Lingfeng Zeng

Can Chinese Herbal Medicine Adjunctive Therapy Improve Outcomes of Senile Vascular Dementia? Systematic Review with Meta-analysis of Clinical Trials.

Many publications have reported the growing application of complementary and alternative medicine, particularly the use of Chinese herbal medicine (CHM) in combination with routine pharmacotherapy (RP) for senile vascular dementia (SVD), but its efficacy remains largely unexplored. The purpose of this study is to evaluate the efficacy of CHM adjunctive therapy (CHMAT), which is CHM combined with RP, in the treatment of SVD. Publications in seven electronic databases were searched extensively, and 27 trials with a total of 1961 patients were included for analysis. Compared with RP alone, CHMAT significantly increased the effective rate [odds ratio (OR) 2.98, 95% confidence interval (CI) 2.30, 3.86]. In addition, CHMAT showed benefits in detailed subgroups of the Mini‐Mental State Exam (MMSE) score from time of onset to 4u2009weeks (WMD 3.01, 95% CI 2.15, 3.87), 8u2009weeks (weighted mean difference (WMD) 2.30, 95% CI 1.28, 3.32), 12u2009weeks (WMD 2.93, 95% CI 2.17, 3.69), and 24u2009weeks (WMD 3.25, 95% CI 2.61, 3.88), and in the activity of daily living scale score from time of onset to 4u2009weeks (WMD −4.64, 95% CI −6.12, −3.17), 8u2009weeks (WMD −4.30, 95% CI −6.04, −2.56), 12u2009weeks (WMD −3.89, 95% CI −4.68, −3.09), and 24u2009weeks (WMD −4.04, 95% CI −6.51, −1.57). Moreover, CHMAT had positive effects on changes in the Hasegawa dementia scale, National Institutes of Health Stroke Scale, Clinical Dementia Rating, and Montreal Cognitive Assessment scores, as well as blood fat levels (total cholesterol, triglyceride, high‐density lipoprotein cholesterol, low‐density lipoprotein cholesterol, and apolipoprotein E), platelet aggregation rate (1‐min platelet aggregation rate, 5‐min platelet aggregation rate, and maximal platelet aggregation rate), and blood rheology (whole‐blood viscosity and hematocrit). No serious or frequently occurring adverse effects were reported. Weaknesses of methodological quality in most trials were assessed using the Cochrane risk of bias tool, while the quality level of Grades of Recommendations Assessment Development and Evaluation (GRADE) evidence classification indicated ‘very low’. This systematic review suggests that CHM as an adjunctive therapy can improve cognitive impairment and enhance immediate response and quality of life in SVD patients. However, because of limitations of methodological quality in the included studies, further research of rigorous design is needed. Copyright

Role of Medicinal Plants for Liver-Qi Regulation Adjuvant Therapy in Post-stroke Depression: A Systematic Review of Literature

Current evidence demonstrated certain beneficial effects of medicinal herbs as an adjuvant therapy for post‐stroke depression (PSD) in China; Chai‐hu (Chinese Thorowax Root, Radix Bupleuri) is an example of a medicinal plant for Liver‐Qi regulation (MPLR) in the treatment of PSD. Despite several narrative reports on the antidepressant properties of MPLR, it appears that there are no systematic reviews to summarize its outcome effects. Therefore, the aim of this review was to assess the effectiveness and safety of MPLR adjuvant therapy in patients with PSD. Seven databases were extensively searched from January 2000 until July 2016. Randomized control trials (RCTs) involving patients with PSD that compared treatment with and without MPLR were taken into account. The pooled effect estimates were calculated based on Cochrane Collaborations software RevMan 5.3. Finally, 42 eligible studies with 3612 participants were included. Overall, MPLR adjuvant therapy showed a significantly higher effective rate (RRu2009=u20091.23; 95% CIu2009=u20091.19, 1.27; pu2009<u20090.00001) compared to those without. Moreover, the administration of MPLR was superior to abstainers regarding Hamilton Depression Scale (HAMD) score changes after 3u2009weeks (WMDu2009=u2009−4.83; 95% CIu2009=u2009−6.82, −2.83; pu2009<u20090.00001), 4u2009weeks (WMDu2009=u2009−3.25; 95% CIu2009=u2009−4.10, −2.40; pu2009<u20090.00001), 6u2009weeks (WMDu2009=u2009−4.04; 95% CIu2009=u2009−5.24, −2.84; pu2009<u20090.00001), 8u2009weeks (WMDu2009=u2009−4.72; 95% CIu2009=u2009−5.57, −3.87; pu2009<u20090.00001), and 12u2009weeks (WMDu2009=u2009−3.07; 95% CIu2009=u2009−4.05, −2.09; pu2009<u20090.00001). In addition, there were additive benefits in terms of response changes for the National Institutes of Health Stroke Scale (NIHSS) and other self‐rating scores. No frequently occurring or serious adverse events were reported. We concluded that there is supporting evidence that adjuvant therapy with MPLR is effective in reducing the depressive symptoms and enhancing quality of life for patients with PSD. More well‐designed RCTs are necessary to explore the role of MPLR in the treatment of PSD. Copyright

