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| 1 | Enhanced recovery program is safe and improves postoperative insulin resistance in gastrectomy显示文摘AIM: To assess the safety of enhanced recovery after surgery(ERAS) program in gastrectomy and influences on nutrition state and insulin-resistance. METHODS: Our ERAS program involved shortening the fasting periods and preoperative carbohydrate loading. Eighty gastrectomy patients were randomly assigned to either the conventional group(CG) or ERAS group(EG). We assessed the clinical characteristics and postoperative outcomes prospectively. The primary endpoint was noninferiority in timely discharge from the hospital within 12 d. Secondary endpoints were the incidence of aspiration at anesthesia induction, incidence of postoperative complications, health related quality of life(HRQOL) using the SF8 Health Survey questionnaire, nutrition state [e.g., albumin, transthyretin(TTR), retinal-binding protein(RBP), and transferrin(Tf)], the homeostasis model assessment-insulin resistance(HOMA-R) index, postoperative urine volume,postoperative weight change, and postoperative oral intake.RESULTS: The ERAS program was noninferior to the conventional program in achieving discharge from the hospital within 12 d(95.0% vs 92.5% respectively; 95%CI:-10.0%-16.0%). There was no significant difference in postoperative morbidity between the two groups. Adverse events such as vomiting and aspiration associated with the induction of general anesthesia were not observed. There were no significant differences with respect to postoperative urine volume, weight change, and oral intake between the two groups. EG patients with preoperative HOMA-R scores above 2.5 experienced significant attenuation of their HOMA-R scores on postoperative day 1 compared to CG patients(P = 0.014). There were no significant differences with respect to rapid turnover proteins(TTR, RBP and Tf) or HRQOL scores using the SF8 method.CONCLUSION: Applying the ERAS program to patients who undergo gastrectomy is safe, and improves insulin resistance with no deterioration in QOL. | Nobuaki Fujikuni Kazuaki Tanabe Noriaki Tokumoto Takahisa Suzuki Minoru Hattori Toshihiro Misumi Hideki Ohdan | 2016 | World Journal of Gastrointestinal Surgery2016，8，5： | 23 |
| 2 | Effects of entecavir and lamivudine for hepatitis B decompensated cirrhosis: Meta-analysis显示文摘AIM:To compare the effects of entecavir(ETV)and lamivudine(LAM)for the treatment of hepatitis B decompensated cirrhosis using a meta-analysis.METHODS:We conducted a literature search for all eligible studies published prior to May 30,2013 using PUBMED,MEDLINE,EMBASE,the China National Knowledge Infrastructure(CNKI),the VIP database,the Wanfang database and the Cochrane Controlled Trial Register.Randomized controlled trials(RCTs)comparing ETV with LAM for the treatment of hepatitis B decompensated cirrhosis were included.The data were analyzed with Review Manager Software 5.0.2.We used RR as an effect measure,and reported its95%CI.The meta-analysis was performed using either a fixed-effect or random-effect model,based on the absence or presence of significant heterogeneity.Two reviewers assessed the risk of bias and extracted data independently and in duplicate.The analysis was executed using the main outcome parameters including hepatitis B virus(HBV)DNA undetectability,HBV DNA level,hepatitis B e antigen(HBeAg)seroconversion,alanine aminotransferase(ALT)level,albumin level,total bilirubin(TBIL)level,prothrombin time activity(PTA)level,Child-Turcotte-Pugh(CTP)score,mortality,drugresistance,and adverse reactions.Meta-analysis of the included trials and subgroup analyses were conducted to examine the association between pre-specified characteristics and the therapeutic effects of the two agents.RESULTS:Thirteen eligible trials(873 patients in total)were included and evaluated for methodological quality and heterogeneity.Of these studies,all had baseline comparability,12 of them reported baseline values of the two treatment groups in detail.Following various treatment durations(12,24,36,48 and>48 wk),both ETV and LAM significantly reduced HBV DNA level,however,reductions were greater in the ETV group(MD=-0.66,95%CI:-0.83-0.50,P<0.00001),(MD=-0.93,95%CI:-1.36-0.51,P<0.0001),(MD=-1.4,95%CI:-1.78-1.01,P<0.00001),(MD=-1.18,95%CI:-1.90-0.46,P=0.001),(MD=-0.14,95%CI:-0.17-0.11,P<0.00001,respectively).At 12,24 and48 wk of treatment,ETV had a significant effect on the rate of HBV DNA undetectability(RR=1.55,95%CI:1.22-1.99,P=0.0004),(RR=1.25,95%CI:1.13-1.38,P<0.0001),(RR=1.2,95%CI:1.10-1.32,P<0.0001,respectively).Although HBeAg seroconversion in the ETV group was more pronounced than that in the LAM group at 24 wk(27.90%vs 26.19%)and 48 wk(31.52%vs 25.00%)of treatment,there was no statistically significant difference between them(RR=1.49,95%CI:0.98-2.28,P=0.07),(RR=1.27,95%CI:0.98-1.65,P=0.07,respectively).Following various treatment durations,both the ETV group and the LAM group showed significantly improved liver function(ALT,AIB,TBIL,PTA and CTP levels)and reduced mortality(ETV 6.37%,LAM 7.89%).The effects in the ETV group(0.33%)were statistically lower than those in the LAM group(14.33%)regarding the rate of drug-resistance(RR=0.1,95%CI:0.04-0.24,P≤0.00001).In addition,no severe adverse reactions were observed in the two treatment groups.CONCLUSION:ETV and LAM significantly improved liver function and reduced mortality.Both drugs produced similar serological responses,and were safe and well tolerated.However,ETV resulted in a better virological response and lower drug-resistance,but is more expensive. | Xiao-Guang Ye Qi-Min Su | 2013 | World Journal of Gastroenterology2013，19，39： | 18 |
