Efficacy and Safety of Acupuncture for Functional Constipation

Phase 3

Completed

Conditions: Constipation

Interventions: Drug: mosapride citrate
Other: acupuncture

Registration Number: NCT01411501

Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 684

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
medicine	mosapride citrate	oral use of mosapride citrate
Acupuncture at ST25 and BL25	acupuncture	the points formula of back-shu point combination with front-mu point.
Acupuncture at LI11 and ST37	acupuncture	the points formula of He-points
Acupuncture at ST25, BL25, LI11 and ST37	acupuncture	the formula of He-point,back-shu point and front-mu point

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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. \[the average score of one week at the 8th week\]-\[the average score of one week at baseline\]