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.

Botulinum toxin type A for treating chronic low back pain:A double blinded randomized control study

BACKGROUND Low back pain(LBP)is a prevalent issue that orthopedic surgeons frequently address in the outpatient setting.LBP can arise from various causes,with stiffness in the paraspinal muscles being a notable contributor.The administration of Botulinum toxin type A(BoNT-A)has been found to alleviate back pain by relaxing these stiff muscles.While BoNT-A is approved for use in numerous conditions,a limited number of randomized clinical trials(RCTs)validate its efficacy specifically for treating LBP.AIM To study the safety and the efficacy of BoNT-A in minimizing pain and improving functional outcomes in patients of chronic LBP(CLBP).METHODS In this RCT,adults aged 18-60 years with mechanical LBP persisting for at least six months were enrolled.Participants were allocated to either the Drug group,receiving 200 Ipsen Units(2 mL)of BoNT-A,or the Control group,which received a 2 mL placebo.Over a 2-month follow-up period,both groups were assessed using the Visual Analog Scale(VAS)for pain intensity and the Oswestry Disability Index(ODI)for disability at the start and conclusion of the study.A decrease in pain by 50%was deemed clinically significant.RESULTS The study followed 40 patients for two months,with 20 in each group.A clinically significant reduction in pain was observed in 36 participants.There was a statistically significant decrease in both VAS and ODI scores in the groups at the end of two months.Nonetheless,when comparing the mean score changes,only the reduction in ODI scores(15 in the placebo group vs 16.5 in the drug group,clinically insignificant)was statistically significant(P=0.012),whereas the change in mean VAS scores was not significant(P=0.45).CONCLUSION The study concludes that BoNT-A does not offer a short-term advantage over placebo in reducing pain or improving LBP scores in CLBP patients.

Dietary Therapy of Qi-Yin-Reinforcing Porridge for the Alleviation of Chemotherapy Related Symptoms of Gastrointestinal Tumors:A Single-Case Randomized Controlled Study

Objective： To investigate the efficacy of dietary therapy of qi-yin-reinforcing porridge for the alleviation of clinical symptoms during FOLFOX chemotherapy. Methods： A single-case randomized controlled study was carded out. Fourteen patients with gastrointestinal tumors accepting FOLFOX chemotherapy were enrolled using self-crossover control design. On days 1-7 of chemotherapy, the dietary therapy expedmental group and the placebo control group were given dietary therapy of qi-yin-reinforcing porridge and dextrin-prepared porridge which had the same appearance, smell, color and taste as the qi-yin-reinforcing porridge, respectively. Fourteen clinical symptoms, including debility, vomiting and nausea, etc. were observed. Restdts： Ten patients completed the study and were estimable. The qi-yin-reinforcing porridge demonstrated certain efficacy in alleviating clinical symptoms of patients with gastrointestinal tumors during the pedod of chemotherapy. Better effect of alleviating debility was found in the dietary therapy expedmantal group than in the placebo control group, and the difference was statistically significant （Z=2.27, P=0.02）. No statistically significant difference was found between the experimental group and the control group with respect to the effect of alleviating the other 13 clinical symptoms including anorexia, nausea, vomiting, dry stool, loose stool, etc. and body weight （P〉0.05）. Conclusion： Dietary therapy of qi-yin-reinforcing porridge shows an additional benefit in alleviating debility of patients during chemotherapy and deserves clinical use and popularization.

