OBJECTIVE: To study the efficacy and safety of the combined treatment with compound Reinhartdt and Sea Cumber Capsule (RSC, a Chinese medicinal preparation consisted mainly of Reinhartdt and Sea Cumber) and Donepezil for vascular dementia (VD), and its effect on thyroid function axis. METHODS:Sixty-three patients with VD were treated respectively with RSC, Donepezil and the combined treatment. MMSE, ADAS-Cog and ADL scales were used to evaluate the condition of patients before treatment as well as at 3 months and 6 months after treatment. Meanwhile, levels of thyroid hormones, including (TSH, FT3, FT4, TT3, TT4) were measured with radioimmunoassay. RESULTS: As 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, P<0.01), the improvement in the Donepezil group was more significant than that in the RSC group after 6 months of treatment (P < 0.05), but the combined treatment group showed the best efficacy (P < 0.01). After 3 months of treament, the levels of FT3 and FT4 in the combined treatment group increased, but showed no statistical significance (P >0.05). However, significant changes were found at 6 months after combined treatment (P < 0.01). No significant changes were seen at all in levels of TSH, TT3 and TT4 (P > 0.05). FT3, FT4 increased without statistical significance after 6 months Donepezil treatment, TSH, TT3 and TT4 also showed no significant difference in the Donepezil group and no other significant changes of thyroid hormones was seen in patients treated with RSC (P > 0.05). No obvious adverse reaction occurred in any of the three groups. CONCLUSION: Combined treatment of RSC and Donepezil was effective and safe on VD patient, with the efficacy much better than either of them alone. No significant adverse reaction was observed. The regulation on thyroid hormones may one of the mechanisms of the combined treatment in improving cognitive function.
RCT Entities:
OBJECTIVE: To study the efficacy and safety of the combined treatment with compound Reinhartdt and Sea Cumber Capsule (RSC, a Chinese medicinal preparation consisted mainly of Reinhartdt and Sea Cumber) and Donepezil for vascular dementia (VD), and its effect on thyroid function axis. METHODS: Sixty-three patients with VD were treated respectively with RSC, Donepezil and the combined treatment. MMSE, ADAS-Cog and ADL scales were used to evaluate the condition of patients before treatment as well as at 3 months and 6 months after treatment. Meanwhile, levels of thyroid hormones, including (TSH, FT3, FT4, TT3, TT4) were measured with radioimmunoassay. RESULTS: As 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, P<0.01), the improvement in the Donepezil group was more significant than that in the RSC group after 6 months of treatment (P < 0.05), but the combined treatment group showed the best efficacy (P < 0.01). After 3 months of treament, the levels of FT3 and FT4 in the combined treatment group increased, but showed no statistical significance (P >0.05). However, significant changes were found at 6 months after combined treatment (P < 0.01). No significant changes were seen at all in levels of TSH, TT3 and TT4 (P > 0.05). FT3, FT4 increased without statistical significance after 6 months Donepezil treatment, TSH, TT3 and TT4 also showed no significant difference in the Donepezil group and no other significant changes of thyroid hormones was seen in patients treated with RSC (P > 0.05). No obvious adverse reaction occurred in any of the three groups. CONCLUSION: Combined treatment of RSC and Donepezil was effective and safe on VD patient, with the efficacy much better than either of them alone. No significant adverse reaction was observed. The regulation on thyroid hormones may one of the mechanisms of the combined treatment in improving cognitive function.