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Practice of traditional Chinese herbal medicine shops in central London
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Phytochemistry Letters 1 (2008) 94–98 www.elsevier.com/locate/phytol
Practice of traditional Chinese herbal medicine shops in central London Lida Teng a, Debbie Shaw b, Joanne Barnes c,* a
Centre for Pharmacognosy and Phytotherapy, School of Pharmacy, University of London, 29/39 Brunswick Square, London WC1N 1AX, UK b Medical Toxicology Unit, Guy’s & St Thomas’ NHS Foundation Trust, Avonley Road, London SE14 5ER, UK c School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, New Zealand Received 10 March 2008; received in revised form 7 April 2008; accepted 7 April 2008 Available online 5 May 2008
Abstract The popularity of traditional Chinese herbal medicine (TCHM) in the UK raises questions about the safety of practice of TCHM retail outlets/ shops. This pilot study involving twelve TCHM outlets included interviews with six employees to understand some aspects of TCHM practices in London and to assess the feasibility of undertaking this type of work. Overall, eight shops displayed names of medical uses/conditions at their premises. There were 274 occurrences of 137 different terms for uses/conditions displayed; after classification by British National Formulary 49 chapters, the most frequent therapeutic categories to which displayed uses/conditions belonged were Central Nervous System (n = 53/274; 19.3%), Obstetrics, Gynaecology and Urinary-tract Disorders (14.2%) and Skin (13.5%). Most staff interviewed believed TCHM was more effective for chronic problems, and inappropriate for acute conditions. Interviewees considered TCHM safer than western medicines. Interviewees used several strategies to ensure safe and effective practice of TCHM, e.g. giving medical advice to customers. Adverse effects (AEs) occurring during TCHM treatments were considered part of the normal response (e.g. diarrhoea is ‘‘expected’’ with treatments for ‘‘clearing heat’’). Staff’s actions to reported AEs included asking customers to stop taking medicines and consulting colleagues. There are areas where interviewees described behaviours or expressed opinions suggesting a lack of awareness of current safety issues; communication of information on herbal safety between the UK competent authority for regulating medicines and TCHM shops appears to be inadequate. # 2008 Phytochemical Society of Europe. Published by Elsevier B.V. All rights reserved. Keywords: Traditional Chinese medicine; Chinese herbal medicine; Ethnopharmacy; Efficacy; Safety; Interviews; Qualitative research; Cross-sectional study
1. Introduction Traditional Chinese herbal medicine (TCHM) is a wellknown form of traditional medicine in the UK. TCHM comprises Chinese crude herbal formulae and Chinese patent medicine (CPM; manufactured herbal products). In the UK, TCHM can be widely purchased as over-the-counter (OTC) products from high street TCHM shops. Most TCHM products on the UK market are unlicensed and manufacturers have not had to demonstrate the quality, safety and efficacy of their products before marketing. Several high-profile safety problems associated with TCHM products and improper practices have occurred (MHRA, 2008a,b). For example, although Aristolochia species have been prohibited in the UK since 1999 due to their renal toxicity, TCHM containing Aristolochia species continue to be found (MHRA, 2008a). The EU Directive for Traditional Herbal
* Corresponding author. Tel.: +64 9 373 7599x89691; fax: +64 9 373 7624. E-mail address: [email protected] (J. Barnes).
Medicinal Products (THMPD; 2004/24/EC) provides a new regulatory framework for traditional herbal medicines, requiring manufacturers of herbal products registered under the scheme to adhere to strict guidelines on product quality (Commission of the European Communities, 2004). This initiative will help to address some of the problems of poor-quality products being sold in the UK. However, a 7-year transition period to allow manufacturers time to comply with the new regulations means it is likely that poor quality and possibly unsafe TCHMs will remain available for some years (MHRA, 2008b). In the UK, there is no statutory regulation for TCHM practitioners, although this is under discussion. No formal qualifications are required to practise TCHM, and the precise number of current practitioners is unknown. The properties and traditional therapeutic effects of TCHM materia medica used in China are well established. TCHM materia medica maintains a key position in the Chinese Pharmacopoeia: the 2005 edition listed 538 Chinese crude medicinal materials used in TCHM, 9.5% of which are animal products and 4.5% minerals (Pharmacopoeia Commission of
1874-3900/$ – see front matter # 2008 Phytochemical Society of Europe. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.phytol.2008.04.001
L. Teng et al. / Phytochemistry Letters 1 (2008) 94–98
PRC, 2005). The development of phytochemistry and ethnopharmacology has played an important role in drug discovery and exploration of TCHM pharmacological effects and, by 1994, around 200 medicinal products had been developed from Chinese medicinal plants (Xiao, 1994). While the pharmacological properties of many Chinese herbs have been documented, there is a lack of information on how Chinese herbs are actually used in practice outside China. Several studies have addressed this (Bensoussan et al., 2000; Hsu, 2002; Jennings, 2005), but none has examined these issues in the UK. This study is the first of its kind to understand aspects of TCHM retail outlets in the UK and provides insights into the experiences, practices and knowledge – and their influences on each other – of employees in TCHM outlets in an urban district of London. This work adds to the small body of ethnopharmacological research that has as its focus ‘‘real’’ people in specific cultural and political settings (Etkin and Elisabetsky, 2005) and has resonance with the approach of other studies described as urban ethnopharmacology or ethnopharmacy (Pieroni et al., 2005; Balick et al., 2000; Waldstein, 2006). This pilot study aimed to explore TCHM shop staff’s views and behaviours toward safe and effective use of TCHM, to develop a systematic searching approach to identifying TCHM outlets in an urban area, and to test the feasibility of these methods and the feasibility of undertaking ethnopharmacy research with TCHM outlets for an extended study. 