ABSTRACT
Background: Patients not eligible for stem cell transplantation (SCT) have been treated with melphalan (M) plus prednisone (P); however, the standard of care has shifted to MP plus thalidomide(T) due to a greater survival benefit. Bortezomib (B) and lenalidomide have also emerged as effective agents. Methods: Randomized clinical trials (RCTs) that compared MP to any otherregimen were identified from the databases of Cochrane Library, PubMed, LILACS, EMBASE and Scirus. Results: Twenty-two trials were included from 2159 potential eligible references. MP vs.M plus dexamethasone (MD): (3 RCTs) MD was superior in partial response (PR) rate and non-hematological toxicity. MP vs. T-based regimens: (4 RCTs) significant differences favoring T-basedregimens in complete response (CR) rate, partial response (PR) rate, and progression-free survival (PFS). MP vs. B based regimens: (1 RCT) significant differences in overall survival (OS) , time to progression (TTP), CR and PR rate favored B-based regimens according to the European Group for Blood and Marrow Transplantation (EBMT) criteria. MP vs. chemotherapy regimens withoutM: (3 RCTs) A significantly higher number of patients treated with BP achieved a CR. TTP was alsosignificantly longer in BP-treated patients (p < 0.02). MP vs. other polychemotherapy regimens:(13 RCTs) No significant differences in PR, OS, hematological or other type of toxicity were observed between MP and the other chemotherapy regimens. Conclusions: Symptomatic multiplemyeloma patients ineligible for SCT should receive as first-line treatment a combination of MP plus B or T; these regimens are associated with improved outcome but greater toxicity comparedto MP alone. More homogeneous clinical trials using a cytogenetic risk approach are required
Subject(s)
Humans , Meta-Analysis as Topic , Multiple Myeloma , Drug Therapy , Transplantation, AutologousABSTRACT
El significado de una investigación, "el qué significa", es el elemento del informe de investigación que tiene mayor probabilidad de influir sobre las opciones y las decisiones reales acerca de los tratamientos. Es una de las preguntas clave que recomendaba el Prof. Bradford Hill, pionero de los ensayos clínicos aleatorizados. Hoy cuando el volumen de la información en temas de salud, con énfasis en intervenciones o tratamiento, es inconmensurable, cuando la calidad de lo publicado no siempre es directamente proporcional a la cantidad, el tiempo para leer lo publicado resulta ínfimo. Cuando más que "leer", lo fundamental es analizar cómo se hizo el estudio, es obligatoria la selección de las investigaciones que tengan la mayor fiabilidad posible, un mayor grado de certeza. En consecuencia, se impone decidir entre una revisión narrativa y una revisión sistemática, para responder con eficiencia la interrogante del Dr. Hill. La toma de decisiones en las gestiones clínica y pública deben estar basadas en la mejor evidencia posible, con el menor riesgo de sesgo para aproximarse a lo que Descartes expresó en su día como una medicina basada en demostraciones infalibles. El objetivo de esta comunicación es mostrar la comparación entre las revisiones sistemática y narrativa, con la finalidad de que el lector determine motus propio, la utilidad de sendos tipos de investigaciones secundarias, en el ámbito de la toma de decisiones en salud basadas, en la mejor evidencia. Con ese fin, sirva de ejemplo la indicación de la proteína C humana recombinante en los pacientes con sepsis
The conclusion of an investigation. "What does it mean?" is the most impotant element of any report of an investigation which is most likely to influence the actual choices and decisions about treatment. It was one of the key questions recommended by Professor Bradford Hill, the pioneer of randomized controlled trials. Today, the burden of information in health issues related to therapy is immeasurable. But, when the quality of what is published is not proportional to the quantity, and the time available for reading is short, the most important thing is to determinate how the research was conducted. This is very important in order to select the most valid research to make a better decision. According to this, one must choose between a narrative review or a systematic review in order to answer Dr. Braford Hills question. Public and clinical management decision making should be based on the best evidence possible with the lowest risk of bias. This is in the spirit of Descartes expression, looking for infallible demonstrations based in medicine. The aim of the paper is to show a comparison between a systematic review and a narrative review. Its goal is for the reader him- or herself to determine the usefulness of these types of secondary analyses, in order to make the best medical decision associated with the highest safety for the patient. Use of the human activated recombinant protein C in people with severe sepsis will be used as an example