With the implementation of “Good Clinical Practice”, the quality of clinical trials in China has increased constantly and more importance has been attached to the protection of the subject. Large scale clinical trials are primarily featured by long-term intervention, large sample size, many participant organizations, different levels of investigators, long test periods, and lots of adverse events. Consequently, the protection of subject is full of extensive complexities and difficulties and currently there is little experience to refer to. Hence, the article introduces the subject’s protection method adopted in the National Program Subject of Secondary Prevention Clinical Trial about Effect of Qi Shen Tonifying Qi on Myocardial Infarction (MISPS-TCM).
Objective To compare the effectiveness of integrated traditional Chinese medicine (TCM) with Western medicine and Western medicine alone for acute episodes of withdrawal in alcoholism. Methods According to the criteria of alcohol dependence and acute alcochol withdrawal syndrome of Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-Ⅳ) , 62 consecutive patients were divided into two groups: 31 patients with odd numbers were allocated to the treatment group (4 patients were excluded because they left hospital early), 31 patients with even numbers were allocated to the control group. According to the four diagnostic methods of TCM, all patients in the treatment group were further divided into 4 types. The treatment group received valium, tiopronin, transfusion therapy and herbs (potion per day). The control group received the same therapy as the treatment group did but without oral herbs. Results Liver function, especially the difference between before and after treatment of GOT and γ-GT,the treatment group showed more improvement than the control group (P=0.046 and 0.001). The scores of anxiety and depression test, especially the HAMD, the treatment group showed more improvement than the control group (t=3.165, P=0.003). The treatment group used significantly less time than the control group (P=0.01), but no statistically significant difference was seen in the dosage of valium between the two groups (P=0.434). Conclusions The efficacy of integrated TCM with Western medicine is better than Western medicine alone for acute episodes of withdrawal in alcoholism.
Objective To observe the influence of “liqitongxia decoction” on intestinal barrier dysfunction of acute pancreatitis (AP). Methods Forty AP patients were randomly divided into “liqitongxia decoction” group (n=20) and magnesium sulfate group (n=20). APACHE Ⅱ score and gastrointestinal functions score (GFS) on admission， at 24 h, 48 h, 72 h and on day 5 after admission were recorded. The ratio of urine lactulose to mannitol (L/M), plasma activity of diamine oxidase (DAO) and the levels of endotoxin, TNF-α and IL-6 on admission, at 72 h and on the day 5 after admission were detected. Results The ratio of severe AP was not significantly different between two groups (P＞0.05). On the day 5 after admission, APACHEⅡscore and GFS in two groups decreased. The ratio of L/M, the activity of DAO, the levels of endotoxin, TNF-α and IL-6 decreased in “liqitongxia decoction” group and elevated in magnesium sulfate group. The APACHE Ⅱ score was not significantly different between two groups on the day 5 of admission (P＞0.05), but the GFS, the ratio of L/M, the activity of DAO, levels of endotoxin, TNF-α and IL-6 were significantly different between two groups (P＜0.05, P＜0.01). Conclusion The “liqitongxia decoction” may ameliorate the intestinal barrier dysfunction of patients with acute pancreatitis.
ObjectiveTo evaluate the methodological quality of cross-sectional surveys about Chinese medicine syndrome in a population at potential risk of cerebrovascular diseases. Methods The CNKI, WanFang Data, CBM and PubMed databases were electronically searched to collect cross-sectional surveys about Chinese medicine syndromes in a population at potential risk of cerebrovascular diseases from inception to December, 2022. The methodological quality was assessed using the JBI scale. Results A total of 105 studies were included. The average reporting rate of JBI was 52.06%, and the items with the highest scores included "sufficient coverage of the identified sample in data analysis" (100%), "description of study subjects and setting" (92.38%), and "using valid methods for the identification of the condition" (86.67%). Items with the lowest scores included "adequate sample size" (13.33%), "adequate response rate or low response rate managed appropriately" (14.29%), and "study participants recruited in an appropriate way" (20.95%). Subgroup analysis suggested that type of publication and number of implementation centers were potential factors influencing methodology quality (P<0.05). Conclusion The methods essential to a cross-sectional survey such as sampling, sample size calculation and handling with the response rate, and the syndrome diagnosis scales specific to Chinese medicine require further improvement.
