Introduction
Functional gastrointestinal disorders (FGIDs) are more prevalent in female than in male patients [1,2]. This triggers the question whether this is also reflected in medical care, especially also in self-medication, where often botanicals are used. A potential source of data to address this question is the PhytoVIS study, a pharmacoepidemiological study conducted in Germany in more than 20,000 patients taking herbal medicinal products.
Aims & Methods
To have a large and homogenous data base for a gender-related evaluation, records for a clinically proven herbal medicinal product (HMP) often used in FGIDs, STW 5 [3,4], were evaluated to uncover potential gender-related differences in the pharmacotherapy of FGIDs.
Results
1513 records were evaluated, 71 % of them from females and 29 % from males, i.e. a 4 % higher proportion of females compared to the overall population of the PhytoVIS study. Main criterium for the evaluation was the Clinical Global Impression Scale – Efficacy (CGI-E). No major differences between females and males were found, apart that women perceived a minimally better effect of the therapy. The reported symptoms were differentiated into symptoms associated with functional dyspepsia (FD), irritable bowel syndrome (IBS), or symptoms that can be associated with both. As far as the records allow a differentiation, no gender differences could be observed. This applies also to the perceived efficacy, the tolerability and the onset of action.
Conclusion
So, while there are differences in the prevalence of FGIDs in women and men, there are no therapeutically relevant pharmacoepidemiological differences in patients with functional gastrointestinal diseases treated with a medicinal product indicated in these diseases, so suggesting that there is no gender gap in this highly relevant therapeutic field.
References
1. Kim YS, Kim N. Sex-Gender Differences in Irritable Bowel Syndrome. J Neurogastroenterol Motil. 2018;24:544-558
2. Houghton LA, Heitkemper M, Crowell M, Emmanuel A, Halpert A, McRoberts JA, Toner B. Age, Gender and Women's Health and the Patient. Gastroenterology. 2016; S0016-5085(16)00183-9;
3. Malfertheiner P. STW 5 (Iberogast) Therapy in Gastrointestinal Functional Disorders. Dig Dis. 2017;35 Suppl 1:25-29
4. Madisch A, Vinson BR, Abdel-Aziz H, Kelber O, Nieber K, Kraft K, Storr M. Modulation of gastrointestinal motility beyond metoclopramide and domperidone : Pharmacological and clinical evidence for phytotherapy in functional gastrointestinal disorders. Wien Med Wochenschr. 2017;167:160-168
Disclosure
JW and EC were interns, OK, is employee of Steigerwald Arzneimittelwerk GmbH, Darmstadt, Germany, KN und KK have received fees from the same company.