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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 double-blind placebo-controlled study.
Participants 78 patients complaining of nausea or vomiting in pregnancy, gestation was over 20 weeks for some participants:
13-24 weeks’ gestation: 8 in treatment group, 4 in placebo.
25-36 weeks: 6 in placebo group.
Not specified: 1 in placebo group.
Interventions Treatment group: fluphenazine 1 mg (repeat action tablet) plus 50 mg pyridoxine
Placebo: identically appearing placebo tablets.
Outcomes Intensity of nausea and vomiting graded by women at outset and at the conclusion of 1 week of therapy. 6-point scale (0-6) ranged from no nausea or vomiting (0) to vomiting more than 3 times/day (6). Initial symptoms: 1-2 classified as mild, 3-4 as moderate and 5-6 as severe. Effectiveness was measured by deducting the post-treatment score from the initial score - therapeutic response for each category of initial symptoms is expressed as excellent, good or poor by proper assignment of numerical values (based on their initial score)
Notes
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear Investigator bias is eliminated by the provision of a numbered series of bottles in which drug and identically appearing placebo tablets are randomly distributed; no details of how randomised
Allocation concealment? Unclear Not described - patients were given 1 of successively numbered bottles in the series
Blinding?
Change in grade of nausea or vomiting at second visit compared to first
Yes Blinding implied - identities of the coded tablets revealed after outcome data collected
Incomplete outcome data addressed?
Change in grade of nausea or vomiting at second visit compared to first
Yes All participants included in reported results.
Free of selective reporting? Yes Outcomes reported according to classification.
Free of other bias? Yes Later gestation of some participants in placebo group.