Objective To evaluate the effectivenss of Chinese herbal retention enema in viral hepatitis patients. Methods Such databases as The Cochrane library, PubMed, EMbase, VIP, CNKI, CBM and WanFang Data were searched from the inception to December, 2011 to collect the randomized controlled trials (RCTs) about Chinese herbal retention enema in treating viral hepatitis, and the references of the included literature were also retrieved. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted the data, and evaluated and cross-checked the methodological quality. Then meta-analysis was conducted using RevMan 5.0 software. Results A total of 20 RCTs involving 1 735 patients were included. The subgroup analyses based on the length of intervention time showed that: a) after 2-week intervention: the overall effective rate of the Chinese herbal retention enema group was higher than that of the control group, with a significant difference (OR=3.19, 95%CI 1.87 to 5.44, Plt;0.000 1). Compared with the control group, the Chinese herbal retention enema group better promoted the recovery of liver function by more reduction of AST (MD= ?82.50, 95%CI ?145.66 to ?19.34, P=0.01), ALT (MD= ?44.78, 95%CI 65.90 to ?23.66, Plt;0.000 1) and TBIL (MD= ?37.51, 95%CI ?74.07 to ?0.95, Plt;0.0001). b) After 1-month intervention: The overall effective rate of the Chinese herbal retention enema group was higher than that of the control group, with a significant difference (OR=4.17, 95%CI 2.37 to 7.32, Plt;0.000 01). Compared with the control group, the Chinese herbal retention enema group better promoted the recovery of liver function by more reduction of AST (MD= ?17.86, 95%CI ?29.97 to ?5.76, P=0.004), ALT (MD= ?27.84, 95%CI ?42.45 to ?13.24, P=0.000 2), and TBIL (MD= ?54.15, 95%CI ?116.52 to ?8.23, P=0.09). Conclusion Chinese herbal retention enema can improve the overall effective rate for viral hepatitis patients, alleviate virus damage to liver cell and promote liver function recovery. The commonly used Chinese medicinals for enema are Radix et Rhizoma Rhei, Herba Artemisiae Capillaris, Salvia miltiorrhiza, and Radix Paeoniae Rubra.
Objective To learn the current situation of traditional Chinese medicine (TCM) systematic reviews/meta-analyses published in Chinese journals. Methods All TCM systematic reviews/meta-analyses published from 1978 to July 31, 2009 were searched in the Chinese Biomedical Database (CBM). According to the inclusion and exclusion criteria, relevant information was extracted on the basis of research purpose. Meanwhile, publication year, journal name, author’s district, number of authors and their articles, types of diseases and interventions were took as the indexes, and then descriptive analysis was performed using SPSS 15.0 software. Results A total of 245 articles including 238 in Chinese and 7 in English were included. All of them were published in 117 different journals from 1998 to 2008, showing an accelerating growth trend of article number. In addition to only one article with first author from Germany, the first author of other 244 were from 24 domestic provinces (autonomous regions and municipalities); the number of authors ranged from 1 to 11; a total of 186 people had published articles as first author, and the number of their published articles ranged from 1 to 29. There were 16 types of diseases according to the International Classification of Diseases 10th Edition (ICD-10). Totally, 218 articles took drugs as interventions (including 106 listed drugs, 25 self-made prescriptions, 70 related to both listed drugs and self-made prescriptions, and 17 without reporting detailed interventions), accounting for 89%; and 27 articles were about non-drug interventions (including 26 about acupuncture and 1 about massage), accounting for 11%. Most (95.8%) of the articles about self-made prescriptions and listed drugs/self-made prescriptions adopted inappropriate pooled analyses. Conclusion Evidence-based medicine has been spread into the field of TCM, the number of TCM systematic reviews/meta-analyses shows an accelerated growth trend. The types of diseases discussed in the literature were almost the same as the diseases those could be effectively treated by TCM, but there existed imbalance in districts. In the future, systematic review/meta-analysis on drug intervention should aim at Chinese patent medicines and single medicines rather than self-made prescriptions, and should pay more attention to advantageous drugs and advantageous treatments of diseases. Moreover, importance should be also attached to clinical heterogeneity controlling when using acupuncture as a non-drug intervention.
Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
Objective To assess the efficacy and safety of Chinese herbal medicine for the treatment of functional dyspepsia (FD) and compare the difference of efficacy between Chinese herbal medicine and western medicine. Methods Based on the principles and methods of Cochrane systematic reviews, we searched the Cochrane Central Register of Controlled Trials, MEDLINE, CBMdisc and CNKI from inception to Dec. 2008. And we also handsearched relevant journals and conference proceedings. We evaluated the risk of bias in the included randomized controlled trials(RCTs) according to the Cochrane Handbook for Systematic Reviews. The Cochrane Collaboration’s software RevMan 4.2.8 was used for meta-analysis. Results Seven studies involving 981 patients were identified. The results of meta-analysis showed that: (1) There was no significant difference between Dalitong granule and cisaprid in effective rates (RR=1.03, 95%CI 0.97 to 1.09, P=0.36), piman syndrome (RR=1.06, 95%CI 0.96 to 1.18, P=0.23), gastric emptying function (RR=1.05, 95%CI 0.76 to 1.45, P=0.78), syndromes of TCM (WMD=0.41, 95%CI –1.05 to 1.87, P=0.58), pulse and tongue picture (RR=1.00, 95%CI 0.69 to 1.45, P=0.98), and adverse reaction (RR=1.00, 95%CI 0.69 to 1.45, P=0.46). (2) There was no significant difference between Weishuan pellet and cisaprid on effective rates (RR=1.02, 95%CI 0.96 to 1.07, P=0.53), piman syndrome (RR=1.06, 95%CI 0.97 to 1.15, P=0.19), gastric emptying function (RR=1.05, 95%CI 0.86 to 1.28, P=0.63), syndromes of TCM (WMD=0.70, 95%CI 0.11 to 1.29, P=0.02) and adverse reaction (RR=0.33, 95%CI 0.02 to 5.28, P=0.44). (3) There was no significant difference among Jianpiyiqi prescription (RR=1.16, 95%CI 1.00 to 1.34, P=0.05), Liqifuwei oral liquid (RR=1.00, 95%CI 0.91 to 1.11, P=0.94) and Jianpixiaozhang granules (RR=0.88, 95%CI 0.76 to 1.00, P=0.06) compared with cisaprid in effective rates (Pgt;0.05). (4) There was no significant difference between Hewei Xiaopi Capsule and domperidone on effective rates (RR=1.11, 95%CI 0.87 to 1.41, P=0.42) and piman syndrome (RR=1.07, 95%CI 0.93 to 1.24, P=0.35). Conclusion Chinese herbal medicine has a better clinical cure rate and marks of TCM syndrome on FD than western medicine. But we have no adequate evidence to confirm whether western medicine can be substituted by Chinese herbal medicine for the treatment of FD. Therefore, we need more high quality RCTs to confirm this conclusion.