| 3 | 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显示文摘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. | Ya-ru Huangfu Wei Peng Bao-jun Guo Zhi-fu Shen Li Li Shi-wei Liu Hui Zheng You-ping Hu | 2019 | Journal of Integrative Medicine2019，17，3： | 15 |
| 4 | Effect of electrically stimulating acupoint, Zusanli(ST 36), on patient’s recovery after laparoscopic colorectal cancer resection: a randomized controlled trial显示文摘OBJECTIVE:To investigate the effect of transcutaneous electrical acupoint stimulation (TEAS) on enhanced recovery after surgery (ERAS) in laparoscopic colorectal cancer resection and its clinical significance.METHODS:Sixty-four patients undergoing laparoscopic colorectal resection were randomly divided into two groups,the control group (group A) and the TEAS group (group B).Patients in the TEAS group received electroacupuncture stimulation of bilateral Zusanli (ST 36) at 30 min before anesthesia to the end of surgery.The patients in the control group were not given the stimulation.Perioperative anesthesia management of the two groups were performed according to the ERAS guidelines,and postoperative patient-controlled intravenous analgesia (PCIA) was used.The amount of remifentanil used in the two groups was observed and recorded,and the visual analogue scale (VAS) of the 4,12,24 and 48 h after surgery in the two groups was recorded.Moreover,postoperative anal exhaust time,postoperative feeding time,postoperative first ambulation time and postoperative hospital stay length were compared between the two groups.RESULTS:Compared with group A,the VAS score of group B decreased significantly at 48 h after operation (P < 0.05).The postoperative anal exhaust time in group B was significantly shorter than that of group A (P < 0.05).There was no significant difference between the two groups with regards to remifentanil consumption,postoperative feeding time,postoperative first ambulation time and postoperative hospital stay (all P > 0.05).CONCLUSION:TEAS can promote the recovery of postoperative gastrointestinal function and reduce the pain intensity 48 h after surgery,thus satisfying the need of early postoperative analgesia. | Huang Wei Yu Tingyu Long Wenfei Xiao Jianbin Zhao Gaofeng | 2019 | Journal of Traditional Chinese Medicine2019，39，3： | 14 |
| 5 | Effect of Essential Oil on Patients with Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Pilot Randomized Controlled Trial显示文摘Objective: To evaluate the efficacy and safety of essential oil treatment for type Ⅲ chronic prostatitis/chronic pelvic pain syndrome(CP/CPPS). Methods: A randomized controlled trial was conducted from December 2014 to October 2015. Seventy type Ⅲ CP/CPPS patients were assigned to the essential oil group(35 cases) or almond placebo oil control group(35 cases) by a random number table. The oil was smeared by self-massage on the suprapubic and sacral region once a day for 4 weeks. The National Institutes of Health Chronic Prostatitis Syndrome Index(NIH-CPSI) and expressed prostatic secretions(EPS) were examined. The primary outcome was NIH-CPSI pain domain. The secondary outcomes included other NIH-CPSI domains and laboratory examinations of EPS. Adverse events were also observed. Results: Sixty-six subjects completed the full 4-week treatment. There was no significant difference between almond oil control and essential oil groups in terms of the total score of NIH-CPSI, pain, quality of life and urination domain scores of NIH-CPSI and EPS examinations(P>0.05). In the essential oil group, pain between rectum and testicles(perineum) in the domain of pain or discomfort was significantly reduced at week 2 and week 4 compared with almond oil control group(P<0.01). No serious adverse events occurred. Conclusion: The essential oil may reduce the pain or discomfort in the perineum region in patients with CP/CPPS. | YING Jian ZHOU Min-jie CHEN Hai-yong CHEN Lei ZHANG Wei JI Jun YU Chao ZHANG Zhang-jin | 2019 | Chinese Journal of Integrative Medicine2019，25，2： | 13 |
