Model validity of randomised placebo-controlled trials of non-individualised homeopathic treatment.

BACKGROUND: The comprehensive systematic review of randomised placebo-controlled trials (RCTs) in homeopathy requires examination of a study's model validity of homeopathic treatment (MVHT) as well as its risk of bias (extent of reliable evidence). OBJECTIVE: To appraise MVHT in those RCTs of non-individualised homeopathy that an associated investigation had judged as 'not at high risk of bias'. DESIGN: Systematic review. METHODS: An assessment of MVHT was ascribed to each of 26 eligible RCTs. Another 49 RCTs were ineligible due to their high risk of bias. MAIN OUTCOME MEASURES: MVHT and the prior risk of bias rating per trial were merged to obtain a single overall quality designation ('high', 'moderate', 'low'), based on the GRADE principle of downgrading. RESULTS: The trials were rated as 'acceptable MVHT' (N = 9), 'uncertain MVHT' (N = 10) and 'inadequate MVHT' (N = 7); and, previously, as 'reliable evidence' (N = 3) and 'non-reliable evidence' (N = 23). The 26 trials were designated overall as: 'high quality' (N = 1); 'moderate quality' (N = 18); 'low quality' (N = 7). CONCLUSION: Of the 26 RCTs of non-individualised homeopathy that were judged 'not at high risk of bias', nine have been rated 'acceptable MVHT'. One of those nine studies was designated 'high quality' overall ('acceptable MVHT' and 'reliable evidence'), and is thus currently the only reported RCT that represents best therapeutic practice as well as unbiased evidence in non-individualised homeopathy. As well as minimising risk of bias, new RCTs in this area must aim to maximise MVHT and clarity of reporting.

Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment.

BACKGROUND: To date, our programme of systematic reviews has assessed randomised controlled trials (RCTs) of individualised homeopathy separately for risk of bias (RoB) and for model validity of homeopathic treatment (MVHT). OBJECTIVES: The purpose of the present paper was to bring together our published RoB and MVHT findings and, using an approach based on GRADE methods, to merge the quality appraisals of these same RCTs, examining the impact on meta-analysis results. DESIGN: Systematic review with meta-analysis. METHODS: As previously, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were the subject of study. MAIN OUTCOME MEASURES: For each trial, the separate ratings for RoB and MVHT were merged to obtain a single overall quality designation ('high', 'moderate, "low", 'very low'), based on the GRADE principle of 'downgrading'. RESULTS: Merging the assessment of MVHT and RoB identified three trials of 'high quality', eight of 'moderate quality', 18 of 'low quality' and three of 'very low quality'. There was no association between a trial's MVHT and its RoB or its direction of treatment effect (P>0.05). The three 'high quality' trials were those already labelled 'reliable evidence' based on RoB, and so no change was found in meta-analysis based on best-quality evidence: a small, statistically significant, effect favouring homeopathy. CONCLUSION: Accommodating MVHT in overall quality designation of RCTs has not modified our pre-existing conclusion that the medicines prescribed in individualised homeopathy may have small, specific, treatment effects.

Healing Environments: Integrative Medicine and Palliative Care in Acute Care Settings.

Conventional medicine is excellent at saving lives; however, it has little to offer to address the physical, mental, and emotional distress associated with life-threatening or life-limiting disease. An integrative approach to palliative care in acute care settings can meet this need by creating healing environments that support patients, families, and health care professionals. Mindful use of language enhances the innate healing response, improves communication, and invites patients and families to participate in their care. Staff should be offered access to skills training to cultivate compassion and mindful practice to enhance both patient and self-care.

Model validity of randomised placebo-controlled trials of individualised homeopathic treatment.

