Constipation
Conditions
Keywords
Acupuncture, Functional constipation
Brief summary
A multi-center clinical trial done recently by us(NCT00508482) shows that needling on ST25 has the same effect as lactulose in unaided self-defecation frequency of a week and has better effect in symptoms improvement (in press). The object is to evaluate whether acupuncture is effective for functional constipation. As an explanatory research, it took one single point as its intervention and sham acupuncture as its control group (patients were blinded). On the basis of its confirmed effect, we are taking a pragmatic randomized controlled trial to further evaluate whether acupuncture is more effective than routine treatment. Acupuncture prescriptions used in this trial are individually prescribed according to syndrome differentiation, which can improve clinical effect. .
Detailed description
functional constipation,acupuncture,effects and safety,pragmatic RCT
Interventions
OTHERacupuncture
Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA). Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used. Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks.
4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
Sponsors
Ministry of Science and Technology of the People´s Republic of China
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who has been diagnosed with functional constipation according to Rome Ⅲ criteria * Patients who are aged 18-75 years old * Stop medication or acupuncture (if any) 1 week before randomization and uninvolved in other trials * Sign the informed consent out of one's own will
Exclusion criteria
* Secondary constipation * Patients with consciousness impairment, psychotic patients or patients unable to express clearly * Patients with malignant tumor in progressive stage, severe wasting disease and liable to be infected and bleed * Patients with severe cardiovascular disease, hepatic injury, renal damage, digestive disease or hematological diseases * Women in pregnancy and lactation period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the SBMs From Baseline at Week 4 | baseline and at 4 weeks | \[average number of spontaneous bowel movements in a week at week 4\]-\[average number of spontaneous bowel movements in a week at baseline\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Bristol Stool Scale at the 4th Week | baseline and at 4 weeks | Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 4th week-the Bristol Stool Scale at baseline. |
| Change From Baseline in Difficulty Degree of Defecation at the 4th Week | baseline and at 4 weeks | This outcome describes how much effort the patients with while defecating.It ranges from 0 to 3. 0-Without difficulty 1. Defecation straining 2. Severe defecation straining 3. Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings. \[the average score of one week at the 4th week\]-\[the average score of one week at baseline\] |
| Changes of the SBMs From Baseline at Week 8 | baseline and at 8 weeks | \[average number of spontaneous bowel movements in a week at week 8\]-\[average number of spontaneous bowel movements in a week at baseline\] |
| Change From Baseline in the Bristol Stool Scale at the 8th Week | baseline and at 8 weeks | Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 8th week-the Bristol Stool Scale at baseline. |
| Change From Baseline in Difficulty Degree of Defecation at the 8th Week | baseline and at 8 weeks | This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3. 0-Without difficulty 1. Defecation straining 2. Severe defecation straining 3. Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings. \[the average score of one week at the 8th week\]-\[the average score of one week at baseline\] |
Countries
China
Participant flow
Recruitment details
The participants were recruited through the inpatients and outpatients settings in the 8 hospitals.We also recruited the participants through television and newspapers advertisements.
Pre-assignment details
Nine enrolled participants refused to join in the trial after signing the informed consent. So they were excluded from the trial.
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture at ST25 and BL25 the points formula of back-shu point combination with front-mu point.