| 6 | Effectiveness and safety of moxibustion in treatment of lumbar disc herniation: a systematic review and Meta-analysis显示文摘OBJECTIVE: To evaluate the effectiveness and safety of moxibustion therapy in the treatment of lumbar disc herniation (LDH). METHODS: Four Chinese databases and three English databases were searched from their inception to April 2018.Randomized controlled trials (RCTs) were included if moxibustion was used as the sole treatment or as a part of combination therapy with other treatments in patients with LDH. Two reviewers independently extracted the data and assessed the methodological quality using the Cochrane criteria for the risk of bias. The Meta-analysis was performed using Review Manager 5.3 software. RESULTS: In total, 16 RCTs including 1186 patients with LDH were analyzed. The Meta-analysis showed favorable effects of moxibustion in combination with massage therapy on the visual analog scale score compared with massage therapy alone [mean difference (MD)=? 1.32, 95% confidence interval (CI)(? 2.12,? 0.51), P = 0.001]. The subgroup Meta-analysis failed to show favorable effects of electro-acupuncture plus moxibustion on the efficacy rate compared with electro-acupuncture alone [relative risk (RR)= 1.06, 95% CI (0.98, 1.14), P = 0.15]. However, acupuncture or massage therapy plus moxibustion improved the efficacy rates compared with acupuncture or massage therapy alone [RR = 1.33, 95% CI (1.18, 1.49), P < 0.000 01][χ^2 = 2.76, P = 0.25, I2 = 27%],[RR = 1.15, 95% CI (1.06, 1.25), P = 0.001][χ^2 = 0.00, P = 0.95, I2 = 0%]. With respect to the Japanese Orthopaedic Association (JOA) scores, acupuncture or massage therapy in addition to moxibustion produced results different from those of acupuncture or massage therapy alone [MD = 5.58, 95% CI (4.15, 7.00), P < 0.000 01][χ^2 = 0.58, P = 0.45, I2 = 0%],[MD = 3.61, 95% CI (3.01, 4.21), P < 0.000 01]. There were no significant differences in the JOA score for subjective symptoms, objective symptoms, daily living ability, and other parameters. In six RCTs, no adverse reactions occurred during moxibustion. CONCLUSION: Whether moxibustion is an effective intervention for LDH is unclear because of the small sample size of qualified RCTs and the high risk of bias. More high-quality RCTs that overcome the methodological shortcomings of the existing evidence are needed. | Wang Yang Zhang Huiling Xia Liping Sun Zhiling Xu Xiao Du Shizheng | 2019 | Journal of Traditional Chinese Medicine2019，39，5： | 11 |
| 7 | Effect and Safety of Huannao Yicong Formula(还脑益聪方) in Patients with Mild-to-Moderate Alzheimer’s Disease: A Randomized, Double-Blinded, Donepezil-Controlled Trial显示文摘Objective: To assess the effect and safety of Huannao Yicong Formula (还脑益聪方, HYF) in the treatment of patients with mild-to-moderate Alzheimer's disease (AD). Methods: Sixty patients with mild-to moderate AD were evenly randomized into HYF group and donepezil group with the random number method. Patients in the HYF group took 5 g of HYF granules twice daily and 5 mg placebo of donepezil once daily. Patients in the donepezil group took 5 mg donepezil once daily and 5 g placebo of HYF granules twice daily. The intervention lasted for 6 months. Clinical researchers, participants and statisticians were blinded to the treatment assignment throughout the study. The primary outcomes were scores of Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and Chinese Medicine Symptom Scale (CM-SS). The secondary outcomes were scores of Montreal Cognitive Assessment (MoCA) test and Mini-Mental State Exam (MMSE). The serum levels of acetylcholinesterase (AchE) and amyloid-β protein 42 (Aβ 42) were detected with enzyme linked immunosorbent assay kits. The scale assessments were conducted at baseline, the 3rd and 6th months of treatment, respectively. Biochemistry tests were conducted at baseline and the 6th month of treatment. Results: A total of 52 patients completed the trial, 28 in HYF group and 24 in donepezil group. Compared with the baseline, HYF and donepezil significantly decreased the total scores of ADAS-Cog and CM-SS, and significantly increased the scores of MoCA and MMSE after 6-month treatment (all P<0.01). Both treatments remarkably reduced the serum levels of AchE and Aβ 42 (both P<0.05). The CM-SS total effective rate of HYF was significantly higher than donepezil [75.00%(21/28) vs. 54.17%(13/24), P<0.05]. No severe adverse events were observed in both groups. Conclusion: HYF is effective and safe for improving the cognitive function in mild to-moderate AD patients.[Trial registration: Chinese Clinical Trial Registry (Reg No. ChiCTR-IOR-17011746)]. | YANG Yang LIU Jian-ping FANG Jun-yan WANG Hui-chan WEI Yun CAO Yu LIU Jian-gang LIU Long-tao LI Hao | 2019 | Chinese Journal of Integrative Medicine2019，25，8： | 9 |