2. Results and discussion In total, 12 of 173 (7%) healthcare outlets were identified as walk-in shops selling TCHMs in the research area (W1 postcode area in Central London). Six staff from four shops were interviewed (Supplementary data 1). Interviewees were all of Chinese origin. Five interviews were conducted in English, one in Chinese. The mean interview time was 38 minutes (range: 16–75 minutes). W1 was chosen as it is the main shopping area with a dense population and includes London Chinatown, which attracts many Asian migrants; therefore, the number of TCHM shops was likely to be high relative to that in other areas. Two conventional pharmacies were found selling CPMs. Both were located in Chinatown with Chinese staff providing healthcare products mainly for a Chinese population. None of the 52 pharmacies outside Chinatown sold TCHM. 2.1. Advertised therapeutic and consultation services All 12 TCHM shops listed therapeutic services on the shop exterior; the median number of services listed was five (QL = 2, QU = 6). Five shops listed ‘‘consultation’’ services, four of which were stated to be ‘‘free’’. Popular services listed were herbal medicine (n = 8 shops), acupuncture (n = 7), massage (n = 6), and reflexology (n = 5). Overall, 11/12 outlets displayed CPMs and 9/12 used drawers or transparent jars to display Chinese crude/loose herbs. The visible number of jars/drawers for displaying herbs ranged from 5 to 180. Jars/drawers were labelled using Chinese characters, Pin Yin (Roman alphabet for
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transliterating Chinese characters), English common names and/ or botanical names. Eight of twelve outlets listed medical uses/conditions visible to the passing public from outside the shops; the median number of uses/conditions listed was 25.5 (QL = 16.25, QU = 59.5). There were 274 occurrences of 137 different terms for uses/ conditions; each term was counted once only for each shop. From these, similar terms were combined to produce 108 use/condition categories. Table 1 shows the ten most frequently presented therapeutic categories to which uses/conditions belonged after classification by British National Formulary chapters (BMA and RPSGB, 2004). Uses/conditions displayed of particular interest included diabetes (n = 4 shops), epilepsy (n = 2), cancer (n = 1), HIV infection (n = 1), leukaemia (n = 1) and Parkinson’s disease (n = 1). Most TCHM shops used the words ‘‘help’’ and/or ‘‘treat’’ in association with the medical conditions listed. Clearly, some TCHM outlets are not adhering to UK restrictions on written medical claims and advertisements for medical conditions, such as diabetes and cancer, when treated outside the conventional medical system. TCHM outlets need to be fully informed of and aware of these regulations, with subsequent enforcement of the law if these continue to be flouted (MHRA, 2007). Providing TCHM treatments without involvement of statutorily regulated healthcare professionals for these conditions may be unsafe, as these conditions need proper diagnosis and treatment. Medical uses/conditions were advertised using westernised medical terms (e.g. diabetes, hypertension) rather than TCHM terminology (e.g. blood-heat), and mostly in English. Westernised medical terms may be considered more understandable and identifiable than TCHM terms and, therefore, more likely to attract the passing public’s attention. In addition, proper description of a specific health problem using TCHM terms can only be achieved after a consultation with a TCHM practitioner, and the description would vary for different patients with the same health problem. TCHM staff’s explanations for displaying uses/conditions in western medical terms were not explored. Nevertheless, displaying lists of conditions may give the impression that TCHM can prevent, treat or cure these conditions. 2.2. General outlet information obtained via interviews Participating shops usually supply crude herbal formulae to customers in packages for daily use. The cost to patients of crude herbal formulae was around £35–40 a week. Printed forms were available in some shops for obtaining patient personal and medical details before a first consultation. Some outlets kept written patient medical records; information kept included age, contact information, health reason for consultation, medical and allergy history, family history, treatment plan and prescriptions. Some consultations in participant shops were carried out with the aid of Chinese–English translators. Interviewees stated that single crude herbs and mixtures of crude herbs in a prescription generally could not be purchased OTC and must be prescribed by a practitioner after a consultation. However, some single herbs (such as Dang Gui, Angelica sinensis root) considered suitable
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Table 1 Medical uses/conditions most frequently visible outside TCHM shops in W1, central London BNF chapter
Total frequency (% of total N; N = 274)
Use/condition category displayed by more than five shops
Frequency (% of total N; N = 274)
(4) Central nervous system
53 (19.3%)
Stress/anxiety/relaxation Slimming/weight loss/obesity Insomnia Smoking
10 (3.6%) 8 (2.9%) 7 (2.6%) 5 (1.8%)
(7) Obstetrics, gynaecology, and urinary-tract disorders
39 (14.2%)
Infertility Menstrual problem Impotence Menopausal problem
8 7 6 6
(2.9%) (2.6%) (2.2%) (2.2%)
(13) Skin
34 (12.4%)
Hair loss Eczema Psoriasis Acne
7 6 6 5
(2.6%) (2.2%) (2.2%) (1.8%)
(10) Musculoskeletal and joint diseases
30 (10.9%)
Back pain/lumbago/sciatica Arthritis
11 (4.0%) 8 (2.9%)
(3) Respiratory system
26 (9.5%)
Asthma Hay fever
6 (2.2%) 6 (2.2%)
(0) Miscellaneous uses/conditionsa (1) Gastro-intestinal system (5) Infections (2) Cardiovascular system (12) Ear, nose, and oropharynx
22 19 19 11 9
None Irritable bowel syndrome None None Tinnitus
N/A 6 (2.2%) N/A N/A 5 (1.8%)
(8.0%) (6.9%) (6.9%) (4.0%) (3.3%)
N/A = not applicable. a Uses/conditions unclassifiable by British National Formulary 49 (BMA and RPSGB, 2004) chapter included appetite, bad breath, children’s disease, cysts, detox, dust deposits, energy/fatigue, fibroids, hangover, hiatus hernia, lupus, polyp, sclerosis, sun disease, myalgic encephalomyelitis, ulcer, and reduce drinking.
