ObjectivesTo systematically review the efficacy and safety of butylphthalide soft capsule with routine treatment for Alzheimer’s disease (AD).MethodsDatabases including CNKI, WanFang Data, VIP, CBM, PubMed, EMbase, and The Cochrane Library were electronically searched from September 2002 to July 2018 to collect randomized controlled trials of butylphthalide soft capsule with routine treatment for Alzheimer’s disease. The trial was screened based on inclusion and exclusion criteria, and the methodological quality of the included trial was assessed. Meta-analysis was then performed by Revman 5.3 software.ResultsA total of 8 studies involving 576 patients were included. The butylphthalide soft capsule group included 283 patients and the control group included 293 patients. The result of meta-analysis showed that butylphthalide soft capsule with routine treatment (Donepezil hydrochloride or Memantine or EGb761) significantly improved the score of mini-mental state examination (MMSE) (MD=3.19, 95% CI 2.69 to 3.69, P<0.001) and clinical efficacy (RR=1.36, 95%CI 1.21 to 1.53, P<0.001). There was no significant difference in number of adverse events between the butylphthalide group and the control group (RR=1.13, 95%CI 0.77 to 1.67, P=0.52).ConclusionsBased on the routine treatment, combining with butylphthalide soft capsule can further facilitate cognitive function of AD and improve clinical efficacy. At the same time, no increase in adverse reactions has been found. However, due to the low quality of the included studies, more high quality randomized controlled trials are required to verify the results.
ObjectivesTo systematically evaluate the efficacy and safety of butylphthalide soft capsule in the treatment of vascular dementia (VaD).MethodsDatabases including CNKI, WanFang Data, VIP, CBM, PubMed, EMbase, The Cochrane Library were electronically searched to collect randomized controlled trials of butylphthalide soft capsule in the treatment of vascular dementia published from September 2002 to July 2018. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software.ResultsA total of 15 studies involving 1 149 patients were included. The butylphthalide soft capsule treatment group included 578 patients and the control group included 571 patients. The results of meta-analysis showed that compared with the control group (donepezil hydrochloride tablets or memantine hydrochloride tablets or EGb761 or negative control), the butylphthalide soft capsule treatment group improved the MMSE score of patients with VaD (MD=3.52, 95%CI 2.59 to 4.46, P<0.01), CDR score (MD=−0.72, 95%CI −0.80 to −0.65, P<0.01), and treatment efficiency (RR=1.31, 95%CI 1.20 to 1.43, P<0.01). However, there was no statistical difference in the number of adverse reactions between the treatment and control groups.ConclusionsButylphthalide soft capsule can be used in the treatment of patients with mild to moderate VaD. It can improve the cognitive function, raking of clinical dementia, and increase the effect rate of treatment. It can also work in conjunction with other drugs that improve cognitive function and no increase in adverse reactions has been found. However, due to the low quality of the included studies and small sample size, the actual efficacy strength is uncertain and the above conclusions are still required to be verified by more high-quality randomized controlled trials.