The efficacy of Jianpi Yiqi therapy for chronic atrophic gastritis: A systematic review and meta-analysis

Jianpi Yiqi therapy (JYT) is a classical therapy in treating chronic atrophic gastritis (CAG), but the clinical effects of it are still contentious. The purpose of this article is to evaluate the efficacy and safety of JYT for CAG. Seven electronic databases including PubMed, Embase, Springer Link, CNKI (China National Knowledge Infrastructure), VIP (Chinese Scientific Journals Database), Wan-fang database, and CBM (Chinese Biomedicine Database) were searched from their inception to November 1, 2016. 13 randomized controlled trials (RCTs) with a total of 1119 participants were identified for analysis. Meta-analyses demonstrated that both JYT (RR 1.41; 95% CI 1.27, 1.57; P < 0.00001) and JYT + western medicine (RR 1.27; 95% CI 1.17, 1.38; P < 0.00001) were more efficacious than only western medicine. Furthermore, JYT had potential improvement on traditional Chinese medicine (TCM) symptoms scores such as stomachache, stomach distention, belching, fatigue, et al. In addition, no serious adverse events were reported in the selected trials. The Cochrane Collaboration’s risk of bias tool was evaluated for the weaknesses of methodological quality, while the quality level of Grades of Recommendations Assessment Development and Evaluation (GRADE) evidence classification indicated “Very low”. This meta-analysis indicates that JYT may have potential effects on the treatment of patients with CAG. However, due to limitations of methodological quality and small sample size of the included studies, further standardized research of rigorous design should be needed.

Oral Chinese herbal medicine for kidney nourishment in Alzheimer's disease: A systematic review of the effect on MMSE index measures and safety

OBJECTIVEnTo evaluate the effectiveness and safety of the Chinese herbal medicine for kidney nourishment (CHMK) assessed with the Mini-Mental Status Examination (MMSE) index objective outcome measures in individuals with Alzheimers disease.nnnMETHODSnSearches were conducted in 7 medical databases from their inceptions until July 19, 2014 for randomized controlled trials (RCTs) that compared the oral administration of CHMK plus conventional pharmacotherapy with the same conventional pharmacotherapy alone with MMSE index measures as outcomes. Relevant resources were also manually retrieved. Two reviewers screened the citations of the reports, assessed the risk of bias and extracted data independently. Data analysis was carried out with Cochrane Collaborations RevMan5.2.6 software and evidence quality grading evaluation of the systematic review was conducted with Grades of Recommendations Assessment Development and Evaluation (GRADE) profiler software.nnnRESULTSnA total of 20 studies involving 1682 participants were included in the meta-analysis. There were 15 trials that compared CHMK with conventional pharmacotherapy and 5 trials that compared CHMK plus conventional pharmacotherapy with conventional pharmacotherapy alone. The main meta-analysis results showed relative benefits in effective rates in five studies (odds ratio [OR] 2.74, 95% confidence interval [CI] 1.55-4.85) and cure rate/clinical-control rates in five studies (OR 1.91, 95% CI 1.27-2.88) in favor of the CHMK plus conventional pharmacotherapy group. As for CHMK compared with conventional pharmacotherapy, no significant differences were noted in the effective rate (OR 1.09, 95% CI 0.82-1.46; cure rate (OR 1.06, 95% CI 0.81-1.38) and detailed sub-group of MMSE scores from the onset time to 4 weeks (weighted mean difference [WMD] 0.31, 95% confidence interval [CI] -0.81 to 1.42, 8 weeks WMD 1.12, 95% CI -0.54 to 2.78, 12 weeks (WMD 0.43, 95% CI -1.62 to 2.48, or 24 weeks WMD 1.92, 95% CI -1.60 to 5.44) follow-up and the overall effect (WMD 0.79, 95% CI -0.11 to 1.69). Moreover, weaknesses in methodological quality were identified in most studies according to Cochrane Risk of Bias tool assessment, while the quality level of GRADE classification indicated very low. The incidence of adverse events with CHMK (0.87%) was lower than in the conventional pharmacotherapy group (4.08%), which revealed use of CHMK was relatively safer than conventional pharmacotherapy alone.nnnCONCLUSIONnThe effectiveness and safety of oral administration of CHMK cannot be currently determined because of publication bias and the low quality level of the included trials. Further studies on a larger scale and with more rigorous designs are required to define the role of CHMK in the treatment of AD.

