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

Development of a Prognostic Factor Prediction Model in Patients with Musculoskeletal Pain Treated with Homeopathy: An Individual Patient Data Meta-Analysis of Three Randomized Clinical Trials

&lt;b&gt;&lt;i&gt;Background:&lt;/i&gt;&lt;/b&gt; Prognostic factor research methodology has not yet been applied to randomized clinical trial data of homeopathic medicines. &lt;b&gt;&lt;i&gt;Objectives:&lt;/i&gt;&lt;/b&gt; To investigate the principle of individualization in homeopathy by developing a prognostic factor prediction model. &lt;b&gt;&lt;i&gt;Method:&lt;/i&gt;&lt;/b&gt; A pooled, in­dividual patient data meta-analysis of 3 randomized trials ­investigating the efficacy of a homeopathic gel (Spiroflor SRL®) containing &lt;i&gt;Rhus toxicodendron&lt;/i&gt; as a key ingredient in osteoarthritis of the knee and acute low back pain. The prognostic value of a predefined set of 5 typical &lt;i&gt;R. toxicodendron&lt;/i&gt; symptoms was investigated by assessing treatment-by-symptom interactions on pain as an outcome measure in a regression model. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; The pooled dataset consisted of 284 patients in the Spiroflor SRL group and 275 patients in the control group. Adjusted for pain at baseline, a statistically significant effect modification for the symptoms “numbness or tingling of the affected part” (+2.0 mm VAS; &lt;i&gt;p&lt;/i&gt; = 0.02), “amelioration by movement” (–5.6 mm VAS; &lt;i&gt;p&lt;/i&gt; = 0.01), and “amelioration of pain by local heat” (+7.0 mm VAS; &lt;i&gt;p&lt;/i&gt; = 0.02) was found. &lt;b&gt;&lt;i&gt;Conclusions:&lt;/i&gt;&lt;/b&gt; Investigating aspects of treatment individualization in homeopathy using randomized trial data and standard meta-analytical techniques is possible. The symptom amelioration by local heat is of possible value as a homeopathic symptom (prognostic factor) predicting an increased likelihood of pain relief following treatment with the homeopathic product. </jats:p

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

Treatment of Dyspepsia, Heartburn, and Related Symptoms with Gastricumeel Compared to Proton Pump Inhibitors: A Prospective Reference-Controlled Observational Study

&lt;b&gt;&lt;i&gt;Background:&lt;/i&gt;&lt;/b&gt; Dyspepsia and heartburn are extremely common conditions, thus a search for safe and effective treatment alternatives is justified. &lt;b&gt;&lt;i&gt;Objectives:&lt;/i&gt;&lt;/b&gt; To demonstrate the noninferiority of Gastricumeel (Ga6) in terms of effectiveness and safety to proton pump inhibitors (PPIs) in the treatment of patients with dyspepsia and/or heartburn. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; Prospective, comparative, observational cohort study. Patients with dyspepsia or heartburn were treated either with Ga6 or with PPIs as monotherapy during approximately 6 weeks. The intensity of eight symptoms was assessed as well as overall condition, treatment compliance and tolerability, and any adverse drug reactions. Adjustment for covariates was done via the calculation of propensity scores in logistic regression. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; A total of 640 patients (447 Ga6, 193 PPIs) from 48 German general practices participated. More than half the patients had suspected acute gastritis and around 40% of patients had heartburn. Adjusted between-treatment difference scores of changes in the intensity of the eight assessed symptoms were within the bounds for noninferiority of Ga6 compared to PPIs. Effectiveness ratings were comparable; compliance and tolerability were rated better in the Ga6 group. &lt;b&gt;&lt;i&gt;Conclusion:&lt;/i&gt;&lt;/b&gt; It is worth considering Ga6 as a safe and effective treatment option in the management of dyspepsia and heartburn. </jats:p