Objective To evaluate the methodological quality of clinical trials on traditional Chinese medicine (TCM) nursing in recent six years.Methods Such databases as CNKI, VIP, WanFang Data and CBM were searched for collecting clinical trials on TCM nursing published from January 2006 to September 2011, and domestic primary nursing journals were also searched from January 2010 and September 2011. Methodological quality of included studies was assessed using quality assessment criteria of the Cochrane systematic review guideline. Results A total of 854 clinical trials were retrieved, including 706 (82.7%) randomized controlled trials (RCTs), 108 (12.6%) quasi-randomized controlled trials and 40 (4.7%) non-randomized controlled trials. In the methodological quality analysis, the comparability of baseline was mentioned in 784 trials (91.8%), a total of 498 (58.3%) reported definite diagnosis criteria. 178 (20.8%) reported exclusive criteria. 831 studies (97.3%) applied relevant statistical methods properly. However, only 55 trials (6.4%) mentioned the method of randomization sequence. 10 studies (1.2%) described the method of randomiztion assignment. Blinding was mentioned in 22 studies (2.6%). 98 trials (11.5%) did prospective follow-up. 93 trials (10.9%) had safety description. 20 trials (2.3%) reported lost and with drawl cases, but only 2 conducted intention-to-treat analysis. It was hard to determine whether there was selective reporting bias or not because all the studies did not have protocols. Only 21 studies (2.5%) mentioned the lack of outcome indicators which could be the evidence for existing of bias. By annual analysis, there were 81 trials which conformed to at least 2 low risk criteria. 10 trials (12.3%) was published in 2009, 26 trials (32.1%) published in 2010, and 27 trials published by September 2011, indicated an uptrend. Conclusions According to the Cochrane Collaboration’s tool for assessing risk of bias, the overall quality of clinical trials on TCM nursing is low with defects in different degrees, but it rises gradually over years.
OBJECTIVE To study the character of cefazolin (CEZ) pharmacokinetics on Neijiang pig and human. METHODS The serum concentration of CEZ in 8 normal Chinese adult men, 9 of 8-month male Neijiang pigs and 5 of 4-month male Neijiang pigs were detected by high-performance liquid chromatography (HPLC). RESULTS The pharmacokinetic parameters suggested that two-compartment model was found in all groups after intramuscular injection of CEZ. In normal men, 8-month pigs and 4-month pigs, the peak time (Tmax) was (58.8 +/- 13.0), (19.7 +/- 9.9) and (18.2 +/- 8.6) min respectively, T1/2 alpha was (42.3 +/- 19.7), (19.0 +/- 7.7) and (9.3 +/- 1.9) min, the peak concentration (Cmax) was (101.6 +/- 14.6), (28.7 +/- 9.0) and (23.5 +/- 4.6) mg/L; Vd was (0.096 +/- 0.016), (0.374 +/- 0.184) and (0.386 +/- 0.211) L/kg; T1/2ka was (22.5 +/- 6.8), (8.6 +/- 4.8) and (10.6 +/- 10.2) min; T1/2 beta was (117.3 +/- 8.6), (84.2 +/- 9.8) and (45.1 +/- 11.5) min; clean rate of plasma Cl was (0.8 +/- 0.1), (6.8 +/- 1.2) and (11.0 +/- 3.0) ml/kg.min; AUC was (21,803 +/- 4,145), (2,407 +/- 443) and (1,636 +/- 685) mg.min/L. CONCLUSION It could conclude that the Neijiang pigs could eliminate CEZ effectively, but the absorption, distribution and elimination of CEZ in pigs were quicker than that of in human while the absorption from muscle in both pig groups were lower than that in human.