Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT).

OBJECTIVE: To determine the effect of population level implementation of a test-and-treat approach to correction of suboptimal vitamin D status (25-hydroxyvitamin D (25(OH)D) <75 nmol/L) on risk of all cause acute respiratory tract infection and covid 19. DESIGN: Phase 3 open label randomised controlled trial. SETTING: United Kingdom. PARTICIPANTS: 6200 people aged ≥16 years who were not taking vitamin D supplements at baseline. INTERVENTIONS: Offer of a postal finger prick test of blood 25(OH)D concentration with provision of a six month supply of lower dose vitamin D (800 IU/day, n=1550) or higher dose vitamin D (3200 IU/day, n=1550) to those with blood 25(OH)D concentration <75 nmol/L, compared with no offer of testing or supplementation (n=3100). Follow-up was for six months. MAIN OUTCOME MEASURES: The primary outcome was the proportion of participants with at least one swab test or doctor confirmed acute respiratory tract infection of any cause. A secondary outcome was the proportion of participants with swab test confirmed covid-19. Logistic regression was used to calculate odds ratios and associated 95% confidence intervals. The primary analysis was conducted by intention to treat. RESULTS: Of 3100 participants offered a vitamin D test, 2958 (95.4%) accepted and 2674 (86.3%) had 25(OH)D concentrations <75 nmol/L and received vitamin D supplements (n=1328 lower dose, n=1346 higher dose). Compared with 136/2949 (4.6%) participants in the no offer group, at least one acute respiratory tract infection of any cause occurred in 87/1515 (5.7%) in the lower dose group (odds ratio 1.26, 95% confidence interval 0.96 to 1.66) and 76/1515 (5.0%) in the higher dose group (1.09, 0.82 to 1.46). Compared with 78/2949 (2.6%) participants in the no offer group, 55/1515 (3.6%) developed covid-19 in the lower dose group (1.39, 0.98 to 1.97) and 45/1515 (3.0%) in the higher dose group (1.13, 0.78 to 1.63). CONCLUSIONS: Among people aged 16 years and older with a high baseline prevalence of suboptimal vitamin D status, implementation of a population level test-and-treat approach to vitamin D supplementation was not associated with a reduction in risk of all cause acute respiratory tract infection or covid-19. TRIAL REGISTRATION: ClinicalTrials.gov NCT04579640.

Risk factors for developing COVID-19: a population-based longitudinal study (COVIDENCE UK).

BACKGROUND: Risk factors for severe COVID-19 include older age, male sex, obesity, black or Asian ethnicity and underlying medical conditions. Whether these factors also influence susceptibility to developing COVID-19 is uncertain. METHODS: We undertook a prospective, population-based cohort study (COVIDENCE UK) from 1 May 2020 to 5 February 2021. Baseline information on potential risk factors was captured by an online questionnaire. Monthly follow-up questionnaires captured incident COVID-19. We used logistic regression models to estimate multivariable-adjusted ORs (aORs) for associations between potential risk factors and odds of COVID-19. RESULTS: We recorded 446 incident cases of COVID-19 in 15 227 participants (2.9%). Increased odds of developing COVID-19 were independently associated with Asian/Asian British versus white ethnicity (aOR 2.28, 95% CI 1.33 to 3.91), household overcrowding (aOR per additional 0.5 people/bedroom 1.26, 1.11 to 1.43), any versus no visits to/from other households in previous week (aOR 1.31, 1.06 to 1.62), number of visits to indoor public places (aOR per extra visit per week 1.05, 1.02 to 1.09), frontline occupation excluding health/social care versus no frontline occupation (aOR 1.49, 1.12 to 1.98) and raised body mass index (BMI) (aOR 1.50 (1.19 to 1.89) for BMI 25.0-30.0 kg/m2 and 1.39 (1.06 to 1.84) for BMI >30.0 kg/m2 versus BMI <25.0 kg/m2). Atopic disease was independently associated with decreased odds (aOR 0.75, 0.59 to 0.97). No independent associations were seen for age, sex, other medical conditions, diet or micronutrient supplement use. CONCLUSIONS: After rigorous adjustment for factors influencing exposure to SARS-CoV-2, Asian/Asian British ethnicity and raised BMI were associated with increased odds of developing COVID-19, while atopic disease was associated with decreased odds. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04330599).

Rethinking ADHD intervention trials: feasibility testing of two treatments and a methodology.