Do Chinese Researchers Conduct Ethical Research and Use Ethics Committee Review in Clinical Trials of Anti-Dementia Drugs? An Analysis of Biomedical Publications Originating from China

BACKGROUNDnMedical research using human participants must conform to the basic ethical principles found in the Declaration of Helsinki (DoH) of the World Medical Association.nnnOBJECTIVEnThe purpose of this review was to assess whether journals in China have improved in regard to the fulfillment of ethical disclosure procedures for clinical trials of anti-dementia drugs.nnnMETHODSnFour medical databases were searched for articles reporting clinical trials of oral anti-dementia drugs published in China in 2003, 2009, and 2014. The frequencies of reporting of informed consent from participants (ICP), approval of a regional ethical committee (REC), reference to DoH, and study registration were estimated respectively. Statistical analyses were conducted with SPSS v21 software.nnnRESULTSnAmong those randomized controlled trials published in 2003, 2009, and 2014, disclosure of REC approval was present for 2.67%, 1.15%, and 6.84%; statements of ICP were included in 9.33%, 7.76%, and 17.34%; reference to DoH was found for 4.00%, 1.44%, and 7.45%; and study registration reporting was included in 2.67%, 2.59%, and 9.28%, respectively. Improvements to reporting rates between 2009 and 2014 were seen, with more than twice as many trials reporting REC approval, ICP, reference to DoH, and study registration compared with 2009.nnnCONCLUSIONnCompared with 2003 and 2009, reporting rates for REC approval, ICP, reference to DoH, and study registration for clinical trials of anti-dementia drugs were enhanced in 2014 in the major medical journals of China. However, biomedical publications without definite statements of ethical considerations remain common, and this continues to be seen in Chinese journals. It is imperative that measures are taken to reinforce the ethical protection in clinical trials in China.

An exploration of the role of a fish-oriented diet in cognitive decline: a systematic review of the literature

Epidemiological studies have presented inconsistent evidence of the correlation between a fish-oriented dietary intake (FDI) and the risk of cognitive decline. To address these controversies, we performed this systematic review of prospective studies published in December 2016 and earlier using PubMed, Embase, and Web of Science. Two independent researchers conducted the eligibility assessment and data extraction; all discrepancies were solved by discussion with a third researcher. The pooled relative risks (RRs) focused on the incidence of events were estimated with 95% confidence intervals (CIs). Overall, nine studies containing 28,754 subjects were analyzed. When the highest and lowest categories of fish consumption were compared, the summary RR for dementia of Alzheimer type (DAT) was 0.80 (95%CI = 0.65–0.97); i.e., people with a higher intake of fish had a 20% (95%CI = 3–35%) decreased risk of DAT. Additionally, the dose-response synthesized data indicated that a 100-g/week increase in fish intake reduced the risk of DAT by an additional 12% (RR = 0.88, 95%CI = 0.79–0.99). Non-significant results were observed for the risk of dementia of all causes (DAC) and mild cognitive impairment (MCI). Limited evidence involving heterogeneity was found within subgroups or across studies. In conclusion, this review confirmed that a higher intake of fish could be correlated with a reduced risk of DAT. Further research, especially prospective studies that specifically quantify FDI, will help find a more accurate assessment of the different levels of dietary intake.

Is adjunctive treatment with medication of liver-soothing-oriented method beneficial for depression after cerebrovascular accident?: A PRISMA-compliant meta-analysis.

