N Engl J Med 2013; 369:2218-2225
Mostrando las entradas con la etiqueta treatment. Mostrar todas las entradas
Mostrando las entradas con la etiqueta treatment. Mostrar todas las entradas
05 diciembre, 2013
28 junio, 2013
Despite Low-Risk Prostate Cancer, High-Tech Treatment Rises
The use of the most advanced technologies for treating prostate cancer, such as intensity-modulated radiotherapy and robotic prostatectomy, is common and increasing among the very men least likely to benefit from treatment, according to a report published June 26 in JAMA.
In a retrospective cohort study involving nearly 56,000 men newly diagnosed with prostate cancer during a recent 5-year period, advanced treatment technologies steadily supplanted more conservative approaches in older men who had low-risk disease, a high risk of dying from some other cause, or both, said Dr. Bruce L. Jacobs of the University of Michigan, Ann Arbor, and his associates (JAMA 2013;309:2587-95).
Paradoxically, this increase occurred against a backdrop of “increasing awareness about the indolent nature of some prostate cancers and of growing dialogue about limiting treatment in these patients,” the researchers noted.
“Our findings suggest that, even during this period of enhanced stewardship, incentives favoring the diffusion of these technologies outweighed those related to implementing a more conservative management strategy,” they said.
Dr. Jacobs and his colleagues examined this issue using data from the Surveillance, Epidemiology, and End Results (SEER) Medicare database after noting the rapid growth in the use of advanced treatment technologies, as well as the aggressive direct-to-consumer marketing and other “incentives” propelling that growth. They identified men aged 66 years and older whose prostate cancer was diagnosed during a 5-year period and who were followed for 1-6 years afterward.
The study population comprised 23,633 men who underwent intensity-modulated radiotherapy (IMRT) and 5,881 who had robotic prostatectomy, who were compared with 3,926 men who underwent traditional external-beam radiation therapy, 6,123 who had open radical prostatectomy, and 16,384 who opted for watchful waiting (observation).
The investigators estimated the study subjects’ probability of dying within 10 years based on age, race, comorbidity, socioeconomic class, type of residence (urban or rural), and the region of the country in which they lived.
As expected, the use of the advanced technologies increased over time in the entire study population. But it also increased among the men who “stood to gain the least in terms of survival.”
During the 5-year study period, the use of both IMRT and robotic prostatectomy increased from 32% to 44% of men who had low-risk disease based on the clinical stage of their tumor, Gleason score, and prostate-specific antigen (PSA) level. The use of both also increased from 36% to 57% of men who were at high risk of dying from another cause. And it rose from 25% to 34% of men who had both low-risk disease and a high risk of noncancer mortality.
At the same time, the use of more conservative approaches declined to a similar degree in these low-risk patients.
In a further analysis of the data, the use of advanced treatment technologies in men who were the most unlikely to die of prostate cancer increased from 13% at the start of the 5-year period to 24% at the end, a relative increase of 85%, Dr. Jacobs and his associates said.
These trends are particularly concerning because both IMRT and robotic prostatectomy are considerably more expensive than the less aggressive approaches they are displacing, the researchers added.
Some clinicians and patients may believe that the more advanced technologies yield better outcomes, but “comparative studies have shown that the advantages of these newer treatments are marginal at best,” Dr. Jacobs and his colleagues said.
“More diligence is needed to reduce the potentially unnecessary treatment of men with a low risk of dying from prostate cancer,” they said.
The study was supported by the American Cancer Society, the National Institutes of Health, Blue Cross Blue Shield of Michigan, and the National Cancer Institute. Dr. Jacobs reported no financial conflicts of interest, and two of his associates reported ties to ArborMetrix and HistoSonics.
26 mayo, 2013
Tratamiento farmacologico de la migraña en niños y adolescentes
Fuente: Evidencias en Pediatria
PDF English
AVC | Artículos Valorados Críticamente
El-Chammas K, Keyes J, Thompson N, Vijayakumar J, Becher D, Jackson
JL. Pharmacologic Treatment of Pediatric Headaches: A Meta-analysis. JAMA Pediatr. 2013 Mar 1;167:250-8. D.O.I.: 10.1001/jamapediatrics.2013.508.
Revisores:
Cuello García CA1, Pérez Gaxiola G2
1ITESM. Monterrey. Nuevo León (México).
2Hospital Pediátrico de Sinaloa. Culiacán. Sinaloa (México).
