From the Diabetes Trials Unit (R.R.H., S.K.P., M.A.B.), the Division of Public Health and Primary Health Care (H.A.W.N.), and the National Institute of Health Re- search (NIHR) School for Primary Care Research (H.A.W.N.), Oxford Centre for Diabetes, Endocrinology, and Metabo- lism (R.R.H., S.K.P., M.A.B., D.R.M., H.A.W.N.); and the NIHR Oxford Bio- medical Research Centre (R.R.H., D.R.M., H.A.W.N.) — both in Oxford, United Kingdom. Address reprint requests to Dr. Holman at the Diabetes Trials Unit, Ox- ford Centre for Diabetes, Endocrinology, and Metabolism, Churchill Hospital, Head- ington, Oxford OX3 7LJ, United Kingdom, or at rury.holman@dtu.ox.ac.uk. Background During the United Kingdom Prospective Diabetes Study (UKPDS), patients with type 2 diabetes mellitus who received intensive glucose therapy had a lower risk of microvascular complications than did those receiving conventional dietary therapy. We conducted post-trial monitoring to determine whether this improved glucose con- trol persisted and whether such therapy had a long-term effect on macrovascular outcomes. Methods Of 5102 patients with newly diagnosed type 2 diabetes, 4209 were randomly assigned to receive either conventional therapy (dietary restriction) or intensive therapy (either sulfonylurea or insulin or, in overweight patients, metformin) for glucose control. In post-trial monitoring, 3277 patients were asked to attend annual UKPDS clinics for 5 years, but no attempts were made to maintain their previously assigned thera- pies. Annual questionnaires were used to follow patients who were unable to attend the clinics, and all patients in years 6 to 10 were assessed through questionnaires. We examined seven prespecified aggregate clinical outcomes from the UKPDS on an intention-to-treat basis, according to previous randomization categories. Results Between-group differences in glycated hemoglobin levels were lost after the first year. In the sulfonylurea-insulin group, relative reductions in risk persisted at 10 years for any diabetes-related end point (9%, P = 0.04) and microvascular disease (24%, P = 0.001), and risk reductions for myocardial infarction (15%, P = 0.01) and death from any cause (13%, P = 0.007) emerged over time, as more events occurred. In the metformin group, significant risk reductions persisted for any diabetes-relat- ed end point (21%, P = 0.01), myocardial infarction (33%, P = 0.005), and death from any cause (27%, P = 0.002). Conclusions Despite an early loss of glycemic differences, a continued reduction in microvascu- lar risk and emergent risk reductions for myocardial infarction and death from any cause were observed during 10 years of post-trial follow-up. A continued benefit after metformin therapy was evident among overweight patients. (UKPDS 80; Current Controlled Trials number, ISRCTN75451837.)

/pdf/10-year-follow-up-of-intensive-glucose-control-in-type-2-4xcz0wwz4q.pdf

10-Year Follow-up of Intensive Glucose Control in Type 2 Diabetes

Adequate reporting of randomized, controlled trials (RCTs) is necessary to allow accurate critical appraisal of the validity and applicability of the results. The CONSORT (Consolidated Standards of Reporting Trials) Statement, a 22-item checklist and flow diagram, is intended to address this problem by improving the reporting of RCTs. However, some specific issues that apply to trials of nonpharmacologic treatments (for example, surgery, technical interventions, devices, rehabilitation, psychotherapy, and behavioral intervention) are not specifically addressed in the CONSORT Statement. Furthermore, considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement. Therefore, the CONSORT group developed an extension of the CONSORT Statement for trials assessing nonpharmacologic treatments. A consensus meeting of 33 experts was organized in Paris, France, in February 2006, to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments. The participants extended 11 items from the CONSORT Statement, added 1 item, and developed a modified flow diagram. To allow adequate understanding and implementation of the CONSORT extension, the CONSORT group developed this elaboration and explanation document from a review of the literature to provide examples of adequate reporting. This extension, in conjunction with the main CONSORT Statement and other CONSORT extensions, should help to improve the reporting of RCTs performed in this field.

/pdf/extending-the-consort-statement-to-randomized-trials-of-39t9d1gijb.pdf

Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.

Publication and related bias in meta-analysis : power of statistical tests and prevalence in the literature

Background Although the benefits of public knowledge of physical diseases are widely accepted, knowledge about mental disorders (mental health literacy) has been comparatively neglected.

Aims To introduce the concept of mental health literacy to a wider audience, to bring together diverse research relevant to the topic and to identify gaps in the area.

Method A narrative review within a conceptual framework.

Results Many members of the public cannot recognise specific disorders or different types of psychological distress. They differ from mental health experts in their beliefs about the causes of mental disorders and the most effective treatments. Attitudes which hinder recognition and appropriate help-seeking are common. Much of the mental health information most readily available to the public is misleading. However, there is some evidence that mental health literacy can be improved.

Conclusions If the public's mental health literacy is not improved, this may hinder public acceptance of evidence-based mental health care. Also, many people with common mental disorders may be denied effective self-help and may not receive appropriate support from others in the community.

https://www.cambridge.org/core/services/aop-cambridge-core/content/view/5563369643662EC541F33D1DD307AD35/S000712500022730Xa.pdf/div-class-title-mental-health-literacy-div.pdf

Mental health literacy. Public knowledge and beliefs about mental disorders.

This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs). Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.

