OBJECTIVETo study the efficacy and safety of Reinhartdt and sea cucumber capsule (RSC) combined with donepezil in treating Alzheimer's disease (AD), and its effect on thyroid function axis.

METHODSSixty-eight patients were randomly assigned to the RSC group, the Donepezil group and the combined treatment group, who were treated for 3 and 6 months with RSC, Donepezil and RSC combined with Donepezil, respectively. The curative effect was evaluated by scoring according to Mini-Mental State Examination (MMSE), ADAS-Cog and ADL chart, and the level of thyroid hormones, including TSH, FT3, FT4, TT3 and TT4, were measured with radioimmunoassay before treatment, 3 and 6 months after treatment respectively.

RESULTSAs compared with the baseline, MMSE score increased, ADAS-Cog score and ADL score decreased significantly in all the three groups after 3 months and 6 months of treatment (P < 0.05 and P < 0.01), but the improvement in the combined treatment group was more significant than that in the other two groups (P < 0.01). After 6 months of treatment, the levels of FT3 and FT4 in the combined treatment group were significantly changed (P < 0.01), but no significant change in all the thyroid hormones was found in the other two groups. No obvious adverse reaction occurred in all the three groups.

CONCLUSIONRSC combined with Donepezil in treating AD is effective and safe with no evident adverse reaction, better than single drug treatment, which may be through influencing the metabolism of thyroid hormones to improve the cognition function of AD patients.