BACKGROUND: Though potentially an important limitation in the literature of randomised controlled trials (RCTs) of homeopathy, the model validity of homeopathic treatment (MVHT) has not previously been systematically investigated. OBJECTIVE: As an integral part of a programme of systematic reviews, to assess MVHT of eligible RCTs of individualised homeopathic treatment. METHODS: From 46 previously identified papers in the category, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were thus the subject of the study. For each of six domains of assessment per trial, MVHT was judged independently by three randomly allocated assessors from our group, who reached a final verdict by consensus discussion as necessary. RESULTS: Nineteen trials were judged overall as 'acceptable' MVHT, nine as 'uncertain' MVHT, and four as 'inadequate' MVHT. CONCLUSIONS: These results do not support concern that deficient MVHT has frequently undermined the published findings of RCTs of individualised homeopathy. However, the 13 trials with 'uncertain' or 'inadequate' MVHT will be a focus of attention in supplementary meta-analysis. New RCTs of individualised homeopathy must aim to maximise MVHT and to enable its assessment through clear reporting.

Homeopathic Oscillococcinum® for preventing and treating influenza and influenza-like illness.

BACKGROUND: Influenza is a highly infectious viral disease that is particularly common in the winter months. Oscillococcinum® is a patented homeopathic medicine that is made from a 1% solution of wild duck heart and liver extract, which is then serially diluted 200 times with water and alcohol. OBJECTIVES: To determine whether homeopathic Oscillococcinum® is more effective than placebo in the prevention and/or treatment of influenza and influenza-like illness in adults or children. SEARCH METHODS: We searched CENTRAL (2014, Issue 8), MEDLINE (1966 to August week 4, 2014), MEDLINE In-Process & Other Non-Indexed Citations (4 September 2014), AMED (2006 to September 2014), Web of Science (1985 to September 2014), LILACS (1985 to September 2014) and EMBASE (1980 to September 2014). We contacted the manufacturers of Oscillococcinum® for information on further trials. SELECTION CRITERIA: Randomised, placebo-controlled trials of Oscillococcinum® in the prevention and/or treatment of influenza and influenza-like illness in adults or children. DATA COLLECTION AND ANALYSIS: Three review authors independently extracted data and assessed risk of bias in the eligible trials. MAIN RESULTS: No new trials were included in this 2014 update. We included six studies: two prophylaxis trials (327 young to middle-aged adults in Russia) and four treatment trials (1196 teenagers and adults in France and Germany). The overall standard of trial reporting was poor and hence many important methodological aspects of the trials had unclear risk of bias. There was no statistically significant difference between the effects of Oscillococcinum® and placebo in the prevention of influenza-like illness: risk ratio (RR) 0.48, 95% confidence interval (CI) 0.17 to 1.34, P value = 0.16. Two treatment trials (judged as 'low quality') reported sufficient information to allow full data extraction: 48 hours after commencing treatment, there was an absolute risk reduction of 7.7% in the frequency of symptom relief with Oscillococcinum® compared with that of placebo (risk difference (RD) 0.077, 95% CI 0.03 to 0.12); the RR was 1.86 (95% CI 1.27 to 2.73; P value = 0.001). A significant but lesser effect was observed at three days (RR 1.27, 95% CI 1.03 to 1.56; P value = 0.03), and no significant difference between the groups was noted at four days (RR 1.11, 95% CI 0.98 to 1.27; P value = 0.10) or at five days (RR 1.06, 95% CI 0.96 to 1.16; P value = 0.25). One of the six studies reported one patient who suffered an adverse effect (headache) from taking Oscillococcinum®. AUTHORS' CONCLUSIONS: There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum® in the prevention or treatment of influenza and influenza-like illness. Our findings do not rule out the possibility that Oscillococcinum® could have a clinically useful treatment effect but, given the low quality of the eligible studies, the evidence is not compelling. There was no evidence of clinically important harms due to Oscillococcinum®.

Mindfulness intervention for child abuse survivors: a 2.5-year follow-up.

OBJECTIVE: The present study reports on the long-term effects of a mindfulness-based stress reduction (MBSR) program for adult survivors of childhood sexual abuse. METHOD: Of the study participants, 73% returned to the clinic for a single-session follow-up assessment of depression, posttraumatic stress disorder (PTSD), anxiety, and mindfulness at 2.5 years. RESULTS: Repeated measures mixed regression analyses revealed significant long-term improvements in depression, PTSD, anxiety symptoms, and mindfulness scores. The magnitude of intervention effects at 128 weeks ranged from d = .5 to d = 1.1. CONCLUSION: MBSR may be an effective long-term treatment for adults who have experienced childhood sexual abuse. Further investigation of MBSR with this population is warranted given the durability of treatment effects described here.

Homeopathic treatment of patients with influenza-like illness during the 2009 A/H1N1 influenza pandemic in India.

INTRODUCTION: We conducted a prospective, multi-centre, data collection survey of homeopathic practice in treatment of influenza-like illness in India during the 2009 pandemic of A/H1N1 influenza ('swine flu', SF). AIMS: To survey the practice of homeopathic practitioners in India in the management of SF, with respect to: (a) patients' symptoms at presentation and at follow-up (FU) consultation; (b) homeopathic medicines prescribed. METHODS: Data collection took place from October 2009 to February 2010, at the peak of the pandemic. All patients satisfying the minimum diagnostic symptoms of SF were eligible for inclusion. Data per appointment (in person or by telephone) were recorded by practitioners in spreadsheet format. All records were anonymised and included: whether patient was immunised against A/H1N1; influenza symptoms at consultation; the homeopathic medicine/s prescribed; whether antiviral medicine prescribed. RESULTS: Twenty-three homeopathic physicians contributed to data collection. At the first appointment, 1126 patients had valid SF symptoms. A total of 89 different combinations of SF symptoms was observed, the most common being temperature >38°C + cough + runny nose (n = 170; 15.1%). A total of 44 different remedies (or combinations of remedies) were used at these first appointments, the most frequently prescribed being Arsenicum album (n = 265; 23.5%). For a total of 99 FU appointments with valid SF symptoms, Arsenicum album was prescribed most frequently overall (n = 28; 28.0%). CONCLUSIONS: In our sample, the 2009 A/H1N1 influenza pandemic in India was characterised by several prominent symptoms and symptom/medicine associations, particularly temperature >38°C + cough + runny nose, associated with Arsenicum album. Future studies should collect additional keynote prescribing symptoms that influence the choice of homeopathic medicine.

The BraveNet prospective observational study on integrative medicine treatment approaches for pain.

BACKGROUND: Chronic pain affects nearly 116 million American adults at an estimated cost of up to $635 billion annually and is the No. 1 condition for which patients seek care at integrative medicine clinics. In our Study on Integrative Medicine Treatment Approaches for Pain (SIMTAP), we observed the impact of an integrative approach on chronic pain and a number of other related patient-reported outcome measures. METHODS: Our prospective, non-randomized, open-label observational evaluation was conducted over six months, at nine clinical sites. Participants received a non-standardized, personalized, multimodal approach to chronic pain. Validated instruments for pain (severity and interference levels), quality of life, mood, stress, sleep, fatigue, sense of control, overall well-being, and work productivity were completed at baseline and at six, 12, and 24 weeks. Blood was collected at baseline and week 12 for analysis of high-sensitivity C-reactive protein and 25-hydroxyvitamin D levels. Repeated-measures analysis was performed on data to assess change from baseline at 24 weeks. RESULTS: Of 409 participants initially enrolled, 252 completed all follow-up visits during the 6 month evaluation. Participants were predominantly white (81%) and female (73%), with a mean age of 49.1 years (15.44) and an average of 8.0 (9.26) years of chronic pain. At baseline, 52% of patients reported symptoms consistent with depression. At 24 weeks, significantly decreased pain severity (-23%) and interference (-28%) were seen. Significant improvements in mood, stress, quality of life, fatigue, sleep and well-being were also observed. Mean 25-hydroxyvitamin D levels increased from 33.4 (17.05) ng/mL at baseline to 39.6 (16.68) ng/mL at week 12. CONCLUSIONS: Among participants completing an integrative medicine program for chronic pain, significant improvements were seen in pain as well as other relevant patient-reported outcome measures. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01186341.

Homeopathic Oscillococcinum(®) for preventing and treating influenza and influenza-like illness.

BACKGROUND: Influenza is a highly infectious viral disease that is particularly common in the winter months. Oscillococcinum(®) is a patented homeopathic medicine that is made from a 1% solution of wild duck heart and liver extract, which is then serially diluted 200 times with water and alcohol. OBJECTIVES: To determine whether homeopathic Oscillococcinum(®) is more effective than placebo in the prevention and/or treatment of influenza and influenza-like illness in adults or children. SEARCH METHODS: We searched CENTRAL (2012, Issue 7), MEDLINE (1966 to July week 4, 2012), MEDLINE In-Process & Other Non-Indexed Citations (6 August 2012), AMED (2006 to August 2012), Web of Science (1985 to August 2012), LILACS (1985 to August 2012) and EMBASE (1980 to August 2012). We contacted the manufacturers of Oscillococcinum(®) for information of more trials. SELECTION CRITERIA: Randomised, placebo-controlled trials of Oscillococcinum(®) in the prevention and/or treatment of influenza and influenza-like illness in adults or children. DATA COLLECTION AND ANALYSIS: Three review authors independently extracted data and assessed risk of bias in the eligible trials. MAIN RESULTS: We included six studies: two prophylaxis trials (327 young to middle-aged adults in Russia) and four treatment trials (1196 teenagers and adults in France and Germany). The overall standard of trial reporting was poor and hence many important methodological aspects of the trials had unclear risk of bias. There was no statistically significant difference between the effects of Oscillococcinum(®) and placebo in the prevention of influenza-like illness: risk ratio (RR) 0.48, 95% confidence interval (CI) 0.17 to 1.34, P = 0.16. Two treatment trials (judged as 'low quality') reported sufficient information to allow full data extraction: 48 hours after commencing treatment, there was an absolute risk reduction of 7.7% in the frequency of symptom relief with Oscillococcinum(®) compared with that of placebo (risk difference (RD) 0.077; 95% CI 0.03 to 0.12); the RR was 1.86 (95% CI 1.27 to 2.73; P = 0.001). A significant but lesser effect was observed at three days (RR 1.27, 95% CI 1.03 to 1.56; P = 0.03), and no significant difference between the groups was noted at four days (RR 1.11, 95% CI 0.98 to 1.27; P = 0.10) or at five days (RR 1.06; 95% CI 0.96 to 1.16; P = 0.25). One of the six studies reported one patient who suffered an adverse effect (headache) from taking Oscillococcinum(®). AUTHORS' CONCLUSIONS: There is insufficient good evidence to enable robust conclusions to be made about Oscillococcinum(®) in the prevention or treatment of influenza and influenza-like illness. Our findings do not rule out the possibility that Oscillococcinum(®) could have a clinically useful treatment effect but, given the low quality of the eligible studies, the evidence is not compelling. There was no evidence of clinically important harms due to Oscillococcinum(®).

Patients seek integrative medicine for preventive approach to optimize health.

CONTEXT: Despite the tremendous growth of integrative medicine (IM) in clinical settings, IM has not been well characterized in the medical literature. OBJECTIVE: To describe characteristics and motivation of patients seeking care at an IM clinic. DESIGN, SETTING, AND PARTICIPANTS: Patients from a nine-site practice-based research network participated in this cross-sectional survey. Clinicians documented patients' medical conditions. MAIN OUTCOME MEASURES: Patients provided information on demographics, lifestyle factors, and reasons for seeking care at an IM center. Clinicians documented the medical condition treated and procedures performed at the visit. RESULTS: A total of 4,182 patients (84.5% white; 72.7% college-educated; and 73.4% female) reported their most important reasons for seeking IM. Top-ranked reasons were (1) "to improve health and wellness now to prevent future problems" (83.9%); (2) "to try new options for health care" (76.7%); and (3) "to maximize my health regardless of whether or not my illness is curable" (74.6%). Interestingly, the same top reasons were reported by subgroups of patients who sought IM for wellness, acute care, or chronic illness. Patient reports of lifestyle also demonstrated healthier behaviors than national samples indicate. Patients seeking clinical care at IM centers desire an expanded paradigm of health care, one that seeks to maximize health.

