Evidence - Based Study On The Pain Of Aconite Treatment And Early Warning Of Its Toxicity

Objective:To observe the effect of Fuzi for Liver, Heart, Kidney and Nerve, and compare the effect in different time and different dose. To find the bio-markers for toxicity early detection. To research the effect of Fuzi for musculoskeletal pain and find evidence from existing trials.Method:1 Animal experiment 160 male Wistar rats were divided randomly into 4 groups with 40 rats in each group. After 7-days adaptation, they were given Fuzi of certain dose. After 3 days,7 days,14 days and 21 days respectively,10 rats from each group were taken, their blood and urine were collected. ALT, AST, TBA, CRE, BUN, CK, CK-MB were detected by automatic machine, serum TnT, TnI, NT-proBNP, NSE, a-GST, OCT, Cys C, NGAL, MBP, Urinary KIM-1, IL-18, NGAL were detected by ELISA.2 Clinical Research Patients with musculoskeletal pain and using Fuzi were recruited in Dongfang Hospital. Pain VAS, Chill sensitivity VAS and SF-36 scale were evaluated before using Fuzi and after 4-weeks’ treatment. Serum biochemical items and early detection bio-markers were tested. Adverse events were observed.3 Systematic Review PubMed, The Cochrane Library, China Network Knowledge Infrastructure (CNKI), Chinese Biomedicine (CBM), Chinese Scientific Journals Database (VIP) and Wan Fang Database were retrieved from their inception till October 2014. Clinical trials with control groups irrespective of design were included.Patients suffering from pain regardless of the diagnosis. All types of preparations containing Chuanwu (Aconiti Radix Cocta), Caowu (Aconiti Kusnezoffii Radix Cocta) or Fuzi (Aconiti Lateralis Radix praeparata) will be included. Chuanwu (Aconiti Radix Cocta), Caowu (Aconiti Kusnezoffii Radix Cocta) or Fuzi (Aconiti Lateralis Radix praeparata) is required to be the main medicine in the formula according to the rule of traditional Chinese medicine. Both orally taken and external use will be accepted. The courses of treatment should be no less than 7 days. The Downs and Black scale were used to assess the methodological quality of the trials.Results:1 Animal Experiment Kruskal-Wallis test showed that there’s no significant difference among different Fuzi dose in biochemical items, a-GST, OCT, CysC, uKIM-1 and uIL-18. There’s significant difference among different Fuzi dose in NGAL, NSE, MBP, TnI, TnT, uNGAL. There’s no significant difference among different time in ALT, TBA, Urea and TnT. There’s significant difference among different time in AST, CRE, CK, CK-MB, α-GST, OCT, NGAL, CysC, NSE, MBP, NT-proBNP,TnI,uIL-18, uKIM-1, uNGAL.2 Clinical Research 82 cases were recruited in the research with 13 male cases and 69 female cases. Pain VAS and chill sensitivity VAS descended after treatment. Scores in all the dimensions in SF-36 scales were increased. The differences were significant.3 Systematic Review 9 trials of low quality were included,8 of which are randomized clinical trials and the other one is case-control study. Meta-analysis were conducted in studies about osteoarthritis. Standard mean difference is -0.51,95%confidence intervene is-1.02-0.00. The heterogeneity was high.Conclusion:Fuzi-containing components have no pathological harm for liver, heart or kidney of Wistar rats. The dose of Fuzi in the component has less effect for a-GST, OCT, CysC, uKIM-1 and uIL-18, has significant effect for NGAL, NSE, MBP, TnI, TnT, uNGAL. The time of usage has less effect for ALT, TBA, UREA, TnT, and has significant effect for AST, CRE, CK, CK-MB, a-GST, OCT, NGAL, CysC, NSE, MBP, NT-proBNP, TnI, uIL-18, uKIM-1 and uNGAL. TnT, TnI, a-GST, NGAL, NSE, MBP and uNGAL can be the index for early detection of the toxicity. Clinical usage of Fuzi could relieve pain and chill sensitivity and improve quality of life. Correct usage could help avoid adverse event. The systematic review showed Aconite-containing Chinese medicine could relieve pain. As the quality of the included trials were low, more trials of high quality were needed to get a solid evidence.