Beneficial effects of fenugreek glycoside supplementation in male subjects during resistance training: A randomized controlled pilot study

Purpose： To evaluate the efficacy and safety of the glycoside fraction of fenugreek （Trigonellafoenum-graecum） seeds （Fenu-FG） on physiologi- cal parameters related to muscle anabolism, androgenic hormones, and body fat in healthy male subjects during an 8-week resistance training program using a prospective, randomized, double-blind, placebo controlled design. Methods： Sixty healthy male subjects were randomized to ingest capsules of Fenu-FG （1 capsule of 300 rag, twice per day） or the matching placebo at a 1：1 ratio. The subjects participated in a supervised 4-day per week resistance-training program for 8 weeks. The outcome measurements were recorded at recruitment （baseline） and at the end of the treatment （8 weeks）. The efficacy outcome included serum testosterone （total and free） levels, muscle strength and repetitions to failure, metabolic markers for anabolic activity （serum creatinine and blood urea nitrogen）, and % body fat. The standard safety measurements such as adverse events monitoring, vital signs, hematology, biochemistry, and urinalysis were performed. Results： Fenu-FG supplementation demonstrated significant anabolic and androgenic activity as compared with the placebo. Fenu-FG treated subjects showed significant improvements in body fat without a reduction in muscle strength or repetitions to failure. The Fenu-FG supplemen- tation was found to be safe and well-tolerated. Conclusion： Fenu-FG supplementation showed beneficial effects in male subjects during resistance training without any clinical side effects.

DENSE CRANIAL ELECTROACUPUNCTURE STIMULATION FOR MDD: A PET/CT RANDOMIZED CONTROLLED STUDY

The purpose of this study was to determine the effectiveness of Dense Cranial Electroacupuncture Stimulation(DCEAS)as additional therapy and neuroimaging correlates in patients with major depressive disorder(MDD)using PET-CT.A single-blind,randomized,controlled trial was conducted in 25 MDD patients treated with antidepressants combined with sham or active

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.

An integrative Tai Chi program for patients with breast cancer undergoing cancer therapy:study protocol for a randomized controlled feasibility study

Background： Breast cancer patients experience various side effects during cancer therapy, often resulting in reduced quality of life and poor adherence to treatment. A limited range of proven interventions has been developed to target such side effects. While Tai Chi offers benefits for the health and well-being of breast cancer survivors, the effectiveness of Tai Chi across the treatment continuum has not been evalu- ated. Improved patient education and support has been suggested as a priority for breast cancer care. This pilot study assesses the feasibility of a randomized controlled trial （RCT） to evaluate the effectiveness of ＂an integrative Tai Chi＂ （ANITA） program for breast cancer patients undergoing cancer therapy. Methods/design： This is a single-centre, two-arm feasibility RCT. Twenty-four patients with breast cancer who have undergone surgical treatment will be recruited from the Dunedin Hospital （New Zealand） over a 12-month period （from August 2017 to July 2018）. Subject to informed consent, patients will be ran- domized to receive standard cancer treatment alone or standard cancer treatment plus the ANITA pro- gram, consisting of peer support, health education, and Tai Chi Ruler exercise. The program runs alongside the patient＇s adjuvant cancer therapy, which may include chemotherapy, radiation therapy, antibody treatment, and/or antihormonal therapy. Analysis in this study will focus on process evaluation of participant recruitment, retention, treatment fidelity, acceptability of the program, and occurrence of adverse events. Clinical outcomes （i.e., fatigue, sleep quality, anxiety and depression and quality of life） will be assessed at baseline, and at 12 weeks and 24 weeks post-randomization. Discussion： Outcomes from this study will inform the feasibility and methodology for a future fully- powered RCT.

Low-dose and high-dose ^(131)I therapy for low and intermediate risk differentiated thyroid cancer: a randomized controlled clinical study

Objective To compare the ablation efficacy and therapy response with low-dose（1.1 GBq）and high-dose（3.7 GBq） 131I in postoperative patients with low and in-termediate risk DTC.Methods A total of 140 patients（37 males,103 females,age range:18-75 years）were enrolled from October 2014 to June 2015,and

Delayed improvements in visual memory task performance among chronic schizophrenia patients after high-frequency repetitive transcranial magnetic stimulation

