A randomized controlled trial of acupuncture to treat functional constipation: design and protocol

Table 1 Trial processes chart

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				√

SF-36, MOS item Short Form health survey; SAS, Self-Rating Anxiety Scale; SDS, Self-rating Depression Scale; PAC-QOL, patient assessment of constipation quality of life questionnaire.