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Background: In the UK, urinary tract infections (UTIs) are the most common bacterial infection presented by women in primary care. Recurrent urinary tract infections (RUTIs) are defined as three episodes of UTI in the last 12 months, or two episodes in the last 6 months. Between 20 and 30 % of women who have had one episode of UTI will have an RUTI, and approximately 25 % of these will develop subsequent recurrent episodes. RUTIs can have a significant negative effect on the quality of life, and have a high impact on health care costs as a result of outpatient visits, diagnostic tests and prescriptions. Chinese herbal medicine (CHM) has a recorded history of treatments for the symptoms of UTIs for more than 2000 years. More recent clinical research in China has provided some preliminary evidence that CHM can alleviate the symptoms of UTIs and reduce the rate of recurrence, but more rigorous investigation is required.Methods/design: The RUTI trial is a double-blind, randomised, placebo-controlled, feasibility trial. A total of 80 women will be randomised to 'individualised' herbs prescribed by a Chinese herbal practitioner or to 'standardised' herbs provided by primary care clinicians. Both arms will have herbs for prevention of UTIs and treatment of acute episodes. Treatment duration is for 16 weeks. The primary outcomes are the number of episodes of recurrent UTIs during the trial period and in the 6 months of follow-up, and the number of days of symptoms rated moderately bad or worse based on patient diaries. Secondary outcomes will assess participant expectations and beliefs, adherence to the treatment, adverse events and health economics and provide quantitative and qualitative assessments of the impact of recurrent infections on the lives of women.Discussion: The RUTI trial is the first instance of CHM delivered as a clinical trial of an investigatory medicinal product in the UK. This study provides important information regarding the feasibility and acceptability of researching and using CHM in Primary care. Once completed, it will provide provisional estimates of the variance of change in continuous outcomes to inform a power calculation for a larger, more definitive trial.Trial Registration: EudraCT, 2013-004657-24 . Registered on 5 September 2014. [ABSTRACT FROM AUTHOR]

Ethnopharmacological relevance Chinese herbal medicine (CHM) has a recorded history of over 2000 years that may be used to authenticate and guide modern treatments for disease, and also identify neglected but potentially useful treatment strategies. However this process is often based on over-simplistic conceptions of tradition and history that fail to take into account the dynamic nature of ‘traditions’ and underestimate the importance of contextual factors in their interpretation. Materials and methods As part of a process of defining good practice for a clinical trial of CHM for recurrent urinary tract infections, a selective review of classical Chinese medical texts was undertaken to investigate the historical treatment of urinary diseases specified by the traditional category of Lin diseases. Results The historical review provided interesting insights into the evolution and meaning of Lin diseases and how pertinent data may be found, precisely, outside the boundaries of the categories on which the original investigation was premised. Although there were interesting parallels and continuities in the classical and modern understandings of the aetiology, pathophysiology and treatment of urinary diseases, there were also important divergences. Conclusions It became apparent that, in the search for ‘traditional’ herbs to treat a particular modern syndrome it is essential to contextualise remedies, including as far as possible the intertextual, social, cultural, and gender context, and conditions of practice. Historical ethnopharmacology adds a level of subtlety and complexity to over-simplistic attempts at bioprospecting. Some insights that emerged from this historical review could inform the proposed clinical trial but these have had to be filtered through the constraints of modern regulatory procedures. Further research is required on how best to integrate the wealth of data that exists in historical texts with the desire to produce effective herbal products for the modern world. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: We aim to evaluate the feasibility of, and pilot procedures for, a randomised study in the UK administering Chinese herbal medicine (CHM) to women with polycystic ovary syndrome (PCOS) related oligo- and/or amenorrhoea. Our primary aim of this feasibility study is to evaluate how appropriate oligo- and amenorrhoea is as the primary outcome of the main study. Methods: A prospective, multi-centre, randomised, patient- and practitioner-blind, feasibility and pilot study will be conducted. 40 women with PCOS-related oligo- and/or amenorrhoea will be randomised to one of two parallel arms comparing standardised CHM treatment against individualised CHM treatment as usual for 6 months. Participants will be prescribed 8g of CHM granulated extracts twice daily, totalling 16g per day. Feasibility will be determined by collecting data on menstrual regularity, body mass index, waist hip ratio, weight, Polycystic Ovary Syndrome Questionnaire, Measure Yourself Medical Outcome Profile, Dermatology Life Quality Index, Morisky Medication Adherence Scale, modified Ferriman–Gallwey scale, liver and kidney function, practitioner-blinding questionnaire and participant feedback forms. Process data will also inform feasibility such as recruitment rate, completion rate and reasons for dropout. Statistical analysis will be piloted in this study. We will present descriptive statistics for primary and secondary variables and use analysis of variance and Chi-squared tests where appropriate. Results and conclusion: This study received ethical approval in December 2012. 40 participants were recruited between January 2013 and August 2013 and the study is expected to complete in March 2014. [Copyright &y& Elsevier]

