Searching for the Genus Epidemicus in Chinese Patients: Findings from the Clificol COVID-19 Clinical Case Registry.

BACKGROUND  The Clificol COVID-19 Support Project is an innovative international data collection project aimed at tackling some of the core questions in homeopathy. This paper reports on the further investigation of the genus epidemicus concept during the first wave of the pandemic in the Chinese population. METHODS  The design is an observational clinical case registry study of Chinese patients with confirmed or suspected coronavirus disease 2019 (COVID-19). The symptoms were prospectively collected via a 150-item questionnaire. The concept of genus epidemicus, including the role of treatment individualization, was investigated by analyzing whether presenting symptoms clustered into distinct groups. Two standard statistical analysis techniques were utilized: principal component analysis for extracting the most meaningful symptoms of the dataset; the k-means clustering algorithm for automatically assigning groups based on similarity between presenting symptoms. RESULTS  20 Chinese practitioners collected 359 cases in the first half of 2020 (766 consultations, 363 prescriptions). The cluster analysis found two to be the optimum number of clusters. These two symptomatic clusters had a high overlap with the two most commonly prescribed remedies in these sub-populations: in cluster 1 there were 297 prescriptions, 95.6% of which were Gelsemium sempervirens; in cluster 2 there were 61 prescriptions, 95.1% of which were Bryonia alba. CONCLUSION  This is the first study to investigate the notion of genus epidemicus by using modern statistical techniques. These analyses identified at least two distinct symptom pictures. The notion of a single COVID-19 genus epidemicus did not apply in the studied population

The Hawthorne Effect: a randomised, controlled trial

Background: The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow- up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia.Methods: Participants in a dementia trial were randomised to intensive follow- up (with comprehensive assessment visits at baseline and two, four and six months post randomisation) or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months). Our primary outcomes were cognitive functioning (ADAS-Cog) and participant and carer-rated quality of life (QOL-AD).Results: We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT), with available data. In the ANCOVA model with baseline score as a co- variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95% Cl -3.914, -0.121; p = 0.037 favouring the intensive follow-up group), and on participant- rated quality of life score (n = 142; mean difference = -1.382; 95% Cl -2.642, -0.122; p = 0.032 favouring minimal follow-up group). There was no significant difference on carer quality of life.Conclusion: We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning

The Safety and Effectiveness of a Novel Annular Keratopigmentation Method: A Case Report

Background: We investigated the safety and effectiveness of a novel aesthetic femtosecond-assisted annular keratopigmentation technique. Case Report: A 21-year-old female patient in good general and ophthalmological health with the wish to change the colour of her eyes was treated with a femtosecond-assisted annular keratopigmentation technique. Pigment was inserted in a channel in the cornea (external diameter 9.3 mm; internal diameter 5.5 mm) created with a femtosecond laser at a depth of 225 μm. Eight months post-operatively, there were no signs of leakage, diffusion, inflammation or any other detrimental effects on the cornea both objectively and subjectively. Conclusion: This procedure is a promising safe and effective option for those who want annular keratopigmentation for aesthetic reasons

Effectiveness of the Homeopathic Preparation Neurexan® Compared with that of Commonly used Valerian-Based Preparations for the Treatment of Nervousness/Restlessness – an Observational Study

Mild anxieties, nervousness, and restlessness are common in the general population and are commonly treated by complementary and alternative medical (CAM) therapies. A prospective, nonrandomized, noninterventional, observational study, using conventional or CAM practices, was conducted in 49 German practices. Each practice could include up to 15 subjects treated with either the homeopathic preparation Neurexan® or with combination formulations based on valerian extracts. There was no placebo group. Choice and doses of study therapies were at the respective physician's discretion. The planned treatment duration was 2 weeks. A total of 826 subjects were included in the study and 777 (553 Neurexan and 224 valerian) subjects were available for the final examination. Subjects receiving Neurexan tended to weigh less, to have fewer concomitant illnesses and slightly milder severity of nervousness/restlessness, and were likelier to be female than the subjects receiving valerian therapies. The summary score for nervousness/restlessness was reduced from 19.0 ± 6.1 at baseline to 7.4 ± 6.8 at the end of the observation period in the Neurexan group, a reduction of 11.5 ± 7.3 score units. In the valerian group, the summary score was reduced from 21.4 ± 6.0 to 12.6 ± 7.3, a reduction of 9.0 ± 6.6 score units. The changes from baseline and the differences between the groups were statistically significant. Similar significant differences in effects were seen on the subscores and on the subjects' assessments of effectiveness. Both study therapies were well tolerated. Neurexan appears to be an effective and well-tolerated alternative to valerian-based combination therapies for the treatment of nervousness/restlessness in subjects favorable towards a CAM-based therapy

World integrated medicine forum on the regulation of homoeopathic medicinal products: National and global strategies

The first World Integrated Medicine Forum on the regulation of homoeopathic medicinal products included 50 delegates from 25 countries to discuss the current state of regulation of homoeopathic medicinal products (HMPs). The stakeholders in attendance included government officials, manufacturers, pharmacopoeia organisations, pharmacists, and healthcare providers worldwide. The Minister of Ayurveda, Yoga, Unani, Siddha and Homoeopathy from India, who is likely the only high ranking national official in the world specifically dedicated to oversight of traditional medicines including Homoeopathy, was the keynote speaker for the meeting. The core presentations delivered information on the country-to-country variance in regulatory requirements for homoeopathic medicine manufacture and marketing. Different speakers addressed the current pharmacopeia structures in various countries, variance in premarket approval process, regulatory frameworks for homoeopathic medicines, labelling requirements, safety requirements, marketing approaches and good manufacturing practices. Debates focused on quality control testing, stability of intermediate stocks, shelf life of finished products, pre-market approval process and labelling and they shed light on regional differences in regulation. A lengthy discussion was held on the potential value of harmonisation of pharmacopoeias, manufacturing standards, safety evaluation and labelling. The group consensus was to meet again to pursue specific topics. Daily summaries of take-away points are provided at the end of each day's talk summaries. Much acclaim was won by the organisers for materialising this unique forum which proved to be an apt platform for rigorous discussions on lesser discussed, but very vital points such as regulations of HMPs, harmonisation of pharmacopeias and linking industry and regulators' sectors for unified efforts for global development of Homoeopathy

Ginkgo biloba for mild to moderate dementia in a community setting: a pragmatic, randomised, parallel-group, double-blind, placebo-controlled trial.

OBJECTIVES: Doubt over the cost-effectiveness of the cholinesterase inhibitors in dementia has renewed interest in alternative treatments such as Ginkgo biloba. We aimed to determine the effectiveness and the safety profile of Ginkgo biloba for treating early stage dementia in a community setting. METHODS: We conducted a community-based, pragmatic, randomised, double-blind, parallel-group trial where participants were given a standardised extract of Ginkgo biloba (120 mg daily) or a placebo control for 6 months. Our primary outcomes were cognitive functioning (ADAS-Cog) and participant and carer-rated quality of life (QOL-AD). RESULTS: We recruited 176 participants, mainly through general practices. In the ANCOVA model with baseline score as a co-variate (n = 176), Ginkgo did not have a significant effect on outcome at six months on either the ADAS-Cog score (p = 0.392), the participant-rated QOL-AD score (p = 0.787) nor the carer-rated QOL-AD score (p = 0.222). CONCLUSION: We found no evidence that a standard dose of high purity Ginkgo biloba confers benefit in mild-moderate dementia over 6 months

World Integrated Medicine Forum 2017: A feedback survey analysis

Introduction: The first-of-its-kind World Integrated Medicine Forum (WIMF) on the regulation of homoeopathic medicinal products (HMPs) which was attended by various stakeholders from 23 countries witnessed rigorous discussions to strengthen existing regulatory framework of homoeopathic medicines in the world, as well as to bring harmony within the Homoeopathy market for drug manufacture standards including pharmacopoeial convergence. Materials and Methods: A feedback questionnaire was shared with the participants through SurveyMonkey online platform to seek their opinion about the Forum, obtain their country-specific views about regulations of HMPs, to evaluate the extent to which the Forum could meet its objectives and also to identify areas of improvements which may be taken note for organising a future WIMF. Results: Sixty-one percent participants from 18 countries returned the survey. Analysis of the responses revealed a group consensus about the remarkable organisation of the Forum, its usefulness from a national perspective, etc. The questions could also fetch insight about country-specific reforms that are required in the availability and regulations of HMPs. All the respondents who took the survey recommended a next Forum on the same lines, out of which 92% said they would recommend it to other colleagues. Conclusion: Homoeopathy is a widely recognised and accepted system worldwide. Based on its increasing demand, a harmonised regulatory system for homeopathic medicines must be developed to ensure good quality of HMPs, and this can be achieved through cooperative interactions among various stakeholders, both nationally and globally. A Forum such as this, at least once every 2 years, can provide the right push on this front

Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial

Objective To determine the effects of a policy of “use acupuncture” on headache, health status, days off sick, and use of resources in patients with chronic headache compared with a policy of “avoid acupuncture.” Design Randomised, controlled trial. Setting General practices in England and Wales. Participants 401 patients with chronic headache, predominantly migraine. Interventions Patients were randomly allocated to receive up to 12 acupuncture treatments over three months or to a control intervention offering usual care. Main outcome measures Headache score, SF-36 health status, and use of medication were assessed at baseline, three, and 12 months. Use of resources was assessed every three months. Results Headache score at 12 months, the primary end point, was lower in the acupuncture group (16.2, SD 13.7, n = 161, 34% reduction from baseline) than in controls (22.3, SD 17.0, n = 140, 16% reduction from baseline). The adjusted difference between means is 4.6 (95% confidence interval 2.2 to 7.0; P = 0.0002). This result is robust to sensitivity analysis incorporating imputation for missing data. Patients in the acupuncture group experienced the equivalent of 22 fewer days of headache per year (8 to 38). SF-36 data favoured acupuncture, although differences reached significance only for physical role functioning, energy, and change in health. Compared with controls, patients randomised to acupuncture used 15% less medication (P = 0.02), made 25% fewer visits to general practitioners (P = 0.10), and took 15% fewer days off sick (P = 0.2). Conclusions Acupuncture leads to persisting, clinically relevant benefits for primary care patients with chronic headache, particularly migraine. Expansion of NHS acupuncture services should be considered

Acupuncture of chronic headache disorders in primary care: randomised controlled trial and economic analysis

OBJECTIVES: To determine the effects of a policy of using acupuncture, compared with a policy of avoiding acupuncture, on headache in primary care patients with chronic headache disorders. The effects of acupuncture on medication use, quality of life, resource use and days off sick in this population and the cost-effectiveness of acupuncture were also examined. DESIGN: Randomised, controlled trial. SETTING: General practices in England and Wales. PARTICIPANTS: The study included 401 patients with chronic headache disorder, predominantly migraine. INTERVENTIONS: Patients were randomly allocated to receive up to 12 acupuncture treatments over 3 months or to a control intervention offering usual care. MAIN OUTCOME MEASURES: Outcome measures included headache score; assessment of Short Form 36 (SF-36) health status and use of medication at baseline, 3 months and 12 months; assessment of use of resources every 3 months; and assessment of incremental cost per quality-adjusted life-year (QALY) gained. RESULTS: Headache score at 12 months, the primary end-point, was lower in the acupuncture group than in controls. The adjusted difference between means was 4.6. This result was robust to sensitivity analysis incorporating imputation for missing data. Patients in the acupuncture group experienced the equivalent of 22 fewer days of headache per year. SF-36 data favoured acupuncture, although differences reached significance only for physical role functioning, energy and change in health. Compared with controls, patients randomised to acupuncture used 15% less medication, made 25% fewer visits to GPs and took 15% fewer days off sick. Total costs during the 1-year period of the study were on average higher for the acupuncture group than for controls because of the acupuncture practitioners' costs. The mean health gain from acupuncture during the year of the trial was 0.021 QALYs, leading to a base-case estimate of GBP9180 per QALY gained. This result was robust to sensitivity analysis. Cost per QALY dropped substantially when the analysis incorporated likely QALY differences for the years after the trial. CONCLUSIONS: The study suggests that acupuncture leads to persisting, clinically relevant benefits for primary care patients with chronic headache, particularly migraine. It is relatively cost-effective compared with a number of other interventions provided by the NHS. Further studies could examine the duration of acupuncture effects beyond 1 year and the relative benefit to patients with migraine with compared to tension-type headache. Trials are also warranted examining the effectiveness and cost-effectiveness of acupuncture in patients with headache receiving more aggressive pharmacological management