| Methods |
Design: four group parallel trial
Purpose: examine the prophylactic antiemetic effect of transcutaneous electrical stimulation (TENS) of the P6 (Neiguan) acupuncture point |
| Participants |
Patients: in‐patients in need of major surgery and at risk of opoid analgesic‐induced nausea
Baseline comparability: yes (type of analgesic) |
| Interventions |
Placebo: TENS with machine turned off
Untreated: no TENS
Experimental: TENS with machine turned on
(Co‐intervention: pharmacological analgesic and anti‐emetic medication) |
| Outcomes |
Number of patients with nausea
Number of patients with vomiting |
| Notes |
Inconsistent data reporting in original trial report clarified by contact with author.
Not 1:1 randomisation. |
| 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/acupuncture) |
| 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? |
Low risk |
N = 72 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Allocation not clearly concealed |