for cooking purposes were available for OTC purchase. Although some professional registers have a Code of Practice to guide their members, TCHM practice behaviours vary between different shops and shop staff. Staff considered mental health problems (e.g. stress, depression), achieving weight loss, skin problems and liver disorders the most common health reasons for customers seeking TCHM treatments. In the UK, most high-profile safety issues have been associated with the supply of poor-quality CPMs for weight loss and as slimming aids (MHRA, 2008a,b; Lai et al., 2006). There have been numerous warnings about the presence of undeclared pharmaceutical medicines in herbal weight-loss products. In addition, some TCHM have been associated with adverse liver effects (MHRA, 2008a). It is important to ensure that such herbs are avoided in individuals with existing liver disorders; also, treatment of hepatitis and other potentially serious conditions without proper diagnosis may not be appropriate. Safety assessment for the herbal medicines used for these frequently advertised conditions may be necessary.
risk than Chinese medicine’’. However, staff also indicated ‘‘with any medicine, too much is not good’’ and ‘‘has to be prescribed by doctors’’. Interviewees described several health problems for which TCHM is considered effective and for which TCHM is not recommended (Supplementary data 2). In addition, interviewees provided examples of specific Chinese herbs that they considered particularly safe and unsafe (Supplementary data 3). However, a single Chinese name may refer to more than one botanical species (e.g. Chinese herb Ban Lan Gen can represent two species from different genera, Isatis indigotica and Baphicacanthus cusia) Ban Lan Gen was described as both safe and unsafe by different interviewees, indicating that the interpretation of ‘safe’ and ‘unsafe’ varies. Ban Lan Gen is commonly used for treating throat inflammation and respiratory conditions, but its adverse drug reaction (ADR) profile has not been well explored. Potential ADRs include digestive system problems and haemolysis (Gao, 2002). CPMs containing this herb are sold in TCHM shops and Chinese supermarkets in the UK for preventing cold and flu.
2.3. Views on effectiveness and safety of TCHM
2.4. Advice to customers when selling or prescribing TCHM
Compared with western medicines (WMs), interviewees generally believed that TCHM had its own ‘‘priority’’ or ‘‘advantage’’. They typically considered TCHM to be ‘‘safer’’ than WM and that TCHM has ‘‘no side effect’’ and is ‘‘always safe’’, while ‘‘for the side effect, western medicine has more
Interviewees gave advice to their customers when selling or prescribing TCHM; typically, advice was given orally and some shops provided written or printed instructions to their customers. Advice given included: preparation methods of herbal decoction, dosage of TCHM, ingredients contained in
L. Teng et al. / Phytochemistry Letters 1 (2008) 94–98
herbal formulae, functions of herbal ingredients, dietary suggestions and duration of treatment. Staff also informed customers regarding the unpleasant taste of decoctions. One practitioner also suggested ‘‘the way how they [patients] deal with different kind of medicines, for example, whether is it important for them to use western medicines at the same times?’’ and for some conditions, this practitioner will ‘‘suggest them [patients] stop the western treatment and started the Chinese way’’. The encouragement of concurrent use of TCHM and WM, and advising cessation of WM treatment, give cause for concern. Several serious conditions, such as diabetes and HIV infection, were advertised by outlets, and patients seeking TCHM for these conditions are likely to be receiving conventional medications. Concurrent use of TCHM and WM could result in important drug–herb interactions; stopping WM treatment abruptly and without the supervision of a WM prescriber may have serious consequences. While TCHM practitioners may have some knowledge of WM as some have learned or practised WM in China, many TCHM practitioners are not registered as WM healthcare professionals in the UK. Nevertheless, the study showed that TCHM practitioners were aware of the possibility of using TCHM and WM concurrently by consumers and the potential existence of drug– herb interactions.
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medical advice, and such AEs are unlikely to be documented and reported. Moreover, although some TCHM associations, such as the Register of Chinese Herbal Medicine (RCHM), have their own ADR reporting schemes, none of the participants said they would report any suspicious AEs occurring during their practice to the relevant associations. 2.6. Communication of information Interviewees generally considered obtaining information on herbal safety as ‘‘very important’’; some received regular safetyrelated information. Some interviewees knew of the Medicines and Healthcare products Regulatory Agency (MHRA; the UK competent authority for regulating medicines), however, some were not familiar with Herbal Safety News on the MHRAwebsite (MHRA, 2008a). TCHM associations in the UK were considered the main information sources for shops to obtain herbal safety news; staff preferred to receive information from their associations and companies. Interviewees referred to the need for communication of information to be more frequent and to include more information on herbs. The current communication of herbal safety information is limited to communication within TCHM associations and companies owning TCHM shops; this suggests there is inadequate communication between the MHRA and TCHM shops.