Correspondencia: Carlos Alberto Cuello García. Correo electrónico: carlos.cuello@gmail.com
Palabras clave: Migraña; Cefalea
Keywords: Migraine Disorders; Headache
Fecha de recepción: 19/04/2013 Fecha de aceptación: 02/05/2013 Fecha de publicación: 16/05/2013
Resumen Estructurado
Objetivo: comparar la eficacia de diversos tratamientos farmacológicos en la prevención de cefalea en niños y adolescentes.
Diseño: revisión sistemática (RS) con metaanálisis (MA).
Fuente de datos: se realizaron búsquedas en PubMed, EMBASE y CENTRAL hasta agosto de 2012. Se buscó en referencias bibliográficas. No hubo restricción del idioma. No se contactó con otros autores. La búsqueda incluyó medicamentos alfa-bloqueantes, bloqueadores del receptor de la angiotensina, anticonvulsivos, beta-bloqueantes, bloqueadores de los canales del calcio, inhibidores de la recaptación de la serotonina, agonistas de la serotonina y antidepresivos tricíclicos.
Selección de estudios: se limitó la búsqueda a ensayos clínicos aleatorios que evaluaron la eficacia de los medicamentos, comparados con placebo o con otro medicamento, para reducir la frecuencia o gravedad de cefaleas en menores de 18 años. Se incluyeron estudios con pacientes con migraña, cefalea tensional y cefalea crónica diaria.
Extracción de datos: la eligibilidad, la calidad y los datos de los estudios fueron evaluados de manera independiente por al menos dos autores, y las discrepancias se resolvieron por consenso. La calidad de los estudios se evaluó mediante la herramienta de valoración de sesgos de Cochrane y la escala de Jadad. El desenlace primario a evaluar fue la diferencia en la media de frecuencia de la cefalea con su intervalo de confianza del 95% (IC 95%), definida como número de eventos al mes, a las 12 semanas de seguimiento. Se realizó metaanálisis usando el modelo de efectos aleatorios para medicamentos individuales y también para grupos de medicamentos que tienen un mecanismo de acción similar. Se evaluó el efecto placebo mediante metarregresión. La heterogeneidad se evaluó con la I2. Se buscó sesgo de publicación con los métodos de Peters y de Egger.
Resultados principales: se incluyeron 21 ensayos clínicos (13 comparando con placebo, y 10 comparando entre medicamentos). Veinte de los ensayos incluyeron pacientes con migraña. Solo dos medicamentos alcanzaron significancia estadística: el topiramato (tres ensayos) redujo el número de episodios mensuales en -0,71 (IC 95%: -1,19 a -0,24), y la trazodona (un ensayo) los redujo por -0,60 ( IC 95%: -1,09 a -0,11). No se encontró sesgo de publicación. Los medicamentos con mayor número de efectos secundarios fueron el topiramato y el valproato.
Conclusión: el topiramato y la trazodona podrían disminuir los episodios mensuales de cefalea en pacientes menores de 18 años.
Conflicto de intereses: no existe.
Fuente de financiación: no se menciona.
Comentario Crítico
Justificación: la cefalea tensional y la migraña son entidades clínicas de frecuente presentación en niños y adolescentes. La prevalencia fluctúa alrededor del 15% para la cefalea tensional y del 4% para la migraña1, para la cual existen variados tratamientos farmacológicos, tanto para el tratamiento en la fase aguda (abortivos) como para prevenir la misma (profilácticos), cuya cantidad justifica una revisión sistemática de la evidencia. Dentro de los medicamentos profilácticos se encuentran los antiepilépticos, antidepresivos, antihistamínicos, bloqueadores del canal del calcio, antihipertensivos y antinflamatorios no esteroides (AINE). La presente revisión sistemática se enfoca a las terapias profilácticas.
Validez o rigor científico: se trata de una revisión sistemática con metaanálisis de ensayos clínicos aleatorios (ECA). Se incluyeron tanto los estudios que comparaban las terapias con placebo, como aquellos que comparaban terapias entre sí. La metodología de la presente revisión es adecuada, la población del estudio se define claramente, así como el factor de estudio (cefaleas en menores de 18 años), con una búsqueda exhaustiva, sensible y sin limitaciones. Tanto el cribado como la extracción de datos, la evaluación del sesgo de los estudios individuales, la evaluación de heterogeneidad, la búsqueda por sesgo de publicación y la estimación puntual mediante MA se pueden considerar adecuados. Es de notar que hubo 21 ECA que incluían a niños, adolescentes y adultos en el mismo estudio y que los autores no incluyeron en la revisión sistemática/metaanálisis porque no se podía separar por grupos de edad con los datos obtenidos. La heterogeneidad entre los estudios se detectó en el subgrupo de flunarizina (I2 = 85%), y propranolol (I2 = 84%) frente a placebo.