Attention deficit hyperactivity disorder (ADHD) is a lifelong condition associated with considerable costs. The long-term effectiveness and acceptability of treatments to improve outcomes remains in doubt. Long-term trials are needed comparing interventions with standard care and each other. The Sheffield Treatments for ADHD Research (STAR) project used the Trials within Cohorts (TwiCs) approach. A cohort of children with ADHD was recruited and outcomes collected from carers and teachers. A random selection was offered treatment by homoeopaths (hom) or nutritional therapists (NT). Their outcomes (Conners Global ADHD Index) were compared with those not offered interventions. The feasibility of the methods and interventions was assessed. The TwiCs approach was feasible with modifications. 144 participants were recruited to the cohort, 83 offered treatment, 72 accepted, and 50 attended 1+ appointments. Results according to carers assessments at 6 months were as follows: t = 1.08, p = .28 (- 1.48, 4.81) SMD .425 (hom); t = 1.71, p = .09 (- .347, 5.89), SMD = .388 (NT). Teachers' responses were too few and unstable. No serious treatment adverse events occurred.Conclusion: the STAR project demonstrated the feasibility of the TwiCs approach for testing interventions for children with ADHD. What is Known: • Attention deficit hyperactivity disorder (ADHD) is a lifelong condition associated with considerable costs to ADHD stakeholders. Children are at risk of negative outcomes and in need of pre-emptive strategies • The long-term effectiveness and acceptability of recommended treatments to improve outcomes remains in doubt What is New: • A small-scale test of the design demonstrated that the Trials within Cohorts (TwiCs) approach is feasible and can make a useful contribution regarding testing the effectiveness of interventions for children with ADHD to improve long-term negative outcomes • Treatment by homoeopaths and nutritional therapists may offer novel opportunities to improve outcomes.

Depressed patients treated by homeopaths: a randomised controlled trial using the "cohort multiple randomised controlled trial" (cmRCT) design.

BACKGROUND: Despite controversy regarding homeopathy, some patients consult homeopaths for depression. Evidence is required to determine whether this is an effective, acceptable and safe intervention for these patients. METHODS: A pragmatic trial using the "cohort multiple randomised controlled trial" design was used to test the effectiveness of adjunctive treatment by homeopaths compared to usual care alone, over a period of 12 months in patients with self-reported depression. One third of patients were randomly selected for an offer of treatment provided by a homeopath. The primary outcome measure was the Patient Health Questionnaire (PHQ-9) at 6 months. Secondary outcomes included depression scores at 12 months; and the Generalised Anxiety Disorder (GAD-7) outcome at 6 and 12 months. RESULTS: The trial over-recruited by 17% with a total of 566 patients. Forty percent took up the offer and received treatment. An intention-to-treat analysis of the offer group at 6 months reported a 1.4-point lower mean depression score than the no offer group (95% CI 0.2, 2.5, p = 0.019), with a small standardized treatment effect size (d = 0.30). Using instrumental variables analysis, a moderate treatment effect size in favour of those treated was found (d = 0.57) with a between group difference of 2.6 points (95% CI 0.5, 4.7, p = 0.018). Results were maintained at 12 months. Secondary analyses showed similar results. Similar results were found for anxiety (GAD-7). No evidence suggested any important risk involved with the intervention. CONCLUSION: This trial provides preliminary support for both the acceptability and the effectiveness of treatment by a homeopath for patients with self-reported depression. Our results provide support for further pragmatic research to provide more precise estimates of treatment effect. TRIAL REGISTRATION: ISRCTN registry, ISRCTN02484593 . Registered on 7 January 2013.

Prevalence of homeopathy use by the general population worldwide: a systematic review.

AIM: To systematically review surveys of 12-month prevalence of homeopathy use by the general population worldwide. METHODS: Studies were identified via database searches to October 2015. Study quality was assessed using a six-item tool. All estimates were in the context of a survey which also reported prevalence of any complementary and alternative medicine use. RESULTS: A total of 36 surveys were included. Of these, 67% met four of six quality criteria. Twelve-month prevalence of treatment by a homeopath was reported in 24 surveys of adults (median 1.5%, range 0.2-8.2%). Estimates for children were similar to those for adults. Rates in the USA, UK, Australia and Canada all ranged from 0.2% to 2.9% and remained stable over the years surveyed (1986-2012). Twelve-month prevalence of all use of homeopathy (purchase of over-the-counter homeopathic medicines and treatment by a homeopath) was reported in 10 surveys of adults (median 3.9%, range 0.7-9.8%) while a further 11 surveys which did not define the type of homeopathy use reported similar data. Rates in the USA and Australia ranged from 1.7% to 4.4% and remained stable over the years surveyed. The highest use was reported by a survey in Switzerland where homeopathy is covered by mandatory health insurance. CONCLUSIONS: This review summarises 12-month prevalence of homeopathy use from surveys conducted in eleven countries (USA, UK, Australia, Israel, Canada, Switzerland, Norway, Germany, South Korea, Japan and Singapore). Each year a small but significant percentage of these general populations use homeopathy. This includes visits to homeopaths as well as purchase of over-the-counter homeopathic medicines.

