Good practice in reviewing and publishing studies on herbal medicine, with special emphasis on traditional Chinese medicine and Chinese materia medica

Ethnopharmacological relevance: Studies on traditional Chinese medicine (TCM), like those of other systems of traditional medicine (TM), are very variable in their quality, content and focus, resulting in issues around their acceptability to the global scientific community. In an attempt to address these issues, an European Union funded FP7 consortium, composed of both Chinese and European scientists and named “Good practice in traditional Chinese medicine” (GP-TCM), has devised a series of guidelines and technical notes to facilitate good practice in collecting, assessing and publishing TCM literature as well as highlighting the scope of information that should be in future publications on TMs. This paper summarises these guidelines, together with what has been learned through GP-TCM collaborations, focusing on some common problems and proposing solutions. The recommendations also provide a template for the evaluation of other types of traditional medicine such as Ayurveda, Kampo and Unani. Materials and methods: GP-TCM provided a means by which experts in different areas relating to TCM were able to collaborate in forming a literature review good practice panel which operated through e-mail exchanges, teleconferences and focused discussions at annual meetings. The panel involved coordinators and representatives of each GP-TCM work package (WP) with the latter managing the testing and refining of such guidelines within the context of their respective WPs and providing feedback. Results: A Good Practice Handbook for Scientific Publications on TCM was drafted during the three years of the consortium, showing the value of such networks. A “deliverable – central questions – labour division” model had been established to guide the literature evaluation studies of each WP. The model investigated various scoring systems and their ability to provide consistent and reliable semi-quantitative assessments of the literature, notably in respect of the botanical ingredients involved and the scientific quality of the work described. This resulted in the compilation of (i) a robust scoring system and (ii) a set of minimum standards for publishing in the herbal medicines field, based on an analysis of the main problems identified in published TCM literature.

Traditional Chinese medicine research in the post-genomic era: good practice, priorities, challenges and opportunities

Background and aims: GP-TCM is the 1st EU-funded Coordination Action consortium dedicated to traditional Chinese medicine (TCM) research. This paper aims to summarise the objectives, structure and activities of the consortium and introduces the position of the consortium regarding good practice, priorities, challenges and opportunities in TCM research. Serving as the introductory paper for the GPTCM Journal of Ethnopharmacology special issue, this paper describes the roadmap of this special issue and reports how the main outputs of the ten GP-TCM work packages are integrated, and have led to consortium-wide conclusions. Materials and methods: Literature studies, opinion polls and discussions among consortium members and stakeholders. Results: By January 2012, through 3 years of team building, the GP-TCM consortium had grown into a large collaborative network involving ∼200 scientists from 24 countries and 107 institutions. Consortium members had worked closely to address good practice issues related to various aspects of Chinese herbal medicine (CHM) and acupuncture research, the focus of this Journal of Ethnopharmacology special issue, leading to state-of-the-art reports, guidelines and consensus on the application of omics technologies in TCM research. In addition, through an online survey open to GP-TCM members and non-members, we polled opinions on grand priorities, challenges and opportunities in TCM research. Based on the poll, although consortium members and non-members had diverse opinions on the major challenges in the field, both groups agreed that high-quality efficacy/effectiveness and mechanistic studies are grand priorities and that the TCM legacy in general and its management of chronic diseases in particular represent grand opportunities. Consortium members cast their votes of confidence in omics and systems biology approaches to TCM research and believed that quality and pharmacovigilance of TCM products are not only grand priorities, but also grand challenges. Non-members, however, gave priority to integrative medicine, concerned on the impact of regulation of TCM practitioners and emphasised intersectoral collaborations in funding TCM research, especially clinical trials. Conclusions: The GP-TCM consortium made great efforts to address some fundamental issues in TCM research, including developing guidelines, as well as identifying priorities, challenges and opportunities. These consortium guidelines and consensus will need dissemination, validation and further development through continued interregional, interdisciplinary and intersectoral collaborations. To promote this, a new consortium, known as the GP-TCM Research Association, is being established to succeed the 3-year fixed term FP7 GP-TCM consortium and will be officially launched at the Final GP-TCM Congress in Leiden, the Netherlands, in April 2012.

The classification and application of toxic Chinese Materia Medica

Many important drugs in the Chinese materia medica (CMM) are known to be toxic, and it has long been recognized in classical Chinese medical theory that toxicity can arise directly from the components of a single CMM or may be induced by an interaction between combined CMM. Traditional Chinese Medicine presents a unique set of pharmaceutical theories that include particular methods for processing, combining and decocting, and these techniques contribute to reducing toxicity as well as enhancing efficacy. The current classification of toxic CMM drugs, traditional methods for processing toxic CMM and the prohibited use of certain combinations, is based on traditional experience and ancient texts and monographs, but accumulating evidence increasingly supports their use to eliminate or reduce toxicity. Modern methods are now being used to evaluate the safety of CMM; however, a new system for describing the toxicity of Chinese herbal medicines may need to be established to take into account those herbs whose toxicity is delayed or otherwise hidden, and which have not been incorporated into the traditional classification. This review explains the existing classification and justifies it where appropriate, using experimental results often originally published in Chinese and previously not available outside China.

