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

Objective. Sudden hearing loss (SHL) is a frightening symptom that often prompts an urgent or emergent visit to a physician. This guideline provides evidence-based recommendations for the diagnosis...

/pdf/clinical-practice-guideline-sudden-hearing-loss-8acwe9fo8a.pdf

Clinical practice guideline: sudden hearing loss.

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140673605668717.pdf

Acupuncture in patients with osteoarthritis of the knee: a randomised trial

ContextAcupuncture is widely used to prevent migraine attacks, but the available
evidence of its benefit is scarce.ObjectiveTo investigate the effectiveness of acupuncture compared with sham acupuncture
and with no acupuncture in patients with migraine.Design, Setting, and PatientsThree-group, randomized, controlled trial (April 2002-January 2003)
involving 302 patients (88% women), mean (SD) age of 43 (11) years, with migraine
headaches, based on International Headache Society criteria. Patients were
treated at 18 outpatient centers in Germany.InterventionsAcupuncture, sham acupuncture, or waiting list control. Acupuncture
and sham acupuncture were administered by specialized physicians and consisted
of 12 sessions per patient over 8 weeks. Patients completed headache diaries
from 4 weeks before to 12 weeks after randomization and from week 21 to 24
after randomization.Main Outcome MeasuresDifference in headache days of moderate or severe intensity between
the 4 weeks before and weeks 9 to 12 after randomization.ResultsBetween baseline and weeks 9 to 12, the mean (SD) number of days with
headache of moderate or severe intensity decreased by 2.2 (2.7) days from
a baseline of 5.2 (2.5) days in the acupuncture group compared with a decrease
to 2.2 (2.7) days from a baseline of 5.0 (2.4) days in the sham acupuncture
group, and by 0.8 (2.0) days from a baseline if 5.4 (3.0) days in the waiting
list group. No difference was detected between the acupuncture and the sham
acupuncture groups (0.0 days, 95% confidence interval, −0.7 to 0.7 days; P = .96) while there was a difference between
the acupuncture group compared with the waiting list group (1.4 days; 95%
confidence interval; 0.8-2.1 days; P<.001). The
proportion of responders (reduction in headache days by at least 50%) was
51% in the acupuncture group, 53% in the sham acupuncture group, and 15% in
the waiting list group.ConclusionAcupuncture was no more effective than sham acupuncture in reducing
migraine headaches although both interventions were more effective than a
waiting list control.

https://jamanetwork.com/journals/jama/articlepdf/200822/joc50026.pdf

Acupuncture for patients with migraine: a randomized controlled trial.

Objective. Tinnitus is the perception of sound without an external source. More than 50 million people in the United States have reported experiencing tinnitus, resulting in an estimated prevalence of 10% to 15% in adults. Despite the high prevalence of tinnitus and its potential significant effect on quality of life, there are no evidence-based, multidisciplinary clinical practice guidelines to assist clinicians with management. The focus of this guideline is on tinnitus that is both bothersome and persistent (lasting 6 months or longer), which often negatively affects the patient’s quality of life. The target audience for the guideline is any clinician, including nonphysicians, involved in managing patients with tinnitus. The target patient population is limited to adults (18 years and older) with primary tinnitus that is persistent and bothersome. Purpose. The purpose of this guideline is to provide evidence-based recommendations for clinicians managing patients with tinnitus. This guideline provides clinicians with a logical framework to improve patient care and mitigate the personal and social effects of persistent, bothersome tinnitus. It will discuss the evaluation of patients with tinnitus, including selection and timing of diagnostic testing and specialty referral to identify potential underlying treatable pathology. It will then focus on the evaluation and treatment of patients with persistent primary tinnitus, with recommendations to guide the evaluation and measurement of the effect of tinnitus and to determine the most appropriate interventions to improve symptoms and quality of life for tinnitus sufferers. Action Statements. The development group made a strong recommendation that clinicians distinguish patients with bothersome tinnitus from patients with nonbothersome tinnitus. The development group made a strong recommendation against obtaining imaging studies of the head and neck in patients with tinnitus, specifically to evaluate tinnitus that does not localize to 1 ear, is nonpulsatile, and is not associated with focal neurologic abnormalities or an asymmetric hearing loss. The panel made the following recommendations: Clinicians should (a) perform a targeted history and physical examination at the initial evaluation of a patient with presumed primary tinnitus to identify conditions that if promptly identified and managed may relieve tinnitus; (b) obtain a prompt, comprehensive audiologic examination in patients with tinnitus that is unilateral, persistent (≥ 6 months), or associated with hearing difficulties; (c) distinguish patients with bothersome tinnitus of recent onset from those with persistent symptoms (≥ 6 months) to prioritize intervention and facilitate discussions about natural history and follow-up care; (d) educate patients with persistent, bothersome tinnitus about management strategies; (e) recommend a hearing aid evaluation for patients who have persistent, bothersome tinnitus associated with documented hearing loss; and (f) recommend cognitive behavioral therapy to patients with persistent, bothersome tinnitus. The panel recommended against (a) antidepressants, anticonvulsants, anxiolytics, or intratympanic medications for the routine treatment of patients with persistent, bothersome tinnitus; (b) Ginkgo biloba, melatonin, zinc, or other dietary supplements for treating patients with persistent, bothersome tinnitus; and (c) transcranial magnetic stimulation for the routine treatment of patients with persistent, bothersome tinnitus. The development group provided the following options: Clinicians may (a) obtain an initial comprehensive audiologic examination in patients who present with tinnitus (regardless of laterality, duration, or perceived hearing status); 545325

/pdf/clinical-practice-guideline-tinnitus-3ptl4asefl.pdf

Clinical Practice Guideline: Tinnitus

Prospective Investigation of Adverse Effects of Acupuncture in 97 733 Patients

Background and Objective: We report the design and essentials of the protocols of two Acupuncture Randomized Trials (ART) investigating whether acupuncture is more efficacious than no treatment and minimal acupuncture in the interval treatment of migraine and tension-type headache. Design: Randomized controlled multicenter trials with three treatment arms and a total observation period of 28 weeks. Setting: 30 practitioners and outpatient units in Germany specialized in acupuncture treatment. Patients: Per study 300 patients with migraine and episodic or chronic tension-type headache, respectively (diagnosis according to the criteria of the International Headache Society). Interventions: Patients are randomly assigned to receive either (1) semi-standardized acupuncture (150 patients), (2) standardized minimal acupuncture (75 patients), or (3) no interval treatment for 12 weeks followed by semi-standardized acupuncture (75 patients, waiting list control). Acupuncture treatment consists of 12 sessions per patient over a period of 8 weeks. Main Outcome Measure: Main outcome measure in the migraine trial is the difference between the number of days with headache of moderate or severe intensity during the 4 weeks before randomization and weeks 9 to 12 after randomization. In the study on tension-type headache the main outcome measure is similar to that described above, but for the number of headache days regardless of intensity. Outlook: The results of these two studies (available in 2004) will provide health care providers and policy makers with the information needed to make scientifically sound assessments of acupuncture therapy.

S Reitmayr

Papers

Prospective Investigation of Adverse Effects of Acupuncture in 97 733 Patients

Acupuncture Randomized Trials (ART) in patients with migraine or tension-type headache--design and protocols.

Das Modellvorhaben Akupunktur der Ersatzkassen

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

A large observational study on acupuncture for chronic pain in Germany – preliminary results