| 8 | Acupoint Catgut Embedding Alleviates Insomnia in Different Chinese Medicine Syndrome Types: A Randomized Controlled Trial显示文摘Objective: To investigate the effects and safety of catgut embedding on alleviating insomnia. Methods: Totally 510 patients with insomnia were divided into 5 Chinese medicine(CM) syndrome types: Xin(Heart) and Pi(Spleen) deficiency, yin deficiency with excess fire, Xin and gut qi deficiency, Wei(Stomach) disorder, and qi and blood deficiency, respectively. These 5 types of patients were randomly assigned to a catgut embedding group, an acupuncture group or a medication group(30 cases in Xin and Pi deficiency type, Wei disorder type, Xin and gut qi deficiency type, respectively;40 cases in yin deficiency with excess fire type and qi and blood deficiency type, respectively). In the catgut embedding group, patients were treated by implanting catgut into acupoints once every 10 days for a total of 30 days. In the acupuncture group, patients were treated with acupuncture once per day over 30 days(excluding weekends);and patients in the medication group took 1 mg Eurodin Tablet orally every night for 30 days. Pittsburgh Sleep Quality Index(PSQI) was evaluated before treatment, on 30 and 60 days after the first treatment, respectively. The International Unified Sleep Efficiency Value(IUSEV) was measured at 30 and 60 days. The safety was evaluated after treatment and adverse events were analyzed. Results: The objective PSQI scores including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, daytime dysfunction, and total scores at 30 days were significantly improved compared with pre-treatment in the catgut embedding and acupuncture groups(P<0.01 or P<0.05). At 30 days, the PSQI scores in catgut embedding group were superior to the medication group in the patients with each type of insomnia, with the exception of sleep duration(P<0.01 or P<0.05). At 60 days, significant differences were found between the catgut embedding group and the medication group(P<0.01 for all indices). The IUSEV scores in the catgut embedding group were significantly higher than the acupuncture group at 60 days, and the scores in acupuncture group were higher than the medication group at 30 days(P<0.05 for all types). No severe adverse events were found in this study. Conclusions: Acupoint catgut embedding and acupuncture were more effective than medication in alleviating insomnia syndrome in different Chinese medicine syndrome type. However, the sustained effects of acupoint catgut embedding were superior to acupuncture. | XU Fu XUAN Li-hua ZHOU Hai-jiang CHEN Fei-yu ZHENG Zhao-jian BI Ying WU Xiang | 2019 | Chinese Journal of Integrative Medicine2019，25，7： | 9 |
| 9 | Effects of premedication with Pronase for endoscopic ultrasound of the stomach: A randomized controlled trial显示文摘AIM To analyze the effects of premedication with Pronase for endoscopic ultrasound(EUS) examination of the stomach.METHODS This was a prospective, randomized and controlled clinical study. All patients were randomly assigned to either the Pronase group or placebo group. The pretreatment solution was a mixed solution of 20000 U of Pronase and 60 m L sodium bicarbonate solution in the Pronase group, while an equal amount of sodium bicarbonate solution was administered to the placebo group. All operators, image evaluators and experimental recorders in EUS did not participate in the preparation and allocation of pretreatment solution. Two blinded investigators assessed the obscurity scores for the EUS images according to the size of artifacts(including ultrasound images of the gastric cavity and the gastric wall). Differences in imaging quality, the duration of examination and the usage of physiological saline during the examination process between the Pronase group and the control group were compared.RESULTS No differences existed in patient demographics between the two groups. For the gastric cavity, the Pronase group had significantly lower mean obscurity scores than the placebo group(1.0476 ± 0.77 vs 1.6129 ± 0.96, respectively, P = 0.000). The mean obscurity scores for the gastric mucosal surface were significantly lower in the Pronase group than the placebo group(1.2063 ± 0.90 vs 1.7581 ± 0.84, respectively, P = 0.001). The average EUS procedure duration for the Pronase group was 11.60 ± 3.32 min, which was significantly shorter than that of the placebo group(13.13 ± 3.81 min, P = 0.007). Less saline was used in the Pronase group than the placebo group, and the difference was significant(417.94 ± 121.38 m L vs 467.42 ± 104.52 mL, respectively, P = 0.016).CONCLUSION The group that had Pronase premedication prior to the EUS examination had clearer images than the placebo group. With Pronase premedication, the examination time was shorter, and the amount of saline used during the EUS examination was less. | Guo-Xin Wang Xiang Liu Sheng Wang Nan Ge Jin-Tao Guo Si-Yu Sun | 2016 | World Journal of Gastroenterology2016，22，48： | 8 |
