| Methods |
Design: three group parallel trial
Purpose: study the effect of acupuncture on discomfort, pain and anxiety during colonoscopy |
| Participants |
Patients: patients scheduled to undergo colonoscopy
Baseline comparability: yes (age, pre‐colonoscopy anxiety) |
| Interventions |
Placebo: needling and electrical stimulation on sites not regarded analgesic acupuncture sites
Untreated: no needling
Experimental: needling and electrical stimulation on sites regarded analgesic acupuncture sites (L14, S36, SP6, SP9)
(Co‐intervention: midazolam 15 minutes before procedure and as required) |
| Outcomes |
Escape medication (midazolam)
Pain at 4 times during the procedure (5‐point scale)
Procedure acceptability (5‐point scale)
Patient satisfaction
Technical difficulty of the procedure (physician and nurse)
Satisfaction with sedation (physician and nurse)
Total procedural time |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
‘computer‐generated sequence of numbers' |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Unclear risk |
NS |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (binary outcome) |
| Trial size > 49? |
High risk |
N = 20 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
