Methods |
Design: three group parallel trial
Purpose: examine the effect of acupressure on nausea and vomiting during pregnancy |
Participants |
Patients: pregnant women with nausea without treatment
Baseline comparability: not for week of pregnancy (yes for age, week of pregnancy at start of nausea) |
Interventions |
Placebo: acupressure waistband at the upper side of the wrist (not P6) for two weeks
Untreated: no acupressure
Experimental: acupressure waistband at P6
(Co‐intervention: no) |
Outcomes |
Nausea (100 mm VAS) after 2 weeks
Vomiting |
Notes |
The drop‐out rate was 25% (20 out of 80). Trial probably stopped prematurely before inclusion of the planned 300 women |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
each woman ‘drew an envelope from a box' |
Allocation concealment? |
Low risk |
The drawn envelopes had 'the same appearance but different content', and 'The women were asked not to open the envelope until returning home' |
Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/acupressure) |
Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
Incomplete outcome data addressed?
All outcomes |
High risk |
|
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 = 40 |
Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |