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) |
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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 |