gms | German Medical Science

Aim: The use of metoclopramide (MCP) has recently been restricteddue to the risk of extrapyramidal side effects,that of domperidone due to cardiovascular side effects, based on provisions of the European Regulatory Agency EMA and national regulatory authorities. Thus, both are no longer available for the treatment of chronic conditions such as dyspepsia and gastro-oesophageal reflux diseases. This necessitates revisiting of the clinical data for alternative treatments with equivalent clinical efficacy and a more benign safety profile, which were less visible in the past.

Method: As herbal medicinal products (HMPs) are widely used for functional gastrointestinal diseases including functional dyspepsia (FD) and irritable bowel syndrome (IBS) and with a favorable safety profile, a systematic review was conducted, in compliance with the PRISMA statement, to identify HMPs with a therapeutic efficacy comparable to MCP, using a data base search complemented by cross referencing and hand searching for assuring completeness.

Results: 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 were therefore 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 despite its small size 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 analysis 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 literature search assessing the safety of STW 5 identified studies in more than 50.000 patients with FD and IBS [3], with a high degree of safety also in children [4], [5] and without any severe side effects and without an interaction potential with other medicines.A randomized placebo controlöled clinical-pharmacological study revealed a relaxation of corpus and fundus and a stimulation of the antrum of the stomach as mechanisms of action [6].

Conclusion: For the treatment of functional gastrointestinal diseases such as FD, STW 5 was identified as a treatment with clinical efficacy equivalent to MCP but a superior safety profile. This allows an excellent long term treatment for patients with FD in the post MCP age.