1 © Chinese Medicine Times - Volume 2 Issue 1 - 2007 A Critique of Case Studies Discussing He Shou Wu. An Analysis of Data Sources Used Within Hospitals and the Use of the Yellow Card Scheme by Attilio D'Alberto Introduction Prevalence of herbal medicine use in the UK umerous surveys have attempted to define the prevalence of alternative medicine use. In the UK, self-care life-time prevalence rates were much higher than practitioner only – in the region of 40– 50 per cent compared with 10–30 per cent (Thomas et al. 1991, 2001; Ernst and White 2000). Thomas et al. (2001) report that over 12 months (data relative to 1998), herbal remedies accounted for 19.8 per cent of over-the-counter (OTC) transactions. Another UK survey conducted in 1999 found an overall one-year prevalence of 20 per cent and suggested that herbal medicine was more popular than any other form of alternative medicine (Ernst and White 2000) (cited in W.H.O. 2000). With the forthcoming regulation of herbal medicine in the UK and its continued integration into healthcare practices, public use is set to increase. The number of suspected adverse reactions to herbal remedies is likely to increase as a result. Availability He Shou Wu (Radix Polygoni Multiflori) is available from groceries in Chinatowns in Australia (Park et al. 2001). It can be sought without prescription from various websites located within Europe and the USA. In the UK it can only be prescribed after a consultation with a qualified herbalist. TCM Mechanisms Shou Wu Pian is the pill form of He Shou Wu (root tuber). He Shou Wu first appeared in the text Materia Medica of Ri Hua Zi. It is used in Chinese medicine to tonify the Liver and Kidney in order to treat the symptoms of weak lower back, dizziness, premature greying hair, etc (Bensky and Gamble 1993). The raw herb is a laxative, but is rarely used because excessive dosage or prolonged use can cause diarrhoea and the loss of Yin. Justification for a Review of Literature and Protocols Currently, if a patient is admitted to hospital with a suspected adverse liver reaction caused by a Chinese herbal remedy, information available to the treating doctors can come from numerous sources, i.e. books, associations, experts, etc (MHRA personal communication). This information can be varied and subjective. When a Chinese herbal remedy is associated with an adverse liver reaction, the Yellow Card Scheme is initiated. The Yellow Card Scheme is the spontaneous reporting scheme used by the Medicines and Healthcare products Regulatory Agency (MHRA) for collating adverse drug reactions (ADRs) to identify signals of drug safety issues with medicines and herbal products. Healthcare professionals including non herbalists and patients can report their suspicions of ADRs to the MHRA via the Yellow Card Scheme. The Yellow Card Scheme's primary role is to detect signals - potential associations between a drug/herb or herbal reaction, which have not been previously identified. All signals are evaluated further, using other data sources, to see whether or not they represent a true association (adverse effect) with the medicine. Other data sources regularly used in the monitoring of drug safety in the UK include formal safety studies, published medical literature, information from pharmaceutical companies and other Regulatory Authorities throughout the world together with information on the level of usage (MHRA personal communication). N