Abstract: As part of the GP-TCM project a team of experienced clinical researchers and Chinese herbal, medicine (CHM) practitioners have developed clinical trial guidelines for CHM that combine an, appreciation for traditional methods of practice with detailed and practical advice on rigorous research, methodology. This paper presents the full account of this work that has previously only been published, as an executive summary. It introduces the practice of CHM and the key considerations that need to be, addressed whilst researching this traditional medical system. These guidelines emphasise the, importance of identifying best practice, and then developing and applying appropriate and rigorous, research methodologies to investigate CHM as a whole system. It is hoped that this will encourage a, thoughtful and meticulous process of investigation that will clarify the contribution that CHM can make, to our future healthcare. Innovative new approaches are considered including the application of the, new “omic” technologies and systems biology as a way of enhancing our understanding of traditional, practice. This article belongs to the Special Issue: Clinical Guidelines for Integrated Practice. [Copyright &y& Elsevier]

Abstract: Background: There is a need to develop an evidence base for Chinese herbal medicine (CHM) that is both rigorous and reflective of good practice. This paper proposes a novel methodology to test individualised herbal decoctions using a randomised, double blinded, placebo controlled clinical trial. Method: A feasibility study was conducted to explore the role of CHM in the treatment of endometriosis. Herbal formulae were pre-cooked and dispensed as individual doses in sealed plastic sachets. This permitted the development and testing of a plausible placebo decoction. Participants were randomised at a distant pharmacy to receive either an individualised herbal prescription or a placebo. Results: The trial met the predetermined criteria for good practice. Neither the participants nor the practitioner-researcher could reliably identify group allocation. Of the 28 women who completed the trial, in the placebo group (n =15) 3 women (20%) correctly guessed they were on placebo, 8 (53%) thought they were on herbs and 4 (27%) did not know which group they had been allocated to. In the active group (n =13) 2 (15%) though they were on placebo, 8 (62%) thought they were on herbs and 3 (23%) did not know. Randomisation, double blinding and allocation concealment were successful and the study model appeared to be feasible and effective. Conclusion: It is now possible to subject CHM to rigorous scientific scrutiny without compromising model validity. Improvement in the design of the placebo using food colourings and flavourings instead of dried food will help guarantee the therapeutic inertia of the placebo decoction. [Copyright &y& Elsevier]

Abstract: Background: Non-small cell lung cancer (NSCLC) remains a major global health problem because of its prevalence and poor prognosis. Treatment options are limited and there is a need to explore alternatives. This systematic review evaluates the role of Chinese herbal medicine (CHM) in association with chemotherapy for NSCLC. Methods: English and Chinese databases were searched for RCTs comparing CHM with conventional biomedical treatment or placebo. Papers were reviewed systematically and data were analysed using standard Cochrane software Revman 5. Results: Fifteen Chinese trials involving 862 participants met the inclusion criteria. All trials were of poor quality with a considerable risk of bias. There was a significant improvement in quality of life (QoL) (increased Karnofsky Performance Status) (RR 1.83, 95% CI 1.41–2.38, p <0.00001 for both stages III, IV only NSCLC and all stages NSCLC) and less anaemia (RR 0.37, 95% CI 0.15–0.91, p =0.03 for stages III, IV only NSCLC; p =0.005 for all stages NSCLC) and neutropenia (RR 0.42, 95% CI 0.22–0.82, p =0.01 for stages III, IV only NSCLC; p <0.00001 for all stages NSCLC) when CHM is combined with chemotherapy compared to chemotherapy alone. There was no significant difference in short term effectiveness and limited inconclusive data concerning long term survival. Five promising herbs have been identified. Conclusion: It is possible that oral CHM used in conjunction with chemotherapy may improve QoL in NSCLC. This needs to be examined further with more rigorous methodology. [Copyright &y& Elsevier]

