Effects of Lycium barbarum polysaccharide on cytokines in adolescents with subthreshold depression:a randomized controlled study

Strong evidence has accumulated to show a correlation between depression symptoms and inflammatory responses.Moreover,anti-inflammatory treatment has shown partial effectiveness in alleviating depression symptoms.Lycium barbarum polysaccharide(LBP),derived from Goji berries,exhibits notable antioxidative and anti-inflammatory properties.In our recent double-blinded randomized placebo-controlled trial,we found that LBP significantly reduced depressive symptoms in adolescents with subthreshold depression.It is presumed that the antidepressant effect of LBP may be associated with its influence on inflammatory cytokines.In the double-blinded randomized controlled trial,we enrolled 29 adolescents with subthreshold depression and randomly divided them into an LBP group and a placebo group.In the LBP group,adolescents were given 300 mg/d LBP.A 6-week follow up was completed by 24 adolescents,comprising 14 adolescents from the LBP group(15.36±2.06 years,3 men and 11 women)and 10 adolescents from the placebo group(14.9±1.6 years,2 men and 8 women).Our results showed that after 6 weeks of treatment,the interleukin-17A level in the LBP group was lower than that in the placebo group.Network analysis showed that LBP reduced the correlations and connectivity between inflammatory factors,which were associated with the improvement in depressive symptoms.These findings suggest that 6-week administration of LBP suppresses the immune response by reducing interleukin-17A level,thereby exerting an antidepressant effect.

Functional and psychosocial effects of pulmonary Daoyin on patients with COPD in China:study protocol of a multicenter randomized controlled trial

BACKGROUND： Chronic obstructive pulmonary disease （COPD） is a major public health problem worldwide. Pulmonary rehabilitation （PR） is an established intervention for the management of patients with COPD. Exercise training is an important part of PR, and its effectiveness in patients with COPD is well established. However, alternative methods of PR training such as Daoyin have not been appropriately studied. Hence, alternative forms of exercise training that require less exercise equipment and no specific training place should be evaluated. This paper describes the study protocol of a clinical trial that aims to determine if pulmonary Daoyin training will improve the exercise capacity and psychosocial function of patients with COPD in China. METHODS AND DESIGN： A multicenter, randomized, controlled trial will be conducted. A total of 464 patients meeting the inclusion criteria will be enrolled into this study with 232 patients in each of the trial group and the control group. Based on patient education, patients in the trial group will receive pulmonary Daoyin and continue with their usual therapy for three months. In the control group, patients will continue with their usual therapy. The primary outcome measures are exercise capacity assessed by the six-minute walking distance test and lung function. Secondary outcomes include dyspnea and quality of life. Measurements will be taken at baseline （month 0） and after the study period （month 3）. DISCUSSION： It is hypothesized that pulmonary Daoyin will have beneficial effects in improving exercise capacity and psychosocial function of patients with stable COPD, and will provide an alternative form of exercise training that is accessible for the large number of people with COPD. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is NCT01482000.

Human umbilical cord mesenchymal stem cells to treat spinal cord injury in the early chronic phase: study protocol for a prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial

Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019.

A Double-Blind, Randomized, Placebo-Controlled Nutritional Study Using an Insoluble Yeast Beta-Glucan to Improve the Immune Defense System

Purpose: In a placebo-controlled, double-blind, randomized clinical trial, the effect of an insoluble yeast beta-glucan preparation on the incidences of common colds and its effect on common cold symptoms were compared to placebo. Methods: 100 healthy participants with recurring infections were randomly assigned to receive either placebo or yeast beta-glucan (Yestimun?;n = 50 each group) over a period of 26 weeks. The subjects had to document each common cold episode in a diary, and rate 6 predefined infections symptoms on a 3-point rating scale during an infection period, resulting in an infection score. The common cold episodes were confirmed by the investigators. Results: A total of 171 common cold episodes were documented. Of these, 76 were experienced by 38 subjects in the beta-glucan group and 96 were experienced by 48 subjects in the placebo group (p = 0.406). The beta-glucan group had significantly more subjects without incidences of common cold than the placebo group (15.6% vs 2.0%;p = 0.019). During the most intense infection season (first 13 weeks of the study), the beta-glucan group had significantly less infections compared to placebo (p = 0.02). Beta-glucan significantly reduced the typical cold symptoms (“sore throat and/or difficulty swallowing”, “hoarseness and/or cough” and “runny nose”) as opposed to placebo. Conclusion: The present study demonstrates a prophylactic effect of yeast beta-glucan on the occurrence of common colds as opposed to placebo. In addition, when these episodes occurred, they were from the beginning less pronounced and subsided faster.