| 10 | Irsogladine maleate and rabeprazole in non-erosive reflux disease: A double-blind, placebo-controlled study显示文摘AIM:To evaluate the efficacy of adding irsogladine maleate(IM) to proton-pump inhibitor(PPI) therapy in non-erosive reflux disease(NERD) treatment.METHODS:One hundred patients with NERD were recruited and randomized to receive rabeprazole plus IM(group I) or rabeprazole plus placebo(group P).The efficacy of the treatment was assessed using the Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease(FSSG) and the short form(SF)-36 quality of life questionnaires after four weeks of treatment.We also assessed whether patients with NERD with minimal changes(grade M) had different responses to the therapies compared with patients who did not have minimal changes(grade N).RESULTS:Group I and group P showed significant improvements in their FSSG scores after the treatment(from 17.9 ± 7.9 to 9.0 ± 7.6, and from 17.7 ± 7.3 to 11.2 ± 7.9, respectively, P = 0.0001), but there was no statistically significant difference between the FSSG scores in group I and those in group P.Subgroup analysis showed that significant improvements in the FSSG scores occurred in the patients in group I who had NERD grade N(modified Los Angeles classification)(7.8 ± 7.4 vs 12.5 ± 9.8, P = 0.041).The SF-36 scores for patients with NERD grade N who had received IM and rabeprazole were significantly improved in relation to their vitality and mental health scores.CONCLUSION:The addition of IM to rabeprazole significantly improves gastroesophageal reflux diseasesymptoms and the quality of the lives of patients with NERD grade N. | Takayoshi Suzuki Masashi Matsushima Aya Masui Shingo Tsuda Jin Imai Jun Nakamura Yoko Tsukune Tetsufumi Uchida Hiroki Yuhara Muneki Igarashi Jun Koike Tetsuya Mine | 2015 | World Journal of Gastroenterology2015，21，16： | 8 |
| 11 | Fire-needle acupuncture for upper limb spastic paralysis after stroke:Study protocol for a randomized controlled trial显示文摘Background: Fire-needle acupuncture, an important kind of acupuncture therapy, has been clinically used to treat upper limb spastic paralysis(ULSP) after stroke. Clinical experience has indicated that fire-needle acupuncture treatment takes less time, requires fewer visits, and has more rapid results and fewer side effects compared to chemical medicine alternatives. This study will evaluate the effects of fire-needle acupuncture for ULSP in the context of standardized clinical research and provide high-quality data to inform clinical procedures and future study design.Methods/Design: A randomized controlled trial will be carried out to evaluate the effects of fire-needle acupuncture therapy in patients with ULSP from stroke. ULSP patients(n = 120) will be recruited at Changhai Hospital in Shanghai, China. Patients will be randomly divided into three groups, including fire-needle acupuncture group(FAG), filiform-needle acupuncture group(FFAG) and rehabilitation treatment group(RTG). During the 3-week treatment, the FAG will be treated every two days, while FFAG and RTG will be treated 5 d in a row and then rest for 2 d. The Simplified Fugl-Meyer Motor Function Scale and Modified Ashworth Scale will be used as the primary outcome measures. Statistical analysis will be conducted by an independent statistician.Discussion: Through this study, the utility of fire-needle acupuncture in treating ULSP after stroke will be tested, and some specific claims of fire-needle acupuncture therapy will be evaluated, such as relieving spasm and muscular tension, improving activities of daily living, rapidity of response and less frequency of treatment compared with other treatments. | Xin-yu Yue Zhuo-qi Feng Xi-yi Yu Jia-min Hu Xiao-Jing He Shi Shu | 2019 | Journal of Integrative Medicine2019，17，3： | 8 |
| 12 | Post-marketing Re-evaluation of Tongxiening Granules (痛泻宁颗粒) in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome:A Multi-center,Randomized,Double-Blind,Double-Dummy and Positive Control Trial显示文摘Objective: To evaluate the efficacy and safety of Tongxiening Granules(痛泻宁颗粒, TXNG) in the treatment of irritable bowel syndrome with predominant diarrhea(IBS-D). Methods: A randomized, double-blind, double-dummy, and positive paral el control ed clinical trial was conducted from October 2014 to March 2016. Total y 342 patients from 13 clinical centers were enrolled and randomly assigned(at the ratio of 1:1) to a treatment group(171 cases) and a control group(171 cases) by a random coding table. The patients in the treatment group were administered oral y with TXNG(5 g per time) combined with pinaverium bromide Tablet simulator(50 mg per time), 3 times per day. The patients in the control group were given TXNG simulator(5 g per time) combined with pinaverium bromide Tablets(50 mg per time), 3 times per day. The treatment course lasted for 6 weeks. The improvement of Irritable Bowel Syndrome Symptom Severity Score(IBS-SSS) was used to evaluate the primary outcome. Secondary outcomes included adequate relief(AR) rate, Irritable Bowel Syndrome-Quality of Life Questionnaire(IBS-QOL), Hamilton Anxiety Scale(HAMA), Hamilton Depression Scale(HAMD), and the recurrence rate at fol ow-ups. Safety indices including the adverse events(AEs) and related laboratory tests were evaluated. Results: Primary outcome: IBS-SSS at baseline, weeks 2, 4, 6 showed no statistical significance in both full analysis set(FAS) and per protocol set(PPS, P>0.05). After 6 weeks of