Zehuai Wen

Efficacy of a Chinese herbal medicine for the treatment of atopic dermatitis: A randomised controlled study

BACKGROUND More randomised control trials are required to assess the efficacy of traditional Chinese medicine. This multi-centre, randomised, assessor-blind, controlled study assessed the efficacy of the Chinese herbal formula Pei Tu Qing Xin Tang (PTQXT) for treating patients with atopic dermatitis (AD). METHODS Patients aged 5-25 years with moderate-to-severe AD were randomised to receive a 12-week treatment involving either oral administration of PTQXT; oral administration of PTQXT combined with an external application of Chinese herbs; or oral administration of antihistamine and a placebo of PTQXT pills added to topical 1% mometasone furoate. The primary end-point measure was the change in the Scoring Atopic Dermatitis Index (SCORAD) at the end of the observation period, and secondary end-points included quality of life (QOL). The outcomes were evaluated at baseline, then every 4 weeks from week 4 to week 12 and every 8 weeks from week 12 to week 36. RESULTS Two hundred and seventy-five patients were recruited. During the 12-week treatment period, up to the primary end-point, the mean SCORAD decreased gradually in all three groups. At week 28 and week 36, there was a significantly greater decrease in the mean SCORAD for the Chinese herbal medicine-treated groups than for the control group (at week 28, P=0.002 and P=0.036, respectively; at week 36, P<0.001 and P=0.002, respectively). At week 36, the difference in QOL scores showed a significantly greater improvement in both Chinese herbal medicine-treated groups than in the control group (P<0.001 and P<0.001, respectively). CONCLUSIONS PTQXT is effective in decreasing the severity of the disease and improving the QOL in patients with moderate-to-severe AD. TRIAL REGISTRATION Chinese Clinical Trial Registry: ChiCTR-TRC-08000156.

Oral huangqi formulae for stable chronic obstructive pulmonary disease: A systematic review and meta-analysis

Objective. To evaluate the efficacy and safety of oral Huangqi formulae for the treatment of stable COPD. Methods. The major databases were searched until September 2010 and supplemented with a manual search. Randomized controlled trials (RCTs) of oral Huangqi formulae that reported on lung function, St. Georges Respiratory Questionnaire, symptom improvement and/or frequency of exacerbations were extracted by two reviewers. The Cochrane tool was used for the assessment of risk of bias in the included trials. Data were analyzed with RevMan 5.1.2 software. Results. 25 RCTs (1,661 participants) were included. Compared with conventional therapy (CT) alone, oral Huangqi formulae plus CT increased FEV1, and a similar result was found comparing Huangqi formulae with no treatment. Improvements in SGRQ total score, COPD-related symptoms and reduction of frequency of exacerbations were found in patients receiving Huangqi formulae plus CT compared to those receiving CT alone or CT plus placebo. No serious adverse events were reported. However, there were some methodological inadequacies in the included studies. Conclusions. The benefits of Huangqi formulae for stable COPD were promising, but its efficacy and safety have not been established due to methodological weakness and possible bias in the reported results. Further rigorously designed studies are warranted.

Effect of Combining Therapy with Traditional Chinese Medicine-Based Psychotherapy and Herbal Medicines in Women with Menopausal Syndrome: A Randomized Controlled Clinical Trial

This multicenter, randomized, controlled clinical study was designed to address the effectiveness of combined traditional-Chinese-medicine- (TCM-) based psychotherapy and Chinese herbal medicine (CHM) in the treatment of menopausal syndrome. Altogether 424 eligible women diagnosed as menopausal syndrome and categorized as Kidney-Yin/Kidney-Yang deficiency pattern in TCM were randomly assigned into 4 groups and accepted TCM-based psychotherapy (PSY), CHM, PSY + CHM, or placebo therapies, respectively, for 12 weeks, and another 12 weeks were taken as the followup. Kupperman Index (KI) and the Menopause-Specific Quality of Life (MENQOL) with its four subscales (vasomotor, physical, psychosocial, and sexual) were employed for efficacy assessment. Results showed that 400 participants completed 12-week treatment, of which 380 finished the record of KI and MENQOF at week 24. The average adjusted number of KI score decreased between baseline and 12 weeks in all groups. Statistically significant differences were detected in the average adjusted change between the PSY + CHM group and placebo at overall time points (P < 0.05). No severe adverse events occurred in each group and no significant differences were indicated between any of the three groups and placebo in adverse event proportion. We concluded that TCM psychotherapy combined with CHM has a favorable outcome in treating menopausal syndrome.