A comparative consecutive case series of 20 children with a diagnosis of ADHD receiving homeopathic treatment, compared with 10 children receiving usual care.

20 consecutively enrolled children age 5-16 with Attention Deficit Hyperactivity Disorder (ADHD) received treatment by a homeopath (8 consultations and individualized remedies) for one year. Ten subsequently enrolled children received similar time and attention for 4 months. The study explored optimum treatment protocols; the effectiveness, deliverability and acceptability of treatment; and the feasibility of outcome measurement and recruitment. Parents completed Conners' Parent Rating Scale, Revised Long Version ( CPRS-R: L) every 4 months, from which DSMIV total scores were extracted; and Measure Your Own Medical Outcome Profile (MYMOP) every consultation. An interaction between time (baseline/4 months) and group (treatment/non-treatment) was found .756 F (1,28)=9.06, p=0.005. The intervention was associated with statistically significant improvements in treated children over the year: CPRS-R: L (t (18)=4.529, p≤0.000); MYMOP (t (18)=6.938, p≤0.000). Mean DSMIV total t scores decreased at each time point: baseline: 85 (SD 5.1); 4 months 76.2 (SD 10.9); and 12 months 71.5 (SD 12.77). Recruitment of control participants was problematic. Recruitment to treatment was feasible via ADHD support groups, charities, police support agencies and social services, not schools or NHS services. Attending appointments was problematic for some participants, but home visits did not improve uptake. The best venue was a familiar clinic. Some participants took medicines inappropriately, but generally taking homeopathic remedies was acceptable and well implemented. CPRS-R: L (80 items) was problematic for some parents. MYMOP was preferred by parents but not acceptable to stakeholders. In this small consecutive sample the intervention was associated with improvements in criminality, anger and children with a concomitant diagnosis of Autism Spectrum Disorder ASD. Treatment by a homeopath was associated with sustained, increasing improvements and the intervention was acceptable to participants. More methodically rigorous research is warranted. "We recommend that future research in this area uses comparative effectiveness randomised controlled trial designs. We also recommend that these trials measure outcomes of relevance to stakeholder needs - the people and services who care for those with ADHD - parents, teachers and social workers and the criminal justice system".

Encouraging breastfeeding: financial incentives.

The NOSH (Nourishing Start for Health) three-phase research study is testing whether offering financial incentives for breastfeeding improves six-eight-week breastfeeding rates in low-rate areas. This article describes phase one development work, which aimed to explore views about practical aspects of the design of the scheme. Interviews and focus groups were held with women (n = 38) and healthcare providers (n = 53). Overall both preferred shopping vouchers over cash payments, with a total amount of £200-250 being considered a reasonable amount. There was concern that seeking proof of breastfeeding might impact negatively on women and the relationship with their healthcare providers. The most acceptable method to all was that women sign a statement that their baby was receiving breast milk: this was co-signed by a healthcare professional to confirm that they had discussed breastfeeding. These findings have informed the design of the financial incentive scheme being tested in the feasibility phase of the NOSH study.

Healthcare providers' views on the acceptability of financial incentives for breastfeeding: a qualitative study.

