OBJECTIVES:To evaluate the Royal London Hospital for Integrated Medicine (RLHIM) multicomponent fibromyalgia service.METHODS:Mixed methods approach consisting of the completion of validated quantitative outcome measures (Patient Health Questionnaire-9; Generalised Anxiety Disorder-7; Pain Catastrophising Scale; Patient Self-Efficacy Questionnaire) pre- and post-treatment to explore the impact of treatment; and qualitative focus groups with patients at their follow-up appointments to explore patients' experiences and perspectives on the service.RESULTS:138 fibromyalgia patients attended the RLHIM group fibromyalgia service during the period of the evaluation. Baseline scores demonstrate that patients were significantly impaired pre-treatment according to all outcome measures. At the end of the course of treatment, scores for all outcome measures showed clinically and statistically significant improvements. These improvements were maintained at both 6- and 9-month follow-up appointments. Qualitative analysis indicated that those participating valued the multicomponent treatment approach, and perceived the service as having a positive impact on their fibromyalgia and overall quality of life, enabling patients to effectively manage their condition.CONCLUSIONS:Patients attending the RLHIM multicomponent fibromyalgia service appear to have demonstrable improvements in presenting symptoms, and quality of life. The findings support a multicomponent approach to the treatment of fibromyalgia.

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a heterogeneous condition of unknown aetiology characterized by multiple symptoms including fatigue, post-exertional malaise and cognitive impairment, lasting for at least 6 months. Recently, two clinical trials of B cell depletion therapy with rituximab (anti-CD20) reported convincing improvement in symptoms. A possible but undefined role for B cells has therefore been proposed. Studies of the relative percentages of B cell subsets in patients with ME/CFS have not revealed any reproducible differences from healthy controls (HC). In order to explore whether more subtle alterations in B cell subsets related to B cell differentiation exist in ME/CFS patients we used flow cytometry to immunophenotype CD19⁺ B cells. The panel utilized immunoglobulin (Ig)D, CD27 and CD38 (classical B cell subsets) together with additional markers. A total of 38 patients fulfilling Canadian, Centre for Disease Control and Fukuda ME/CFS criteria and 32 age- and sex-matched HC were included. We found no difference in percentages of classical subsets between ME/CFS patients and HC. However, we observed an increase in frequency (P < 0·01) and expression (MFI; P = 0·03) of CD24 on total B cells, confined to IgD⁺ subsets. Within memory subsets, a higher frequency of CD21⁺ CD38⁻ B cells (> 20%) was associated with the presence of ME/CFS [odds ratio: 3·47 (1·15-10·46); P = 0·03] compared with HC, and there was a negative correlation with disease duration. In conclusion, we identified possible changes in B cell phenotype in patients with ME/CFS. These may reflect altered B cell function and, if confirmed in other patient cohorts, could provide a platform for studies based on clinical course or responsiveness to rituximab therapy.

Objectives: To determine the non-inferiority of placebo Individualised Western Herbal Medicine (IWHM) tinctures compared with true IWHM tinctures.Design: Randomised double blind comparability study.Setting: Pharmacy department of an NHS integrated medicine hospital.Interventions: The IWHM intervention consisted of mixed tinctures of five herbs from a list of eleven herbs for which chronic knee pain is an established indication. Placebo IWHM tinctures contained food and colouring extracts, designed to mimic as closely as possible the taste, smell and appearance of true IWHM.Main outcome measures: The primary outcome of the study was the proportion of patients who indicated that they believed they were taking true IWHM. Secondary outcomes included the palatability of the true and placebo tinctures.Results: 64% of the placebo group indicated that they believed they had consumed true IWHM, compared with 60% of the true IWHM group. The palatability of the placebo IWHM was also acceptable to participants, and similar to the palatability of true IWHM.Conclusions: The findings from the present study indicate that the placebo tinctures were non-inferior to the true IWHM tinctures in terms of participants' ability to correctly identify them as herbal tinctures by their taste, smell and appearance. The placebo tinctures could be utilised in future double blind, placebo controlled randomised trials of IWHM (C) 2013 Published by Elsevier Ltd.

