From: A randomized controlled trial of acupuncture to treat functional constipation: design and protocol
Week | -1 | 0 | 2 | 4 | 8 |
---|---|---|---|---|---|
Baseline | Treatment | Follow-up | |||
Patients | |||||
Medical history | √ | ||||
Physical examination | √ | √ | √ | √ | |
Laboratory examination | √ | √ | |||
Informed consent | √ | ||||
Randomization | √ | ||||
Expectation of acupuncture | √ | ||||
Intervention | |||||
Electro-acupuncture (EA) group | 16 sessions of electro-acupuncture | ||||
Mosapride (M) group | 5 mg mosapride citrate tablet, three times a day | ||||
Mosapride & Sham | 16 sessions of sham electro-acupuncture and 5 mg mosapride citrate tablet, three times a day | ||||
Electro-acupuncture (MS) group | |||||
Outcomes | |||||
Number of defecating events per week | √ | √ | √ | √ | |
Shape and properties of stool | √ | √ | √ | √ | |
Intensity of defecating difficulty | √ | √ | √ | √ | |
SF-36 | √ | √ | |||
SAS | √ | √ | √ | ||
SDS | √ | √ | √ | ||
PAC-QOL | √ | √ | √ | √ | |
Trial evaluation | |||||
Safety of electro-acupuncture | √ | √ | √ | ||
Adverse event | √ | √ | √ | ||
Reasons of drop-outs or withdrawals | √ | ||||
Patient’s compliance | √ |