BACKGROUND: Despite a gradual increase in breastfeeding rates, overall in the UK there are wide variations, with a trend towards breastfeeding rates at 6-8 weeks remaining below 40% in less affluent areas. While financial incentives have been used with varying success to encourage positive health related behaviour change, there is little research on their use in encouraging breastfeeding. In this paper, we report on healthcare providers' views around whether using financial incentives in areas with low breastfeeding rates would be acceptable in principle. This research was part of a larger project looking at the development and feasibility testing of a financial incentive scheme for breastfeeding in preparation for a cluster randomised controlled trial. METHODS: Fifty-three healthcare providers were interviewed about their views on financial incentives for breastfeeding. Participants were purposively sampled to include a wide range of experience and roles associated with supporting mothers with infant feeding. Semi-structured individual and group interviews were conducted. Data were analysed thematically drawing on the principles of Framework Analysis. RESULTS: The key theme emerging from healthcare providers' views on the acceptability of financial incentives for breastfeeding was their possible impact on 'facilitating or impeding relationships'. Within this theme several additional aspects were discussed: the mother's relationship with her healthcare provider and services, with her baby and her family, and with the wider community. In addition, a key priority for healthcare providers was that an incentive scheme should not impact negatively on their professional integrity and responsibility towards women. CONCLUSION: Healthcare providers believe that financial incentives could have both positive and negative impacts on a mother's relationship with her family, baby and healthcare provider. When designing a financial incentive scheme we must take care to minimise the potential negative impacts that have been highlighted, while at the same time recognising the potential positive impacts for women in areas where breastfeeding rates are low.

Interim results of a randomised controlled trial of homeopathic treatment for irritable bowel syndrome.

Irritable bowel syndrome (IBS) is a chronic condition for which there is no consensus on the optimum treatment. Gastroenterology problems are some of the most common conditions treated by homeopaths, yet few trials have explored the effectiveness of individualised homeopathic treatment for IBS. A three-armed trial was conducted which compared: usual care, homeopathic treatment plus usual care and supportive listening plus usual care. The primary outcome was change in irritable bowel symptom severity score between baseline and 26 weeks, calculated using ANCOVA. An interim ANCOVA adjusted for baseline IBS severity, age and employment status found no statistically significant difference between the three arms. However, a post-hoc test comparing homeopathic treatment plus usual care to usual care alone found a statistically significant difference in favour of homeopathic treatment. In addition, 62.5 percent of patients in the homeopathic treatment arm (compared to 25.0 percent of those in the usual care arm), achieved a clinically relevant change in irritable bowel symptom severity score, which indicates a promising effect for homeopathic treatment, though these results should be interpreted with caution due to the low number of participants in the study.

Depression treated by homeopaths: a study protocol for a pragmatic cohort multiple randomised controlled trial.

BACKGROUND: The most commonly recommended treatments for depression are psychological/psychotherapeutic treatments, and antidepressant drugs. However, 38 percent of patients with depression do not use these recommended treatments. Some patients seek homeopathic treatment for depression, but insufficient evidence exists to conclude as to the effectiveness, cost-effectiveness and safety of treatment by homeopaths for patients with depression. The aim of this trial is to evaluate the acceptability and comparative clinical and cost-effectiveness of the offer of adjunctive treatment provided by homeopaths for patients with self-reported depression. METHOD: This pragmatic randomised controlled trial is embedded within the population based South Yorkshire Cohort (SYC) of whom nine percent self-report long-term depression. The SYC is designed to facilitate 'cohort multiple' randomised controlled trials (cmRCT). A self-completed questionnaire will be used to both screen and collect baseline data from potential trial participants. The primary outcome is PHQ-9. One-hundred-and-sixty-two participants will be randomly selected to the intervention group (Offer of treatment by a homeopath). The results of the Offer and the No Offer groups will be compared at 6 and 12 months using both an intention to treat (ITT) and complier average causal effect (CACE) analysis. Cost-effectiveness analysis will involve calculation of quality adjusted life year (QALY). In order to help interpret the quantitative findings a selection of up to 30 patients in the offer group will be invited to participate in qualitative interviews after the first consultation and after a minimum of 6 months. Interviews will be assessed by two researchers and results will be analysed using thematic analysis. Triangulation will be used to combine results from qualitative and quantitative methodologies at the interpretation stage, to see if results agree, offer complementary information on the same issue or contradict each other.

Prevalence of visits to massage therapists by the general population: a systematic review.

OBJECTIVE: To systematically review 12-month prevalence of visits to massage therapists by representative samples of the general population across countries. METHODS: Surveys reporting estimates of overall CAM use were included. Studies were identified via database searches. Study quality was assessed using a six-item tool. RESULTS: Twenty-two surveys across six countries were included. Estimates for 12-month prevalence of visits to massage therapists by adults ranged from 0.4% to 20% and the median was 5.5%. Estimates for children were 0.3%-3.8% (median 0.7%), while estimates for older adults were 1.5%-16.2% (median 5.2%). 16 surveys (73%) met at least four of six quality criteria. CONCLUSIONS: This review summarises 12-month prevalence of visits to massage therapists in six countries (USA, UK, Canada, Australia, Singapore and South Korea). A small but significant percentage of these general populations visit massage therapists each year.

Prevalence of visits to five types of complementary and alternative medicine practitioners by the general population: a systematic review.

OBJECTIVE: To systematically review surveys of 12-month prevalence of visits to complementary and alternative medicine (CAM) practitioners for five therapies: acupuncture, homeopathy, osteopathy, chiropractic, and medical herbalism. METHODS: Studies were identified via database searches to 2011. Study quality was assessed using a six-item tool. RESULTS: Forty-one surveys across 12 countries were included. Twenty-five (61%) met four of six quality criteria. Prevalence of visits by adults were (median, range): acupuncturists 1.4% (0.2-7.5%, N = 27 surveys), homeopaths 1.5% (0.2-2.9%, N = 20 surveys), osteopaths 1.9% (0.2-4.4%, N = 9 surveys), chiropractors 7.5% (0.3-16.7, N = 33 surveys), medical herbalists 0.9% (0.3-4.7%, N = 14 surveys). Estimates were slightly lower for children and higher for older adults. There was little change over the past 15-20 years. CONCLUSIONS: This review summarises 12-month prevalence of visits to CAM practitioners in Europe, North America, Australia, East Asia, Saudi Arabia and Israel. A small but significant percentage of these general populations visit CAM practitioners each year.

Implications of the 'placebo effect' for CAM research.

The 'placebo effect' concept is intrinsic to the architecture of the double blind placebo randomised controlled trial (RCT), the oft quoted 'gold standard' method of clinical research whose findings are supposed to inform our understanding of the interventions used in clinical practice. The 'placebo effect' concept is often used in discussions of both clinical practice and clinical research, particularly when discussing why patients report improvements with complementary and alternative medicines (CAMs). Despite its frequent use, 'placebo effect' is a non-sequitur, thus confusion abounds. In routine healthcare patients are not told that they might receive placebo. However, in clinical trials the opposite is true. Telling people that they might receive a placebo really complicates things. The uncertainty invoked by information that a placebo may be given can impact trial recruitment, the delivery of the intervention, and the reporting of outcomes, as can the 'meaning responses' invoked by other types of information provided to patients in standard RCT designs. Future CAM research should consider alternative RCT designs that help ensure that participants' experiences are uncontaminated by 'meaning responses' to information that they may receive fake treatments, i.e. placebos.

A protocol for a trial of homeopathic treatment for irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome is a chronic condition with no known cure. Many sufferers seek complementary and alternative medicine including homeopathic treatment. However there is much controversy as to the effectiveness of homeopathic treatment. This three-armed study seeks to explore the effectiveness of individualised homeopathic treatment plus usual care compared to both an attention control plus usual care and usual care alone, for patients with irritable bowel syndrome. METHODS/DESIGN: This is a three-armed pragmatic randomised controlled trial using the cohort multiple randomised trial methodology. Patients are recruited to an irritable bowel syndrome cohort from primary and secondary care using GP databases and consultants lists respectively. From this cohort patients are randomly selected to be offered, 5 sessions of homeopathic treatment plus usual care, 5 sessions of supportive listening plus usual care or usual care alone. The primary clinical outcome is the Irritable Bowel Syndrome Symptom Severity at 26 weeks.From a power calculation, it is estimated that 33 people will be needed for the homeopathic treatment arm and 132 for the usual care arm, to detect a minimal clinical difference at 80 percent power and 5 percent significance allowing for loss to follow up. An unequal group size has been used for reasons of cost. Analysis will be by intention to treat and will compare homeopathic treatment with usual care at 26 weeks as the primary analysis, and homeopathic treatment with supportive listening as an additional analysis. DISCUSSION: This trial has received NHS approval and results are expected in 2013. TRIAL REGISTRATION: Current Controlled Trials ISRCTN90651143.

The 'Pounds for Pounds' weight loss financial incentive scheme: an evaluation of a pilot in NHS Eastern and Coastal Kent.