Bias-Variation Dilemma Challenges Clinical Trials: Inherent Limitations of Randomized Controlled Trials and Meta-Analyses Comparing Hernia Therapies

Purpose:Evaluation of hernia therapies according to the current rules of Evidence Based Medicine is widely reduced to results of RCTs or meta-analyses. RCTs have been accepted as a most important tool to confirm a superior effect of an intervention. Unfortunately, in hernia surgery, comparisons of RCTs and correspondingly their use in meta-analyses, are not, surprisingly often, able to confirm any significant impact of a specific procedure due to intrinsic restrictions in a multi-causal setting with its web of influences. Methods:Based on our own experiences of clinical studies in surgery, the present article outlines several situations, with their respective reasons, which argue the severe limitations of RCTs and meta-analysis to define an optimum treatment. Results:Meta-analyses accumulate the variations of each trial, which then may cover any clear causal relationship. RCTs usually are dealing with subgroups of standard patients thus excluding the majority of our patients. Low statistical power of current cohort sizes restricts the analysis of subgroups or of effects with low incidences. Simple comparisons of means frequently are hampered by nonlinear relationships to outcome. The relevance of a specific variable is difficult to separate from other influences. The limited surveillance period of studies ignores a delayed change in outcome. Randomization cannot guarantee a standardized patient’s condition. All the arguments have to be considered as a crucial and fundamental consequence of the bias-variance dilemma or principle of uncertainty in medicine, and underline the many limitations of RCTs to evaluate any specific impact of hernia therapies on e.g. infection, pain or recurrence. Conclusions: Many surgical issues cannot be and should not be investigated by RCTs, in particular, if a marked patients’ heterogeneity has to be considered or the low incidences of the outcome readout cannot be addressed with sufficient statistical power without getting lost in the variation mire. Registries with their non-restricted data-acquisition should be regarded as reliable alternatives for postoperative outcome quality surveillance studies.

Tolerability of a Proprietary Larch Arabinogalactan Extract: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial in Healthy Subjects

In a placebo-controlled, double-blind, randomized clinical trial, the tolerability of a proprietary larch arabinogalactan preparation (ResistAidTM) was investigated. METHODS: 199 healthy participants were randomly assigned to receive either placebo (n = 98) or an arabinogalactan preparation (n = 101) over a period of 12 weeks. As safety parameters the total number of adverse events, changes in various biochemical and laboratory parameters as well as the global evaluation of tolerability by investigator and subjects compared to placebo were evaluated. RESULTS: In total 16 adverse events were observed in 16 subjects, with no difference between the arabinogalactan and the placebo group (p = 0.935). There were no differences in the mean changes of the measured biochemical and laboratory parameters. The tolerability of the arabinogalactan extract was rated as “very good” or “good” by the investigators for 99% of the subjects and by 98% subjects in self-assessment with no statistical differences to placebo. CONCLUSION: The measured parameters as well as the evaluation of the tolerability by the investigators and the subjects demonstrate a very good tolerance profile of the proprietary arabinogalactan extract with no differences to placebo when taken for 12 weeks.

Trial characteristics and treatment effect estimates in randomized controlled trials of Chinese herbal medicine: A meta-epidemiological study

