British Dietetic Association evidence-based guidelines for the dietary management of irritable bowel syndrome. Participants will continue their daily record of abdominal pain and bowel movements. Participants will be reassessed at 4 weeks post-treatment (Week 12), 12 weeks post-treatment (Week 20) and 24 weeks post-treatment (Week 32) with assessors on site. The planned duration of participation in the trial will be 33-34 weeks from signing the informed consent to the completion of follow-up visits (screening up to 10 days, treatment 8 weeks and follow-up 24 weeks).
Sponsors
New Zealand College of Chinese Medicine
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Patients who are newly diagnosed with IBS-D by New Zealand registered western medical professionals, according to ROME IV criteria will be potentially eligible to participate in the study. ROME IV criteria: Patients with recurrent abdominal pain at least one day per week in the last three months on average, associated with at least 2 of the criteria below. The criteria are fulfilled with symptoms onset six months before diagnosis: 1 Related to defecation, either increasing or improving pain 2 Associated with a change in stool frequency 3 Associated with a change in stool form (appearance) The Bristol Stool Form Scale (BSFS) is used to record stool consistency. The IBS-D subtype is defined as follows: more than 25% of bowel movements using the BSFS are type 6 or 7, and less than 25% of bowel movements are type 1 or 2 (European Medicines Agency, 2015; FDA, 2012). IBS-D patients can be diagnosed in a clinical situation when a patient reports that abnormal bowel movements are usually diarrhoea (BSFS type 6 or 7) (Moayyedi et al., 2017).
Exclusion criteria
Patients who meet the criteria below will be excluded from the study: 1 Age younger than 18 or older than 50 2 Individuals who cannot make independent decisions and consent 3 Previously diagnosed with IBS and having received standard care 4 Currently taking the following medications more than three days a week: antibiotics, narcotics, cholestyramine, colchicine, iron supplements, antispasmodics, benzodiazepines, antidepressants 5 Current diagnosis of haemophilia, hepatitis, HIV or cancer 6 Having had major gastrointestinal, and/or gynaecological, and/or urological surgery within the past six months 7 Currently receiving complementary therapies such as acupuncture, herbs, massage and behavioural therapies 8 Having bleeding disorders 9 Regularly taking anticoagulants 10 Having skin conditions 11 Having an immunocompromised disease or taking immunosuppressant 12 Having a history of convulsions 13 Pregnancy 14 A history of psychosis or substance abuse 15 Individuals with plans for travel, lifestyle change, or other activity that would preclude attending the planned study sessions
Outcome results
None listed