The use of herbal medicines by people with cancer: a qualitative study.

BACKGROUND: Between 7% and 48% of cancer patients report taking herbal medicines after diagnosis. Because of the possibility of unwanted side effects or interactions with conventional treatments, people with cancer are generally advised to tell the professionals treating them if they are taking any form of medication, including herbal medicines and supplements. Studies suggest that only about half do so and that the professionals themselves have at best very limited knowledge and feel unable to give informed advice. This study is intended to inform the future development of information resources for cancer patients, survivors and healthcare professionals including tools for use before or during consultation to make it easier for patients to mention, and for healthcare professionals to ask about, use of herbal medications. METHODS/DESIGN: This is a three-phase study. In phase 1, a systematic review of the literature on self-medication with herbal medicines among UK populations living with cancer will establish the current evidence base on use of herbal medicine, sources of information, characteristics and motivations. This will allow us to better understand what aspects need further investigation and inform the topic guide for a qualitative study (phase 2). Six focus groups of six to eight cancer patients who have used at least one herbal preparation since diagnosis will explore behaviour, beliefs, knowledge, information sources and needs in an informal conversational setting.Informed by the findings of the systematic review and qualitative study, in phase 3 we will construct and pilot a questionnaire for a future large-scale survey to quantify and prioritise people's beliefs, needs and information preferences. DISCUSSION: Despite known interactions with conventional cancer treatments and contraindications for some herbal remedies with specific cancers, reliable information resources for patients are very limited. Identifying cancer patients' information needs and preferences is the first step in creating a suitable resource for both the public and the professionals advising them.

The European Herbal Medicines Directive: could it have saved the lives of Romeo and Juliet?

Herbal medicines have a long tradition of therapeutic use. However, they may occasionally cause dose-related (type A) or idiosyncratic (type B) toxicity and herb-drug interactions are also possible. Toxicity can arise as a result of misidentification or adulteration of the preparation. Legislation (the Directive on traditional herbal medicinal products 2004/24/EC) was enacted on 30 April 2004 to improve public health protection and promote the free movement of traditional medicinal products in the EU. It requires each Member State to set up a simplified registration scheme for manufactured traditional herbal medicines that are suitable for use without medical supervision. Evidence of 30 years of traditional use, at least 15 years of which should normally be within the EU, is required to permit minor claims, replacing the requirement to demonstrate efficacy. Safety is based on evidence in the published literature, although the regulator can also ask for more data if there are safety concerns. The pharmacovigilance requirements and quality standards are the same as for licensed medicines. Patient information is similar to that for any over-the-counter medicine, with an additional requirement for a statement on labels and in advertisements that the indication is based on traditional use. A European positive list of herbal substances will set out the indication, strength, dosing recommendations, route of administration and other information on safe use. Where a product complies with the list, the applicant will not need to demonstrate either the traditional use or the safety of the product. The list will be compiled by the recently established Committee on Herbal Medicinal Products at the European Medicines Agency. EU Member States were required to comply with the Directive by 30 October 2005. Traditional herbal medicinal products already on the market when the Directive became law need not comply with its provisions for 7 years after its coming into force. The public need to be aware that 'natural' does not necessarily mean 'safe' in all circumstances. They should be fully informed about all medicines they take. Consideration also needs to be given to effective regulation of herbal medicines practitioners, so that they are identifiable in law, are governed by professional codes of practice and have agreed standards of training and competency. There are many references to herbal medicines in Shakespeare's tragedy, Romeo and Juliet, which was written around 1595. A herbal medicine (distilled liquor) was almost certainly used to put Juliet into a deep sleep. A poison, possibly of herbal origin, was used by Romeo to take his own life when he thought his beloved Juliet was dead, rather than sleeping. While European herbal medicines regulation seeks to protect the public health by ensuring the necessary guarantees of quality, safety and efficacy, it was poor communication that appears to have triggered the chain of events leading to the death of Romeo and Juliet. Good communication between regulators, practitioners, patients and the public is necessary so that those who choose to take herbal medicines can do so with acceptable safety.