Importancia clínica: los únicos dos medicamentos que, al compararse con placebo, presentaron diferencias significativas matemáticas fueron el topiramato, con 0,7 episodios menos al mes (IC 95%: 1,19 a 0,24) y la trazodona, con 0,6 episodios menos al mes (IC 95%: 1,09 a 0,11). Esta diferencia, sin embargo, es mínima, pues en los pacientes en estudio, el promedio de episodios de cefalea iba desde 3,8 hasta 13,5 al mes (media de 7,1), es decir, estas terapias disminuirán en promedio, de siete episodios/mes, a solo seis al mes. Por otra parte, si tenemos en cuenta el desenlace dicotómico de mejoría (o no mejoría) en al menos un 50% en el número de episodios, solo un estudio, con serias deficiencias metodológicas, que comparó propranolol frente a placebo pudo demostrar este efecto benéfico. Ni el topiramato ni la trazodona pudieron demostrar este resultado. Es de notar que el placebo tuvo un efecto significativo de reducir los episodios de 5,6/mes a 2,9/mes (p = 0,03); mejor que muchos medicamentos aquí estudiados. En una revisión sistemática de la Cochrane del año 20032,se encontró alguna evidencia a favor de flunarizina pero con baja calidad metodológica. Igualmente, en otra RS3 no incluida en este metaanálisis que comentamos, se encontró cierto efecto protector del topiramato, pero con efectos secundarios importantes, ambas revisiones fueron comentadas en una articulo anterior de nuestra revista4.
Aplicabilidad en la práctica clínica: la evidencia hallada en esta revisión sistemática presenta una calidad moderada a baja, principalmente por riesgo de sesgo, y moderada heterogeneidad para el desenlace de reducción de los episodios de cefalea. La recomendación clínica que se puede obtener sólo puede considerarse débil para prescribir topiramato o trazodona, siempre y cuando se tenga en mente y se comunique a los pacientes y padres que el efecto es mínimo y puede no ser satisfactorio, tanto para el clínico como para el paciente.
Conflicto de intereses de los autores del comentario: no existe.
Cómo citar este artículo
Cuello García CA, Pérez Gaxiola G. La evidencia para el tratamiento de la cefalea y la migraña en niños y adolescentes sigue siendo limitada. Evid Pediatr. 2013;9:26.Bibliografía
- Arruda MA, Guidetti V, Galli F, Albuquerque RC, Bigal ME. Primary headaches in childhood: a population-based study. Cephalalgia. 2010;30:1056-64.
- Victor S, Ryan SW. Drugs for preventing migraine headaches in children. Cochrane Database Syst Rev. 2003;4:CD002761.
- Bakola E, Tzoufi M, Damigos D, Mavreas V. Anticonvulsant drugs for pediatric migraine prevention: An evidence-based review. Eur J Pain. 2009;13:893-901.
- García Lara NR, Frías García ME. Tratamiento preventivo para la migraña en niños: cuándo y cómo. Evid Pediatr. 2010;6:3.
28 septiembre, 2011
05 agosto, 2011
New H.I.V. Cases Steady Despite Better Treatment
Image via CrunchBaseSource. NYTby DONALD G. McNEIL Jr.
Despite years of great progress in treating AIDS, the number of new infections with the virus that causes it has remained stubbornly around 50,000 a year in the United States for a decade, according to new figures released on Wednesday by federal officials.
Mary Altaffer/Associated Press
Activists urged full financing for AIDS treatment during a demonstration in New York in June.
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Times Topic: AIDS / H.I.V.
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Readers shared their thoughts on this article.
The American epidemic is still concentrated primarily in gay men, and is growing rapidly worse among young black gay men.
That realization is causing a rift in the AIDS community. Activists say the persistent H.I.V. infection rate proves that the government prevention policy is a flop. Federal officials are on the defensive even as they concede that the epidemic will grow if prevention does not get better, which they know is unlikely while their budgets are being cut.
And some researchers believe it is impossible to wipe out a fatal, incurable disease when it is transmitted through sex and carries so much stigma that people deny having it and avoid being tested for it.
Looking back, epidemiologists at the Centers for Disease Control and Prevention believe that new cases peaked at 130,000 a year in the 1980s, sank slowly during the ’90s and reached a plateau at 50,000 around the year 2000.
Larry Kramer, a longtime AIDS activist and the author of “The Normal Heart,” a play about the epidemic’s early days, said: “It means I don’t see an AIDS policy, and I don’t see anyone in charge. It’s so dispiriting that it’s hard to find something to say about it. How many times can you yell ‘Help!’ without ever getting anywhere?”