Background:Previously published meta-epidemiological studies focused on Western medicine have identified some trial characteristics that impact the treatment effect of randomized controlled trials(RCTs).Nevertheless,it remains unclear if similar associations exist in RCTs on Chinese herbal medicine(CHM).Further,Chinese medicine-related characteristics have not been explored yet.Objective:To investigate trial characteristics related to treatment effect estimates on CHM RCTs.Search strategy:This meta-epidemiological study searched 5 databases for systematic reviews on CHM treatment published between January 2011 and July 2021.Inclusion criteria:An eligible systematic review should only include RCTs of CHM and conduct at least one meta-analysis.Data extraction and analysis:Two reviewers independently conducted data extraction on general characteristics of systematic reviews,meta-analyses and included RCTs.They also assessed the risk of bias of RCTs using the Cochrane risk of bias tool.A two-step approach was used for data analyses.The ratio of odds ratios(ROR) and difference in standardized mean differences (dSMD) with 95%confidence interval (CI) were applied to present the difference in effect estimates for binary and continuous outcomes,respectively.Results:Ninety-one systematic reviews,comprising 1338 RCTs were identified.For binary outcomes,RCTs incorporated with syndrome differentiation (ROR:1.23;95%CI:[1.07,1.39]),adopting Chinese medicine formula (ROR:1.19;95%CI:[1.03,1.34]),with low risk of bias on incomplete outcome data (ROR:1.29;95%CI:[1.06,1.52]) and selective outcome reporting (ROR:1.12;95%CI:[1.01,1.24]),as well as a trial size≥100 (ROR:1.23;95%CI:[1.04,1.42]) preferred to show larger effect estimates.As for continuous outcomes,RCTs with Chinese medicine diagnostic criteria (dSMD:0.23;95%CI:[0.06,0.41]),judged as high/unclear risk of bias on allocation concealment (dSMD:-0.70;95%CI:[-0.99,-0.42]),with low risk of bias on incomplete outcome data (dSMD:0.30;95%CI:[0.18,0.43]),conducted at a single center (dSMD:-0.33;95%CI:[-0.61,-0.05]),not using intention-to-treat analysis (dSMD:-0.75;95%CI:[-1.43,-0.07]),and without funding support (dSMD:-0.22;95%CI:[-0.41,-0.02]) tended to show larger effect estimates.Conclusion:This study provides empirical evidence for the development of a specific critical appraisal tool for risk of bias assessments on CHM RCTs.

Comparative mitochondrial genome analysis of Cynoglossidae(Teleost:Pleuronectiformes)and phylogenetic implications

Generally,a teleostean group(e.g.,family or genus)owns one type or a set of similar mitochondrial gene arrangement.It is interesting,however,that four different types of gene arrangement have been found in the mitochondrial genome(mitogenome)of Cynoglossidae species.So far,the possible mechanisms of mitogenomic gene rearrangement and its potential implications have aroused widespread attention and caused lots of controversy.Here,a total of 21 Cynoglossidae mitogenomes and a newly sequenced mitogenome of Cynoglossus puncticpes(Pleuronectiformes:Cynoglossidae)were compared.The length ranges from 16417 bp to 18369 bp,which is mainly caused by the length heteroplasmy of control region(CR).Further analysis reveals that the difference of tandem repeats acts as a determining factor resulting in the length heterogeneity.Like most gene rearrangements of Cynoglossinae mitogenomes,tRNA-Gln gene encoded by the L-strand has translocated to the H-strand(Q inversion),accompanied by the translocation of CR in C.puncticpes mitogenome.The typical IQM order(tRNA-Ile-Gln-Met)changed to QIM order.Tandem duplication/random loss and mitochondrial recombination were accepted as the most possible models to account for the rearrangements in C.puncticpes mitogenome.Phylogenetic trees showed a strong correlation between the gap spacer in the rearranged QIM area and phylogeny,which provides a fresh idea for phylogenetic studies in future.

Stochastic resonance whole body vibration reduces musculoskeletal pain:A randomized controlled trial

AIM:To examined the effects of stochastic resonance whole-body vibration training on musculoskeletal pain in young healthy individuals.METHODS:Participants were 43 undergraduate students of a Swiss University.The study was designed as a randomized controlled trial(RCT)with randomized group allocation.The RCT consisted of two groups each given 12 training sessions during four weeks with either 5 Hz-Training frequency(training condition)or 1.5 Hz Training frequency(control condition).Outcome was current musculoskeletal pain assessed in the evening on each day during the four week training period.RESULTS:Multilevel regression analysis showed musculoskeletal pain was significantly decreased in the training condition whereas there was no change in the control condition(B=-0.023,SE=0.010,P=0.021).Decrease in current musculoskeletal pain over four weeks was linear.CONCLUSION:Stochastic resonance whole-body vibration reduced musculoskeletal pain in young healthy individuals.Stochastic resonance vibration and not any other exercise component within training caused pain reduction.

