A pilot study of traditional acupuncture as an additional treatment for irritable bowel syndrome-diarrhoea

INTERVENTION: 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 wi CONDITION: Alternative and Complementary Medicine ‐ Other alternative and complementary medicine irritable bowel syndrome; ; irritable bowel syndrome Oral and Gastrointestinal ‐ Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon SECONDARY OUTCOME: IBS‐Adequate Relief (IBS‐AR) is a single dichotomous item that asks participants, “Over the past week have you had adequate relief of your IBS symptoms?” (Mangel & Fehnel, 2006; Mangel et al., 1998). [The participants will be requested to complete this questionnaire at 4 weeks and 8 weeks after receiving treatment (treatment period), and 4 weeks, 12 weeks and 24 weeks after the completion of the 8‐week treatment (follow‐up period). ; ] IBS‐Quality of Life (IBS‐QOL) is a 34‐item measure assessing the degree to which IBS interferes with a patient’s quality of life. Each item is rated on a 5‐point Likert scale, thus yielding a total score that has a theoretical range of 34 to 170, with higher scores indicating worse QOL (Drossman et al., 2000; Patrick, Drossman, Frederick, Dicesare, & Puder, 1998).[The participants will be requested to complete this questionnaire at the screening period, 4 weeks and 8 weeks after receiving treatment (treatment period), and 4 weeks, 12 weeks and 24 weeks after the completion of the 8‐week treatment (follow‐up period).] 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. 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) PRIMARY OUTCOME: For the evaluation of abdominal pain, an 11‐point numerical rating scale (NRS) will be used as it has been validated for use in IBS and is therefore regarded as acceptable (Spiegel et al., 2009). ; ; Participants will be asked to rate daily their worst abdominal pain over the past 24‐hours. Changes in abdominal pain intensity from baseline will be measured at different time intervals. [Changes in abdominal pain intensity from baseline will be measured at 4 weeks and 8 weeks after receiving treatment (treatment period), and 4 weeks, 12 weeks and 24 weeks after the completion of the 8‐week treatment (follow‐up period). The baseline score for evaluation is the mean of non‐missing abdominal pain scores recorded during the 7‐day baseline diary assessment period before the randomisation.; ] For the evaluation of stool consistency, the Bristol Stool Form Scale (BSFS) (O’Donnell, Virjee, & Heaton, 1990) will be used, rating from 1‐7:; ; Rating Description; 1 Separate hard lumps, like nuts (hard to pass); 2 Sausage‐shaped but lumpy; 3 Like a sausage but with cracks on its surface; 4 Like a sausage or snake, smooth and soft; 5 Soft blobs with clear‐cut edges (passed easily); 6 Fluffy pieces with ragged edges, a mushy stool; 7 Watery, no solid pieces, entirely liquid; ; Daily BSFS scores will be recorded to represent discrepancies from a 'normal' stool type 4. ; ; The following means will be calculated and compared for each participant:; ; Baseline = mean (day ‐7 to day ‐1); Week 4 = mean (day 22 to day 28); Week 8 = mean (day 50 to day 56); Week 12 = mean (day 78 to day 84); Week 20 = mean (day 134 to day 140); Week 32 = mean (day 218 to day 224) ; [Changes from baseline will be measured at 4 weeks and 8 weeks after receiving treatment (treatment period), and 4 weeks, 12 weeks and 24 weeks after the completion of the 8‐week treatment (follow‐up period).] IBS Syndrome Severity Score (IBS‐SSS) will be used as the primary outcome measure. It contains five questions that measure the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life (Francis et al., 1997). Each component contributes 100 points to yield a theoretical range of 0‐500, with a higher score indicating a worse condition. Previous studies have established that scores below 175 represent mild IBS symptoms, 175–300 represent moderate severity, and scores above 300 represent severe IBS (Francis et al., 1997). The total severity score on the IBS‐SSS is treated as the gold standard measure of IBS severity. This measure will also be used to set the eligibility to participate in the trial (exclusion criteria: patients whose scores are < 175) at screening time.[The participants will be requested to complete this questionnaire at the screening period, 4 weeks and 8 weeks after receiving treatment (treatment period), and 4 weeks, 12 weeks and 24 weeks after the completion of the 8‐week treatment (follow‐up period).] 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: 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 th