Background:Adjunctive treatment with medication of liver-soothing-oriented method (MLSM) is one of the most commonly used approaches for subjects with depression after cerebrovascular accident (DCVA) in China. The purpose of this meta-analysis was to evaluate the outcome of MLSM treatment in subjects with DCVA using relevant published literature. Methods:The PubMed, Cochrane Library, Embase, Chinese databases of China National Knowledge Infrastructure, WanFang, Sinomed, and VIP were used to collect all publications until March 2016. Randomized controlled trials comparing treatments with and without MLSM for subjects with DCVA were included. The quality of each publication was assessed based on the recent Handbook (5.1 version) for Cochrane Reviewers. Cochrane Collaborations software RevMan 5.3 software was applied for data analysis. Results:Thirty studies, including 2599 cases, were identified and collected. Adjunctive treatment with MLSM noticeably enhanced total effective rates (odds ratio 3.76; 95% confidence interval [CI] 2.92–4.85, I2u200a=u200a0%, Pu200a=u200a0.96) in comparison to non-MLSM conventional pharmacotherapy. Compared to non-MLSM treatment, the changes of Hamilton Depression Scale in adjunctive treatment with MLSM, respectively, decreased and showed beneficial effects after 3 weeks (weighted mean difference [WMD] −4.83; 95% CI −6.82 to −2.83; I2u200a=u200a86%, Pu200a<u200a0.001), 4 weeks (WMD −4.20; 95% CI −5.06 to −3.33; I2u200a=u200a78%, Pu200a<u200a0.001), 6 weeks (WMD −3.36; 95% CI −4.05 to −2.68; I2u200a=u200a54%, Pu200a=u200a0.02), 8 weeks (WMD −4.83; 95% CI −5.62 to −4.04; I2u200a=u200a73%, Pu200a<u200a0.001), and 12 weeks (WMD −2.88; 95% CI −4.09 to −1.67; I2u200a=u200a58%, Pu200a=u200a0.09). As for changes in inflammatory cytokine levels, adjunctive treatment with MLSM was associated with a significant decrease in tumor necrosis factor-&agr;, IL-6, and interleukin-1&bgr; levels in comparison to non-MLSM treatment. Moreover, there were positive effects on score changes for National Institute of Health Stroke Scale, activities of daily living, Hamilton Anxiety Scale, Modified Edinburgh Scandinavian Stroke Scale, and Self-Rating Anxiety Scale. No serious adverse events were reported. Conclusion:MLSM appears to improve symptoms of depressive disorders, enhance immediate responses, and the quality of life in subjects with DCVA. The positive action of MLSM might be potentially connected with its immunoregulating effects. More prospective trials with strict design and larger sample sizes are warranted to clarify its effectiveness and safety.

Clinical Efficacy and Safety of Chinese Herbal Medicine Auxiliary Therapy for Childhood Cough Variant Asthma: A Systematic Review and Meta-analysis of 20 Randomized Controlled Trials

This study aimed to evaluate the efficacy and safety of Chinese herbal medicine auxiliary therapy (CHMAT) in treating childhood cough variant asthma (CVA). A systematic literature review was conducted on RCTs that compared CHMAT, i.e., Chinese herbal medicine (CHM) plus pharmacotherapy (PT), versus the same PT alone in the treatment of CVA. All included trials were assessed for quality and risk bias and analyzed according to the criteria of the Cochrane Handbook based on the Review Manager 5.3 software program. Twenty studies were identified and the CHMAT group had a positive effect on the total effective rate and a lower recurrence rate compared with the control group. CHMAT may have positive effects on CVA, leading to better improvement in disorders of cough and asthma and less adverse effects. However, the methodology and reporting quality of current studies are generally low. Further studies should include larger sample sizes with a strict design to confirm these findings.

Are short-stem prostheses superior to conventional stem prostheses in primary total hip arthroplasty? A systematic review and meta-analysis of randomised controlled trials

Objective Cementless total hip arthroplasty (THA) is associated with reliable clinical results and high patient satisfaction. Short-stem prostheses (SS) were designed to achieve superior preservation of proximal bone stock and stability compared with those of conventional-stem prostheses (CS). This meta-analysis was conducted to determine the proximal bone remodelling, revision rate, Harris Hip Score, radiolucent line and maximum total point motion values of both SS and CS for primary THA. Method Relevant randomised controlled trials (RCTs) involving SS and CS in primary THA were identified from electronic databases, such as EMBASE, PubMed and the Cochrane Library. Result Ultimately, 12 RCTs involving 1130 patients (1387 hips) were included. The results showed that compared with CS, SS resulted in less bone mineral density (BMD) changes in Gruen zone 7 at 1u2009year and 2 years postoperatively (mean difference (MD)=5.11; 95% CI, 1.61, 8.61; P=0.30; and MD=4.90; 95%u2009CI, 1.01, 8.79; P=0.17, respectively). No difference in BMD changes was found for Gruen zone 1 (MD=2.66; 95%u2009CI, −3.31, 8.64; P<0.00001), and no differences were observed for the revision rate (relative risk (RR)=1.52; 95%u2009CI, 0.71, 3.26; P=0.94), Harris Hip Score (MD=−0.38; 95%u2009CI, −1.02, 0.26; P=0.89) or stem migration (MD=0.02; 95%u2009CI, −0.07, 0.11; P=0.04). Conclusion Our results suggest that compared with CS, SS may provide superior bone remodelling and similar survival rates and clinical outcomes. However, the short-term follow-up of the included studies was inadequate to determine the long-term performance of SS.

A Population Perspective on Ethical Compliance with Drug Trial Standards of Practice

Protection of individual rights and vulnerable groups is critical, and it is increasingly recognized that all countries wishing to engage with the international scientific community must set high standards, have robust regional ethical committees (RECs), and ensure genuine and complete compliance [1–3]. Despite raising concerns over the protection of subjects, over 90% of the included articles did not mention the reporting of REC approval [4]. These results are unexpected, because most journals request authors to report REC approval or ethical considerations. In views of this, Dr. Rosenberg’s paper [5]