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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 RCT.
Participants 98 pregnant women with symptoms of nausea and vomiting, of not more than 14 weeks’ gestation were recruited; exclusion criteria: women with molar pregnancy, multifetal pregnancy, blighted ovum, hyperemesis gravidarum, or current use of anti-emetic medication
Interventions Treatment group: auricular acupuncture, using round magnetic balls as ear pellets. These were placed with adhesive tape at the auricles of both ears (on auricular point at inner surface of auricle at the concha ridge zone, according to the meridians of Traditional Chinese Medicine). Women in this group were instructed to start pressing the magnets for 30 seconds 4 times a day (before meals and at bedtime), starting on the third day until the 6th day. First 2 days used as control days
Control group: no treatment, except oral anti-emetic drugs (as below)
Both groups were allowed to take 1 tablet of 50mg dimenhydrinate every 6 hours as required if they could not tolerate their symptoms; remaining tablets were counted at end of 1 week of the study
Outcomes Frequency, duration and distress of nausea and vomiting and retching symptoms was measured using the Rhodes Index (range 0-32, 8 5-point self-report items); completed every morning for 6 days. Scores from day 4-6 used to measure treatment effect
Notes
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Yes Patients were randomised using a random table of numbers.
Allocation concealment? Unclear No details stated.
Blinding?
Change in grade of nausea or vomiting at second visit compared to first
No No blinding. Did not use placebo on ear due to stated limited area on the ear and possibility of affecting the treatment point; self-reporting of outcomes
Incomplete outcome data addressed?
Change in grade of nausea or vomiting at second visit compared to first
Yes 91 patients completed the study. 7 patients lost to follow up, 4 in the treatment group, 3 in the control group. No explanation given
Free of selective reporting? Yes All outcomes reported. Stated in results section that no one in treatment group experienced any adverse effect from acupressure and satisfaction with treatment is also reported as (% of treatment group satisfied). Adverse effects and satisfaction not stated as outcomes to be measured
Free of other bias? Unclear Differences between groups on education, income and occupation within baseline characteristics reported (women in control group were more educated, higher income and a higher percentage were housewives, in the occupational category)