| Methods |
Design: three group parallel trial
Purpose: examine the effect of acustimulation in patients undergoing gastroscopy |
| Participants |
Patients: out‐patients undergoing gastroscopy
Baseline comparability: yes (age, gender) |
| Interventions |
Placebo:
‐electrical device attached to electrodes and acustimulation performed on a site not regarded acupuncture site
‐electrical device attached to electrodes but no acustimulatiuon performed
Untreated: no electrical device attached nor acustimulation performed
Experimental: acustimulation on point P6
(Co‐intervention: no) |
| Outcomes |
Proportion of patients scoring 1 to 4 on a VAS for nausea
Proportion of patients scoring 1 to 4 on a VAS for difficulty of swallowing gastroscopy
Proportion of patients scored 1 to 4 by gastrocopist on a VAS for nausea/retching
Proportion of patient who accept re‐gastroscopy |
| Notes |
The results from the two placebo groups were combined |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/acustimulation) |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| 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? |
Low risk |
N = 235 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |
