RESUMEN
BACKGROUND: Alzheimer's disease (AD) is a slowly progressive neurodegenerative disease which cannot be cured at present. The aim of this study was to assess whether the combined application of ß-asarone and tenuigenin could improve the efficacy of memantine in treating moderate-to-severe AD. PATIENTS AND METHODS: One hundred and fifty-two patients with moderate-to-severe AD were recruited and assigned to two groups. Patients in the experiment group received ß-asarone 10 mg/d, tenuigenin 10 mg/d, and memantine 5-20 mg/d. Patients in the control group only received memantine 5-20 mg/d. The Mini Mental State Examination (MMSE), Clinical Dementia Rating Scale (CDR), and Activities of Daily Living (ADL) were used to assess the therapeutic effects. The drug-related adverse events were used to assess the safety and acceptability. Treatment was continued for 12 weeks. RESULTS: After 12 weeks of treatment, the average MMSE scores, ADL scores, and CDR scores in the two groups were significantly improved. But, compared to the control group, the experimental group had a significantly higher average MMSE score (p<0.00001), lower average ADL score (p=0.00002), and lower average CDR score (p=0.030). Meanwhile, the rates of adverse events were similar between the two groups. Subgroup analysis indicated that the most likely candidates to benefit from this novel method might be the 60-74-years-old male patients with moderate AD. CONCLUSION: These results demonstrated that the combined application of ß-asarone and tenuigenin could improve the efficacy of memantine in treating moderate-to-severe AD. The clinical applicability of this novel method showed greater promise and should be further explored.
Asunto(s)
Enfermedad de Alzheimer/tratamiento farmacológico , Anisoles/administración & dosificación , Medicamentos Herbarios Chinos/administración & dosificación , Memantina/administración & dosificación , Actividades Cotidianas , Anciano , Derivados de Alilbenceno , Enfermedad de Alzheimer/fisiopatología , Anisoles/uso terapéutico , Quimioterapia Combinada , Medicamentos Herbarios Chinos/uso terapéutico , Humanos , Masculino , Memantina/uso terapéutico , Persona de Mediana Edad , Escalas de Valoración Psiquiátrica , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
BACKGROUND: Mailuoning is widely used in the treatment of acute ischaemic stroke in China. Animal experimental studies and clinical pharmacological research indicate that mailuoning might improve blood circulation, prevent ischaemic injury, and protect heart and brain tissue. This review was last published in 2009. As new data have become available, it is necessary to reassess the evidence from randomised controlled trials. OBJECTIVES: To determine the effects and safety of mailuoning agents (injection or oral liquid) in the treatment of people with acute ischaemic stroke. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (May 2014), the Cochrane Central Register of Controlled Trials (CENTRAL;2014, Issue 4), MEDLINE (1966 to May 2014), Embase (1980 to May 2014), AMED (1985 to May 2014), the Chinese Stroke Trials Register (June 2014), the China Biological Medicine Database (CBM-disc; 1979 to June 2014), China Science and Technology Journal database (CSTJ; 1979 to June 2014), Wanfang Data Chinese databases (1979 to June 2014), and the China National Knowledge Infrastructure (1979 to June 2014). We searched clinical trials and research registers, handsearched 10 Chinese journals including relevant conference proceedings, scanned reference lists, and contacted the pharmaceutical company that manufactures mailuoning. We also attempted to contact trial authors to obtain further data. SELECTION CRITERIA: Randomised controlled trials comparing mailuoning with placebo or mailuoning plus other treatment compared with that other treatment in people with acute ischaemic stroke. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, assessed trial quality, and extracted data. MAIN RESULTS: We included 21 trials, involving 1746 participants, in this update; six trials were new. The included trials did not report the numbers of dead and dependent participants at the end of at least three months' follow-up. Of the 12 trials that reported adverse events, five events occurred in two trials. There was no significant difference between the treatment group and the control group. We assessed 20 trials to be of a poor quality: When analysing these trials together, mailuoning was associated with a significant increase in the number of participants with an improved neurological deficit (risk ratio (RR) 0.31, 95% confidence interval (CI) 0.23 to 0.42) and showed a significant improvement of neurological deficit with the European Stroke Scale (ESS) (mean difference (MD) (fixed) 8.29, 95% CI 3.44 to 13.15). One placebo-controlled trial, assessed to be of a better methodological quality, failed to show a significant improvement of neurological deficit at the end of three months' follow-up (MD (fixed) 2.49, 95% CI -1.45 to 6.43) or in quality of life. One trial, which reported cognitive function using the Montreal Cognitive Assessment as a continuous scale, showed a significant improvement of cognitive function (MD (fixed) 2.68, 95% CI 1.82 to 3.54). Two trials assessed activities of daily life: One trial showed a significant improvement, but the other did not. AUTHORS' CONCLUSIONS: This review did not provide sufficient evidence to support the routine use of mailuoning for the treatment of people with acute ischaemic stroke. High-quality large-scale randomised controlled trials are needed to confirm the efficacy of mailuoning.