Both Dr. Kevin Fenton, chief of AIDS prevention for the C.D.C., and Dr. Anthony S. Fauci, chief of AIDS research at the National Institutes of Health, took issue with Mr. Kramer’s interpretation. While both agreed that 50,000 new annual infections was, in Dr. Fauci’s words, “a great concern,” both pointed to some areas where substantial progress had been made. They said that new studies were seeking ways to get more people tested and treated early in the course of the illness, which would make them less infectious and drive transmission rates down.
“The C.D.C. is absolutely not resting,” Dr. Fenton said. “It was a major accomplishment to drop infections from 130,000 to 50,000, and we’re dealing with an epidemic that is dynamic.”
But, he conceded, 50,000 is an “unacceptably high level,” and without better prevention efforts “we’re likely to face an era of rising infection rates.”
Philip Alcabes, a public health epidemiologist at Hunter College in Manhattan, noted that 50,000 is close to the number of Americans who die in road accidents each year — almost 40,000 — “and in some ways, we consider dying on the road an ordinary thing.”
By contrast, he said, nearly one million Americans a year die of heart disease and strokes.
“So it’s not clear that prevention is a failure,” he said. “The average adult’s chances of encountering H.I.V. infection — 0.02 percent a year — are rather low. It’s not reasonable to expect that a sexually transmitted virus will disappear in America, or anywhere else. But I agree with Larry Kramer that there has been a dearth of new policy ideas.”
For most risk groups, infection rates are stable, with 61 percent of cases contracted through gay or bisexual sex, 27 percent through heterosexual sex and 9 percent through drug injections.
But they are increasing rapidly in one subgroup: young gay black men. Black teenage boys who realize they are attracted to men are often too poor to move to gay-friendly cities like San Francisco or New York, researchers said, and often must keep their homosexuality hidden from relatives and friends, making it more likely they will have furtive, risky sex.
They often lack health insurance, meaning they do not get checkups where a doctor might suggest testing. And while new surveys find that they use condoms at about the same rates as young gay white and Hispanic men, sex tends to stay within racial groups and more older black gay and bisexual men are infected. Also, untreated syphilis, whose sores open a path for H.I.V., is more common among blacks.
The National Institutes of Health is supporting studies in the Bronx, Washington and other heavily black urban areas seeking new ways to reach these men, Dr. Fauci said. Results will be ready in two or three years.
Prevention has worked for two groups, Dr. Fenton said. The number of women infecting their children at birth or through breast-feeding has dropped to only 100 a year from about 1,300 two decades ago. In that respect, the United States is like Africa: scarce public clinics focus on women and children, and many poor women see a doctor only when pregnant.
Also, the number of infections through drug use has dropped 80 percent, although that may be a result of changing fashions among addicts: Fewer inject heroin and more smoke or inhale heroin, crack, crystal meth and cocaine or swallow prescription opiates like OxyContin. Only needle-sharing passes virus-tainted blood.
Chris Collins, director of public policy for amfAR, the Foundation for AIDS Research, said the decade-long persistence of 50,000 infections “shows that we’ve failed to target prevention services adequately and have not gotten treatment coverage in many communities that would bring down community viral loads.”
A recent study has shown that getting people on antiretroviral drugs early makes them 96 percent less likely to infect others, so there is a growing outcry for “test and treat” — shorthand for actively seeking out gay men and those injecting drugs and asking them to get tested, and then helping them find medical care if they have the disease.
Dr. Fauci and Dr. Fenton said there was no discussion now of making such tests mandatory — as, for example, syphilis tests once were for marriage licenses.
San Francisco and Vancouver, British Columbia, have lowered new infection rates, Mr. Collins noted. But how applicable those lessons are to the United States as a whole is debatable; both cities have very small black populations, and Vancouver’s success relies partly on a government-approved center where drug addicts can shoot up under the eyes of a nurse and without fear of arrest — an experiment unlikely to be repeated in the United States.
The new C.D.C. figures are based partly on a new blood test that can tell recent infections from old ones, said Joseph Prejean, who led the team that made the new estimates. The test, invented in 2005 and nicknamed the “BED test,” for the B, D and E viral subtypes it uses, measures H.I.V. antibodies in the blood relative to total antibodies. That ratio rises rapidly from infection to about six months, then levels off, he said.
Dr. Alcabes, who was once a harsh critic of C.D.C. estimates, said he believed the new numbers were as accurate as they could get. “They’ve done an enormous amount of number-crunching with stupefying amounts of detail,” he said.
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