The efficacy and safety study of electro-acupuncture for severe chronic functional constipation: study protocol for a...

Area of Science:

• Gastroenterology
• Integrative Medicine
• Clinical Trials

Background:

• Functional constipation is a prevalent condition with significant impact on quality of life.
• Previous studies suggest electro-acupuncture (EA) may offer therapeutic benefits for functional constipation.
• A robust clinical trial is needed to validate EA's efficacy and safety in severe chronic functional constipation.

Purpose of the Study:

• To evaluate the efficacy and safety of electro-acupuncture (EA) for severe chronic functional constipation.
• To compare outcomes between a true EA group and a sham EA control group.
• To provide evidence-based support for EA as a treatment option for this condition.

Main Methods:

• A randomized controlled trial involving 1,034 patients with severe chronic functional constipation.
• Participants are allocated to either EA (n=517) or sham EA (n=517) groups.
• Primary outcome: change in weekly average complete spontaneous bowel movements (CSBMs) over 8 weeks; secondary outcomes include CSBM frequency, stool consistency, defecation difficulty, quality of life, and adverse events.

Main Results:

• The primary outcome measure is the change in weekly average complete spontaneous bowel movements (CSBMs) over an 8-week treatment period.
• Secondary outcome measures include the proportion of participants achieving ≥3 CSBMs/week, changes in CSBMs from weeks 9-20, spontaneous bowel movement frequency, stool consistency, defecation difficulty, quality of life (PAC-QOL), adverse events, and medication usage.

Conclusions:

• This randomized controlled trial protocol is designed to rigorously assess the efficacy and safety of electro-acupuncture (EA) for severe chronic functional constipation.
• The findings will contribute to understanding the role of EA in managing this challenging gastrointestinal disorder.