| Methods |
Design: three period, Latin square, cross‐over trial
Purpose: examine the effect of acustimulation on chemotherapy‐induced nausea |
| Participants |
Patients: cancer patients receiving chemotherapy who previously have experienced moderate or severe chemotherapy‐induced nausea |
| Interventions |
Placebo: acustimulation wrist‐band without stimulation of point PC‐6
Untreated: no acustimulation write band
Experimental: acustimulation wrist band with stimulation on point PC‐6
(Co‐intervention: 'antiemetic pills') |
| Outcomes |
Antiemetic use (pills per day)
Nausea
Acute nausea
Delayed nausea |
| Notes |
The outcome data was not available from the first period only, and was calculated as deriving from a parallel group trial. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| 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? |
Unclear risk |
The outcome data from this cross‐over trial was not available from the first period only, and was calculated as deriving from a parallel group trial. |
| 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? |
Low risk |
N = 54 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
