Abstract
In this explorative longitudinal survey, self-reported data was collected from
persons suffering from chronic gastrointestinal symptoms, who were seeking
relief employing self-medication with a grapefruit seed extract (GKE). This is
not a clinical trial nor a non-interventional study, but an explorative
longitudinal survey with self-reports. The data was collected online and there
were no personal contacts with a physician or a study nurse. Participants
followed their own decision to use GKE and to provide their data to a data
retrieval system, following informed consent according to existing national
regulations on data protection. The test product was provided by the sponsor to
make sure that the correct product was used for the intended observation
period.
Drop in criteria were chronic gastrointestinal symptoms, including those of
functional dyspepsia (FD, resp. non-ulcer dyspepsia NUD) and/or irritable bowel
syndrome (IBS) for more than 4 weeks, resulting in a score of an expanded Nepean
Index (‘total gastrointestinal score’) higher than 20. Symptoms were documented
4–12 days (VA) prior to GKE use on day 1 and then on day 1, days 28, 42 and 56
of continuous oral use. New symptoms, predominating symptoms, stool habits,
amount of oral intake and global status was retrieved every day during the
observation period. On day 56 some global assessments were additionally
recorded.
The evaluation cohort was intended to be at least 100, and within the survey
cohort we were able to evaluate 100 subjects (15 m and 85 f). Total
gastrointestinal symptom score decreased from a mean (±SD) of 78.7±36.9 points
by 26.4% on day 14, by 53.1% on day 28, by 58.7% on day 42, and by 49.9% on day
56, when compared to day 1. Upper gastrointestinal symptoms like heartburn
improved better compared to lower GI symptoms (by 57.9% versus 47.3% on day 56).
Overall complaints were rated as “very strongly improved” by 30%, “strongly
improved” by 42%, “somewhat improved” or “unchanged” by 20% and as
“deteriorated” by 1%. GKE was tolerated well. Minor adverse events reported were
judged as most probably unrelated by the authors. More than half of the
participants rated the intake as “very pleasant” or “pleasant” and intended to
continue GKE beyond the observation period.
In this prospective uncontrolled survey, GKE seemed to improve GI-symptoms, based
on users reports. These results need to be confirmed in controlled clinical
trials proofing efficacy and tolerance of GKE in functional GI-diseases. Data
collected from participants without any personal contact bear a high risk of
bias. Evaluation of self-treatment as presented here is clearly restricted to
marketed products and may report interesting details of self-treatment outside
prescription settings.
Keywords
Gastrointestinal symptoms - dyspepsia - IBS - grapefruit - online-survey - herbal