2.5. Adverse effects and complaints associated with TCHM 2.7. Study strengths and limitations Interviewees typically used the word ‘‘complaint’’ rather than adverse effects (AEs) when answering the questions regarding the reports of AEs from their customers. Customers’ complaints included unpleasant taste of Chinese herbal decoction, difficult preparation methods and the large amount of TCHM to take. Interviewees also mentioned receiving complaints about the effectiveness of TCHM from customers, and interviewees gave explanations that TCHM treatments required ‘‘longer time’’ (e.g. 2–3 months). On receiving reports from customers of unwanted effects associated with TCHM, interviewees said they would advise customers to stop taking TCHM and consult TCHM practitioners. Interviewees also described factors to consider when looking for the cause of an AE: Firstly, we have to analyse what’s the reason . . . is it because of . . . the herbs. Or maybe the way they [patients] cook [the herbs], if not proper way. Or maybe because of the health conditions . . . life-style, or maybe patient’s situation of the disease . . . Or maybe the amount the herbs prescribed by doctors. And then we will give, conclude, the treatment, and manage to solve the problem. (ID #2) In some cases, respondents tell patients to continue treatment if the AE was considered part of the normal response (e.g. diarrhoea was described as an expected AE and was considered necessary for the treatment to clear ‘internal heat’). The interpretation of certain symptoms as normal, even desirable, responses to treatment rather than as AEs has potentially serious implications: patients may continue with treatment that is causing harm, and may not receive appropriate
This work has identified aspects of TCHM practice that may help minimise potential harms from TCHM. However, other aspects, such as interpretation of certain symptoms during TCHM treatment as expected/desirable rather than as AEs, and TCHM practitioners’ reluctance to report suspected AEs to TCHM organisations, raise concerns about safety monitoring in TCHM practice. These issues are being examined in further work. During the study, identification of TCHM shops was problematic and a comprehensive list of TCHM providers may be impossible to achieve without statutory regulation and registration of TCHM practitioners and providers. As interviews and shop visits were undertaken by a Chinese researcher with knowledge of TCHM, this may have influenced participant and shop recruitment. The option to be interviewed in Chinese and by someone with a similar cultural background may have encouraged some participants; conversely, some potential participants might have been concerned that a Chinesespeaking researcher could identify products labelled in Chinese that, unbeknown to shop staff, are illegal. Some participants stated that they would trust a Chinese researcher to explore TCHM practice in a fair way, whereas some non-participants were concerned about the study in case it was damaging for TCHM. During interviews, social desirability bias may have influenced interviewees’ responses to certain questions, particularly those concerning advice given to TCHM consumers and responses to reports of AEs. As with all retrospective research, recall bias may have occurred. Translation of responses in Chinese into English was under-
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taken by one researcher and it is possible that some responses or nuances may have been misinterpreted. 3. Experimental This pilot work comprised a cross-sectional study to investigate the features of TCHM shops, and qualitative in-depth interviews to explore views on and experiences with TCHM. Data collection tools are presented in Supplementary data 4. A systematic approach was used to identify TCHM retail outlets in the study area (Supplementary data 4). TCHM shops were identified over November 2004 to January 2005. One week before the data collection period (March 2005) a letter describing the study was posted to each identified TCHM shop. Data on shops’ characteristics were collected for the exterior of all shops and detailed ‘interior’ observations were made for outlets consenting to this. All staff working in identified shops at the time of the investigator’s visits were invited to participate in a one-toone interview. Participants completed a questionnaire to collect data on their socio-demographic background. Interviews were recorded using a digital voice recorder where participants gave consent for this. Recorded interviews were transcribed verbatim and translated into English where necessary. Data were coded manually using a framework approach comprising key themes identified a priori and emerging from the data. Acknowledgements This work was carried out as a part of Lida Teng’s PhD study at the School of Pharmacy, University of London. We thank all TCHM shop/clinic staff and managers in London involved in piloting the study tools, those who participated in the study, and Arti Bhatt, MPharm student, School of Pharmacy, University of London, for her assistance with data collection. Appendix A. Supplementary data Supplementary data associated with this article can be found, in the online version, at doi:10.1016/j.phytol.2008.04.001.