Aspirin as a potential modality for the chemoprevention of breast cancer: A dose-response meta-analysis of cohort studies from 857,831 participants

Background Previous meta-analyses on the relationship between aspirin use and breast cancer risk have drawn inconsistent results. In addition, the threshold effect of different doses, frequencies and durations of aspirin use in preventing breast cancer have yet to be established. Results The search yielded 13 prospective cohort studies (N=857,831 participants) that reported an average of 7.6 cases/1,000 person-years of breast cancer during a follow-up period of from 4.4 to 14 years. With a random effects model, a borderline significant inverse association was observed between overall aspirin use and breast cancer risk, with a summarized RR = 0.94 (P = 0.051, 95% CI 0.87-1.01). The linear regression model was a better fit for the dose-response relationship, which displayed a potential relationship between the frequency of aspirin use and breast cancer risk (RR = 0.97, 0.95 and 0.90 for 5, 10 and 20 times/week aspirin use, respectively). It was also a better fit for the duration of aspirin use and breast cancer risk (RR = 0.86, 0.73 and 0.54 for 5, 10 and 20 years of aspirin use). Methods We searched MEDLINE, EMBASE and CENTRAL databases through early October 2016 for relevant prospective cohort studies of aspirin use and breast cancer risk. Meta-analysis of relative risks (RR) estimates associated with aspirin intake were presented by fixed or random effects models. The dose-response meta-analysis was performed by linear trend regression and restricted cubic spline regression. Conclusion Our study confirmed a dose-response relationship between aspirin use and breast cancer risk. For clinical prevention, long term (>5 years) consistent use (2-7 times/week) of aspirin appears to be more effective in achieving a protective effect against breast cancer.

Epidemiology and Outcomes of Complicated Skin and Soft Tissue Infections among Inpatients in Southern China from 2008 to 2013

Complicated skin and soft tissue infections (cSSTI) are some of the most commonly treated infections in hospitals, and place heavy economic burdens on patients and society. Here we report the findings from an analysis of cSSTI based on a retrospective study which was conducted within the Chinese inpatient population. We focused our research on the analysis of the patient population, antibiotic treatment, clinical outcome and economic burden. The study population comprised 527 selected patients hospitalized between 2008 and 2013. Among the hospitalizations with microbiological diagnoses, 61.41% (n = 113) were diagnosed as infected with Gram-positive bacteria, while 46.20% (n = 85) were infected with Gram-negative bacteria. The most commonly found Gram-positive bacteria was Staphylococcus aureus (40.76%, n = 75), and the most common Gram-negative bacteria was Escherichia coli (14.13%, n = 26). About 20% of the Staphylococcus aureus were methicillin-resistant. The resistance rate of isolated Staphylococcus aureus or Escherichia coli to penicillin was around 90%; in contrast, the resistance rate to vancomycin, linezolid or imipenem was low (<20%). A large percentage of patients were treated with cephalosporins and fluoroquinolones, while vancomycin and imipenem were also included to treat drug-resistant pathogens. Over half of the hospitalizations (58.43%, n = 336) experienced treatment modifications. The cost to patients with antibiotic modifications was relatively higher than to those without. In conclusion, our study offers an analysis of the disease characteristics, microbiological diagnoses, treatment patterns and clinical outcomes of cSSTI in four hospitals in Guangdong Province, and sheds lights on the current clinical management of cSSTI in China.

