OBJECTIVES:To assess the methodological and report quality of the randomized controlled trials (RCTs) using multi-formula Chinese medicine in the treatment of Senile Dementia. Individual assesement for each RCT articles was carried out to evaluate the research quality level and to find the inherent problems. This quality review aims to raise the standard of Chinese Medicine treatment for Senile Dementia and to provide reference for clinical researchers. The methods of TCM treatment on Senile Dementia were summarized for further studies.METHODS:Research articles published in recent 10 years were searched from CNKI and PubMed websites and eligible studies were selected according to the inclusion criteria. Jadad scale and individual analysis were used to assess the quality of the researches based on the principles of Evidence-Based Medicine (EBM) and clinical epidemiology. The percentage is calculated for the analysis of the treatment measures of Chinese medicine. Microsoft Office Excel 2007 was used for data processing and statistical analysis.RESULTS:1 Research quality reviewThere were 19 RCT studies or 15% of total 128 RCT studies score 3 marks or above in Jadad scale, which are considered as high quality studies. The main problems found in the 45 research articles with Jadad scoreā„2 are:(1)Only 25% studies provide the method of randomization. No description on allocation concealment; (2)Only 11% studies are double-blinded trials. Only 9% studies have the description on blind method; (3)Only 7% studies report withdrawals or drop-outs; (4)Lack of standardized diagnosis criteria. Diagnosis criteria and inclusion criteria for patient selection are not reported clearly; (5)Lack of standardized measurement tools for evaluating efficacy; (6)Lack of the description on diagnosis criteria and sympdrom types based on Chinese medicine theory; (7)Small sample size. Lack of multi-centre studies with large sample size; (8)Only half of the RCT studies include safety evaluation and/or report adverse cases; (9)Absence of follow-up observations on long term effect; (10)Full formula are not provided.2 Analysis on treatment measures of Chinese MedicineAs the number of AD studies are too small, this thesis only analyses the treatment measures of Chinese Medicine used in 34 studies on VD. The result are:(1)Symptom types: Brain disfunction caused by liver and kidney deficiency, Stagnation caused by phlegm and Blood stasis combined with Qi depression are the three main symptom types of VD patients; (2)Treatment measures:Tonify the kidney and nourish the brain, Promoting blood circulation to dissipate blood stasis and Dispel phlegm to induce resuscitation are the main treatment measures for VD; (3)Commonly used herbs:The top 10 herbs most commonly used for treating VD is Rhizoma Acori Graminei, Rhizoma Chuanxiong, Radix Polygoni Multiflori, Radix Astragal Fructus Lycii, Radix Salviae Miltiorrhizae, Radix Ginseng, Radix Angelicae Sinensis, Radix Polygalae, Hirudo and Pheretima.CONCLUSION:The thesis conducts research review on the RCT studies using multi-formula Chinese Medicine treatment for Senile Dementia. The review finds that the methodological and report quality of the RCT studies need to be further improved to meet the standard requirement of RCT. The treatment measures of Chinese Medicine are summarized for further studies on efficacy and mechanism of Chinese Medicine for treatment of Senile Dementia. |