References Balick, M.J., Kronenberg, F., Ososki, A.L., Reiff, M., Fugh-Berman, A., O’Connor, B., Roble, M., Lohr, P., Atha, D., 2000. Medicinal plants used by Latino healers for women’s health conditions in New York City. Economic Botany 54, 344–357. Bensoussan, A., Myers, S.P., Carlton, A.L., 2000. Risks associated with the practice of traditional Chinese medicine: an Australian study. Archives of Family Medicine 9, 1071–1078. British Medical Association (BMA) and the Royal Pharmaceutical Society of Great Britain (RPSGB), 2004. British National Formulary (BNF), vol. 49. Pharmaceutical Press, London. Etkin, N.L., Elisabetsky, E., 2005. Seeking a transdisciplinary and culturally germane science: the future of ethnopharmacology. Journal of Ethnopharmacology 100, 23–26. Commission of the European Communities, 2004. Directive 2004/24/EC of the European Parliment and the Council of 31March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community Code relating to medicinal products for human use. Official Journal of the European Union 47, L136/85-L136/90. Gao, X.M., 2002. Zhong Yao Xue (Chinese Materia Medica). China Press of Traditional Chinese Medicine, Beijing (in Chinese). Hsu, E., 2002. ‘The medicine from China has rapid effects’: Chinese medicine patients in Tanzania. Anthropology & Medicine 9, 291–313. Jennings, M., 2005. Chinese medicine and medical pluralism in Dar es Salaam: globalisation or glocalisation? International Relations 19, 457–473. Lai, V., Smith, A., Thorburn, D., Raman, V.S., 2006. Severe hepatic injury and adulterated Chinese medicines. British Medical Journal 332, 304–305. Medicines and Healthcare Products Regulatory Agency (MHRA), 2007. Press Release: Chinese Clinic Rapped for Making False Claims. MHRA Press Office, London. Medicines and Healthcare Products Regulatory Agency (MHRA), 2008a. Herbal Safety News. http://www.mhra.gov.uk/Howweregulate/Medicines/ Herbalandhomoeopathicmedicines/Herbalmedicines/HerbalSafetyNews/ index.htm (last accessed: February 17, 2008). Medicines and Healthcare Products Regulatory Agency (MHRA), 2008b. Press Release: Dangerous Practices in the Unlicensed Herbals Sector. MHRA Press Office, London. Pharmacopoeia Commission of PRC, 2005. Pharmacopoeia of the People’s Republic of China, vol. I. Chemical Industry Press, Beijing (in Chinese). Pieroni, A., Muenz, H., Akbulut, M., Baser, K.H.C., Durmuskahya, C., 2005. Traditional phytotherapy and trans-cultural pharmacy among Turkish migrants living in Cologne, Germany. Journal of Ethnopharmacology 102, 69–88. Waldstein, A., 2006. Mexican migrant ethnopharmacology: pharmacopoeia, classification of medicines and explanations of efficacy. Journal of Ethnopharmacology 108, 299–310. Xiao, P.G., 1994. Ethnopharmacological investigation of Chinese medicinal plants. Ciba Foundation Symposium 185, 169–173.
Phytochemistry Letters 1 (2008) 94–98 www.elsevier.com/locate/phytol
Practice of traditional Chinese herbal medicine shops in central London Lida Teng a, Debbie Shaw b, Joanne Barnes c,* a
Centre for Pharmacognosy and Phytotherapy, School of Pharmacy, University of London, 29/39 Brunswick Square, London WC1N 1AX, UK b Medical Toxicology Unit, Guy’s & St Thomas’ NHS Foundation Trust, Avonley Road, London SE14 5ER, UK c School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Private Bag 92019, Auckland, New Zealand Received 10 March 2008; received in revised form 7 April 2008; accepted 7 April 2008 Available online 5 May 2008
Abstract The popularity of traditional Chinese herbal medicine (TCHM) in the UK raises questions about the safety of practice of TCHM retail outlets/ shops. This pilot study involving twelve TCHM outlets included interviews with six employees to understand some aspects of TCHM practices in London and to assess the feasibility of undertaking this type of work. Overall, eight shops displayed names of medical uses/conditions at their premises. There were 274 occurrences of 137 different terms for uses/conditions displayed; after classification by British National Formulary 49 chapters, the most frequent therapeutic categories to which displayed uses/conditions belonged were Central Nervous System (n = 53/274; 19.3%), Obstetrics, Gynaecology and Urinary-tract Disorders (14.2%) and Skin (13.5%). Most staff interviewed believed TCHM was more effective for chronic problems, and inappropriate for acute conditions. Interviewees considered TCHM safer than western medicines. Interviewees used several strategies to ensure safe and effective practice of TCHM, e.g. giving medical advice to customers. Adverse effects (AEs) occurring during TCHM treatments were considered part of the normal response (e.g. diarrhoea is ‘‘expected’’ with treatments for ‘‘clearing heat’’). Staff’s actions to reported AEs included asking customers to stop taking medicines and consulting colleagues. There are areas where interviewees described behaviours or expressed opinions suggesting a lack of awareness of current safety issues; communication of information on herbal safety between the UK competent authority for regulating medicines and TCHM shops appears to be inadequate. # 2008 Phytochemical Society of Europe. Published by Elsevier B.V. All rights reserved. Keywords: Traditional Chinese medicine; Chinese herbal medicine; Ethnopharmacy; Efficacy; Safety; Interviews; Qualitative research; Cross-sectional study
1. Introduction Traditional Chinese herbal medicine (TCHM) is a wellknown form of traditional medicine in the UK. TCHM comprises Chinese crude herbal formulae and Chinese patent medicine (CPM; manufactured herbal products). In the UK, TCHM can be widely purchased as over-the-counter (OTC) products from high street TCHM shops. Most TCHM products on the UK market are unlicensed and manufacturers have not had to demonstrate the quality, safety and efficacy of their products before marketing. Several high-profile safety problems associated with TCHM products and improper practices have occurred (MHRA, 2008a,b). For example, although Aristolochia species have been prohibited in the UK since 1999 due to their renal toxicity, TCHM containing Aristolochia species continue to be found (MHRA, 2008a). The EU Directive for Traditional Herbal
* Corresponding author. Tel.: +64 9 373 7599x89691; fax: +64 9 373 7624. E-mail address: [email protected] (J. Barnes).
