Assessing iIndications for herbal medicinal products: a comparative analysis of EMA monographs and database records.

Abstract

Background: Adverse effects are common during cancer treatment and herbal medicinal products (HMPs) are one way to manage symptoms caused by conventional therapy.

Objectives: This assessment focused on comparing HMP indications listed in European Medicines Agency (EMA) monographs with findings in Medline and the Cochrane Library. The objective of this study was to investigate whether there is evidence that HMP indications may be transferred from non-cancer patients to cancer patients for the treatment of therapy-induced symptoms.

Methods: This study design included a comprehensive review of the relevant literature.

Results: The systematic literature search identified 96 clinical trials from a total of 726 records that met all the inclusion criteria. An analysis was performed on two groups: the EMA indication group vs. the non-EMA-indication group. The EMA indication group comprises trials whose endpoints align with the indications outlined in EMA monographs, representing a slight majority of 58.3% of all eligible clinical trials. In contrast, 41.7% of all studies were found to have non-EMA-indications, i.e. indications for cancer patients not listed in EMA monographs. Approximately 71.1% of all phytopharmaceuticals are approved as traditional use HMPs (THMPs).

Conclusion: The efforts of the EMA represent a fundamental step toward securing the quality of HMPs in the European Union (EU). However, a more systematic approach to conducting studies in such a tradition-bound field is required to generate evidence on HMPs. Given the absence of sufficient data, it is not possible to make a definitive statement on the transferability of HMP scopes listed in EMA monographs to the management of treatment-related symptoms in cancer patients.