treatment, the total effective rate of IBS-SSS scores in the treatment group(147/171, 86.0%) was higher than the control group(143/171, 83.6%) by FAS(P>0.05). In regard to secondary outcomes, after 6-week treatment, there was no significant difference in AR rate, total score of IBS-QOL, improvement of HAMD and HAMA total scores between the two groups(P>0.05). The recurrence rate at 8-week fol ow-up was 12.35%(10/18) in treatment group and 15.79%(12/76) in control group, respectivery(P>0.05). A total of 21 AEs occurred in 15 cases, of which 11 occurred in 8 cases in the treatment group and 10 AEs in 7 cases in the control group. The incidence of AEs had no statistical significance between the two goups(P>0.05). Conclusion: Tongxiening Granules could relieve the symptoms of patients with IBS-D and the treatment effect was comparable to pinaverium bromide.(No. ChiCTR-IPR-15006415) | TANG Xu-dong ZHANG Sheng-sheng HOU Xiao-hua LI Zhen-hua CHEN Su-ning FENG Pei-min YANG Xiao-nan LI Hui-zhen WU Jie-qiong XIA Pei-jun YANG Xiao-jun ZHOU Heng-jun WANG Hai-yan AI Yao-wei LI Kang | 2019 | Chinese Journal of Integrative Medicine2019，25，12： | 7 |
| 13 | Anisodamine accelerates spontaneous passage of single symptomatic bile duct stones ≤ 10 mm显示文摘AIM:To investigate the rate of spontaneous passage of single and symptomatic common bile duct(CBD)stones≤10 mm in diameter in 4 wk with or without a2-wk course of anisodamine.METHODS:A multicenter,randomized,placebocontrolled trial was undertaken.A total of 197 patients who met the inclusion criteria were enrolled.Ninetyseven patients were assigned randomly to the control group and the other 100 to the anisodamine group.The anisodamine group received intravenous infusions of anisodamine(10 mg every 8 h)for 2 wk.The control group received the same volume of 0.9%isotonic saline for 2 wk.Patients underwent imaging studies and liver-function tests every week for 4 wk.The rate of spontaneous passage of CBD stones was analyzed.RESULTS:The rate of spontaneous passage of CBD stones was significantly higher in the anisodamine group than that in the control group(47.0%vs 22.7%).Most(87.2%,41/47)stone passages in the anisodamine group occurred in the first 2 wk,and passages in the control group occurred at a comparable rate each week.Factors significantly increasing the possibility of spontaneous passage by univariate logistic regression analyses were stone diameter(<5 mm vs≥5 mm and≤10 mm)and anisodamine therapy.Multivariate logistic regression analyses revealed that these two factors were significantly associated with spontaneous passage.CONCLUSION:Two weeks of anisodamine administration can safely accelerate spontaneous passage of single and symptomatic CBD stones≤10 mm in diameter,especially for stones<5 mm. | Jun Gao Xue-Mei Ding Shan Ke Yi-Ming Zhou Xiao-Jun Qian Rui-Liang Ma Chun-Min Ning Zong-Hai Xin Wen-Bing Sun | 2013 | World Journal of Gastroenterology2013，19，39： | 7 |
| 14 | Effect of Xinfeng capsule in the treatment of active rheumatoid arthritis: a randomized controlled trial显示文摘OBJECTIVE: To explore the use of Xinfeng capsule(XFC) in the treatment of active rheumatoid arthritis(RA) and its effect on immunoglobulin titer, B cell-activating factor(BAFF) and its receptor(BAFF-R).METHODS: A multi-center randomized, doubleblind, parallel-controlled study was conducted. 45 RA patients were assigned to two groups: one was treated with XFC plus the placebo for leflunomide(LEF) and the second group was treated with LEF plus XFC placebo, for 12 weeks. The clinical and laboratory parameters were collected at baseline and at 12 weeks.RESULTS: After 12 weeks of treatment, patients in the two groups all showed an therapeutic effect when ACR20, ACR50 and ACR70 were compared,but the differences between two groups were not significant(P < 0.05). The serum levels of Ig G1,BAFF and BAFF-R in the XFC group were lower than those in the LEF group(P < 0.05). The level Ig G subtypes correlated with clinical parameters; Ig G2 levels positively correlated with C-reactive protein(CRP)(P < 0.01); Ig G3 levels positively correlated with white blood cell count and CRP(P < 0.01);Ig G4 levels positively correlated with Complement4( C4)(P < 0.01); the level of BAFF negatively correlated with Lymphocyte( LYMPH#)(P < 0.01); however,BAFF-Rpositivelycorrelatedwith Platelet( PLT)and a1-acid glycoprotein(AGP)(P < 0.01).CONCLUSION: XFC can regulate the level of BAFF/BAFF-R in active rheumatoid arthritis and improve the levels of immunoglobulins in RA patients. | Wang Yali Liu Jian Wang Yuan Sun Yue | 2015 | Journal of Traditional Chinese Medicine2015，35，6： | 7 |
