patients with emesis gravidarum who take a chewing gum with vitamin C (verum) "ad libitum" several times daily for 2 weeks

patients with emesis gravidarum who take chewing gum without vitamin C (placebo) "ad libitum" several times daily for 2 weeks

patients with emesis gravidarum who do not use chewing gum during the study phase

Hyperemesis Gravidarum

Nausea Gravidarum

Vitamin C Deficiency

Using a chewing gum with 150mg vitamin C (per piece/gum) for 14 days "ad libitum"

Pregnan-C-Gum(R) chewing gum

Using a chewing gum without vitamin C (per piece/gum) for 14 days "ad libitum"

Placebo chewing gum

Medical University of Vienna, Dept. of Obstetrics and Gynecology

Chewing Gum Containing Vitamin-c to Treat Emesis Gravidarum

Chewing Gum Containing Vitamin-c to Treat Emesis Gravidarum: a Randomized Controlled Trial

validated questionnaire describing individual nausea

Alex Farr, MD PhD

Assistant Professor, Consultant Physician

Medical University of Vienna

Crossover design Placebo first followed by carbidopa

Crossover design carbidopa first followed by placebo

All Study Subjects

Sex: Female, Male

Daily scores were reported on a modified version of the Rhodes Index of Nausea, Vomiting and Retching, which included all 5 items relating to nausea and retching. Items addressing vomiting/throwing up were omitted, as all participants had antireflux surgery that prevented vomiting (Nissen fundoplication). Retching distress, nausea distress, number of nausea episodes per day, number of retching episodes per day, and the amount of time spent feeling nauseous were graded on a 5-point scale. Scores range from 0 (no nausea/distress) to 20 (most nausea/distress).

Carbidopa

Placebo

Composite Daily Score

Number of Episodes of Daily Nausea

Assay of 24 hour dopamine level excretion in urine

24 Hour Dopamine Levels

Subjects will be given placebo first (4 weeks), followed by carbidopa (4 weeks).

Placebo (First), Carbidopa (Second)

Subjects will be given Carbidopa for a 4 week period followed by placebo for a 4 week period.

Carbidopa (First), Placebo (Second)

Carbidopa Titration Period (4 Weeks)

First Intervention (4 Weeks)

Second Intervention (4 Weeks)

Horacio Kaufmann, MD; director of Dysautonomia Center

carbidopa
Carbidopa : The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design.

Placebo
Placebo : The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design.

Familial Dysautonomia

The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design.

decarboxylase/vomiting

Chewing Gum Containing Vitamin-c to Treat Emesis Gravidarum

Carbidopa for the Treatment of Nausea and Vomiting in Familial Dysautonomia

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