Primary Objective . To test the hypothesis that two injections of enzyme-potentiated mosquito antigen significantly reduce the size of experimental mosquito bites in participants with LLR-MB. Design . Randomised, double-blind, placebo-controlled, parallel group comparison over 3 months. Setting . Hospital outpatient clinic. Participants . Fifty adult participants of both sexes. Interventions . Two injections of mosquito antigen or matching placebo, 6 weeks apart. Main Outcome Measures . Early (1 hour) and late (24 hours) mean square root of erythema area (SREA) following controlled mosquito bite with the second bite given at least 6 weeks following the final injection. Results . At 1 hour, mean SREA was slightly higher in the EPD group compared to placebo after adjusting for baseline values (0.46, 95% CI −6.11 to 7.03), but this was not statistically significant ( P = 0.89, ANCOVA analysis); neither were the results at 24 hours (−2.58, 95% CI −11.73 to 6.57) ( P = 0.57). The proportion of participants experiencing a decrease in wheal size at 1 or 24 hours was similar between groups. Conclusions . EPD was not demonstrated to be effective for immediate or delayed LLR-MB. Methodological problems included a high variability in LLR-MB between subjects, suggesting that a crossover design should be used in future.

Introduction: Patients with chronic fatigue syndrome (CFS) may be at risk of osteoporosis due to their relative lack of physical activity and excessive time spent indoors, leading to reduced vitamin D synthesis. We hypothesized that serum 25-OH vitamin D levels are lower in CFS patients than in the general British population. Subjects and methods: We performed a retrospective survey of serum 25-OH vitamin D levels in 221 CFS patients. We compared this to a group of patients attending the hospital for other chronic conditions and to a large British longitudinal survey of 45-year old women, using a variety of appropriate statistical approaches. Results: 25-OH vitamin D levels are moderately to severely suboptimal in CFS patients, with a mean of 44.4 nmol/L (optimal levels >75 nmol/L). These levels are lower and the difference is statistically significant (p<0.0004) than those of the general British population from a recent national survey, but similar to those in patients with other chronic conditions. Conclusions: This data supports the recommendation made in recent NICE guidelines that all patients with moderate to severe CFS should be encouraged to obtain adequate sun exposure and eat foods high in vitamin D. Oral or intramuscular vitamin D supplementation should be considered for those whose levels remain suboptimal.

BACKGROUND:Homeopathic medicines are used by patients with cancer, often alongside conventional treatment. Cancer treatments can cause considerable morbidity and one of the reasons patients use homeopathic medicines is to help with adverse effects. OBJECTIVES:Evaluate effectiveness and safety of homeopathic medicines used to prevent or treat adverse effects of cancer treatments. SEARCH STRATEGY:The following were searched up to November 2008: Cochrane PaPaS Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; CINAHL; BNI; CancerLIT; AMED; CISCOM; Hom-Inform; SIGLE; National Research Register; Zetoc; www.controlled-trials.com; http://clinicaltrials.gov; Liga Medicorum Homeopathica Internationalis (LMHI, Liga) conference proceedings; reference lists of relevant studies were checked; and homeopathic manufacturers, leading researchers and practitioners were contacted. SELECTION CRITERIA:Randomised controlled trials (RCTs) of homeopathic medicines in participants with a clinical or histological diagnosis of cancer where the intervention was aimed at preventing or treating symptoms associated with cancer treatments. All age groups, and all stages of disease were included. DATA COLLECTION AND ANALYSIS:Two review authors independently assessed studies for inclusion and two review authors extracted data. Three review authors independently assessed trial quality using the Delphi List and the Cochrane Collaboration's tool for assessing risk of bias. Disagreements were resolved by consensus. Where available, data were extracted for analysis. MAIN RESULTS:Eight controlled trials (seven placebo controlled and one trial against an active treatment) with a total of 664 participants met the inclusion criteria. Three studied adverse effects of radiotherapy, three studied adverse effects of chemotherapy and two studied menopausal symptoms associated with breast cancer treatment.Two studies with low risk of bias demonstrated benefit: one with 254 participants demonstrated superiority of topical calendula over trolamine (a topical agent not containing corticosteroids) for prevention of radiotherapy-induced dermatitis, and another with 32 participants demonstrated superiority of Traumeel S (a proprietary complex homeopathic medicine) over placebo as a mouthwash for chemotherapy-induced stomatitis. Two other studies reported positive results, although the risk of bias was unclear, and four further studies reported negative results.No serious adverse effects or interactions were reported attributable to the homeopathic medicines used. AUTHORS' CONCLUSIONS:This review found preliminary data in support of the efficacy of topical calendula for prophylaxis of acute dermatitis during radiotherapy and Traumeel S mouthwash in the treatment of chemotherapy-induced stomatitis. These trials need replicating. There is no convincing evidence for the efficacy of homeopathic medicines for other adverse effects of cancer treatments. Further research is required.