Transforming tradition: performances of Jingju ('Beijing Opera') in the UK

Jingju (‘Beijing opera’) is China's most iconic traditional theatre, marketed as a global signifier of Chinese theatre and national identity. Although troupes from mainland China regularly tour Europe, audiences in the UK have also had access to Jingju via two indigenous organizations: the UK Beijing Opera Society (now defunct) and the London Jing Kun Opera Association (now in its ninth year). These organizations consist of Chinese, overseas Chinese and Western performers performing both Jingju and Kunju (‘Kun opera’). Where there is a mix of ethnicity, can ‘traditional Chinese theatre’ still be conceived of as ‘traditional’? How is Jingju mapped onto non-Chinese bodies? Can Jingju performances by ethnically white performers reflect diasporic identities? Drawing on the theories of Judith Butler and Homi Bhabha, this article argues that by highlighting the performativity of identity, the performance of Jingju by non-Chinese performers challenges the notion of Jingju as a global signifier of ‘authentic traditional Chinese theatre’.

What is the new medicines use review ‘patient survey’ attempting to capture in the context of existing patient satisfaction with pharmacy questionnaires and a new conceptual framework?

The community pharmacy service medicines use review (MUR) was introduced in 2005 ‘to improve patient knowledge, concordance and use of medicines’ through a private patient–pharmacist consultation. The MUR presents a fundamental change in community pharmacy service provision. While traditionally pharmacists are dispensers of medicines and providers of medicines advice, and patients as recipients, the MUR considers pharmacists providing consultation-type activities and patients as active participants. The MUR facilitates a two-way discussion about medicines use. Traditional patient–pharmacist behaviours transform into a new set of behaviours involving the booking of appointments, consultation processes and form completion, and the physical environment of the patient–pharmacist interaction moves from the traditional setting of the dispensary and medicines counter to a private consultation room. Thus, the new service challenges traditional identities and behaviours of the patient and the pharmacist as well as the environment in which the interaction takes place. In 2008, the UK government concluded there is at present too much emphasis on the quantity of MURs rather than on their quality.[1] A number of plans to remedy the perceived imbalance included a suggestion to reward ‘health outcomes’ achieved, with calls for a more focussed and scientific approach to the evaluation of pharmacy services using outcomes research. Specifically, the UK government set out the main principal research areas for the evaluation of pharmacy services to include ‘patient and public perceptions and satisfaction’as well as ‘impact on care and outcomes’. A limited number of ‘patient satisfaction with pharmacy services’ type questionnaires are available, of varying quality, measuring dimensions relating to pharmacists’ technical competence, behavioural impressions and general satisfaction. For example, an often cited paper by Larson[2] uses two factors to measure satisfaction, namely ‘friendly explanation’ and ‘managing therapy’; the factors are highly interrelated and the questions somewhat awkwardly phrased, but more importantly, we believe the questionnaire excludes some specific domains unique to the MUR. By conducting patient interviews with recent MUR recipients, we have been working to identify relevant concepts and develop a conceptual framework to inform item development for a Patient Reported Outcome Measure questionnaire bespoke to the MUR. We note with interest the recent launch of a multidisciplinary audit template by the Royal Pharmaceutical Society of Great Britain (RPSGB) in an attempt to review the effectiveness of MURs and improve their quality.[3] This template includes an MUR ‘patient survey’. We will discuss this ‘patient survey’ in light of our work and existing patient satisfaction with pharmacy questionnaires, outlining a new conceptual framework as a basis for measuring patient satisfaction with the MUR. Ethical approval for the study was obtained from the NHS Surrey Research Ethics Committee on 2 June 2008. References 1. Department of Health (2008). Pharmacy in England: Building on Strengths – Delivering the Future. London: HMSO. www. official-documents.gov.uk/document/cm73/7341/7341.pdf (accessed 29 September 2009). 2. Larson LN et al. Patient satisfaction with pharmaceutical care: update of a validated instrument. JAmPharmAssoc 2002; 42: 44–50. 3. Royal Pharmaceutical Society of Great Britain (2009). Pharmacy Medicines Use Review – Patient Audit. London: RPSGB. http:// qi4pd.org.uk/index.php/Medicines-Use-Review-Patient-Audit. html (accessed 29 September 2009).

How is the language of medicines use review leaflets symbolising the service?

