Randomized-controlled observation of naolibao in improvement of memory impairment in aged people with yin deficiency of liver and kidney

Jian WANG; Fanglian LI

ABSTRACT

BACKGROUND:

There are many reports on treatment of senile memory impairment with huperzine A, aniracetam, ginkgobiloba, etc. But, a strict double-blind and double-dummy design is deficit during experiment.

OBJECTIVE:

With cognition, symptoms of yin deficiency of liver and kidney and memory taken as observed indexes, double-blind and doubledummy method was used to observe the therapeutic effects of Chinese drug naolibao on senile memory impairmentof yin deficiency of liver and kidney.

DESIGN:

Prospective clinical experiment with randomized controlled double-blind and double-dummy method was designed.

SETTING:

Department of Neurology of Affiliated Hospital with Changchun College of Chinese Medicine, Department of Medicament of 2nd Clinical Hospital Affiliated to Jilin University.

PARTICIPANTS:

Totally 80 cases of memory impairment were from the clinic of Department of Neurology of affiliated Hospital with Changchun College of Chinese Medicine from April to December 2000. They were aged varied from 40 to 75 years, with mild non-constant poor memory, differentiated as yin deficiency of liver and kidney and diagnosed as questionable dementia in Chinese medicine, scored as 0 or 0.5 according to Clinical Dementia Assessment Scale (CDAS) and their integrals were > 17 (illiteracy) or > 20 (elementary-school educated) or > 23 (juniorschool educated) and < 30 according to MMSE (mini mental status examination).

METHODS:

The patients were randomized into experimental group (n=43) and the control (n=37). In experimental group, naolibao wan was administrated, composed of dihuang (Radix Rehmanniae), tusizi (SemenCuscutae), digupi (Cortex Lycii), yuanzhi (Radix Polygalae), shichangpu (Rhizoma Acori Graminei) and fuling (Poria), 4 pills/times, 3 times/day,and piracetan blank tablet was given, 2 tablets/time, 3 times/d. In the control, piracetan tablet 400 mg/tablet was prescribed, two tablets/time,3 times/day and naolibao blank pill was administrated, 4 pills/time,3 times/day. The course of treatment was 6 weeks. On observed spot,named base-line spot (before treatment) and terminal spot (after treatment), the integrals were examined and recorded on symptoms, physical signs and neuropsychology successively. Follow-up visit was carried on for the cases with remarkable effects. Therapeutic effects of syndromes in Chinese medicine were based on the evaluating criteria of Clinical Plan of Treatment with Naolibao Wan for Senile Memory Disturbance of Yin Deficiency of Liver and Kidney. In comparison of decreased symptomatic integral after treatment with average symptomatic integral before treatment, remarkable effect ≥ 2/3, effect 1/3-2/3, no effect ≤ 1/3. The therapeutic effects on cognition and memory were assessed by the formula [(integral after treatment-integral before treatment)÷integral before treatment] ×100%. Clinical control ≥ 85%, remarkable effect≥ 50%, effect ≥ 20% and no effect ≥ 20%.MAIN OUTCOME

MEASURES:

① Comparison before and after treatment of yin deficiency of liver and kidney in two groups. ② Comparison of integrals before and after treatment for yin deficiency of liver and kidney of two groups. ③ Comparison of evaluation of every index for memory in two groups. ④ Results of follow-up visits for the cases with remarkable effects. ⑤ Harmful accident and side effects.

RESULTS:

Totally 43 cases in experimental group and 37 cases in the control were all employed in result analysis. ① Comparison before and after treatment of yin deficiency of liver and kidney in two groups The reduced score in differentiation of symptoms, improvement of severity of yin deficiency of liver and kidney and promoted therapeutic effects on syndrome in experimental group were superior to those in the control, indicating significant difference (P < 0.05-0.01). ② Comparison of integrals before and after treatment for yin deficiency of liver and kidney of two groups The improvement of dream-disturbed sleep, tinnitus and deafness in experimental group was superior to that in the control, indicating significant difference (P < 0.05-0.01). ③ Comparison of evaluation of every index for memory in two groups The improvement of immediate recall and retarded recall in experimental group was superior to that in the contol,indicating significant difference (P < 0.05-0.01). ④ Results of follow-up visits for the cases with remarkable effects Three months later, the disease was not aggravated among the cases with remarkable effects in two groups.⑤ Harmful accident and side effects After treatment, there was no abnormal alternation and harmful reaction for safe indexes compared with those before treatment, such as blood routine, urine routine, feces routine, liver function, kidney function, etc.

CONCLUSION:

Naolibao wan improves memory, immediate recall, recog nition, dream-disturbed sleep, tinnitus and deafness for aged people, which is superior to piracetan tablet and it is safe and reliable in treatment.