Hypothenar fat pad flap vs conventional open release in primary carpal tunnel syndrome:A randomized controlled trial

AIM To compared outcomes between the hypothenar fat pad flap(HTFPF) and conventional open carpal tunnel release(COR) in primary carpal tunnel syndrome(CTS). METHODS Forty-five patients(49 hands) were enrolled into the study from January 2014 to March 2016, 8 patients were excluded. Randomization was conducted in 37 patients(41 hands) by computer generated(Block of four randomization) into COR and HTFPF group. Nerve conduction study(NCS) included distal sensory latency(DSL), distal motor latency(DML), sensory amplitude (S-amp), motor amplitude(M-amp) and sensory nerve conduction velocity(SCV) were examined at 6 and 12 wk after CTR. Levine score, grip and pinch strength, pain [visual analog scale(VAS)], 2-point discrimination(2-PD), Semmes-Weinstein monofilament test(SWM), Phalen test and Tinel's sign were evaluated in order to compare treatment outcomes.RESULTS The COR group, 19 patients(20 hands) mean age 50.4 years. The HTFPF group, 20 patients(21 hands) mean age 53.3 years. Finally 33 patients(36 hands) were analysed, 5 patients were loss follow-up, 17 hands in COR and 19 hands in HTFPF group. NCS revealed significant difference of DSL in HTFPF group at 6 wk(P < 0.05) compared with the COR group. S-amp was significant improved postoperatively in both groups(P < 0.05) but not significant difference between two groups. No significant difference of DML, M-amp and SCV postoperatively in both groups and between two groups. Levine score, pain(VAS), grip and pinch strength, 2-PD, SWM, Phalen test and Tinel's sign were improved postoperatively in both groups, but there was no significant difference between two groups.CONCLUSION There is no advantage outcome in primary CTS for having additional HTFPF procedure in CTR. COR is still the standard treatment. Nevertheless, improvement of DSL and S-amp could be observed at 6 wk postoperatively.

Efficiency and safety of acupuncture for women with premature ovarian insufficiency:study protocol for a randomized controlled trial

Acupuncture has been widely used as an alternative and complementary therapy for premature ovarian insufficiency(POI)in China.However,research to date has not shown that acupuncture is effective for POI compared with hormone replacement therapy(HRT).We will conduct a randomized,controlled,and outcome assessor-blind trial to evaluate the efficacy and safety of acupuncture on POI.Seventy-six patients with POI will be randomly assigned to two groups.The treatment group will receive twenty-eight one-hour sessions of acupuncture treatments,and the control group will receive 12-week HRT.The whole study will consist of a 12-week treatment plan and a 12-week follow-up session.The primary outcome is measured by changes in serum anti-Müllerian hormone and follicle-stimulating hormone(FSH)levels at weeks 12 and 24.Secondary outcome measures include estradiol,luteinizing hormone(LH),LH/FSH ratio,Kupperman index,and menstrual condition.This trial is expected to clarify whether or not acupuncture is effective and safe for POI compared with HRT.

Inhibitory effects of carbon dioxide insufflation on pneumoperitoneum and bowel distension after percutaneous endoscopic gastrostomy

AIM:To evaluate the inhibitory effects of carbon dioxide (CO2) insufflation on pneumoperitoneum and bowel distension after percutaneous endoscopic gastrostomy (PEG).METHODS:A total of 73 consecutive patients who were undergoing PEG were enrolled in our study.After eliminating 13 patients who fitted our exclusion criteria,60 patients were randomly assigned to either CO2 (30 patients) or air insufflation (30 patients) groups.PEG was performed by pull-through technique after threepoint fixation of the gastric wall to the abdominal wall using a gastropexy device.Arterial blood gas analysis was performed immediately before and after the procedure.Abdominal X-ray was performed at 10 min and at 24 h after PEG to assess the extent of bowel distension.Abdominal computed tomography was performed at 24 h after the procedure to detect the presence of pneumoperitoneum.The outcomes of PEG for 7 d postprocedure were also investigated.RESULTS:Among 30 patients each for the air and the CO2 groups,PEG could not be conducted in 2 patients of the CO2 group,thus they were excluded.Analyses of the remaining 58 patients showed that the patients' backgrounds were not significantly different between the two groups.The elevation values of arterial partial pressure of CO2 in the air group and the CO2 group were 2.67 mmHg and 3.32 mmHg,respectively (P = 0.408).The evaluation of bowel distension on abdominal X ray revealed a significant decrease of small bowel distension in the CO2 group compared to the air group (P < 0.001) at 10 min and 24 h after PEG,whereas there was no significant difference in large bowel distension between the two groups.Pneumoperitoneum was observed only in the air group but not in the CO2 group (P = 0.003).There were no obvious differences in the laboratory data and clinical outcomes after PEG between the two groups.CONCLUSION:There was no adverse event associated with CO2 insufflation.CO2 insufflation is considered to be safer and more comfortable for PEG patients because of the lower incidence of pneumoperitoneum and less distension of the small bowel.

