Abstract
Background
Motion sickness can be triggered in a variety of situations and is characterized primarily by nausea and vomiting. Ginger is widely used in treating conditions including chemotherapy-associated gastrointestinal symptoms, morning sickness, postoperative nausea, and motion sickness.
Objectives
The primary study objective was to evaluate
Zingiber officinale
extract in the treatment of motion sickness. Secondary objectives were to evaluate treatment effect on Motion Sickness Assessment Questionnaire (MSAQ) score and subscores before and after treatment, and to evaluate treatment tolerability.
Methods
Open-label, single-arm study assessing motion sickness outcomes with and without pre-travel oral treatment with
Zingiber officinale
160mg extract (containing 8mg of gingerols). All subjects answered the MSAQ on four separate occasions following a trip of at least 15 minutes in duration: Trip 1 (pre-treatment); Trips 2, 3, and 4 (after oral treatment with study medication). The primary endpoint was percentage of patients presenting improvement ≥20 score points % on the MSAQ during Trip 2, Trip 3 and Trip 4 in comparison to pretreatment score (Trip 1). Secondary endpoints included: (1) percentage of patients presenting improvement in MSAQ subscores during Trips 2, 3, and 4; (2) percentage of patients presenting treatment-related adverse events; (3) pre-and post-treatment Physician Assessment scores.
Results
184 subjects were included and 174 completed treatment. A reduction of ≥20 points in total MSAQ score points % occurred in 26.52%, 29.89% and 29.31% of patients from Trips 2, 3, and 4, respectively. There was no significant difference at Trips 2, 3, and 4 in number of patients presenting improvement ≥20 score points % (p=0.9579). There was a significant reduction in total MSAQ scores from Trips 2, 3 and 4 (p<0.0001) compared to Trip 1. Total MSAQ scores did not vary at each trip taken under treatment (p=0.28). There were significant (p<0.001) improvements in all domain subscores from Trips 2, 3, and 4 in relation to scores from Trip 1. There was a significant improvement in Physician Assessment scores at Visit 2 (p<0.0001). Adverse events were reported among 31 subjects, mainly affecting the gastrointestinal system. Twenty-four patients (13.04%) reported 39 AEs considered related to treatment. No significant change in physical exam was noted at Visit 2 in relation to Visit 1.
Conclusions
These open label, historically controlled study results suggest the need for randomized, blinded, placebo and active substance controlled clinical trials.