BACKGROUND Cognitive impairments are core characteristics of schizophrenia,but are largely resistant to current treatments.Several recent studies have shown that highfrequency repetitive transcranial magnetic stimulation(rTMS)of the left dorsolateral prefrontal cortex(DLPFC)can reduce negative symptoms and improve certain cognitive deficits in schizophrenia patients.However,results are inconsistent across studies.AIM To examine if high-frequency rTMS of the DLPFC can improve visual memory deficits in patients with schizophrenia.METHODS Forty-seven chronic schizophrenia patients with severe negative symptoms on stable treatment regimens were randomly assigned to receive active rTMS to the DLPFC(n=25)or sham stimulation(n=22)on weekdays for four consecutive weeks.Patients performed the pattern recognition memory(PRM)task from the Cambridge Neuropsychological Test Automated Battery at baseline,at the end of rTMS treatment(week 4),and 4 wk after rTMS treatment(week 8).Clinical symptoms were also measured at these same time points using the Scale for the Assessment of Negative Symptoms(SANS)and the Positive and Negative Syndrome Scale(PANSS).RESULTS There were no significant differences in PRM performance metrics,SANS total score,SANS subscores,PANSS total score,and PANSS subscores between active and sham rTMS groups at the end of the 4-wk treatment period,but PRM performance metrics(percent correct and number correct)and changes in these metrics from baseline were significantly greater in the active rTMS group at week 8 compared to the sham group(all P<0.05).Active rTMS treatment also significantly reduced SANS score at week 8 compared to sham treatment.Moreover,the improvement in visual memory was correlated with the reduction in negative symptoms at week 8.In contrast,there were no between-group differences in PANSS total score and subscale scores at either week 4 or week 8(all P>0.05).CONCLUSION High-frequency transcranial magnetic stimulation improves visual memory and reduces negative symptoms in schizophrenia,but these effects are delayed,potentially due to the requirement for extensive neuroplastic changes within DLPFC networks.

Is endoscopic retrograde appendicitis therapy a better modality for acute uncomplicated appendicitis? A systematic review and metaanalysis

BACKGROUND Previous studies had shown endoscopic retrograde appendicitis therapy(ERAT)is an effective treatment for acute appendicitis.However,different studies reported conflicting outcomes regarding the effectiveness of ERAT in comparison with laparoscopic appendectomy(LA).AIM To compare the effectiveness of ERAT with LA.METHODS Randomized controlled trials(RCTs)and retrospective studies of ERAT for acute uncomplicated appendicitis were searched in PubMed,Cochrane Library,Web of Science,Embase database,China National Knowledge Infrastructure(CNKI),the WanFang Database,and Chinese Scientific Journals Database(VIP)from the establishment date to March 12021.Heterogeneity was assessed using the Isquared statistic.Pooled odds ratios(OR),weighted mean difference(WMD),and standard mean difference(SMD),with 95%confidence intervals(CI)were calculated through either fixed-effects or random-effects model.Sensitivity analysis was also performed.Publication bias was tested by Egger's test,and Begg’s test.The quality of included RCT were evaluated by the Jadad scale,while Newcastle-Ottawa scale is adopted for assessing the methodological quality of case-control studies.All statistical analysis was performed using Stata 15.1 statistical software.All statistical analysis was performed using Stata 15.1 statistical software.This study is registered with PROSPERO,CRD42021243955.RESULTS After screening,10 RCTs and 2 case-control studies were included in the current systematic review.Firstly,the length of hospitalizations[WMD=-1.15,95%CI:-1.99,-0.31;P=0.007]was shorter than LA group.Secondly,the level of postoperative CRP[WMD=-10.06,95%CI:(-17.39,-2.73);P=0.007],TNF-α[WMD=-7.70,95%CI:(-8.47,-6.93);P<0.001],and IL-6 Levels[WMD=-9.78,95%CI:(-10.69,-8.88);P<0.001;P<0.001]in ERAT group was significantly lower than LA group.Thirdly,ERAT group had a lower incidence of intestinal obstruction than LA group.[OR=0.19,95%CI:(0.05,0.79);P=0.020].Moreover,the quality of 10 RCTs were low with 0-3 Jadad scores,while the methodological quality of two case-control studies were fair with a score of 2(each).CONCLUSION Compared with LA,ERAT reduces operation time,the level of postoperative inflammation,and results in fewer complications and shorter recovery time,with preserving the appendix and its immune and biological functions.

