Treatment options for functional gastrointestinal diseases: Herbal medicine is equivalent to MCP and has a superior safety profile

After the introduction of prokinetic medicines like metoclopramide (MCP) and cisapride, herbal medicinal products (HMPs) were sometimes seen as outdated. After cisapride and now MCP have been withdrawn resp. restricted due to the risk of serious side effects, according to the European Regulatory Agency EMA and national regulatory authorities, HMPs find increased attention again. A review of respective clinical equivalence studies was therefore conducted in compliance with the PRISMA statement, covering their use for functional gastrointestinal diseases like functional dyspepsia (FD) and irritable bowel syndrome (IBS). Six comparison studies using HMPs and MCP were identified, four of them with ginger in the treatment of emesis and therefore out of scope, while two were conducted in FD and included into the evaluation. In these studies, STW 5, an herbal combination medicine was used. One study is an RCT in 94 patients [1], showing a clear equivalence of both treatments, with a trend towards a faster onset of action and a lower number of UEs in the STW 5 group. The second, a retrospective epidemiologic study, was conducted in 960 patients treated with MCP or STW 5 [2] and confirmed these data in routine clinical practice, with a significantly higher proportion of symptom-free patients and a lower number of days off work in the STW 5 group. A safety assessment identified also a placebo controlled RCT in comparison to cisapride and studies in more than 50.000 patients with FD and IBS [3], with a high degree of safety also in children [4] and without any severe side effects or any interaction potential. For the treatment of functional gastrointestinal diseases such as FD, STW 5 was identified as a treatment with clinical efficacy equivalent to prokinetics like MCP but a superior safety profile. This allows also a long term treatment for patients with functional gastroenterological diseases without a need for prokinetics, which can not longer be used.

Keywords: Functional dyspepsia, irritable bowel syndrome, Iberis amara, Iberogast, STW 5, prokinetics, FD, IBS

References:

[1] Nicolay K et al., 1984, Gastro-Entero-Hepatologie 4: 24 – 28.

[2] Raedsch R et al., 2007, Z Gastroenterol 45: 1041 – 1048.

[3] Ottillinger et al., 2013, Wien Med Wochenschr 163: 65 – 72.

[4] Radke M., 2011, Gastroenterologe 6: 486 – 495.