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. Author manuscript; available in PMC: 2014 Apr 30.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Sep 8;(9):CD007575. doi: 10.1002/14651858.CD007575.pub2
Methods A single blind randomised study.
Participants 66 pregnant women with mild to moderate nausea and vomiting between 6 and 12 weeks’ gestation, in the outpatient setting
Interventions The patients in the acupressure group were advised to apply Sea-Bands on P6 point and identical looking tablets were used as placebo in the same regimen as vitamin B6. Those in vitamin B6 group were advised to apply Sea-Bands on the dummy point and 50 mg tablets of vitamin B6 were prescribed every 12 hours for 5 days
Outcomes Primary outcome: self-recorded nausea and vomiting according to Rhodes Index of Nausea and Vomiting form 2 (8 item, 5-point LIkert-type instrument). Women evaluated their symptoms twice daily for 7 days
Secondary outcomes: weight gain and medication use- use of the rescue drug (oral dimenhydrinate 50 mg every 6 hours when required)
Notes The authors state that the Rhodes Index was “translated into Thai and tested for validity and reliability by experts” but provide no other details on this
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Randomisation was done into 2 groups (acupressure and vitamin B6 groups) by an independent remote researcher who had no prior knowledge of the patients by using a block of 4 technique
Allocation concealment? Yes Sequential sealed envelopes picked by independent, remote researcher
Blinding?
Change in grade of nausea or vomiting at second visit compared to first
Yes “A single blind randomised study.”
A possible concern is whether since the study was conducted in Thailand, participants might have known where the P6 point was and therefore, would have known when they were using ‘placebo’ acupressure on the point that was not P6
Incomplete outcome data addressed?
Change in grade of nausea or vomiting at second visit compared to first
Yes 6 patients did not complete the study (3 in each group). The attrition of the 6 people was explained as follows: “one patient from the withdrawal [sic] group was lost to follow-up”, 1 had irritation from the acupressure band, 2 patients lost their acupressure devices, 2 patients had incomplete forms
ITT analysis was performed, counting all withdrawals as treatment failures
Free of selective reporting? Unclear All outcomes reported but change in Rhodes score only presented graphically; results for weight change and rescue drug use presented fully
Free of other bias? Unclear The initial Rhodes Index score in the B6 group was higher than acupressure group; stated to be not significant, sample size 33 per group
The authors acknowledge that it is possible that the rescue drug provided a large reduction of the symptoms but that it was not possible to exclude it for ethical reasons. They state that the use of the rescue drug did not differ by group (although they also report 0.6+/−1.6 tablets vs 2.8 +/−4.7 tablets P > 0.05 in acupressure and vitamin B6 groups respectively)
They also state that the improvement of nausea and vomiting in the present study may be spontaneous due to a placebo effect, the additional medications used, or either of the treatments