Abstract | OBJECTIVES: We report information about an unpublished 1970s study ("8-way" Bendectin Study) that aimed to evaluate the relative therapeutic efficacy of doxylamine, pyridoxine, and dicyclomine in the management of nausea and vomiting during pregnancy. We are publishing the trial's findings according to the restoring invisible and abandoned trials (RIAT) initiative because the trial was never published. DESIGN: Double blinded, multi-centred, randomized placebo-controlled study. SETTING: 14 clinics in the United States. PARTICIPANTS: 2308 patients in the first 12 weeks of pregnancy with complaints of nausea or vomiting were enrolled. INTERVENTIONS: OUTCOMES: Reported outcomes included the number of hours of nausea reported by patients, the frequency of vomiting reported by patients and the overall efficacy of medication as judged by physicians. RESULTS: Data from 1599 (69% of those randomized) participants were analyzed. Based on the available summary data of physician evaluation of symptoms and ignoring missing data and data integrity issues, the proportion of participants who were "evaluated moderate or excellent" was greater in each of the seven active treatment groups when compared with placebo (57%): doxylamine/ pyridoxine/dicylcomine (14% absolute difference versus placebo; 95% CI: 4 to 24), doxylamine/ pyridoxine (21; 95% CI 11 to 30), dicylomine/ pyridoxine (21; 95% CI 11 to 30), doxylamine (20; 95% CI 10 to 29), dicyclomine/ pyridoxine (4; 95% CI -6 to 14), pyridoxine (9; 95% CI -1 to 19) and dicyclomine (4; 95% CI -6 to 14). Based on incomplete information, the most common adverse events were apparently drowsiness and fatigue. There is a high risk of bias in these previously unpublished results given the high attrition rate in a 7 day trial, the lack of prespecified outcomes or analyses, and the exclusion of some data because of questionable data integrity. CONCLUSION: TRIAL REGISTRATION: Not registered.
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Authors | Rujun Zhang, Navindra Persaud |
Journal | PloS one
(PLoS One)
Vol. 12
Issue 1
Pg. e0167609
( 2017)
ISSN: 1932-6203 [Electronic] United States |
PMID | 28052111
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Drug Combinations
- Placebos
- dicyclomine, doxylamine, pyridoxine drug combination
- Dicyclomine
- Doxylamine
- Pyridoxine
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Topics |
- Cooperative Behavior
- Dicyclomine
(adverse effects, therapeutic use)
- Doxylamine
(adverse effects, therapeutic use)
- Drug Combinations
- Female
- Humans
- Nausea
(complications, drug therapy)
- Physicians
- Placebos
- Pregnancy
- Pregnancy Complications
(drug therapy)
- Publication Bias
- Publications
- Pyridoxine
(adverse effects, therapeutic use)
- Research Report
- Risk
- Vomiting
(complications, drug therapy)
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