| 15 | Effect and Safety of CX-DZ-ⅡIntelligent Electroacupuncture Therapeutic Instrument for Neck Pain Caused by Cervical Spondylos:Study Protocol for A Randomized Controlled Trial显示文摘Background: Neck pain caused by cervical spondylosis(CS) is a chronic pain condition, with an increasingly high incidence in the general population. Electroacupuncture is a common analgesic modality that has been widely applied in neck pain treatment. However, current electroacupuncture instruments used in the clinic have low intelligence levels and obscure parameter standards. We here designed this study for assessing the effect and safety of a new, intelligent electroacupuncture instrument, the CX-DZ-Ⅱ, in treating neck pain. Methods: The present study is a prospective, two-center, randomized, controlled, open-label, non-inferiority trial for CX-DZ-Ⅱ on treating neck pain caused by CS. Totally 160 eligible patients will be included in this trial and randomly assigned to an experimental group and a control group in a 1:1 ratio. A semi-standard acupoint selection strategy will be employed. In the experimental group, selected acupoints will be stimulated by CX-DZ-Ⅱ. Electroacupuncture treatment will be accomplished by a pre-existing electroacupuncture instrument in the control group. The duration of treatment will be 2 weeks. The primary outcome is the change of Visual Analog Scale(VAS) score after one course of treatment. The secondary outcomes include the VAS scores after each treatment, the responder rate, drug-usage rate of non-steroidal antipyretic analgesics, the rate of adverse events occurrence, and the performance of instrument. Discussion: This study will evaluate the effect and safety of the CX-DZ-Ⅱ intelligent electroacupuncture therapeutic instrument in comparison with a pre-existing non-intelligent instrument in the treatment of neck pain caused by CS. The results will hopefully demonstrate a more optimal electroacupuncture instrument for the treatment of neck pain.(Trial registration No. gov NCT03005301). | CHEN Zhi-han LIANG Fan-rong YANG Ming-xiao LI De-hua ZHANG Ya REN Yu-lan | 2020 | Chinese Journal of Integrative Medicine2020，26，5： | 6 |
| 16 | Effect of cream, prepared with Tripterygium wilfordii Hook F and other four medicinals, on joint pain and swelling in patients with rheumatoid arthritis: a double-blinded, randomized, placebo controlled clinical trial显示文摘OBJECTIVE: To investigate the effectiveness a cream onjoint pain and swelling in patients with rheumatoid arthritis(RA). The cream, topically used, in was prepared with Tripterygium wilfordii Hook F(TwHF), Mangxiao(Nalrii Sulfas), Chuanxiong(Rhizoma Chuanxiong), stir-frying with liquid adjuvant Ruxiang(Olibanum), and stir-frying with liquid adjuvant Moyao(Myrrh).METHODS: Patients were 1∶1 randomized to addon TwHF cream twice a day or placebo for 4 weeks.The primary endpoint was achievement rate of20% improvement in American College of Rheuma-tology criteria(ACR20) at week 4. Secondary endpoints were ACR50, 28-joint count Disease Activity Score(DAS28) improvement and safety profiles.Statistical analyses were performed using intention to treat analysis(ITT) set.RESULTS: A total of 70 active RA patients were enrolled. At week 4, the ACR20 was 34.3%(12/35) in TwHF cream group and 11.4%(4/35) in placebo group(P = 0.015). Similarly, a higher ACR50 responder proportion was seen in TwHF cream group with 17.1%(6/35) comparing to it in placebo group with 2.9%(1/35)(P = 0.046). The TwHF cream group also had more improvement than the placebo group on DAS28-ESR(1.1 vs 0.5, P = 0.001), DAS28-CRP(1.4 vs 0.7, P = 0.001), tender joint count(5.5 vs2.6, P = 0.018), swollen joint count(3.5 vs 1.6, P =0.003) and Physician's global assessment(25.8 vs13.0, P = 0.002), as well as C-reactive protein(11.2 vs 2.7, P = 0.048). Except 2 skin allergy events in TwHF cream group, no other substantive adverse events were observed.CONCLUSION: On the short term, TwHF cream is likely to be an effective and safety complimentary treatment in patients with active RA. | Jiao Juan Wei Chengchung Tang Xiaopo Gong Xun Yin Haibo Jiang Quan | 2019 | Journal of Traditional Chinese Medicine2019，39，1： | 6 |
| 17 | Efficacy and safety of Aloe vera syrup for the treatment of gastroesophageal reflux disease: a pilot randomized positive-controlled trial显示文摘OBJECTIVE: To investigate the use of Aloe vera(A.vera) for the treatment of gastroesophageal reflux disease(GERD) symptoms and compare its effects with those of omeprazole and ranitidine.METHODS: In this pilot, randomized controlled trial, 79 subjects were allocated to A. vera syrup(standardized to 5.0 mg polysaccharide per m L of syrup)at a dose of 10 m L/d, omeprazole capsule(20 g/d)or ranitidine tablet(150 mg in a fasted state in the morning and 150 mg 30 min before sleep at night)for a period of 4 weeks. The frequencies of eight main symptoms of GERD(heartburn, food regurgitation, flatulence, belching, dysphagia, nausea,vomiting and acid regurgitation) were assessed at weeks 2 and 4 of the trial.RESULTS: A. vera was safe and well tolerated and reduced the frequencies of all the assessed GERD symptoms, with no adverse events requiring withdrawal.CONCLUSION: A. vera may provide a safe and effective treatment for reducing the symptoms of GERD. | Yunes Panahi Hossein Khedmat Ghasem Valizadegan Reza Mohtashami Amirhossein Sahebkar | 2015 | Journal of Traditional Chinese Medicine2015，35，6： | 5 |