Ginkgo biloba Extract for Patients with Early Diabetic Nephropathy: A Systematic Review

Objectives. To evaluate the effectiveness and safety of a Ginkgo biloba extract for patients with early diabetic nephropathy. Methods. Randomised controlled trials (RCTs) conducted on adults with early diabetic nephropathy which used Gingko biloba extract were included. The major databases were searched, and manufacturers of Gingko biloba products were contacted for information on any published or unpublished studies. Two authors independently extracted the data from the included studies. Data analysis was conducted using Review Manager 5.0 software. Results. Sixteen RCTs were included. Ginkgo biloba extract decreased the urinary albumin excretion rate (UAER), fasting blood glucose (FBG), serum creatinine (SCR), and blood urea nitrogen (BUN). The extract also improved hemorheology. The methodological quality in the included studies was low. The explicit generation of the allocation sequence was described in only 6 trials. None of the included trials were confirmed to use blinding. Three studies had observed adverse events. One study using angiotensin-converting enzyme inhibitor (ACEi) reported mild cough in both groups. No serious adverse effects were reported. Conclusions. Gingko biloba extract is a valuable drug which has prospect in treating early diabetic nephropathy, especially with high UAER baseline level. The safety for early diabetic nephropathy is uncertain. Long-term, double-blinded RCTs with large sample sizes are still needed to provide stronger evidence.

Further validation of the Health Scale of Traditional Chinese Medicine (HSTCM)

BackgroundFew health measurement scales are based on Chinese medicine theory. The Health Scale of Traditional Chinese Medicine (HSTCM) was developed to fill this gap. The aim of this study is to validate the HSTCM.MethodsA convenience sample of 630 participants was recruited in 11 settings. All participants were asked to complete the HSTCM and World Health Organization Quality of Life Measure-Abbreviated Version (WHOQOL-BREF).ResultsProperties of the HSTCM were tested. Intra-class correlation coefficient representing the inter-interviewer reliability was 0.99 (95%CI) for the overall instrument. Spearman-Brown correlation coefficient and Cronbachs coefficient alpha were 0.81 and 0.94 respectively, indicating satisfactory internal reliability and inter-interviewer reliability. Spearmans rho correlation coefficient between the HSTCM and WHOQOL-BREFF was -0.67. A receiver operating characteristic (ROC) curve analysis was performed to test the discriminate validation. Areas under the ROC curve analysis for the HSTCM and its domains ranged 0.71–0.87 and all the lower levels of 95%CI were greater than 0.50.ConclusionThe HSTCM was validated as a generic health scale and may complement existing health measurement scales in Chinese medicine health care.

Does Tai Chi relieve fatigue? A systematic review and meta-analysis of randomized controlled trials

Background Fatigue is not only a familiar symptom in our daily lives, but also a common ailment that affects all of our bodily systems. Several randomized controlled trials (RCTs) have proven Tai Chi to be beneficial for patients suffering from fatigue, however conclusive evidence is still lacking. A systematic review and meta-analysis was performed on all RCTs reporting the effects of Tai Chi for fatigue. Methods In the end of April 2016, seven electronic databases were searched for RCTs involving Tai Chi for fatigue. The search terms mainly included Tai Chi, Tai-ji, Taiji, fatigue, tiredness, weary, weak, and the search was conducted without language restrictions. Methodological quality was assessed using the Cochrane Risk of Bias tool. RevMan 5.3 software was used for meta-analysis. Publication bias was estimated with a funnel plot and Egger’s test. We also assessed the quality of evidence with the GRADE system. Results Ten trials (n = 689) were included, and there was a high risk of bias in the blinding. Two trials were determined to have had low methodological quality. Tai Chi was found to have improved fatigue more than conventional therapy (standardized mean difference (SMD): -0.45, 95% confidence interval (CI): -0.70, -0.20) overall, and have positive effects in cancer-related fatigue (SMD:-0.38, 95% CI: -0.65, -0.11). Tai Chi was also more effective on vitality (SMD: 0.63, 95% CI: 0.20, 1.07), sleep (SMD: -0.32, 95% CI: -0.61, -0.04) and depression (SMD: -0.58, 95% CI: -1.04, -0.11). However, no significant difference was found in multiple sclerosis-related fatigue (SMD: -0.77, 95% CI: -1.76, 0.22) and age-related fatigue (SMD: -0.77, 95% CI: -1.78, 0.24). No adverse events were reported among the included studies. The quality of evidence was moderate in the GRADE system. Conclusions The results suggest that Tai Chi could be an effective alternative and /or complementary approach to existing therapies for people with fatigue. However, the quality of the evidence was only moderate and may have the potential for bias. There is still absence of adverse events data to evaluate the safety of Tai Chi. Further multi-center RCTs with large sample sizes and high methodological quality, especially carefully blinded design, should be conducted in future research. Registration number PROSPERO CRD42016033066