Medicinal Products (THMPD; 2004/24/EC) provides a new regulatory framework for traditional herbal medicines, requiring manufacturers of herbal products registered under the scheme to adhere to strict guidelines on product quality (Commission of the European Communities, 2004). This initiative will help to address some of the problems of poor-quality products being sold in the UK. However, a 7-year transition period to allow manufacturers time to comply with the new regulations means it is likely that poor quality and possibly unsafe TCHMs will remain available for some years (MHRA, 2008b). In the UK, there is no statutory regulation for TCHM practitioners, although this is under discussion. No formal qualifications are required to practise TCHM, and the precise number of current practitioners is unknown. The properties and traditional therapeutic effects of TCHM materia medica used in China are well established. TCHM materia medica maintains a key position in the Chinese Pharmacopoeia: the 2005 edition listed 538 Chinese crude medicinal materials used in TCHM, 9.5% of which are animal products and 4.5% minerals (Pharmacopoeia Commission of
1874-3900/$ – see front matter # 2008 Phytochemical Society of Europe. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.phytol.2008.04.001
L. Teng et al. / Phytochemistry Letters 1 (2008) 94–98
PRC, 2005). The development of phytochemistry and ethnopharmacology has played an important role in drug discovery and exploration of TCHM pharmacological effects and, by 1994, around 200 medicinal products had been developed from Chinese medicinal plants (Xiao, 1994). While the pharmacological properties of many Chinese herbs have been documented, there is a lack of information on how Chinese herbs are actually used in practice outside China. Several studies have addressed this (Bensoussan et al., 2000; Hsu, 2002; Jennings, 2005), but none has examined these issues in the UK. This study is the first of its kind to understand aspects of TCHM retail outlets in the UK and provides insights into the experiences, practices and knowledge – and their influences on each other – of employees in TCHM outlets in an urban district of London. This work adds to the small body of ethnopharmacological research that has as its focus ‘‘real’’ people in specific cultural and political settings (Etkin and Elisabetsky, 2005) and has resonance with the approach of other studies described as urban ethnopharmacology or ethnopharmacy (Pieroni et al., 2005; Balick et al., 2000; Waldstein, 2006). This pilot study aimed to explore TCHM shop staff’s views and behaviours toward safe and effective use of TCHM, to develop a systematic searching approach to identifying TCHM outlets in an urban area, and to test the feasibility of these methods and the feasibility of undertaking ethnopharmacy research with TCHM outlets for an extended study. 2. Results and discussion In total, 12 of 173 (7%) healthcare outlets were identified as walk-in shops selling TCHMs in the research area (W1 postcode area in Central London). Six staff from four shops were interviewed (Supplementary data 1). Interviewees were all of Chinese origin. Five interviews were conducted in English, one in Chinese. The mean interview time was 38 minutes (range: 16–75 minutes). W1 was chosen as it is the main shopping area with a dense population and includes London Chinatown, which attracts many Asian migrants; therefore, the number of TCHM shops was likely to be high relative to that in other areas. Two conventional pharmacies were found selling CPMs. Both were located in Chinatown with Chinese staff providing healthcare products mainly for a Chinese population. None of the 52 pharmacies outside Chinatown sold TCHM. 2.1. Advertised therapeutic and consultation services All 12 TCHM shops listed therapeutic services on the shop exterior; the median number of services listed was five (QL = 2, QU = 6). Five shops listed ‘‘consultation’’ services, four of which were stated to be ‘‘free’’. Popular services listed were herbal medicine (n = 8 shops), acupuncture (n = 7), massage (n = 6), and reflexology (n = 5). Overall, 11/12 outlets displayed CPMs and 9/12 used drawers or transparent jars to display Chinese crude/loose herbs. The visible number of jars/drawers for displaying herbs ranged from 5 to 180. Jars/drawers were labelled using Chinese characters, Pin Yin (Roman alphabet for
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transliterating Chinese characters), English common names and/ or botanical names. Eight of twelve outlets listed medical uses/conditions visible to the passing public from outside the shops; the median number of uses/conditions listed was 25.5 (QL = 16.25, QU = 59.5). There were 274 occurrences of 137 different terms for uses/ conditions; each term was counted once only for each shop. From these, similar terms were combined to produce 108 use/condition categories. Table 1 shows the ten most frequently presented therapeutic categories to which uses/conditions belonged after classification by British National Formulary chapters (BMA and RPSGB, 2004). Uses/conditions displayed of particular interest included diabetes (n = 4 shops), epilepsy (n = 2), cancer (n = 1), HIV infection (n = 1), leukaemia (n = 1) and Parkinson’s disease (n = 1). Most TCHM shops used the words ‘‘help’’ and/or ‘‘treat’’ in association with the medical conditions listed. Clearly, some TCHM outlets are not adhering to UK restrictions on written medical claims and advertisements for medical conditions, such as diabetes and cancer, when treated outside the conventional medical system. TCHM outlets need to be fully informed of and aware of these regulations, with subsequent enforcement of the law if these continue to be flouted (MHRA, 2007). Providing TCHM treatments without involvement of statutorily regulated healthcare professionals for these conditions may be unsafe, as these conditions need proper diagnosis and treatment. Medical uses/conditions were advertised using westernised medical terms (e.g. diabetes, hypertension) rather than TCHM terminology (e.g. blood-heat), and mostly in English. Westernised medical terms may be considered more understandable and identifiable than TCHM terms and, therefore, more likely to attract the passing public’s attention. In addition, proper description of a specific health problem using TCHM terms can only be achieved after a consultation with a TCHM practitioner, and the description would vary for different patients with the same health problem. TCHM staff’s explanations for displaying uses/conditions in western medical terms were not explored. Nevertheless, displaying lists of conditions may give the impression that TCHM can prevent, treat or cure these conditions. 2.2. General outlet information obtained via interviews Participating shops usually supply crude herbal formulae to customers in packages for daily use. The cost to patients of crude herbal formulae was around £35–40 a week. Printed forms were available in some shops for obtaining patient personal and medical details before a first consultation. Some outlets kept written patient medical records; information kept included age, contact information, health reason for consultation, medical and allergy history, family history, treatment plan and prescriptions. Some consultations in participant shops were carried out with the aid of Chinese–English translators. Interviewees stated that single crude herbs and mixtures of crude herbs in a prescription generally could not be purchased OTC and must be prescribed by a practitioner after a consultation. However, some single herbs (such as Dang Gui, Angelica sinensis root) considered suitable
