Methods | RCT. | |
Participants | 593 women less than 14 weeks’ gestation with symptoms of nausea or vomiting | |
Interventions | Traditional acupuncture group (traditional diagnosis and then acupuncture to selected points) P6 acupuncture group (Pericardium point on wrist only). Sham acupuncture group (to points near true points). No acupuncture (control) group (general advice and phoned and asked about their wellbeing). The authors state that to reduce disappointment when women were allocated to the control group, a standardised information sheet was made available about advice on diet, lifestyle and the use of vitamin B6 during the 4-week study period. Not stated if all women got this advice (including about vitamin B6) Treatment was administered weekly for 4 weeks from all 3 acupuncture groups. Very detailed descriptions given |
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Outcomes | Primary outcomes: nausea, vomiting, dry retching at days 7, 14, 21 and 26 (measured by the Rhodes Index of Nausea and Vomiting Form 2) and health status on days 1, 14 and 28 (measured by MOS 36 Short Form Health Survey (SF36)) Pregnancy outcomes: perinatal outcome, congenital abnormalities, pregnancy complications and infant outcomes |
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Notes | Related 2 articles report pregnancy outcomes and placebo response and effect of time and related abstract reports women’s experiences of nausea (data collected prior to randomisation from 253 women) | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | Randomisation sequence in variable balanced blocks. |
Allocation concealment? | Yes | Centralised, external telephone randomisation service. |
Blinding? Change in grade of nausea or vomiting at second visit compared to first |
Yes | Women in acupuncture and sham acupuncture groups were blinded - asked to guess which group they were in (84% guessed correctly that they were in Traditional Acupuncture group, 77% P6 Acupuncture and 41% Sham Acupuncture) (reported unclearly in Table 4 in Smith & Crowther 2002). They were asked why they guessed what they did and this was also related by the study investigators to their beliefs about acupuncture. Authors acknowledge that the trial was advertised in the media, which sensationalised the trial, for example, under the heading “morning sickness cure” |
Incomplete outcome data addressed? Change in grade of nausea or vomiting at second visit compared to first |
Yes | 24% attrition by week 4; number of forms (nausea and vomiting and SF36) not completed and number of pregnancy losses per group stated described in detail |
Free of selective reporting? | Unclear | Many results reported (mean differences not reported). |
Free of other bias? | Unclear | Vitamin B6 advice given to control group not clear whether to others also |