| 18 | Present laparoscopic surgery for colorectal cancer in Japan显示文摘In many clinical studies,laparoscopic surgery(LS) for colon cancer has been shown to be less invasive than open surgery(OS) while maintaining similar safety.Furthermore,there are no significant differences between LS and OS in long-term outcomes.Thus,LS has been accepted as one of the standard treatments for colon cancer.In the treatments of rectal cancer as well,LS has achieved favorable outcomes,with many reports showing long-term outcomes comparable to those of OS.Furthermore,the magnification in laparoscopy improves visualization in the pelvic cavity and facilitates precise manipulation,as well as providing excellent educational effects.For these reasons,rectal cancer has seemed to be well indicated for LS,as has been colon cancer.The indication for LS in the treatment of locally advanced rectal cancer,which is relatively unresectable(e.g.,cancer invading other organs),remains an open issue.In recent years,new techniques such as singleport and robotic surgery have begun to be introduced for LS.Presently,various clinical studies in our country as well as in most Western countries have demonstrated that LS,with these new techniques,are gradually showing long-term outcomes. | Takeo Sato Masahiko Watanabe | 2016 | World Journal of Clinical Oncology2016，7，2： | 5 |
| 19 | Effect of direct current pulse stimulating acupoints of JiaJi (T10-L3) and Ciliao (BL 32) with Han's Acupoint Nerve Stimulator on labour pain in women: a randomized controlled clinical study显示文摘OBJECTIVE: To assess the clinical effect and safety of direct current(DC) pulse produced by Han's Acupoint Nerve Stimulator in reduction(HANS) of labor pain.METHODS: Totally 120 participants were enrolled in this clinical trial, and were randomly divided into4 groups including: HANS group, patient controlled intravenous analgesia(PCIA) group, patient-controlled epidural analgesia(PCEA) group and control group. The HANS group was treated by stimulating the acupoints of Jia Ji(T10-L3) and Ciliao(BL 32)with DC pulse of 100 Hz and 15-30 m A produced by a portable battery-powered Han's Acupoint Nerve Stimulator for 30 min. The PCIA group was intravenously infused Ondansetron(8 mg) for 5 min,then tramadol injection(1.5 mg/kg) was slowly dripped by using Baxter APⅡ electronic pump with50 m L tramadol(0.70%) + ondansetron(8 mg),background infusion 2 m L/h, PCA dose of 2 m L,lockout interval of 10 min. In PCEA group, women received intrathecal injection ropivacaine(3 mg) in L2-3, and epidural catheter was connected to Baxter APⅡ electronic pump, with 100 m L Ropivacaine(0.1%) and Sufentanil(50 ug), background infusion5 m L, Patient controlled analgesia(PCA) dose of 5m L, lockout interval of 10 min. The control group was not received analgesia. The visual analogue scale(VAS), stage and manner of labor, Apgar score of newborn, neonatal weights, oxytocin dosage,postpartum hemorrhage and side effects were monitored in all groups.RESULTS: The vital signs were all stable in the four analgesic groups. After analgesia, there was statistical difference in VAS score between HANS group and control group, between PCEA group and the control group, between PCIA group and control group. The analgesic effect in the PCEA group was significantly better than that of other two groups.The second stage of labor in the PCEA group was longer than the other three groups, showing significant difference between them. The Apgar score of newborn 1min after birth in the PCIA group was slightly lower than that of the other two groups,showing significant difference between them. The neonatal weights between four groups were not significantly different. The rate of cesarean sectionin the control group was significantly higher than that of the labor analgesia group, there was statistically difference in four groups. The number of PCIA group that used oxytocin was lower than that of other three groups. There was no significant difference in postpartum hemorrhage between four groups. The side effects of the PCEA group were itching, uroschesis and neonatal asphyxia and PCIA group were nausea and vomiting and neonatal asphyxia. However, fewer side effects were observed in the HANS group.CONCLUSION: The DC pulse produced by HANS may be a non-pharmacological alternative to labor pain with fewer side effects. | Liu Ye Xu Mingjun Che Xiangming He Junqin Guo Dandan Zhao Guosheng Zhang Guogang Zhang Shuo Kang Kai Zhang Chunlei Wang Yinan Li Shan Zhang Qinglin Xu Li Zhang Ming Han Bin Jing Yumiao Zhang Ning | 2015 | Journal of Traditional Chinese Medicine2015，35，6： | 4 |
| 20 | Stochastic resonance whole body vibration reduces musculoskeletal pain:A randomized controlled trial显示文摘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. | Achim Elfering Jan Thomann Volker Schade Lorenz Radlinger | 2011 | World Journal of Orthopedics2011，2，12： | 4 |
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