| Methods |
Design: three group parallel trial
Purpose: examine the effect of single needle acupuncture in suppressing gag‐reflex during transesophageal echocardiography (TEE) |
| Participants |
Patients: acupuncture naive patients with presumed cardioembolic stroke or transient ischemic attack
Baseline comparability: yes |
| Interventions |
Placebo: needling in the Chengjiang point (CV24) during TEE
Untreated: no needling
Experimental: needling 'at a sham point' (tip of the chin
(Co‐intervention: 0.5% tetracaine spray) |
| Outcomes |
Gag‐reflex (10 point VAS) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
'computer‐evoked' |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Unclear risk |
NS |
| 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? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
High risk |
N = 27 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
