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. .
functional constipation,acupuncture,effects and safety,pragmatic RCT
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
684
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
No.5 Beixiange Street, Xuanwu District
Beijing, China
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
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
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
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.