BACKGROUND: Financial incentive programmes have the potential to modify health-related behaviours, including those associated with achieving weight loss. This study evaluated a pilot NHS commissioned financial incentive weight loss programme, based on the commercial Weight Wins 'Pounds for Pounds' programme. METHODS: Participants chose a weight loss plan based on their target weight. Plans ranged from 15 lb (6.8 kg) weight loss over 3 months to 50 lb (22.7 kg) weight loss over 7 months, with optional additional 'maintenance' periods. Rewards, which were received after successful plan completion, ranged from £70 to £425 per year. RESULTS: Mean baseline weight for the 402 participants was 101.8 kg (SD 46.1 kg), with 77.4% having a BMI ≥30 kg/m(2). Clinically significant weight loss (≥5%) occurred in 44.8% [95% confidence interval (CI): 40.0-49.7%] of participants. Estimated mean weight loss at 12 months was 4.0 kg (95% CI: 2.4-5.6 kg) under the assumption of return-to-baseline weight for those who had left the programme before reporting a 12 month weight. CONCLUSIONS: The estimated mean 12 month weight loss of 4.0 kg at 12 months is comparable to other evaluations of other non-medical weight loss interventions. A randomized controlled trial is required to evaluate the clinical and cost-effectiveness of this financial incentive scheme.

Homeopathy for insomnia: a systematic review of research evidence.

BACKGROUND: Insomnia is a common problem which impacts on quality of life. Current management includes psychological and behavioural therapies and/or pharmacological treatments. OBJECTIVE: To systematically review research evidence for effectiveness of homeopathy in the management of insomnia. METHODS: Comprehensive searches of biomedical databases (MEDLINE, EMBASE, CINAHL, Cochrane library, Science Citation Index), homeopathy-specific and complementary medicine-specific databases were conducted. RESULTS: (A) Homeopathic medicines: four randomised controlled trials (RCTs) compared homeopathic medicines to placebo. All involved small patient numbers and were of low methodological quality. None demonstrated a statistically significant difference in outcomes between groups, although two showed a trend favouring homeopathic medicines and three demonstrated significant improvements from baseline in both groups. A cohort study reported significant improvements from baseline. (B) Treatment by a homeopath: No randomised controlled trials of treatment by a homeopath were identified. One cohort study, three case series and over 2600 case studies were identified. CONCLUSIONS: The limited evidence available does not demonstrate a statistically significant effect of homeopathic medicines for insomnia treatment. Existing RCTs were of poor quality and were likely to have been underpowered. Well-conducted studies of homeopathic medicines and treatment by a homeopath are required to examine the clinical and cost effectiveness of homeopathy for insomnia.

Healthcare provided by a homeopath as an adjunct to usual care for Fibromyalgia (FMS): results of a pilot Randomised Controlled Trial.

OBJECTIVES: To assess the feasibility of a Randomised Controlled Trial (RCT) design of usual care compared with usual care plus adjunctive care by a homeopath for patients with Fibromyalgia syndrome (FMS). METHODS: In a pragmatic parallel group RCT design, adults with a diagnosis of FMS (ACR criteria) were randomly allocated to usual care or usual care plus adjunctive care by a homeopath. Adjunctive care consisted of five in depth interviews and individualised homeopathic medicines. The primary outcome measure was the difference in Fibromyalgia Impact Questionnaire (FIQ) total score at 22 weeks. RESULTS: 47 patients were recruited. Drop out rate in the usual care group was higher than the homeopath care group (8/24 vs 3/23). Adjusted for baseline, there was a significantly greater mean reduction in the FIQ total score (function) in the homeopath care group than the usual care group (-7.62 vs 3.63). There were significantly greater reductions in the homeopath care group in the McGill pain score, FIQ fatigue and tiredness upon waking scores. We found a small effect on pain score (0.21, 95% CI -1.42 to 1.84); but a large effect on function (0.81, 95% CI -8.17 to 9.79). There were no reported adverse events. CONCLUSIONS: Given the acceptability of the treatment and the clinically relevant effect on function, there is a need for a definitive study to assess the clinical and cost effectiveness of adjunctive healthcare by a homeopath for patients with FMS.

Designing clinical trials of homeopathy for menopausal symptoms: a review of the literature.

Homeopathy is a system of therapeutics placed outside the boundaries of orthodox medicine and regarded as a complementary and alternative medicine. Homeopathy has been used to alleviate menopausal symptoms both in the climacteric and in breast cancer survivors. Individualized treatment by a homeopath, regarded as the gold standard of homeopathic care, is a complex intervention where the homeopathic medicine is matched to the individual using holistic principles. This review article describes and interprets the existing evidence from observational studies and clinical trials and makes recommendations for trial design in the future.