As the only NHS hospital consultant specialising in herbal medicine, I found that the article by Ikram et al displayed a second paradox apparently unrecognised by the authors. …

Recent research has established the efficacy, effectiveness and cost effectiveness of acupuncture for some forms of chronic musculoskeletal pain. However, there are practical problems with delivery which currently prevent its large scale implementation in the National Health Service. We have developed a delivery model at our hospital, a ‘high volume’ acupuncture clinic (HVAC) in which patients are treated in a group setting for single conditions using standardised or semi-standardised electroacupuncture protocols by practitioners with basic training. We discuss our experiences using this model for chronic knee pain and present an outcome audit for the first 77 patients, demonstrating satisfactory initial (eight week) clinical results. Longer term (one year) data are currently being collected and the model should next be tested in primary care to confirm its feasibility.

Background: An effectiveness gap (EG) is an area of clinical practice in which available treatments are not fully effective. EGs have not been previously researched. Complementary and alternative medicine (CAM) interventions, by definition, are not generally available through normal health care channels. Therefore, if effective, they have the potential to increase achieved community effectiveness. Aims: A pilot study to determine whether EGs exist, and if so to provide initial data on their nature, frequency, and causes. To obtain preliminary data on whether CAM may offer effective interventions in these clinical areas. Design: Semistructured telephone interviews; literature search. Setting: Twenty-two (22) general practitioners (GPs) in London, U.K. Method: One hundred and fifty-two (152) doctors who had responded to an earlier survey on attitudes to CAM were approached. Respondents were asked to specify EGs and to give reasons why available treatment is unsatisfactory and to estimate the frequency and severity of clinical problems relating to EGs. Sampling was continued to redundancy. A bibliometric study examined the volume and type of published evidence on the effectiveness of CAM interventions in the identified clinical areas. Results: There was good concordance among respondents on EGs encountered in general/family practice. Seventy-eight (78) clinical problems were cited. EGs are encountered quite frequently: 68 of 78 (85%) of EGs were encountered at least once per month. Musculoskeletal problems were cited by 20 of 22 (90%) of respondents as being affected by EGs. Depression, eczema, chronic pain, and irritable bowel syndrome were also frequently mentioned. Systematic reviews and meta-analyses conclude that there is evidence for the effectiveness of various CAM interventions in most of these areas. Conclusions: EGs, mapped against evidence, have the potential to inform service development and research policy. Further study should be undertaken: it should incorporate improved sampling and data collection methodology. Specifically, where effective CAM interventions exist but are not being applied, EGs form part of the "avoidable burden of illness" identified by early work on evidence-based medicine. Practice guidelines should incorporate CAM interventions where there is evidence. The CAM research agenda should focus on areas affected by EGs.

T Brendler, J Grünwald, C Jänicke (eds) Phytopharm Consulting GmbH, Medpharm Scientific Publishers, Stuttgart, 2001 - www.herb-cd.com Price: € 77, ISBN: 3887630920 Runs on MS-Windows-95, 98, NT, 2000 System requirements PC, at least 64 MB RAM, 800×600 pixels

