The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation

Phase 2

Completed

Conditions: Constipation

Interventions: Device: electro-acupuncture
Device: sham electro-acupuncture

Registration Number: NCT01726504

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

Brief Summary: The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe functional constipation compared with sham acupuncture, used as placebo; the secondary purpose is to evaluate the safety and post-treatment effect of electro-acupuncture.

Detailed Description: Chronic functional constipation is a common disease. To date there has not specific therapy on chronic functional constipation. Systematic reviews indicate that acupuncture is probably effective for the disease, but the evidence is limited. Recently, we have finished a multi-center clinical trial of individualized deep electro-acupuncture (EA) for chronic functional constipation (n=460, Registration ID: NCT00508482) which preliminarily showed EA was effective.

This multi-center large-sample randomized controlled clinical trial of acupuncture for severe functional constipation is designed to confirm the efficacy and safety of EA.

This project is conducted by Chinese experts, supported by the Chinese Government. The research result is expected to provide high quality evidence of EA for chronic functional constipation.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1075

Inclusion Criteria

meeting the diagnosis of Rome III criteria for chronic functional constipation;
severe chronic constipation: two or fewer spontaneous complete bowel movements per week for more than 3 months;
18-75 years old;
no use of medicine for constipation during the two weeks before enrollment (except rescue medication);
no acupuncture treatment for constipation in recent 3 months;
never joined any other trial in process in 3 months;
volunteered to join this research and signed the informed consent.

Exclusion Criteria

Irritable bowel syndrome (IBS) and constipation caused by endocrine, metabolic, nervous or postoperative diseases or drugs;
constipation accompanied by serious cardiovascular, hepatic, renal, or psychiatric disease, cognitive dysfunction or aphasia, or severe dystrophy affecting the cooperation for examination or treatment;
pregnant women or women in lactation period
constipation accompanied by abdominal aneurysm, hepatosplenomegaly, etcetera;
bleeding disorders, or regular anticoagulant drug users, such as warfarin and heparin, etcetera;
cardiac pacemaker carrier.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electro-acupuncture	electro-acupuncture	1. The electric stimulator is applied to bilateral ST25andSP14 with dilatational wave10/50 Hz and electric current0.1-1.0mA.They are given acupuncture with 0.3×50mm or 0.35×75mm needles by inserting30-70mm and twirling lifting andthrusting 3 times.Dosage:The needle arrives the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). 2. Bilateral ST37 are given conventional acupuncture with 0.30mm×40mm needles by inserting 25-30mm and twirling lifting and thrusting for 3.Dosage:Local sour and heavy feeling is the appropriate dose. Every session lasts for 30min/day.The participants are treated continuously for 8 weeks.During 8-week treatment the first 2 weeks,5 sessions per week,and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total.
sham electro-acupuncture	sham electro-acupuncture	1. The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave, 10/50 Hz and electric current 0.5mA. The mental wire has been cut off with a same outlook as the treatment group. The electric stimulator is looked normal but with no current output. The needle is inserted by 3mm-5mm (the needle can be vertically fixed on the skin). 2. Bilateral ST37 are given acupuncture with 3mm-5mm (the needle can be vertically fixed on the skin). Length of Treatment and the treatment sessions are the same as treatment group.

Primary Outcome Measures

Name	Time	Method
the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment	Baseline and weeks 1-8	the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline.

Secondary Outcome Measures

Name	Time	Method
the Percentage of Participants With Three or More Weekly CSBMs	1-20 weeks	the percentage of participants with three or more weekly CSBMs during weeks 1-8 and weeks 9-20
Changes in Mean Weekly CSBMs During Weeks 9-20	Baseline and weeks 9-20	The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline.
Mean Weekly SBMs During Weeks 1-8	Baseline and weeks 1-8	The changed number in mean of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline.
Mean Scores for Stool Consistency and Straining During Weeks 1-8	Baseline and weeks 1-8	average weekly stool consistency (Bristol Stool Scale) assessment of self-defecation during the 1-8weeks of treatment,compared with baseline. Bristol Stool Scale including 7-type, scored by 1 to 7 respectively.Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid. Type 3, 4 are normal.
Change of Average Weekly Degree of Difficulty in Defecation From Baseline	Baseline and weeks 1-8	The degree of straining during self-defecation: The severity of straining is graded using a 4-point ordinal scale. 0 = not at all 1. = more straining than not 2. = a great deal 3. = an extreme amount, need finger manipulation to defecate average weekly degree of difficulty in self-defecation during 1-8weeks,compared with baseline
Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL)	baseline and the end of 8th week	Patient-Assessment of Constipation Quality Of Life(PAC-QOL) ranges are 28-140,and higher values represent a worse outcome.Subscales are summed to compute the total score. The changed score of PAC-QOL at week 8, compared with baseline.
Number of Participants With Adverse Events Related to Acupuncture	1-8 weeks
Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used	1-20 weeks	Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.
The Number of Participants Using Rescue Medicine for Constipation	1-20 weeks
Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used	1-20 weeks	Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.