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Trial registered on ANZCTR


Registration number
ACTRN12622000073707
Ethics application status
Approved
Date submitted
14/09/2021
Date registered
21/01/2022
Date last updated
21/01/2022
Date data sharing statement initially provided
21/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of traditional acupuncture as an additional treatment for irritable bowel syndrome-diarrhoea
Scientific title
A pilot study to explore the effect of traditional Chinese acupuncture as an addition to the standard care in patients with diarrhoea predominant irritable bowel syndrome
Secondary ID [1] 305309 0
None
Universal Trial Number (UTN)
U1111-1260-9389
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
irritable bowel syndrome 323625 0
Condition category
Condition code
Alternative and Complementary Medicine 321160 321160 0 0
Other alternative and complementary medicine
Oral and Gastrointestinal 322308 322308 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 321719 0
Treatment: Other
Comparator / control treatment
Participants in the control group will receive 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.

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).
Control group
Active

Outcomes
Primary outcome [1] 328952 0
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.
Timepoint [1] 328952 0
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).
Primary outcome [2] 328953 0
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.
Timepoint [2] 328953 0
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.
Primary outcome [3] 328954 0
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)
Timepoint [3] 328954 0
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).
Secondary outcome [1] 400942 0
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).
Timepoint [1] 400942 0
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).
Secondary outcome [2] 400943 0
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).
Timepoint [2] 400943 0
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).

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants’ allocation will be concealed by using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis of all data in this study will be performed by a specialised statistician, who is blinded to the treatment allocation. Statistical Analysis System-SAS (SAS Institute, NC) or R (GNU) will be used for data analysis.

Both intention-to-treat (ITT) analysis and per-protocol (PP) analysis will be conducted. Primary analyses will follow the principle of ITT. Data will be analysed according to the assigned treatment group at randomisation. Per-protocol (PP) analysis will also be conducted. The Per-protocol analysis will exclude participants who did not complete the assigned treatment or any major protocol violation. No imputation will be performed for missing data. No adjustment will be made for multiple comparisons. Two-sided p-values less than 0.05 will be used in determining statistical significance, and all confidence intervals will be given at a two-sided 95% level unless otherwise stated.

The repeatedly measured continuous outcome will be analysed using the method of mixed model for repeated measure, MMRM, while repeated measure binary outcomes will be analysed using the generalised linear mixed-effects model, GLIMMIX. The binary outcome will be analysed using logistic regression, and the continuous outcome will be analysed using multiple linear regression. An appropriate non-parametric test will be used if the data violated model assumptions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/04/2022
Actual
Date of last participant enrolment
Anticipated
17/10/2022
Actual
Date of last data collection
Anticipated
19/06/2023
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 24118 0
New Zealand
State/province [1] 24118 0
Auckland

Funding & Sponsors
Funding source category [1] 309676 0
Other
Name [1] 309676 0
New Zealand College of Chinese Medicine
Country [1] 309676 0
New Zealand
Primary sponsor type
Other
Name
New Zealand College of Chinese Medicine
Address
321 Great South Road, Greenlane, Auckland 1051, New Zealand
Country
New Zealand
Secondary sponsor category [1] 310698 0
None
Name [1] 310698 0
Address [1] 310698 0
Country [1] 310698 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309444 0
Northern A New Zealand Health and Disability Ethics Committees
Ethics committee address [1] 309444 0
Ethics committee country [1] 309444 0
New Zealand
Date submitted for ethics approval [1] 309444 0
08/04/2021
Approval date [1] 309444 0
12/07/2021
Ethics approval number [1] 309444 0
21/NTA/46

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114182 0
Dr Li Feng
Address 114182 0
New Zealand College of Chinese Medicine
321 Great South Road, Greenlane, Auckland 1051, New Zealand
Country 114182 0
New Zealand
Phone 114182 0
+64 9 5802376 203
Fax 114182 0
Email 114182 0
lifeng@chinesemedicine.ac.nz
Contact person for public queries
Name 114183 0
Lin Zhang
Address 114183 0
New Zealand College of Chinese Medicine
321 Great South Road, Greenlane, Auckland 1051, New Zealand
Country 114183 0
New Zealand
Phone 114183 0
+64 9 5802376 219
Fax 114183 0
Email 114183 0
research.leader@chinesemedicine.ac.nz
Contact person for scientific queries
Name 114184 0
Lin Zhang
Address 114184 0
New Zealand College of Chinese Medicine
321 Great South Road, Greenlane, Auckland 1051, New Zealand
Country 114184 0
New Zealand
Phone 114184 0
+64 9 5802376 219
Fax 114184 0
Email 114184 0
research.leader@chinesemedicine.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.