Effect of neoadjuvant chemoradiotherapy on prognosis and surgery for esophageal carcinoma

AIM:To investigate the role of neoadjuvant chemoradiotherapy in prognosis and surgery for esophageal carcinoma by a meta-analysis.METHODS:PubMed and manual searches were done to identify all published randomized controlled trials(RCTs) that compared neoadjuvant chemoradiotherapy plus surgery(CRTS) with surgery alone(S) for esophageal cancer.According to the test of heterogeneity,a fi xed-effect model or a random effect model was used and the odds ratio(OR) was the principal measure of effects.RESULTS:Fourteen RCTs that included 1737 patients were selected with quality assessment ranging from A to C(Cochrane Reviewers' Handbook 4.2.2).OR(95% CI,P value),expressed as CRTS vs S(values>1 favor CRTS arm),was 1.19(0.94-1.48,P=0.28) for 1-year survival,1.33(1.07-1.65,P=0.69) for 2-year survival,1.76(1.42-2.19,P=0.11) for 3-year survival,1.41(1.06-1.87,P=0.11) for 4-year survival,1.64(1.28-2.12,P=0.40) for 5-year survival,0.82(0.39-1.73,P<0.0001) for rate of resection,1.53(1.33-2.84,P=0.007) for rate of complete resection,1.78(1.14-2.78,P=0.79) for operative mortality,1.12(0.89-2.48,P=0.503) for all treatment mortality,1.33(0.94-1.88,P=0.04) for the rate of adverse treatment,1.38(1.23-1.63,P=0.0002) for local-regional cancer recurrence,1.28(0.85-1.58,P=0.60) for distant cancer recurrence,and 1.27(0.86-1.65,P=0.19) for all cancer recurrence.A complete pathological response to chemoradiotherapy occurred in 10%-45.5% of patients.The 5-year survival benefi t was most pronounced when chemotherapy and radiotherapy were given concurrently(OR:1.45,95% CI:1.26-1.79,P=0.015) instead of sequentially(OR:0.85,95% CI:0.64-1.35,P=0.26).CONCLUSION:Compared with surgery alone,neoadjuvant chemoradiotherapy can improve the long-term survival and reduce local-regional cancer recurrence.Concurrent administration of neoadjuvant chemoradiotherapy was superior to sequential chemoradiotherapy.

Effect of Percutaneous Radiofrequency Ablation and Surgical Resection on Treating of Primary Small Liver Cancer: A Meta-Analysis

Objective:To analyze the clinical effect of primary small liver cancer under radiofrequency ablation(RFA)and surgical resection(SR)treatment,and to explore the best application timing of the two treatment methods.Methods:Randomly controlled clinical trials(RCT)of percutaneous radiofrequency ablation and surgical resection for the treatment of small liver cancer in various databases were searched according to the established search strategy,and Meta data was analyzed based on RevMan5.3 software provided by Cochrane collaborative organization.Results:A total of 10 articles were included in this study,including 1396 patients,699 in the RFA group and 697 in the SR group.Meta-analysis results showed that the two groups had no statistical difference in overall survival rate at 1 and 3 years,1-year disease-free survival rate,and 1-year recurrence rate(P>0.05).The 3-year disease-free survival rate of the RFA group was lower than that of the SR group,and the 3-year recurrence rate was higher than that of the SR group.The higher postoperative complication rate tended to the SR group,and the differences were statistically significant.(P<0.05).Conclusion:For short-term efficacy,radiofrequency ablation and surgical resection show consistency;for long-term efficacy,surgical resection is more effective.

