'It's helped me to learn to deal with it': a mixed methods service evaluation of a multicomponent fibromyalgia service.

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.

A double-blind, randomised trial of a polyphenolic-rich nail bed balm for chemotherapy-induced onycholysis: the UK polybalm study.

PURPOSE: Nail damage is common amongst patients receiving chemotherapy causing disfigurement and pain. This investigation evaluated whether a topical balm containing steam-extracted, bioactive polyphenolic-rich herbal oils blended with organic waxes could protect the nails via their reported anti-inflammatory, analgesic, anti-oxidant and anti-microbial properties. METHODS: 60 patients (23M, 37F) were randomised to apply (2-3/day) either the plant balm (PB) or a petroleum control (PC) to their nail beds. Demographics, type and number of chemotherapy cycles did not differ between the two groups, recruited between Sept 2015 and Sept 2016. An unpaired t test was used to test the differences in symptoms and physical nail damage between the two groups. RESULTS: Symptom scores recorded with the dermatology life quality questionnaire (DLQQ) were significantly better, between the start and end of chemotherapy, in the group applying the PB versus PC. Likewise, the mean fall in nail damage, scored with the Nail Psoriasis Index by the supervising physician, was also significantly different. CONCLUSION: The polyphenolic-rich essential oils and plant-based waxes in this nail bed balm profoundly reduced chemotherapy-related nail damage and improved nail-related quality of life, compared to a control. A further analysis is planned combining this balm with nail bed cooling.

Homeopathic medicines for adverse effects of cancer treatments.

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.

Serum 25-hydroxy vitamin D levels in chronic fatigue syndrome: a retrospective survey.

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.

Towards standard setting for patient-reported outcomes in the NHS homeopathic hospitals.

INTRODUCTION: We report findings from a pilot data collection study within a programme of quality assurance, improvement and development across all five homeopathic hospitals in the UK National Health Service (NHS). AIMS: (1) To pilot the collection of clinical data in the homeopathic hospital outpatient setting, recording patient-reported outcome since first appointment; (2) to sample the range of medical complaints that secondary-care doctors treat using homeopathy, and thus identify the nature and complexity of complaints most frequently treated nationally; (3) to present a cross section of outcome scores by appointment number, including that for the most frequently treated medical complaints; (4) to explore approaches to standard setting for homeopathic practice outcome in patients treated at the homeopathic hospitals. METHODS: A total of 51 medical practitioners took part in data collection over a 4-week period. Consecutive patient appointments were recorded under the headings: (1) date of first appointment in the current series; (2) appointment number; (3) age of patient; (4) sex of patient; (5) main medical complaint being treated; (6) whether other main medical complaint(s); (7) patient-reported change in health, using Outcome Related to Impact on Daily Living (ORIDL) and its derivative, the ORIDL Profile Score (ORIDL-PS; range, -4 to +4, where a score or=+2 indicates an effect on the quality of a patient's daily life); (8) receipt of other complementary medicine for their main medical complaint. RESULTS: The distribution of patient age was bimodal: main peak, 49 years; secondary peak, 6 years. Male:female ratio was 1:3.5. Data were recorded on a total of 1797 individual patients: 195 first appointments, 1602 follow-ups (FUs). Size of clinical service and proportion of patients who attended more than six visits varied between hospitals. A total of 235 different medical complaints were reported. The 30 most commonly treated complaints were (in decreasing order of frequency): eczema; chronic fatigue syndrome (CFS); menopausal disorder; osteoarthritis; depression; breast cancer; rheumatoid arthritis; asthma; anxiety; irritable bowel syndrome; multiple sclerosis; psoriasis; allergy (unspecified); fibromyalgia; migraine; premenstrual syndrome; chronic rhinitis; headache; vitiligo; seasonal allergic rhinitis; chronic intractable pain; insomnia; ulcerative colitis; acne; psoriatic arthropathy; urticaria; ovarian cancer; attention-deficit hyperactivity disorder (ADHD); epilepsy; sinusitis. The proportion of patients with important co-morbidity was higher in those seen after visit 6 (56.9%) compared with those seen up to and including that point (40.7%; P<0.001). The proportion of FU patients reporting ORIDL-PS>or=+2 (improvement affecting daily living) increased overall with appointment number: 34.5% of patients at visit 2 and 59.3% of patients at visit 6, for example. Amongst the four most frequently treated complaints, the proportion of patients that reported ORIDL-PS>or=+2 at visit numbers greater than 6 varied between 59.3% (CFS) and 73.3% (menopausal disorder). CONCLUSIONS: We have successfully piloted a process of national clinical data collection using patient-reported outcome in homeopathic hospital outpatients, identifying a wide range and complexity of medical complaints treated in that setting. After a series of homeopathy appointments, a high proportion of patients, often representing "effectiveness gaps" for conventional medical treatment, reported improvement in health affecting their daily living. These pilot findings are informing our developing programme of standard setting for homeopathic care in the hospital outpatient context.

High volume acupuncture clinic (HVAC) for chronic knee pain--audit of a possible model for delivery of acupuncture in the National Health Service.

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.

Effectiveness gaps: a new concept for evaluating health service and research needs applied to complementary and alternative medicine.

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.