Tracy Lucente

The effect of osteopathic manual therapy (i.e., spinal manipulation) in patients with chronic and subchronic back pain is largely unknown, and its use in such patients is controversial. Nevertheless, manual therapy is a frequently used method of treatment in this group of patients.We performed a randomized, controlled trial that involved patients who had had back pain for at least three weeks but less than six months. We screened 1193 patients; 178 were found to be eligible and were randomly assigned to treatment groups; 23 of these patients subsequently dropped out of the study. The patients were treated either with one or more standard medical therapies (72 patients) or with osteopathic manual therapy (83 patients). We used a variety of outcome measures, including scores on the Roland-Morris and Oswestry questionnaires, a visual-analogue pain scale, and measurements of range of motion and straight-leg raising, to assess the results of treatment over a 12-week period.Patients in both groups improved during the 12 weeks. There was no statistically significant difference between the two groups in any of the primary outcome measures. The osteopathic-treatment group required significantly less medication (analgesics, antiinflammatory agents, and muscle relaxants) (P< 0.001) and used less physical therapy (0.2 percent vs. 2.6 percent, P<0.05). More than 90 percent of the patients in both groups were satisfied with their care.Osteopathic manual care and standard medical care had similar clinical results in patients with subacute low back pain. However, the use of medication was greater with standard care.

The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) is a randomized clinical outcome trial of antihypertensive and lipid-lowering therapy in a diverse population (including substantial numbers of women and minorities) of 42,419 high-risk hypertensives aged > or = 55 years with a planned mean follow-up of 6 years. In this paper, we describe our experience in the identification, recruitment, and selection of clinical centers for this large simple trial capable of meeting the recruitment goals outlined for ALLHAT, and we highlight factors associated with clinical center performance. Over 135,000 recruitment brochures were mailed to physicians. Requests for information and application packets were received from 9351 (6.8%) interested investigators. A total of 1053 completed applications were received and 909 sites (86%) were eventually approved to join the trial. Of the approved sites, 278 either later declined participation or were never activated, and 8 were closed within a year for lack of enrollment. The final 623 randomizing centers exceeded the trial's recruitment goal to enroll at least 40,000 participants into the trial, although the recruitment period was extended 1.5 years longer than planned. Fewer than a quarter of the sites (22.6%) were recruited from academic medical centers or Department of Veterans Affairs Medical Centers. More than half of the sites (54.7%) were private solo or group practices, which contributed 53% of randomized participants. Community health centers comprised about 8% of the ALLHAT sites and 2.9% were part of health maintenance organizations. More than 22% of the principal investigators reported that they had no previous clinical research experience. In summary, ALLHAT was successful in recruiting a diverse group of clinical centers to achieve its patient recruitment goals.

Objective To examine regional differences in the Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) trial. Design Double-blind, randomized, international clinical trial. Setting Six hundred and sixty-one clinical centers in 15 countries. Patients Hypertensive volunteers (n = 16 602) with ≥1 additional cardiovascular risk factor, grouped into four regions: USA (n = 8144), Canada (n = 3405), Western Europe (Spain, UK, Italy, Sweden, Germany; n = 2048) or ‘other’ (Bulgaria, Israel, Mexico, Czech Republic, Hungary, Poland, Slovakia, Brazil; n = 2879); subgroupings included country and state/province within the USA and Canada. Interventions Randomized to COER™-verapamil or the investigator's choice of either atenolol or hydrochlorothiazide, titrated and additional drugs added as required. Main outcome measures Baseline characteristics; blood pressure control, medication adherence and lost-to-follow-up at 2 years; and composite primary endpoint (stroke, myocardial infarction, cardiovascular death) by regional groupings. Results Regional differences were found at baseline for age, gender, blood pressure, percentage receiving antihypertensive drug therapy, initial choice of atenolol or hydrochlorothiazide, and risk factor profile. Blood pressure control rates increased markedly during follow-up in all regions, but varied significantly by region. Blood pressure control, medication adherence and lost-to-follow-up rates were poorest in the USA. After adjustment for baseline differences, the primary-event rate for each region was significantly lower than for the USA. Although baseline factors, blood pressure control and event rates varied by region, treatment differences did not. Conclusion Despite differences in baseline and follow-up measures across geographical regions, the absence of treatment differences by region suggests that the overall findings of CONVINCE are robust.