Introduction The medicines use review (MUR), a new community pharmacy ‘service’, was launched in England and Wales to improve patients’ knowledge and use of medicines through a private, patient–pharmacist appointment. After 18 months, only 30% of pharmacies are providing MURs; at an average of 120 per annum (maximum 400 allowed).1 One reason linked to low delivery is patient recruitment.2 Our aim was to examine how the MUR is symbolised and given meaning via printed patient information, and potential implications. Method The language of 10 MUR patient leaflets, including the NHS booklet,3 and leaflets from multiples and wholesalers was evaluated by discourse analysis. Results and Discussion Before experiencing MURs, patients conceivably ‘categorise’ relationships with pharmacists based on traditional interactions.4 Yet none of the leaflets explicitly describe the MUR as ‘new’ and presuppose patients would become involved in activities outside of their pre-existing relationship with pharmacists such as appointments, self-completion of charts, and pharmacy action plans. The MUR process is described inconsistently, with interchangeable use of formal (‘review meeting‘) and informal (‘friendly’) terminology, the latter presumably to portray an intended ‘negotiation model’ of interaction.5 Assumptions exist about attitudes (‘not understanding’; ‘problems’) that might lead patients to an appointment. However, research has identified a multitude of reasons why patients choose (or not) to consult practitioners,6 and marketing of MURs should also consider other barriers. For example, it may be prudent to remove time limits to avoid implying patients might not be listened to fully, during what is for them an additional practitioner consultation.

Pharmacovigilance of herbal medicines

Pharmacovigilance is essential for developing reliable information on the safety of herbal medicines as used in Europe and the US. The existing systems were developed for synthetic medicines and require some modification to address the specific differences of medicinal herbs. Traditional medicine from many different cultures is used in Europe and the US which adds to the complexities and difficulties of even basic questions such as herb naming systems and chemical variability. Allied to this also is the perception that a ‘natural’ or herbal product must be safe simply because it is not synthetic which means that the safety element of monitoring for such medicines can be overlooked because of the tag associated with such products. Cooperation between orthodox physicians and traditional practitioners is needed to bring together the full case details. Independent scientific assistance on toxicological investigation, botanical verification can be invaluable for full evaluation of any case report. Systematic pharmacovigilance is essential to build up reliable information on the safety of herbal medicines for the development of appropriate guidelines for safe effective use.

Traditional medicine use by cancer patients in Thailand

Ethnobotanical relevance Cancer patients commonly use traditional medicines (TM) and in Thailand these are popular for both self-medication and as prescribed by TM practitioners, and are rarely monitored. A study was conducted at Wat Khampramong, a Thai Buddhist temple herbal medicine hospice, to document some of these practices as well as the hospice regime. Materials and methods Cancer patients (n=286) were surveyed shortly after admission as to which TMs they had previously taken and perceptions of effects experienced. They were also asked to describe their current symptoms. Treatment at the hospice is built upon an 11-herb anti-cancer formula, yod-ya-mareng, prescribed for all patients, and ideally, its effects would have been evaluated. However other herbal medicines and holistic practices are integral to the regime, so instead we attempted to assess the value of the patients׳ stay at the hospice by measuring any change in symptom burden, as they perceived it. Surviving patients (n=270) were therefore asked to describe their symptoms again just before leaving. Results 42% of patients (120/286; 95% CI 36.4%, 47.8%) had used herbal medicines before their arrival, with 31.7% (38/120; 95% CI 24%, 40.4%) using several at once. Mixed effects were reported for these products. After taking the herbal regime at Khampramong, 77% (208/270 95% CI; 71.7%, 81.7%) reported benefit, and a comparison of the incidence of the most common (pain, dyspepsia, abdominal or visceral pain, insomnia, fatigue) showed statistical significance (χ2 57.1, df 7, p<0.001). Conclusions A wide range of TMs is taken by cancer patients in Thailand and considered to provide more benefit than harm, and this perception extends to the temple regime. Patients reported a significant reduction in symptoms after staying at Khampramong, indicating an improvement in quality of life, the aim of hospices everywhere. Based on this evidence, it is not possible to justify the use of TM for cancer in general, but this study suggests that further research is warranted. The uncontrolled use of TMs, many of which are uncharacterised, raises concerns, and this work also highlights the fact that validated, robust methods of assessing holistic medical regimes are urgently needed.

The excavation report as a literary genre: traditional practice in Britain

Although ways of thinking about the past have changed, in Britain the reporting of excavations has followed a series of shared conventions for nearly 100 years. This article considers two of them. It investigates the relationship between accounts of stratigraphic evidence and the publication of the associated artefacts and ecofacts and suggests that it results from the combination of two separate intellectual traditions in the late nineteenth century. It also identifies certain widely shared proportions between the separate components of excavation monographs published over a long period of time. Their existence has never been acknowledged. The excavation report has become a well-established literary genre and authors who are familiar with such texts unconsciously reproduce the same structures in their writing.