/pdf/efficacy-safety-quality-control-marketing-and-regulatory-5f81mj7ngg.pdf

Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents)

Akupunktur bei chronischen Schmerzpatienten: Behandlungsergebnisse — Rolle des Akupunkteurs

Background: Despite the growing proportion of older adults in Europe there is only limited knowledge of CAM use among the elderly. This analysis aims to provide estimates for the prevalence of CAM use in persons with an age of ≥65, and to investigate correlations of CAM use with demographic characteristics. Methods: Based on participants of the MONICA/KORA studies S1-S4 who were born before 1944, a random sample of 1,079 was selected for comprehensive medical examinations. Questions were presented in structured face-to-face interviews conducted from February to November 2009. Results: Data on CAM use were available for 1,026 subjects with a mean age of 76 years, ranging from 65 to 93 years. 14% of the participants were unaware of CAM. The overall prevalence of CAM use was estimated 37% with minor differences between age groups, but clear differences between male (29%) and female (44%) participants. 1-year prevalence of CAM use was 22% (16% males, 28% females). 1-year of CAM use was associated with a higher level of education in both men and women; with higher income in men; and with more actual diseases in women. Conclusion: Findings indicate that awareness of CAM is high even among people ≥65 years. Estimates for the prevalence of CAM use confirm the relevance of this treatment sector in the healthcare system for the elderly.

Prevalence of use and level of awareness of CAM in older people - results from the KORA-Age study.

Legal requirements for quality assurance in German rehabilitation hospitals include comparisons of providers. Objective is to describe and to compare outcome quality of care offered by three hospitals providing in-patient rehabilitative treatment exemplified for patients with chronic headache. We performed a prospective three center observational study on patients suffering from chronic headache. Patients underwent interventions commonly used according to internal guidelines of the hospitals. Measurements were taken at three points in time (at admission, at discharge and 6 months after discharge). Indicators of outcome quality included pain intensity and frequency of pain, functional ability, depression, quality of life and health related behavior. Analyses of differences amongst the hospitals were adjusted by covariates due to case-mix situation. 306 patients from 3 hospitals were included in statistical analysis. Amongst the hospitals, patients differed significantly in age, education, diagnostic subgroups, beliefs, and with respect to some pain-related baseline values (covariates). Patients in all three hospitals benefited from intervention to a clinically relevant degree. At discharge from hospital, outcome quality differed significantly after adjustment according to case-mix only in terms of patients' global assessment of treatment results. Six months after discharge, the only detectable significant differences were for secondary outcomes like improved coping with stress or increased use of self-help. The profiles for satisfaction with the hospital stay showed clear differences amongst patients. The results of this case study do not suggest a definite overall ranking of the three hospitals that were compared, but outcome profiles offer a multilayer platform of reliable information which might facilitate decision making.

https://www.zora.uzh.ch/id/eprint/13438/2/Melchart_et_al_Chronic_Headache_V.pdf

Profiling quality of care for patients with chronic headache in three different German hospitals – a case study

Resumen Antecedentes y objetivo Dentro de los proyectos piloto de la Seguridad Social alemana se estudiaron la eficacia y la tolerabilidad de la acupuntura para el tratamiento de pacientes con dolores cronicos. En el presente trabajo se refieren los resultados del extenso estudio observacional sobre seguridad y tolerabilidad realizado con estos proyectos piloto. Metodos Los aspectos sobre seguridad y tolerabilidad se analizaron de 3 formas diferentes: para todos los 503.397 casos clinicos documentados entre julio de 2001 y junio de 2003, los medicos debian emitir una valoracion global sobre la tolerabilidad del tratamiento y citar los efectos adversos aparecidos. Los efectos adversos graves debian comunicarse antes de finales de 2004 al centro investigador asociado. Ademas, se pregunto directamente a 6.140 pacientes acerca de los posibles efectos secundarios experimentados. Resultados Los medicos refirieron efectos adversos en el 7,8% de los casos, siendo el dolor de la puntura el efecto mencionado con mas frecuencia. Se comunicaron un total de 17 casos de efectos adversos graves, y el acontecimiento citado con mas frecuencia fue el neumotorax (5 casos). El 9,3% de los pacientes respondieron afirmativamente a la pregunta de si habian experimentado efectos secundarios. En una cuarta parte de los casos estos efectos se consideraron muy negativos. Los efectos secundarios citados con mas frecuencia por los pacientes fueron dolores, fatiga y molestias circulatorias. Conclusiones Los efectos adversos graves del tratamiento de acupuntura son muy raros. En cambio, los pacientes indicaron a menudo efectos secundarios mas leves. En conjunto, la acupuntura aplicada por medicos debe contemplarse como un metodo terapeutico comparativamente seguro.

Efectos adversos y complicaciones de la acupuntura: Resultados de un amplio estudio observacional comprendido en los proyectos piloto de la Seguridad Social alemana

Wolfgang Weidenhammer

Papers

Akupunktur bei chronischen Schmerzpatienten: Behandlungsergebnisse — Rolle des Akupunkteurs

Prevalence of use and level of awareness of CAM in older people - results from the KORA-Age study.

Profiling quality of care for patients with chronic headache in three different German hospitals – a case study

Efectos adversos y complicaciones de la acupuntura: Resultados de un amplio estudio observacional comprendido en los proyectos piloto de la Seguridad Social alemana

Befragung der am ‚Modellvorhaben der Ersatzkassen’ teilnehmenden Akupunkturärzte zur Struktur- und Prozessqualität