ANDERSSON, GUNNAR B.J.; LUCENTE, TRACY; DAVIS, ANDREW M.; KAPPLER, ROBERT E.; LIPTON, JAMES A.; LEURGANS, SUE Author Information

Determinar si una nueva forma de verapamilo de liberación retardada (COER) es igual de eficaz que el atenolol y la hidroclorotiazida en la prevención de la enfermedad cardiovascular Ensayo clínico, aleatorio y doble ciego El estudio se llevó a cabo en 661 centros de 15 países. El período de inclusión fue entre septiembre de 1996 y diciembre de 1998 y el seguimiento se prolongó hasta diciembre de 2000 16.602 pacientes con diagnóstico de hipertensión que tenían al menos un factor de riesgo cardiovascular adicional Inicialmente, 8.241 pacientes recibieron 180 mg de verapamilo COER (un nueva forma de liberacion sostenida) y 8.361 recibieron o 50 mg de atenolol o 12,5 mg de hidroclorotiazida. Eventualmente pudieron adicionarse nuevos fármacos como diuréticos, bloqueadores beta o inhibidores de la enzima de conversión de la angiotensina (IECA) para conseguir controlar la presión arterial Un comité de clasificación de los puntos finales externo al estudio revisó todas las historias de los pacientes que padecieron un episodiocardiovascular para decidir los que cumplían criterios. El diagnóstico de infarto de miocardio (IAM) requería al menos dos de las tres condiciones siguientes: a) síntomas compatibles con IAM (p. ej., dolor torácico) que duraran al menos 15 min; b) cambios electrocardiográficos (elevación persistente del ST u ondas Q patológicas en al menos dos derivaciones, o c) aumento de las enzimas cardíacas (al menos el doble del valor normal). El diagnóstico de ictus requirió la presencia de alteraciones neurológicas focales durante un mínimo de 24 h En el grupo tratado con verapamilo COER, la presión arterial sistólica se redujo en 13,6 mmHg y la diastólica en 7,8 mmHg. En el grupo asignado a tratamiento inicial con atenolol o hidroclorotiazida la presión arterial sistólica se redujo en 13,5 mmHg y la diastólica en 7,1 mmHg. En el grupo de verapamilo hubo 364 episodios cardiovasculares primarios y en el grupo de atenolol o hidroclorotiazida, 365, con un riesgo relativo (RR) de 1,02 (intervalo de confianza [IC] del 95%, 0,88–1,18; p = 0,77). Para ictus fatal o no fatal el RR fue de 1,15 (IC del 95%, 0,90–1,48); para IAM fatal o no fatal el RR fue de 0,82 (IC del 95%, 0,65–1,03) y para enfermedad cardiovascular o fallecimiento el RR fue de 1,09 (IC del 95%, 0,93–1,26). El RR fue de 1,05 (IC del 95%, 0,95–1,16) para cualquier acontecimiento cardiovascular y de 1,08 (IC del 95%, 0,93–1,26) para mortalidad por cualquier causa. La hemorragia cerebral fue más común en el grupo tratado con verapamilo COER (n = 118 casos) en comparación con el grupo de atenolol o hidroclorotiazida (n = 79), con un RR de 1,54 (IC del 95%, 1,16–2,04; p = 0,003). En ambos grupos se dieron más casos de episodios cardiovasculares entre las 6:00 y las 12:00 h. Hubo 99/277 casos en el grupo de veramapilo y 88/274 casos en el grupo de atenolol- hidroclorotiazida, lo que supone un RR de 1,15 (IC del 95%, 0,86–1,53) La efectividad del tratamiento con antagonistas del calcio no se diferencia de la que se puede obtener con diuréticos y bloqueadores beta en la reducción de la enfermedad cardiovascular