Clinical characteristics and antimicrobial patterns in complicated intra-abdominal infections: a 6-year epidemiological study in southern China.

Complicated intra-abdominal infection (cIAIs) are a common and important cause of morbidity worldwide. In this study, the clinical features, microbiological profiles, antimicrobial patterns and treatments of 3233 cIAI patients (mean age, 47.6 years; 54.7% male) with 3531 hospitalisations from 2008-2013 were retrospectively investigated. The most commonly isolated bacteria were Escherichia coli (47.6%), Klebsiella pneumoniae (16.9%), Enterococcus faecalis (10.4%) and Pseudomonas aeruginosa (8.8%). Ciprofloxacin, aminoglycoside (gentamicin), piperacillin/tazobactam and carbapenems exhibited activity against 53%, 76%, 88% and 100% of extended-spectrum β-lactamase (ESBL)-positive Enterobacteriaceae isolates, respectively. Pseudomonas aeruginosa isolates exhibited 100%, 95%, 88%, 71% and 76% susceptibility to aminoglycoside (gentamicin), ciprofloxacin, meropenem, imipenem and ceftazidime, respectively, and Enterococcus remained 100% susceptible to vancomycin and linezolid. β-Lactam antibacterials other than penicillin (specifically third-generation cephalosporins) and imidazole derivatives (ornidazole and metronidazole) were the most common first-line treatments. Patients subjected to regimen change after initial antibiotic treatment had predisposing conditions (e.g. older age, more severe co-morbidities) and a higher incidence of P. aeruginosa infection; in addition, these patients encountered a higher average cost of care and worse clinical outcomes compared with those without medication modification. Taken together, these findings indicate the importance of appropriate initial empirical therapy and suggest the use of combination therapy comprising cephalosporins and metronidazole.

Efficacy and Safety of Sanfu Herbal Patch at Acupoints for Persistent Allergic Rhinitis: Study Protocol for a Randomized Controlled Trial

Background. The Sanfu herbal patch (SHP) has been widely used to treat allergic rhinitis (AR) in China. SHP has been reported to be effective for managing the symptoms of AR, but the evidence suffers from methodological limitations. Therefore, we designed a three-armed, randomized, and placebo-controlled trial to evaluate the efficacy and safety of SHP for persistent allergic rhinitis (PAR). Methods. The trial consists of 5 treatment sessions along with a one-year follow-up. This process is then repeated in the second and third years. Eligible participants diagnosed with PAR were randomized at a ratio of 2 : 2 : 1 into one of three groups: (a) SHP group; (b) placebo group; or (c) waiting-list group. The waiting-list group will receive no treatment in the first year but will receive SHP in the following two years. The primary outcome, total nasal symptoms score, is self-assessed at the beginning of each treatment session and during each annual follow-up. Secondary outcomes include the Rhinoconjunctivitis Quality-of-Life Questionnaire, allergic rhinitis attacks, and relief medications. The trial will be stopped if early termination criteria are met during the interim analysis. Ethics. This protocol has been approved by site ethics committee (number B2014-014-01) and is registered with ClinicalTrials.gov NCT02192645.