[A prospective multicenter randomized double-blinded controlled clinical trial on effects of tiantai no.1 in treating mild cognitive impairment].

ABSTRACT

OBJECTIVE: To observe the clinical effectiveness and safety of Tiantai No. 1 (TT1) in treating mild cognitive impairment (MCI). METHODS: With randomized double-blinded method adopted, the 128 MCI patients, selected according to the commonly accepted standard for MCI diagnosis, were assigned to 2 groups, the treatment group (65 cases) treated with TT1 and the control group (63 cases) treated with placebo for six months. Besides, a normal control group with 30 healthy elders was set up. Changes of comprehensive cognitive function, instant memory, short-term memory, calculation ability, orientating ability of time and space, language understanding ability as well as Chinese medicine syndromes before and after treatment were observed and compared. RESULTS: The cognitive function of MCI patients was significantly lower than that of healthy elders (P<0.01). The comprehensive cognitive function, and all the above-mentioned abilities were significantly improved (P<0.05, P<0.01) in the TT1 treated group after treatment, with an effect significantly better than that in the placebo treated group (P<0.01). Overall evaluation of effect and safety suggested that the clinical effectiveness index (CEI) of TT1 was notably higher than that of the placebo. And it was found in one-year follow-up that the incidence of developing to Alzheimer's disease (AD) in the treatment group was strikingly lower than that in the control group (P<0.01). CONCLUSION: TT1 can significantly improve the cognitive function of MCI patients, and reduce their incidence of developing to AD.