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.

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.

Efficacy and safety of Xinfeng capsule in patients with rheumatoid arthritis:a multi-center parallel-group double-blind randomized controlled trial

OBJECTIVE:To evaluate the efficacy and safety of Xinfeng capsule in patients suffering rheumatoid arthritis(RA).METHODS:A multi-center parallel-group designed,double-blind,randomized,controlled trial was conducted.Totally 304 RA patients were assigned to two groups:one group was administered Xinfeng capsule(XFC) plus the placebo of leflunomide and the other given leflunomide(LEF) plus the placebo of XFC for twelve weeks.The clinical and laboratory parameters were compared at baseline and fourth,eighth,and twelfth weeks.RESULTS:After twelve-week treatment,patients in two groups all showed some trend of effectiveness when compared in terms of American Rheumatism Association(ACR) recommended 20%,50%,70%improvement criteria,but it was insignificant.The validity in ameliorate modified disease activity score(DAS28) and laboratory indexes as erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),rheumatoid factor(RF) were also found no difference.The score of health assessment questionnaire(HAQ),self-rating anxiety scale(SAS),self-rating depression scale(SDS) and quality of life questionnaire with rheumatoid arthritis(RAQOL)both lower than the first week and the changes showed no difference.However,the score of SDS dropped more in XFC group than in the other.A total of 147 adverse reaction cases were reported,which shows no difference between the two groups.The most common adverse reactions were hepatic impairment,anemia,leukocytopenia,epigastric discomfort and phalacrosis.CONCLUSION:XFC demonstrated better improvement in the scores of SDS and compared with those of LEF group.

Comparative effects of artemisia vulgaris and charcoal moxa stimulating Zhongwan(CV 12) on body temperature in healthy participants:a cross-over single-blind randomized study

OBJECTIVE:To evaluate the efficacy,safety,satisfaction,discomfort and patient preference of moxa cones of artemisia vulgaris and charcoal moxa.METHODS:This comparative study of moxibustion treatment with Artemisia vulgaris and charcoal moxa cone stimulating Zhongwan(CV 12) is a cross-over single-blinded,randomized clinical trial.A total of 40 healthy subjects(24 males and 16females) participated in this study.Two subjects dropped out of the trial.Thirty-eight subjects were treated with Artemisia vulgaris and charcoal moxa cones for 30 min in a cross-over design.After treatment,the patients underwent a 30 minute waiting period,and then the temperatures at Tanzhong(CV 17),Zhongwan(CV 12) and Guanyuan(CV 4) were measured using digital infrared thermal imaging.RESULTS:After the use of Artemisia vulgaris moxa,the patients' body temperatures were slightly lowered at Tanzhong(CV 17),Zhongwan(CV 12)and Guanyuan(CV 4),but the changes were not statistically significant.After the use of charcoal moxa,the patients' body temperatures were somewhat increased at Zhongwan(CV 12) and Guanyuan(CV 4),but the changes were not statistically significant.After Artemisia vulgaris moxa use,the body temperature difference between Zhongwan(CV 12) and Guanyuan(CV 4)was significantly increased.After charcoal moxa use,the body temperature difference between Tanzhong(CV 17) and Zhongwan(CV 12) was significantly decreased in males and in the whole group.This change was caused by the difference in the moxibustion type and by gender differences.CONCLUSION:This pilot study found that moxibustion did not raise the body temperature,but temperature differences between acupoints were affected.Further large-scale randomized controlled trials are needed for the effect of moxibustion on body temperature.