Abstract: Background: Recurrent urinary tract infections (RUTIs) are common in women and are associated with considerable morbidity and health care costs. Antibiotic prophylaxis is currently successful but infections commonly reoccur and bacterial resistance is an increasing problem. Preliminary data suggests that Chinese herbal medicine (CHM) may have a role to play in managing RUTIs. CHM is a complex intervention that requires a thoughtful process of evaluation and testing. A prospective case series can be used to report ‘real world’ treatment using CHM and to investigate the feasibility of more rigorous research. Methods: Fifteen women with RUTIs seen in routine clinical care by an experienced practitioner over a 6-month period were enrolled in a prospective case series. Treatment involved concentrated CHM powders for 12 weeks. Data was collected on common patterns of presentation, and participant response to CHM including compliance, overall changes in urinary tract symptoms, the frequency and severity of recurrent infection; change in use of antibiotics; and wellbeing. Results: Thirteen out of 14 participants who completed the course of treatment reported improvement in their symptoms and overall wellbeing. Antibiotic use declined. It was possible to detect common diagnostic patterns. Conclusion: A case series can explore the routine delivery of an intervention and provide information on feasibility for future research. It provided a useful opportunity to introduce case record forms, to assess various outcome measures, to gain an idea of common diagnostic presentations, to assess the safety of CHM, and to explore different treatment strategies. It facilitated the identification of commonly used herbs in the treatment of RUTIs (Fig. 2) and allowed preliminary assessment of a standardised herbal formula for treatment of an acute UTI. However a case series lacks experimental rigour and is subject to considerable bias. The findings from this approach should be interpreted cautiously and seen as preliminary data that can help to inform subsequent more rigorous research. [Copyright &y& Elsevier]

Abstract: Background: The clinical use of Chinese herbal medicine granules is gradually increasing. However, there is still no systematic review comparing the effectiveness and safety of granules with the more traditional method of herbal decoctions. Method: A literature search was conducted using China National Knowledge Infrastructure Databases (CNKI), Chinese Science and Technology Periodical Database (VIP), China Biomedical Database web (CBM), Wanfang Database, PubMed, and the Cochrane Library until March 10, 2011. Clinical controlled trials (CCTs) including randomized trials (RCTs) comparing the effectiveness and safety between Chinese herbal medicine granules and decoction were included. Two authors conducted the literature searches, and extracted data independently. The assessment of methodological quality of RCTs was based on the risk of bias from the Cochrane Handbook, and the main outcome data of trials were analyzed by using RevMan 5.0 software. Risk ratio (RR) or mean difference (MD) with a 95% confidence interval (CI) were used as effect measure. Results: 56 clinical trials (n =9748) including 42 RCTs and 14 CCTs were included, and all trials were conducted in China and published in Chinese literature. 40 types of diseases and 15 syndromes of traditional Chinese medicine (TCM) were reported. Granules were provided by pharmaceutical companies in 13 trials. The included RCTs were of generally low methodological quality: 7 trials reported adequate randomization methods, and 2 of these reported allocation concealment. 10 trials used blinding, of which 5 trials used placebo which were delivered double blind (blinded participants and practitioners). 98.2% (55/56) of studies showed that there was no significant statistical difference between granules and decoctions of Chinese herbal medicine for their effectiveness. No severe adverse effects in either group were reported. Conclusions: Due to the poor methodological quality of most of the included trials, it is not possible to reach a definitive conclusion whether both Chinese herbal medicine granules and decoctions have the same degree of effectiveness and safety in clinical practice, but this preliminary evidence supports the continued use of granules in clinical practice and research. Standardization of granules and further more rigorous pharmacological, toxicological and clinical studies are needed to demonstrate the equivalence with decoctions. [Copyright &y& Elsevier]