Effect of Combined Diclofenac and B Vitamins (Thiamine, Pyridoxine, and Cyanocobalamin) for Low Back Pain Management: Systematic Review and Meta-analysis.
Artículo académico
BACKGROUND: Cumulative evidence suggests an analgesic effect of thiamine, pyridoxine, and cyanocobalamin (TPC) in monotherapy, and also when combined with nonsteroidal anti-inflammatory drugs (NSAIDs), particularly diclofenac, in a synergistic manner. The aim of this review was to determine the effects of diclofenac combined with TPC compared with diclofenac monotherapy for low back pain (LBP) management. METHODS: We searched for randomized clinical trials on the MEDLINE, EMBASE, LILACS, and Cochrane databases of records of clinical trials, among other sources. We evaluated the risk of bias regarding randomization, allocation concealment, blinding, incomplete outcome data, selective reporting, and other biases. A random-effects meta-analysis to examine patients with acute LBP (N = 1,108 adults) was performed, along with a subsequent sensitivity analysis. RESULTS: Five studies in patients with LBP were included in the qualitative synthesis. Four of these studies in acute LBP were included in the first meta-analysis. A sensitivity test based on risk of bias (three moderate- to high-quality studies) found that the combination therapy of diclofenac plus TPC was associated with a significant reduction in the duration of treatment (around 50%) compared with diclofenac monotherapy (odds ratio = 2.23, 95% confidence interval = 1.59 to 3.13, P andlt; 0.00001). We found no differences in the safety profile and patient satisfaction. CONCLUSIONS: This meta-analysis demonstrated that combination therapy of diclofenac with TPC might have an analgesic superiority compared with diclofenac monotherapy in acute LBP. However, there is not enough evidence to recommend this therapy in other types of pain due to the scarcity of high-quality studies.
BACKGROUND:Cumulative evidence suggests an analgesic effect of thiamine, pyridoxine, andcyanocobalamin (TPC) in monotherapy, and also when combined with nonsteroidalanti-inflammatory drugs (NSAIDs), particularly diclofenac, in a synergisticmanner. The aim of this review was to determine the effects of diclofenaccombined with TPC compared with diclofenac monotherapy for low back pain (LBP)management.METHODS:We searched for randomized clinical trials on the MEDLINE, EMBASE, LILACS, andCochrane databases of records of clinical trials, among other sources. Weevaluated the risk of bias regarding randomization, allocation concealment,blinding, incomplete outcome data, selective reporting, and other biases. Arandom-effects meta-analysis to examine patients with acute LBP (N = 1,108adults) was performed, along with a subsequent sensitivity analysis.RESULTS:Five studies in patients with LBP were included in the qualitative synthesis.Four of these studies in acute LBP were included in the first meta-analysis. Asensitivity test based on risk of bias (three moderate- to high-quality studies)found that the combination therapy of diclofenac plus TPC was associated with asignificant reduction in the duration of treatment (around 50%) compared withdiclofenac monotherapy (odds ratio = 2.23, 95% confidence interval = 1.59 to3.13, P andlt; 0.00001). We found no differences in the safety profile andpatient satisfaction.CONCLUSIONS:This meta-analysis demonstrated that combination therapy of diclofenac with TPCmight have an analgesic superiority compared with diclofenac monotherapy inacute LBP. However, there is not enough evidence to recommend this therapy inother types of pain due to the scarcity of high-quality studies. ANTECEDENTES: Gran evidencia sugiereun efecto analgesico de la tiamina, piridoxina y cianocobalamina (TPC) en monoterapia,y tambien combinado con AINES, particularmente diclofenac, de una manerasinergica. El objetivo de este trabajo fue determinar los efectos de lacombinación de diclofenaco con TPC comparado con diclofenaco solo, para elmanejo del dolor lumbar agudo. METODOS: se realizó una búsqueda deensayos clínicos controlados aleatorizados en MEDLINE, EMBASE, LILACS, andCochrane. Evaluamos el riesgo de sesgo por aleatorización, datos incompletos,reporte, entre otros. Se hizo un metanalisis de efectos aleatorios paraexaminar pacientes con dolor lumbar agudo ((N = 1,108 adultos), con unconsecuente análisis de sensibilidad. RESULTADOS: Cinco estudios fueronincluidos en el análisis cualitativo. Cuatro de esos estudios fueron incluidosen el primer metanalisis. El test de sensibilidad fue basado según el riesgo desesgo, encontrando que la terapia de combinación fue asociado con una reducciónsignificativa en la duración del tratamiento (alrededor del 50%) comparado conel grupo diclofenaco solo ( (odds ratio = 2.23, 95% confidence interval =1.59 to 3.13, P andlt; 0.00001). No encontramos diferencias en el perfil deseguridad y satisfacción del paciente. CONCLUSIONES: Este metanalisisdemuestra que la terapia en combinación puede tener superioridad analgesica comparadocon diclofenaco en monoterapia en dolor lumbar agudo. Sin embargo, no hayevidencia suficiente para recomendar esta terapia en otros tipos de dolordebido a la escases de estudios de alta calidad.