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Table 1 Medical uses/conditions most frequently visible outside TCHM shops in W1, central London BNF chapter
Total frequency (% of total N; N = 274)
Use/condition category displayed by more than five shops
Frequency (% of total N; N = 274)
(4) Central nervous system
53 (19.3%)
Stress/anxiety/relaxation Slimming/weight loss/obesity Insomnia Smoking
10 (3.6%) 8 (2.9%) 7 (2.6%) 5 (1.8%)
(7) Obstetrics, gynaecology, and urinary-tract disorders
39 (14.2%)
Infertility Menstrual problem Impotence Menopausal problem
8 7 6 6
(2.9%) (2.6%) (2.2%) (2.2%)
(13) Skin
34 (12.4%)
Hair loss Eczema Psoriasis Acne
7 6 6 5
(2.6%) (2.2%) (2.2%) (1.8%)
(10) Musculoskeletal and joint diseases
30 (10.9%)
Back pain/lumbago/sciatica Arthritis
11 (4.0%) 8 (2.9%)
(3) Respiratory system
26 (9.5%)
Asthma Hay fever
6 (2.2%) 6 (2.2%)
(0) Miscellaneous uses/conditionsa (1) Gastro-intestinal system (5) Infections (2) Cardiovascular system (12) Ear, nose, and oropharynx
22 19 19 11 9
None Irritable bowel syndrome None None Tinnitus
N/A 6 (2.2%) N/A N/A 5 (1.8%)
(8.0%) (6.9%) (6.9%) (4.0%) (3.3%)
N/A = not applicable. a Uses/conditions unclassifiable by British National Formulary 49 (BMA and RPSGB, 2004) chapter included appetite, bad breath, children’s disease, cysts, detox, dust deposits, energy/fatigue, fibroids, hangover, hiatus hernia, lupus, polyp, sclerosis, sun disease, myalgic encephalomyelitis, ulcer, and reduce drinking.
for cooking purposes were available for OTC purchase. Although some professional registers have a Code of Practice to guide their members, TCHM practice behaviours vary between different shops and shop staff. Staff considered mental health problems (e.g. stress, depression), achieving weight loss, skin problems and liver disorders the most common health reasons for customers seeking TCHM treatments. In the UK, most high-profile safety issues have been associated with the supply of poor-quality CPMs for weight loss and as slimming aids (MHRA, 2008a,b; Lai et al., 2006). There have been numerous warnings about the presence of undeclared pharmaceutical medicines in herbal weight-loss products. In addition, some TCHM have been associated with adverse liver effects (MHRA, 2008a). It is important to ensure that such herbs are avoided in individuals with existing liver disorders; also, treatment of hepatitis and other potentially serious conditions without proper diagnosis may not be appropriate. Safety assessment for the herbal medicines used for these frequently advertised conditions may be necessary.
risk than Chinese medicine’’. However, staff also indicated ‘‘with any medicine, too much is not good’’ and ‘‘has to be prescribed by doctors’’. Interviewees described several health problems for which TCHM is considered effective and for which TCHM is not recommended (Supplementary data 2). In addition, interviewees provided examples of specific Chinese herbs that they considered particularly safe and unsafe (Supplementary data 3). However, a single Chinese name may refer to more than one botanical species (e.g. Chinese herb Ban Lan Gen can represent two species from different genera, Isatis indigotica and Baphicacanthus cusia) Ban Lan Gen was described as both safe and unsafe by different interviewees, indicating that the interpretation of ‘safe’ and ‘unsafe’ varies. Ban Lan Gen is commonly used for treating throat inflammation and respiratory conditions, but its adverse drug reaction (ADR) profile has not been well explored. Potential ADRs include digestive system problems and haemolysis (Gao, 2002). CPMs containing this herb are sold in TCHM shops and Chinese supermarkets in the UK for preventing cold and flu.
2.3. Views on effectiveness and safety of TCHM
2.4. Advice to customers when selling or prescribing TCHM
Compared with western medicines (WMs), interviewees generally believed that TCHM had its own ‘‘priority’’ or ‘‘advantage’’. They typically considered TCHM to be ‘‘safer’’ than WM and that TCHM has ‘‘no side effect’’ and is ‘‘always safe’’, while ‘‘for the side effect, western medicine has more
Interviewees gave advice to their customers when selling or prescribing TCHM; typically, advice was given orally and some shops provided written or printed instructions to their customers. Advice given included: preparation methods of herbal decoction, dosage of TCHM, ingredients contained in
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herbal formulae, functions of herbal ingredients, dietary suggestions and duration of treatment. Staff also informed customers regarding the unpleasant taste of decoctions. One practitioner also suggested ‘‘the way how they [patients] deal with different kind of medicines, for example, whether is it important for them to use western medicines at the same times?’’ and for some conditions, this practitioner will ‘‘suggest them [patients] stop the western treatment and started the Chinese way’’. The encouragement of concurrent use of TCHM and WM, and advising cessation of WM treatment, give cause for concern. Several serious conditions, such as diabetes and HIV infection, were advertised by outlets, and patients seeking TCHM for these conditions are likely to be receiving conventional medications. Concurrent use of TCHM and WM could result in important drug–herb interactions; stopping WM treatment abruptly and without the supervision of a WM prescriber may have serious consequences. While TCHM practitioners may have some knowledge of WM as some have learned or practised WM in China, many TCHM practitioners are not registered as WM healthcare professionals in the UK. Nevertheless, the study showed that TCHM practitioners were aware of the possibility of using TCHM and WM concurrently by consumers and the potential existence of drug– herb interactions.