Therapeutic Effect of Jinlongshe Granule(金龙蛇颗粒) on Quality of Life of Stage IV Gastric Cancer Patients Using EORTC QLQ-C30:A Double-Blind Placebo-Controlled Clinical Trial

Objective： To evaluate the impact of Jinlongshe Granule （金龙蛇颗粒, JLSG） on quality of life （QOL） of stage IV gastric cancer patients. Methods： This randomized, double-blind and placebo-controlled clinical trial included 50 patients with advanced gastric cancer. They were equally randomized into a JLSG group and a placebo group. Patients in both groups received routine Chinese herbal decoctions according to Chinese medicine （CM） treatment based on syndrome differentiation. Patients in JLSG group received additional JLSG, and those in the placebo group received an additional placebo. In the JLSG group, 19 patients who completed the study were used for analysis. In the placebo group, finally the data of 20 patients who completed the study were used for analysis. The treatment course was at least 3 months, and the follow-up duration was at least 6 months in 5 interviews. Repeated measurements of the subscale items and individual items in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 （EORTC QLQ-C30） obtained at the 5 interviews were compared using different patient groups, changes over time and changes within one group over time independently to observe the tendency of changes in the scores. Results： Using time as the variant, there was significant difference in 4 functional scales （physical, role, emotional and social, P〈0.05）, 3 symptom scales （fatigue, nausea and vomiting and pain, P〈0.05） and a global health status/QOL scale （P〈0.05） and 6 single symptoms dyspnoea （P〉0.05）, insomnia （P〈0.05）, appetite loss （P〈0.05）, constipation （P〈0.05）, diarrhea （P〉0.05） and financial difficulties （P〈0.05）. There was also significant difference in these items between the two groups when the placebo group and group over time were used as variants （P〈0.05 or P〈0.01）. Conclusion： Additional use of JLSG on the basis of routine CM treatment could improve the somatic function, role function, emotional function, social function, cognitive function and general QOL of patients with advanced gastric cancer, and relieve the symptoms of fatigue, nausea and vomiting, pain, loss of appetite and constipation.

Effects of Acupuncture on Chinese Medicine Syndromes of Vascular Dementia

Objective： To study the effects of acupuncture on Chinese medicine syndromes of vascular dementia （VaD）. Methods： Sixty-three VaD patients were divided into three groups. Those willing to be randomized were randomly assigned to receive either acupuncture （random acupuncture group, 24 cases） or rehabilitation training （guided rehabilitation group, 24 cases） for 6 weeks. Those unwilling to be randomized also received acupuncture for 6 weeks （non-random acupuncture group, 19 cases）. Patient syndromes and their severity were evaluated before treatment （baseline）, at the end of treatment, and at 4-week follow-up after the completion of treatment using a CM scoring system （scale of differentiation of syndromes of vascular dementia, SDSVD）. The SDSVD scores of the random and non-random acupuncture groups, and of all patients who received acupuncture （combined acupuncture group, 43 cases）, were compared with those in the guided rehabilitation group. Results： In the random, non-random, and combined acupuncture groups, SDSVD scores were significantly reduced at the end of treatment and at follow- up than at baseline. In the guided rehabilitation group, SDSVD scores were similar to baseline scores at the end of treatment and at follow-up. However, there were no significant differences in SDSVD scores among the three groups or between the combined acupuncture group and the guided rehabilitation group at any time points. In the non-random and combined acupuncture groups, SDSVD scores were significantly reduced at the end of treatment than at baseline in patients with hyperactivity of Liver （Gan）-yang or phlegm obstruction of the orifices. Conclusions： Acupuncture reduced the severity of VaD. The improvement was the greatest in patients undergoing their treatment of choice. Treatments in this study were more effective for excess syndromes, such as Liver-yang hyperactivity or phlegm obstruction of the orifices than deficiency syndromes, such as Kidney （Shen）-essence deficiency.