ABSTRACT
Currently， evidence on the efficacy and risk of traditional Chinese medicine （TCM） injections is seriously insufficient， and it is difficult to evaluate TCM injections comprehensively， truly and objectively using available efficacy evaluation indicators. Therefore， establishing a clinical efficacy evaluation system that can effectively reflect TCM injections is imperative. Core outcome set （COS） has played an important role in screening TCM efficacy evaluation indicators， however， there are still certain problems， such as large differences in efficacy indicators， non-standardization， and lack of featured and specific TCM indicators. Mixed method research （MMR） has the advantages of looking at problems from both quantitative and qualitative perspectives. It is thereby proposed to use COS and MMR integrated model to establish a clinical efficacy evaluation indicator system that not only fully considers the cha-racteristics of TCM injections， but also highlights the efficacy and advantages of TCM injections from the perspective of TCM intervention. Simultaneously， an indicator screening method using MMR to optimize COS research model is formulated， which can provide ideas for the research on efficacy evaluation indicators of TCM injections.
ABSTRACT
OBJECTIVE: To investigate the short-term efficacy and safety outcomes following a sequential treatment with clearing heat and eliminating phlegm (CHEP) formula and tonifying Qi and activating blood circulation (TQABC) formula in patients with acute ischemic stroke (AIS) within a 72 h time window. METHODS: In this randomized, multicenter, double-blinded, placebo-controlled trial, 500 participants will be randomly assigned in a ratio of 1â¶1 to the CHEP+ TQABC group or control group. In addition to guideline-based standard medical care, participants in the treatment group will receive the CHEP formula for the first 5 consecutive days followed by the TQABC formula for another 10 consecutive days, while those in the control group will receive CHEP formula placebo and TQABC formula placebo consecutively. The primary outcome measure will be the comparison of the change in the National Institutes of Health Stroke Scale score from baseline to 15 days after randomization. The secondary outcome measures will include the scores on the modified Rankin Scale, Barthel Index, Patient-Reported Outcomes, TCM symptom pattern (Zheng-hou) evaluation Scale, and the incidence of in-hospital complications. Safety assessment will include the physical examination, laboratory detection, any adverse events or serious adverse events, and the proportion of any complications during hospitalization. DISCUSSION: The results of this study will provide objective and scientific data with which to assess the efficacy and safety of a sequential treatment based on "integrating disease and symptom pattern" for patients with AIS.
Subject(s)
Ischemic Stroke , Stroke , Double-Blind Method , Hospitalization , Hot Temperature , Humans , Multicenter Studies as Topic , Qi , Randomized Controlled Trials as Topic , Stroke/diagnosis , Stroke/drug therapy , Treatment OutcomeABSTRACT
Objective:To compare the effect of local vibration and extracorporeal shock wave therapy (ESWT) on triceps spasticity and the walking ability of hemiplegic stroke survivors.Methods:Sixty-nine stroke survivors with hemiplegia were randomly divided into a control group, a vibration group and an ESWT group. The control group received 60 minutes of conventional Bobath rehabilitation treatment and motor relearning from Monday to Saturday for 4 weeks. For the vibration and ESWT groups, 10 minutes of that traditional therapy were replaced by either local vibration or extracorporeal shock wave treatment every Tuesday, Wednesday and Saturday. Before and after the treatment, the three groups were evaluated using the Comprehensive Spasticity Scale (CSS) and in terms of passive joint range of motion (PROM), ankle plantar flexion angle, 10m maximum walking speed, stride frequency, and stride length.Results:After the intervention the average CSS, PROM, and ankle plantar flexion angle were significantly better for all three groups than before the treatment. At that point the ESWT group′s averages were significantly better than those of the vibration group, and the vibration group′s averages were significantly superior to those of the control group. Walking speed, stride frequency and stride length had also improved significantly in all three groups, with those in the vibration and ESWT groups significantly outperforming the control group. There was no significant difference between the vibration and ESWT groups in terms of walking ability.Conclusions:Both local vibration and extracorporeal shock wave therapy improve triceps spasticity and the walking ability of hemiplegic stroke survivors. Shock waves are more effective for improving spasticity, but there is no significant difference between the therapies in terms of improving walking ability.
ABSTRACT
Objective To evaluate the therapeutic efficacy and safety of micro-invasive craniopuncture scavenging technique (MPST) for treatment of intracranial hematoma in patients with hypertensive cerebral hemorrhage (HICH).Methods All the clinical randomized controlled trial (RCT) studies published on MPST and internal medicine conservative treatment of HICH were searched via computer screening of databases including Cochrane clinical trials database, the Chinese biomedical literature database (CBM), Chinese periodical network full-text special topic database, Chinese science and technology periodical database and electronic periodicals database of Wanfang from January 2006 to January 2017. The study group was given the MPST plus basic treatment, and the control group was given conservative treatment. The studies collected meeting the eligible criteria were sorted and analyzed by the software RevMan 5.0, the differences in therapeutic effect and mortality were compared between the two groups, and a funnel chart was plotted to analyze the potential publication bias.Results A total of 13 RCTs published studies consistent with the eligible criteria were found, including1556 patients. The Meta-analysis showed that the effective rate in the study group was significantly higher than that in the control group [odds ratio (OR) = 4.29, 95% confidence interval (95%CI) 3.33 - 5.53,P < 0.01]; the fatality rate was markedly lower than that of the control group (OR = 0.25, 95%CI 0.19 - 0.35,P < 0.01). The funnel graph showed that each study had asymmetrical scatter plot of the variable quantity of research results, indicating a publication bias being present, which might be related to the subjectivity of the researchers in publishing their results.Conclusions Using MPST to treat HICH can significantly improve the therapeutic efficiency and reduce deterioration rate. However, due to the low quality of clinical research, it is necessary to carry out rigorous andmulti-center randomized controlled studies to further confirm the results.