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. |
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Interventions | Treatment group: fluphenazine 1 mg (repeat action tablet) plus 50 mg pyridoxine Placebo: identically appearing placebo tablets. |
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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. |