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medical advice, and such AEs are unlikely to be documented and reported. Moreover, although some TCHM associations, such as the Register of Chinese Herbal Medicine (RCHM), have their own ADR reporting schemes, none of the participants said they would report any suspicious AEs occurring during their practice to the relevant associations. 2.6. Communication of information Interviewees generally considered obtaining information on herbal safety as ‘‘very important’’; some received regular safetyrelated information. Some interviewees knew of the Medicines and Healthcare products Regulatory Agency (MHRA; the UK competent authority for regulating medicines), however, some were not familiar with Herbal Safety News on the MHRAwebsite (MHRA, 2008a). TCHM associations in the UK were considered the main information sources for shops to obtain herbal safety news; staff preferred to receive information from their associations and companies. Interviewees referred to the need for communication of information to be more frequent and to include more information on herbs. The current communication of herbal safety information is limited to communication within TCHM associations and companies owning TCHM shops; this suggests there is inadequate communication between the MHRA and TCHM shops.
2.5. Adverse effects and complaints associated with TCHM 2.7. Study strengths and limitations Interviewees typically used the word ‘‘complaint’’ rather than adverse effects (AEs) when answering the questions regarding the reports of AEs from their customers. Customers’ complaints included unpleasant taste of Chinese herbal decoction, difficult preparation methods and the large amount of TCHM to take. Interviewees also mentioned receiving complaints about the effectiveness of TCHM from customers, and interviewees gave explanations that TCHM treatments required ‘‘longer time’’ (e.g. 2–3 months). On receiving reports from customers of unwanted effects associated with TCHM, interviewees said they would advise customers to stop taking TCHM and consult TCHM practitioners. Interviewees also described factors to consider when looking for the cause of an AE: Firstly, we have to analyse what’s the reason . . . is it because of . . . the herbs. Or maybe the way they [patients] cook [the herbs], if not proper way. Or maybe because of the health conditions . . . life-style, or maybe patient’s situation of the disease . . . Or maybe the amount the herbs prescribed by doctors. And then we will give, conclude, the treatment, and manage to solve the problem. (ID #2) In some cases, respondents tell patients to continue treatment if the AE was considered part of the normal response (e.g. diarrhoea was described as an expected AE and was considered necessary for the treatment to clear ‘internal heat’). The interpretation of certain symptoms as normal, even desirable, responses to treatment rather than as AEs has potentially serious implications: patients may continue with treatment that is causing harm, and may not receive appropriate
This work has identified aspects of TCHM practice that may help minimise potential harms from TCHM. However, other aspects, such as interpretation of certain symptoms during TCHM treatment as expected/desirable rather than as AEs, and TCHM practitioners’ reluctance to report suspected AEs to TCHM organisations, raise concerns about safety monitoring in TCHM practice. These issues are being examined in further work. During the study, identification of TCHM shops was problematic and a comprehensive list of TCHM providers may be impossible to achieve without statutory regulation and registration of TCHM practitioners and providers. As interviews and shop visits were undertaken by a Chinese researcher with knowledge of TCHM, this may have influenced participant and shop recruitment. The option to be interviewed in Chinese and by someone with a similar cultural background may have encouraged some participants; conversely, some potential participants might have been concerned that a Chinesespeaking researcher could identify products labelled in Chinese that, unbeknown to shop staff, are illegal. Some participants stated that they would trust a Chinese researcher to explore TCHM practice in a fair way, whereas some non-participants were concerned about the study in case it was damaging for TCHM. During interviews, social desirability bias may have influenced interviewees’ responses to certain questions, particularly those concerning advice given to TCHM consumers and responses to reports of AEs. As with all retrospective research, recall bias may have occurred. Translation of responses in Chinese into English was under-
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taken by one researcher and it is possible that some responses or nuances may have been misinterpreted. 3. Experimental This pilot work comprised a cross-sectional study to investigate the features of TCHM shops, and qualitative in-depth interviews to explore views on and experiences with TCHM. Data collection tools are presented in Supplementary data 4. A systematic approach was used to identify TCHM retail outlets in the study area (Supplementary data 4). TCHM shops were identified over November 2004 to January 2005. One week before the data collection period (March 2005) a letter describing the study was posted to each identified TCHM shop. Data on shops’ characteristics were collected for the exterior of all shops and detailed ‘interior’ observations were made for outlets consenting to this. All staff working in identified shops at the time of the investigator’s visits were invited to participate in a one-toone interview. Participants completed a questionnaire to collect data on their socio-demographic background. Interviews were recorded using a digital voice recorder where participants gave consent for this. Recorded interviews were transcribed verbatim and translated into English where necessary. Data were coded manually using a framework approach comprising key themes identified a priori and emerging from the data. Acknowledgements This work was carried out as a part of Lida Teng’s PhD study at the School of Pharmacy, University of London. We thank all TCHM shop/clinic staff and managers in London involved in piloting the study tools, those who participated in the study, and Arti Bhatt, MPharm student, School of Pharmacy, University of London, for her assistance with data collection. Appendix A. Supplementary data Supplementary data associated with this article can be found, in the online version, at doi:10.1016/j.phytol.2008.04.001.
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