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.)

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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.

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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.

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

Objective: Empirical investigation of the influence of patient self-selection during follow-up in a prospective observational study in 4 in-patient facilities for complementary medicine and discussion of further methodological problems. Methods: 2662 patients treated in the 4 hospitals and included in a prospective observational study had been sent follow-up questionnaires 2, 6, and 12 months after admission. Characteristics and therapeutic success at discharge were compared in patients responding and those not responding. Results: Patients not responding to the follow-up questionnaires tended to be older and to assess the benefit of the treatment less positive than patients who responded (hospital one: 56.2% of patients with a follow-up reported a good or very good response to therapy at discharge compared to 37.7% of the patients without a follow-up: hospital two: 63.7% vs. 54.6%; hospital three: 71.1% vs. 65.8%; hospital four: 78,3% vs. 70,9%). Interpretation: When interpreting the results of the observational study a certain degree of bias induced by selection during follow-up has to be taken into account. Discussion: Other methodological problems discussed narratively include spontaneous improvements, reliability of baseline measures, influence of effective cointerventions, side-effects, outcome measures, feasibility, and efficiency. Finally, recommendations for quality management programs in in-patient facilities for complementary medicine are provided.

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Beobachtungsstudien im Rahmen eines naturheilkundlichen Klinikverbunds :Teil IV: Methodische Aspekte, Diskussion und Empfehlungen

[Program for evaluation of patient care with acupuncture--the scientific comparison of models and results].

Background: In two hospitals we performed an open, prospective observational study on patients with chronic headache as a measure of internal quality assurance using identical methods. Available data were subordinately analysed in order to compare both studies. Questions: Are the patient samples of both hospitals comparable? If not, which form of statistical adjustment is recommended? Are there differences in the outcome measures of both facilities? Methods: The outcomes were defined as differences between baseline values and values at discharge from hospital, respectively 6 months after. Frequency of headache attacks, intensity of pain, intensity of general complaints as well as of concomitant symptoms, and quality of life were determined in advance as dependent variables. To compare both patient groups univariate analysis of variance without and with inclusion of covariates were used. For calculating propensity scores (conditional probability of belonging to one of two groups) a logistic regression with the same covariates serving as independent variables was performed. Patients: 426 patients with the main diagnosis ‘Migraine’ and complete data sets concerning the covariates were selected for analysis. 87% of patients are female, the mean age is 45.5 ± 11.7 years (range 14–73 yrs). Results: 4 out of 11 potential covariates show statistically significant differences between the patients of both hospitals. Correct classification of patients by means of the propensity score succeeds in 67%. Comparing the outcomes at discharge from hospital, significant differences between both groups exist which are, with one exception, not affected by controlling for covariates. 6 months after discharge two of the initial differences between both patient groups are no longer present. These findings are independent from the statistical technique of risk adjustment. Conclusions: Because of the observed differences between both patient groups it is recommended to adjust data by regression analysis in order to enhance comparability. The choice for one of the two proposed techniques is secondary. With respect to the analyses clear differences between both hospitals exist in short-term outcomes, disappearing 6 months later.

Treatment outcomes in patients with migraine: an ex-post-facto comparison of two in-patient facilities.

What attitudes and needs do citizens in Europe have in relation to information about complementary and alternative medicine

Quality of Outcome in Treating Patients with Chronic Headache within a Hospital Specialized for Migraine. A Cohort Study with One-Year Follow-Up Aims: To describe characteristics

Wolfgang Weidenhammer

Papers

Beobachtungsstudien im Rahmen eines naturheilkundlichen Klinikverbunds :Teil IV: Methodische Aspekte, Diskussion und Empfehlungen

[Program for evaluation of patient care with acupuncture--the scientific comparison of models and results].

Treatment outcomes in patients with migraine: an ex-post-facto comparison of two in-patient facilities.

What attitudes and needs do citizens in Europe have in relation to information about complementary and alternative medicine

Ergebnisqualität bei der Behandlung chronischer Kopfschmerzpatienten in einer Migräneklinik. Eine Kohortenstudie mit einjähriger Nachbeobachtung