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. | 168 |
| Acupuncture at LI11 and ST37 the points formula of He-points
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. | 172 |
| Acupuncture at ST25, BL25, LI11 and ST37 the formula of He-point,back-shu point and front-mu point
acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks. | 165 |
| Medicine oral use of mosapride citrate
mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal | 170 |
| Total | 675 |
Baseline characteristics
| Characteristic | Acupuncture at ST25 and BL25 | Total | Medicine | Acupuncture at ST25, BL25, LI11 and ST37 | Acupuncture at LI11 and ST37 |
|---|---|---|---|---|---|
| Age, Continuous | 38.9 years STANDARD_DEVIATION 17.4 | 40.1 years STANDARD_DEVIATION 16.9 | 40.6 years STANDARD_DEVIATION 16.7 | 40.7 years STANDARD_DEVIATION 16.8 | 39.9 years STANDARD_DEVIATION 16.8 |
| Bristol scale | 2.8 units on a scale STANDARD_DEVIATION 1.3 | 2.9 units on a scale STANDARD_DEVIATION 1.8 | 2.7 units on a scale STANDARD_DEVIATION 1.4 | 3.0 units on a scale STANDARD_DEVIATION 1.5 | 2.9 units on a scale STANDARD_DEVIATION 1.4 |
| Degree of straining during defecation 0 | 5 participants | 27 participants | 5 participants | 9 participants | 8 participants |
| Degree of straining during defecation 1 | 63 participants | 250 participants | 59 participants | 68 participants | 60 participants |
| Degree of straining during defecation 2 | 68 participants | 267 participants | 72 participants | 58 participants | 69 participants |
| Degree of straining during defecation 3 | 30 participants | 124 participants | 31 participants | 28 participants | 35 participants |
| Degree of straining during defecation no defecation | 2 participants | 7 participants | 3 participants | 2 participants | 0 participants |
| Duration of functional constipation | 7.0 months STANDARD_DEVIATION 6.8 | 6.2 months STANDARD_DEVIATION 5.56 | 5.8 months STANDARD_DEVIATION 4.6 | 5.6 months STANDARD_DEVIATION 4.3 | 6.3 months STANDARD_DEVIATION 6.5 |
| Received Traditional Chinese Medicine therapies Acupuncture | 7 participants | 26 participants | 3 participants | 7 participants | 9 participants |
| Received Traditional Chinese Medicine therapies Both | 7 participants | 25 participants | 5 participants | 8 participants | 5 participants |
| Received Traditional Chinese Medicine therapies Herbs | 38 participants | 173 participants | 44 participants | 43 participants | 48 participants |
| Received Traditional Chinese Medicine therapies Neither | 116 participants | 451 participants | 118 participants | 107 participants | 110 participants |
| Region of Enrollment China | 168 participants | 675 participants | 170 participants | 165 participants | 172 participants |
| SBMs | 2.7 times per week STANDARD_DEVIATION 1.9 | 2.8 times per week STANDARD_DEVIATION 2.1 | 2.9 times per week STANDARD_DEVIATION 2.8 | 2.9 times per week STANDARD_DEVIATION 2 | 2.5 times per week STANDARD_DEVIATION 1.7 |
| Sex: Female, Male Female | 128 Participants | 548 Participants | 142 Participants | 138 Participants | 140 Participants |
| Sex: Female, Male Male | 40 Participants | 127 Participants | 28 Participants | 27 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 168 | 3 / 172 | 6 / 165 | 6 / 170 |
| serious Total, serious adverse events | 0 / 168 | 0 / 172 | 0 / 165 | 0 / 170 |
Outcome results
Primary
Change of the SBMs From Baseline at Week 4
\[average number of spontaneous bowel movements in a week at week 4\]-\[average number of spontaneous bowel movements in a week at baseline\]
Time frame: baseline and at 4 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture at ST25 and BL25 | Change of the SBMs From Baseline at Week 4 | 2.7 times per week |
| Acupuncture at LI11 and ST37 | Change of the SBMs From Baseline at Week 4 | 2.7 times per week |
| Acupuncture at ST25, BL25, LI11 and ST37 | Change of the SBMs From Baseline at Week 4 | 2.2 times per week |
| Medicine | Change of the SBMs From Baseline at Week 4 | 2.4 times per week |
p-value: 0.352ANCOVA
Secondary
Change From Baseline in Difficulty Degree of Defecation at the 4th Week
This outcome describes how much effort the patients with while defecating.It ranges from 0 to 3. 0-Without difficulty 1. Defecation straining 2. Severe defecation straining 3. Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings. \[the average score of one week at the 4th week\]-\[the average score of one week at baseline\]
Time frame: baseline and at 4 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acupuncture at ST25 and BL25 | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 0 | 40 participants |
| Acupuncture at ST25 and BL25 | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 1 | 69 participants |
| Acupuncture at ST25 and BL25 | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 2 | 33 participants |
| Acupuncture at ST25 and BL25 | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 3 | 16 participants |
| Acupuncture at LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 1 | 78 participants |
| Acupuncture at LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 2 | 36 participants |
| Acupuncture at LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 3 | 12 participants |