Method for appraising model validity of randomised controlled trials of homeopathic treatment: multi-rater concordance study.

BACKGROUND: A method for assessing the model validity of randomised controlled trials of homeopathy is needed. To date, only conventional standards for assessing intrinsic bias (internal validity) of trials have been invoked, with little recognition of the special characteristics of homeopathy. We aimed to identify relevant judgmental domains to use in assessing the model validity of homeopathic treatment (MVHT). We define MVHT as the extent to which a homeopathic intervention and the main measure of its outcome, as implemented in a randomised controlled trial (RCT), reflect 'state-of-the-art' homeopathic practice. METHODS: Using an iterative process, an international group of experts developed a set of six judgmental domains, with associated descriptive criteria. The domains address: (I) the rationale for the choice of the particular homeopathic intervention; (II) the homeopathic principles reflected in the intervention; (III) the extent of homeopathic practitioner input; (IV) the nature of the main outcome measure; (V) the capability of the main outcome measure to detect change; (VI) the length of follow-up to the endpoint of the study. Six papers reporting RCTs of homeopathy of varying design were randomly selected from the literature. A standard form was used to record each assessor's independent response per domain, using the optional verdicts 'Yes', 'Unclear', 'No'. Concordance among the eight verdicts per domain, across all six papers, was evaluated using the kappa (κ) statistic. RESULTS: The six judgmental domains enabled MVHT to be assessed with 'fair' to 'almost perfect' concordance in each case. For the six RCTs examined, the method allowed MVHT to be classified overall as 'acceptable' in three, 'unclear' in two, and 'inadequate' in one. CONCLUSION: Future systematic reviews of RCTs in homeopathy should adopt the MVHT method as part of a complete appraisal of trial validity.

Homeopathy in the treatment of influenza: a data collection proposal / Homeopatia no tratamento da influenza: proposta para coleta de dados

Influenza is a common disease, widespread all over the world, that has no satisfactory treatment up to now. Homeopathy has a long tradition of being used to treat influenza and has accumulated empirical and experimental evidence showing positive effects. Large scale observational studies in different continents have never been carried out to assess the overall benefits of homeopathy in flu, what prescription strategy and medicines are more effective and for which group of patients it can be most helpful. On the other hand, there is a predicted pandemic of avian flu and it is important to be proactive and to be prepared to test homeopathy in this context. This worldwide study will collect observational data on patients with influenza or influenza-like illness treated with homeopathic by experienced homeopathic doctors during a period of 2 years. Measurements will include duration of influenza illness, change in total score of symptoms and clinical scales, as well as safety aspects (presence of adverse effects and complications). Homeopathic and any conventional medicines prescribed will be registered. Data will be entered and loaded in a web application, and will be statistically analyzed using descriptive and inferential techniques. Ethical approval will be sought, and all cases are to be submitted in an anonymous way to protect patient identity. This project aims to enable collection of useful data, together with the development of information technology infrastructure, that could be useful in future multi-centre randomized controlled trials in the treatment of influenza patients with homeopathy, besides testing a new strategy for accumulating evidence on the benefit of homeopathic treatment in other diseases and conditions.

A influenza é uma moléstia comum, distribuída no mundo todo, sem tratamento satisfatório na atualidade. A homeopatia possui uma longa tradição de uso na influenza e acumula evidências empíricas e experimentais de seu efeito positivo. No entanto, não têm sido realizados estudos observacionais em larga escala em diversos continentes para determinar quais são os benefícios globais da homeopatia neste quadro; quais são as estratégias prescritivas e os medicamentos mais eficazes e em quais grupos de pacientes pode ser mais benéfica. Por outro lado, está prevista uma pandemia de gripe aviária, motivo pelo qual é fundamental se adotar uma atitude ativa e estar preparados para testar a homeopatia neste contexto. Este estudo, de abrangência mundial, registrará dados observacionais de pacientes com influenza ou moléstias semelhantes, tratados homeopaticamente por médicos experientes, durante um período de 2 anos.