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 |
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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) |