Efficacy and Safety of the Skin Adhesive EpinexusTM in Surgical Patients

This single-center, randomized, and controlled intervention study compared an acrylate skin adhesive, EpinexusTM (Mitsui Chemicals, Inc., Tokyo) with Dermabond AdvancedR (Ethicon, Inc., Somerville, New Jersey). The primary endpoint was cosmetic outcome at 52 weeks after treatment (Manchester Scar Scale), and the secondary endpoints were cosmetic outcome at 4 and 26 weeks after treatment (Manchester Scar Scale), wound closure, and usability. We evaluated 59 patients (29 cases and 30 controls). Failures and adverse events were also evaluated, and 8 adverse events (5 cases and 3 controls) were reported (epidermolysis, n = 4;contact dermatitis, n = 1;eczema, n = 1;and surgical wound dehiscence, n = 2). No difference was observed between groups in cosmetic outcome at 52 and 24 weeks;however, at 4 weeks, cases showed better cosmetic outcome compared with controls. With regard to usability, the treatment duration and application time were significantly longer with EpinexusTM, and ease of application was significantly better with Dermabond AdvancedR.

Study design in evidence-based surgery:What is the role of case-control studies?

Randomized controlled trials(RCTs) are the gold standard in terms of study design, however, in the surgical setting conducting RCTs can often be unethical or logistically impossible. Case-control studies should become the major study design used in surgical research when RCTs are unable to be conducted and definitely replacing case series which offer little insight into surgical outcomes and disease processes.

Procedure for prolapse and hemorrhoids vs traditional surgery for outlet obstructive constipation

AIM: To compare the clinical efficacies of two surgical procedures for hemorrhoid rectal prolapse with outlet obstruction-induced constipation.METHODS: One hundred eight inpatients who underwent surgery for outlet obstructive constipation caused by internal rectal prolapse and circumferential hemorrhoids at the First Affiliated Hospital of Xinjiang Medical University from June 2012 to June 2013 were prospectively included in the study.The patients with rectal prolapse hemorrhoids with outlet obstructioninduced constipation were randomly divided into two groups to undergo either a procedure for prolapse and hemorrhoids(PPH)(n = 54) or conventional surgery(n = 54; control group).Short-term(operative time,postoperative hospital stay,postoperative urinary retention,postoperative perianal edema,and postoperative pain) and long-term(postoperative anal stenosis,postoperative sensory anal incontinence,postoperative recurrence,and postoperative difficulty in defecation) clinical effects were compared between the two groups.The short- and long-term efficacies of the two procedures were determined.RESULTS: In terms of short-term clinical effects,operative time and postoperative hospital stay were significantly shorter in the PPH group than in the control group(24.36 ± 5.16 min vs 44.27 ± 6.57 min,2.1 ± 1.4 d vs 3.6 ± 2.3 d,both P < 0.01).The incidence of postoperative urinary retention was higher in the PPH group than in the control group,but the difference was not statistically significant(48.15% vs 37.04%).Theincidence of perianal edema was significantly lower in the PPH group(11.11% vs 42.60%,P < 0.05).The visual analogue scale scores at 24 h after surgery,first defecation,and one week after surgery were significantly lower in the PPH group(2.9 ± 0.9 vs 8.3 ± 1.1,2.0 ± 0.5 vs 6.5 ± 0.8,and 1.7 ± 0.5 vs 5.0 ± 0.7,respectively,all P < 0.01).With regard to long-term clinical effects,the incidence of anal stenosis was lower in the PPH group than in the control group,but the difference was not significant(1.85% vs 5.56%).The incidence of sensory anal incontinence was significantly lower in the PPH group(3.70% vs 12.96%,P < 0.05).The incidences of recurrent internal rectal prolapse and difficulty in defecation were lower in the PPH group than in the control group,but the differences were not significant(11.11% vs 16.67% and 12.96% vs 24.07%,respectively).CONCLUSION: PPH is superior to the traditional surgery in the management of outlet obstructive constipation caused by internal rectal prolapse with circumferential hemorrhoids.

Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial

Background: Insomnia is a common complaint that is closely related to gastrointestinal symptoms, which is consistent with the traditional Chinese medicine classical theory of ‘‘stomach disharmony leading to restless sleep." Acupuncture is an effective complementary and alternative medicine therapy to improve gastrointestinal function and restore the normal sleep-wake cycle. However, studies on the effectiveness of acupuncture for insomnia due to spleen-stomach disharmony syndrome are limited to case reports and few randomized controlled trials; deeper research on its mechanism is still lacking. This randomized controlled trial aims to assess the treatment efficacy of ‘‘harmonizing stomach to tranquilize mind"acupuncture for insomnia and its influence on the intestinal microbiome.Methods/design: This is a randomized, single-blind, parallel-group study. Sixty eligible patients with insomnia due to spleen-stomach disharmony syndrome will be randomly divided into two groups(1:1 allocation ratio). The intervention group will use ‘‘harmonizing stomach to tranquilize mind"acupuncture, and the control group will receive sham acupuncture. Participants will receive 5 acupuncture treatment sessions per week for 4 consecutive weeks. The Pittsburgh Sleep Quality Index will be used to evaluate the clinical efficacy of acupuncture treatment by making assessments at baseline, the end of treatment and the end of the follow-up. High-throughput 16 S ribosomal ribonucleic acid gene sequencing will be performed to detect changes in the intestinal microbial composition before and after treatment.Discussion: The results of this trial are expected to confirm that ‘‘harmonizing stomach to tranquilize mind" acupuncture can effectively relieve insomnia and alter the intestinal microbiome.

A Randomized Double-blind Placebo-controlled Study of Pu'er Tea(普洱茶) Extract on the Regulation of Metabolic Syndrome

Objective：To explore the regulative efficacy of Pu＇er tea（普洱茶）extract on metabolic syndrome. Methods：Ninety patients with metabolic syndrome were randomly divided into two groups,the intervention group administered with Pu＇er tea extract,and the placebo group with placebo capsules.After 3 months＇ treatment, body mass index,waist hip ratio,blood lipids,blood sugar,immune and inflammatory index,and oxidation index of the patients with metabolic syndrome were tested and analyzed.Results：In the intervention group,the body mass index,waist-hip ratio,fasting and 2 h postprandial blood glucose,serum total cholesterol,triglycerides, low density lipoprotein and apolipoprotein B-100 all decreased in the patients with metabolic syndrome,and also the high-density lipoprotein level increased and apolipoprotein A-1 showed the tendency to increase. Serum C-reactive protein,tumor necrosis factor-α,and interleukin-6 were decreased in the intervention group. lnterleukin-10 level was increased,MDA was decreased and superoxide dismutase was increased.Compared with before treatment and the placebo group,there were significant differences（P0.05,P0.01）.Conclusions： Pu＇er tea demonstrated excellent potential in improving central obesity,adjusting blood lipid,lowering blood sugar,regulating immunity and resisting oxidation.It can adjust the metabolic syndrome of different clinical phenotypes to different degrees,and is ideally fit for early prevention of metabolic syndrome.

Parallel Subgroup Design of a Randomized Controlled Clinical Trial——Comparing the Approaches of Chinese Medicine and Western Medicine

A new method for the comparison of the treatment efficacy for specific diseases or conditions between Chinese medicine and Western medicine, which serve the same medical aim but are based on substantially different theoretical systems, was identified. Abiding by the principle of parallel subgroup design of a randomized controlled trial （PSD-RCT）, participants were recruited following identical inclusion and exclusion criteria and were randomly allocated into two groups to receive treatment using the respective approaches of Chinese medicine and Western medicine. The Chinese medicine group was divided into subgroups according to the theory of Chinese medicine and the Western medicine group was also divided into subgroups according to the theory of Western medicine. The treatment for each subgroup was well defined in the protocol, including major formulae and principles for individualized modifications. The primary outcome measure was ascertained to be directly related to the patients＇ status but independent from both theories of Chinese medicine and Western medicine, while the secondary outcomes were represented by the patient-reported outcomes and some laboratory tests commonly accepted by Chinese medicine and Western medicine. Then, taking functional dyspepsia as an example, the authors explain the framework of the PSD-RCT for efficacy comparisons between Chinese medicine and Western medicine, and recommend that the PSD-RCT can be used to compare treatment efficacy for a specific disease or condition between Chinese medicine and Western medicine, and the comparison among subgroups can provide valuable clues for further studies.