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

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Constipation

Treatments: Device: electro-acupuncture; Device: sham electro-acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT01726504

2012BAI24B01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,075 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,075 participants in 2 patient groups

electro-acupuncture

Experimental group

Description:

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.

Treatment:

Device: electro-acupuncture

sham electro-acupuncture

Sham Comparator group

Description:

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.

Treatment:

Device: sham electro-acupuncture