| Acupuncture at LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 0 | 41 participants |
| Acupuncture at ST25, BL25, LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 2 | 38 participants |
| Acupuncture at ST25, BL25, LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 1 | 76 participants |
| Acupuncture at ST25, BL25, LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 3 | 14 participants |
| Acupuncture at ST25, BL25, LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 0 | 33 participants |
| Medicine | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 3 | 9 participants |
| Medicine | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 1 | 76 participants |
| Medicine | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 0 | 36 participants |
| Medicine | Change From Baseline in Difficulty Degree of Defecation at the 4th Week | 2 | 43 participants |
p-value: 0.841Kruskal-Wallis
Secondary
Change From Baseline in Difficulty Degree of Defecation at the 8th Week
This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3. 0-Without difficulty 1. Defecation straining 2. Severe defecation straining 3. Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings. \[the average score of one week at the 8th week\]-\[the average score of one week at baseline\]
Time frame: baseline and at 8 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Acupuncture at ST25 and BL25 | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 0 | 45 participants |
| Acupuncture at ST25 and BL25 | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 1 | 75 participants |
| Acupuncture at ST25 and BL25 | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 2 | 29 participants |
| Acupuncture at ST25 and BL25 | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 3 | 9 participants |
| Acupuncture at LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 1 | 88 participants |
| Acupuncture at LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 2 | 25 participants |
| Acupuncture at LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 3 | 7 participants |
| Acupuncture at LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 0 | 46 participants |
| Acupuncture at ST25, BL25, LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 2 | 28 participants |
| Acupuncture at ST25, BL25, LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 1 | 83 participants |
| Acupuncture at ST25, BL25, LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 3 | 8 participants |
| Acupuncture at ST25, BL25, LI11 and ST37 | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 0 | 40 participants |
| Medicine | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 3 | 16 participants |
| Medicine | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 1 | 67 participants |
| Medicine | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 0 | 36 participants |
| Medicine | Change From Baseline in Difficulty Degree of Defecation at the 8th Week | 2 | 44 participants |
p-value: 0.035Kruskal-Wallis
Secondary
Change From Baseline in the Bristol Stool Scale at the 4th Week
Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 4th week-the Bristol Stool Scale at baseline.
Time frame: baseline and at 4 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture at ST25 and BL25 | Change From Baseline in the Bristol Stool Scale at the 4th Week | 3.9 units on a scale |
| Acupuncture at LI11 and ST37 | Change From Baseline in the Bristol Stool Scale at the 4th Week | 3.9 units on a scale |
| Acupuncture at ST25, BL25, LI11 and ST37 | Change From Baseline in the Bristol Stool Scale at the 4th Week | 3.9 units on a scale |
| Medicine | Change From Baseline in the Bristol Stool Scale at the 4th Week | 3.9 units on a scale |
p-value: 0.968ANCOVA
Secondary
Change From Baseline in the Bristol Stool Scale at the 8th Week
Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 8th week-the Bristol Stool Scale at baseline.
Time frame: baseline and at 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture at ST25 and BL25 | Change From Baseline in the Bristol Stool Scale at the 8th Week | 3.4 units on a scale |
| Acupuncture at LI11 and ST37 | Change From Baseline in the Bristol Stool Scale at the 8th Week | 3.6 units on a scale |
| Acupuncture at ST25, BL25, LI11 and ST37 | Change From Baseline in the Bristol Stool Scale at the 8th Week | 3.4 units on a scale |
| Medicine | Change From Baseline in the Bristol Stool Scale at the 8th Week | 3.1 units on a scale |
p-value: 0.198ANCOVA
Secondary
Changes of the SBMs From Baseline at Week 8
\[average number of spontaneous bowel movements in a week at week 8\]-\[average number of spontaneous bowel movements in a week at baseline\]
Time frame: baseline and at 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture at ST25 and BL25 | Changes of the SBMs From Baseline at Week 8 | 2.3 times per week |
| Acupuncture at LI11 and ST37 | Changes of the SBMs From Baseline at Week 8 | 2.4 times per week |
| Acupuncture at ST25, BL25, LI11 and ST37 | Changes of the SBMs From Baseline at Week 8 | 2.1 times per week |
| Medicine | Changes of the SBMs From Baseline at Week 8 | 1.4 times per week |
p-value: 0.005ANCOVA