Weiss’s Classic Edition is a reprint of the 6th German edition, written in 1985, in its authorized translation. Weiss, a qualified doctor and ‘founding father’ of modern German phytotherapy, retired in 1961 and devoted his later years to increasing the scientific acceptability of herbal medicine. This included his contribution to the influential German Commission E monographs and this textbook, a summary of his lectures at the Berlin Academy for Postgraduate Medical Teaching from 1937 onwards. Having uniquely provided an introduction to herbal medicine to qualified doctors for two decades, the book has, inevitably, been superceded in both content and form, and is now largely of historical interest. The opening ‘Principles’ section contains three chapters. An introductory chapter contains a useful classification of herbal medicines into gentle, intermediate and powerful, which is referred to throughout the book. Then follows a chapter dealing with types of evidence, which stresses the validity of observation and experience besides the research approach to herbal knowledge. The chapter on prescribing guidelines restricts itself to a few rules for making up compound prescriptions and a list of the commonest types of preparations. Overall, this section is far too sketchy. There is no discussion of the history of herbalism and its various traditions, the possible methodologies, or the classes of active constituents. Some of the latter are found scattered throughout the book under specific herbs but others are not explained at all, and where complex chemical structures are discussed they are rarely illustrated. With the exception of a short discussion on carcinogens, the potential adverse effects and interactions of herbs, both with each other and with orthodox medications are inadequately dealt with. The same can be said of the issues of dosage. The remaining 14 chapters go through the organ systems one by one, with their major herbal remedies. Some are obsolete for modern practice, particularly where the powerful herbs are concerned, such as the use of belladonna for abdominal spasm, intravenous strophanthin for heart failure, and mistletoe for hypertension. The bulk of the text covers the gentle and intermediate herbs and is more relevant. Weiss’s emphasis on the use of only two or three major herbs for each system is to be commended. Each chapter concludes with a series of examples of relevant prescriptions, with precise instructions on administration. However, the units of proportion used are not explained and the strengths of his tinctures are not specified. In general, the text is frustratingly unstructured, with little highlighting and no consistent system of headings for indications, adverse effects, etc. The recent acceleration of research in herbal medicine renders the book in many places out of date. For instance, there is no reference to research on Ginkgo for dementia or St. John’s Wort for depression but conversely, herbs propounded by Weiss as effective have since been withdrawn due to adverse effects, such as Rauwolfia for hypertension and Khella for asthma. Reference to contemporary medical practice is also anachronistic, such as the lack of effective orthodox antihypertensive and asthma drugs, the widespread use of potentially dangerous class I antiarrhythmics, and obsolete diagnostic categories such as ‘ptosis of the stomach’. Such considerations influence the therapeutics of at least one-quarter of the book, making it unlikely to appeal to modern physicians. Weiss’s professed aim to base the book ‘entirely on scientifically confirmed facts’, a landmark notion at the time, is backed up by reference to much contemporary research. However, major inconsistencies are apparent. Data from animal experiments is used to confirm empirical observation, yet rejected as inappropriate where it shows no effect. There are references to ‘positive’ clinical trials involving only five patients, yet barely any to ‘negative’ research, and much mention of other authors’ positive single-case anecdotes as ‘bibliographic’ proof. To his credit, Weiss does dismiss traditional indications where they have proved false (such as Sticta pulmonaris (lungwort) for cough). The referencing system is poor, with no numbers in the text, erratic mention of authors, and such references as are present (without titles) are lumped in a large mass of text at the end of each chapter subheading. In general, his use of research data does not meet today’s standards of rigorous critical appraisal. Other drawbacks are inevitable consequences of translated texts. The proprietary products recommended by Weiss are all German, and unlikely to be available in this country. Reference to contemporary medical practice is based on that in Germany, and Weiss exhibits a bias against ‘foreign’ herb species not growing locally, such as ginger. There are constant references to the German, Swiss and Austrian Pharmacopeias, which will not necessarily be helpful to English readers, and the research papers referred to are mostly German. Despite its many defects, the book contains much of value. Weiss brings his love of the subject and his lengthy personal experience fully to bear. The intimate, chatty style, familiar to readers of homeopathic texts, is punctuated with many practical tips. Examples include a recipe for elderflower juice, the combination of bilberry juice with Quark (soft cheese) to increase its

OBJECTIVE:To determine the extent to which two homeopaths agree on whether symptoms reported by patients in a proving are possibly associated with Mercurius solubilis.DESIGN:Blinded, inter-rater reliability study.PARTICIPANTS:104 subjects in a randomised, double-blind mercury proving.OUTCOME MEASURES:557 symptom episodes spontaneously reported by subjects were classified as 'mercury' or 'not mercury' by two homeopaths working blind to each other's conclusions and to patient allocation.RESULTS:Initial agreement between homeopaths was 70.2%, a kappa of 0.39, (95% CI 0.31, 0.47). Some disagreements appear to have resulted from differing interpretations of the study instructions. After suitable correction, agreement was 76.5% and kappa 0.56 (95% CI 0.49, 0.63).CONCLUSIONS:The study homeopaths had only a moderate level degree of agreement greater than that expected by chance. The main factor seems to have been differences between data from different sources. There is an urgent need for more research on the methods of choosing homoeopathic medicines in order to improve the reliability and validity of homoeopathic diagnoses.

The objective of the study was to reduce the amount of imported grain in fattening diets based on maize silage by the use of high ear content varieties of maize and by abandoning the lower, less nutritious 60 cm of the stover.