Clinical study on the treatment of acute pancreatitis with external application of Yi-Dan Therapy based on the method of“stagnation requiring dispersion”:study protocol for a randomized controlled trial

Background:Acute pancreatitis is an unpredictable and potentially lethal disease,causing tremendous pain in patients.The initial treatment of acute pancreatitis in modern medicine is supportive,but it is generally ineffective in relieving abdominal pain and distension.Traditional Chinese medicine has been shown to be more effective in regulating the body’s homeostasis and reducing the clinical symptoms of pancreatitis.Yi-Dan ointment,derived from Dahuang-Mudan Decoction,is an effective external ointment for treating acute pancreatitis.The aim of this trial is to investigate the clinical efficacy of Yi-Dan ointment,providing a valuable complement to existing treatment options for pancreatitis.Methods:This is a randomized controlled clinical trial with two parallel groups.Patients in the control group were given basic treatment and nursing for 7 days;in the treatment group,Yi-Dan ointment was applied externally in addition to basic treatment and nursing.The main indicator is the overall efficacy,serum amylase,acute physiology and chronic health evaluationⅡscore,symptom score,inflammatory markers,and classification of computed tomography.Conclusion:The trial results will provide high-quality evidence for Yi-Dan ointment,and provide a complement to existing treatment options for pancreatitis.

External use of mirabilite to prevent post-endoscopic retrograde cholangiopancreatography pancreatitis in children:A multicenter randomized controlled trial

BACKGROUND Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography(ERCP).Currently,there is no suitable treatment for post-ERCP pancreatitis(PEP)prophylaxis.Few studies have prospectively evaluated interventions to prevent PEP in children.AIM To assess the efficacy and safety of the external use of mirabilite to prevent PEP in children.METHODS This multicenter,randomized controlled clinical trial enrolled patients with chronic pancreatitis scheduled for ERCP according to eligibility criteria.Patients were randomly divided into the external use of mirabilite group(external use of mirabilite in a bag on the projected abdominal area within 30 min before ERCP)and blank group.The primary outcome was the incidence of PEP.The secondary outcomes included the severity of PEP,abdominal pain scores,levels of serum inflammatory markers[tumor necrosis factor-alpha(TNF-α)and serum interleukin-10(IL-10)],and intestinal barrier function markers[diamine oxidase(DAO),D-lactic acid,and endotoxin].Additionally,the side effects of topical mirabilite were investigated.RESULTSA total of 234 patients were enrolled,including 117 in the external use of mirabilite group and theother 117 in the blank group.The pre-procedure and procedure-related factors were notsignificantly different between the two groups.The incidence of PEP in the external use ofmirabilite group was significantly lower than that in the blank group(7.7%vs 26.5%,P<0.001).The severity of PEP decreased in the mirabilite group(P=0.023).At 24 h after the procedure,thevisual analog scale score in the external use of mirabilite group was lower than that in the blankgroup(P=0.001).Compared with those in the blank group,the TNF-αexpressions weresignificantly lower and the IL-10 expressions were significantly higher at 24 h after the procedurein the external use of mirabilite group(P=0.032 and P=0.011,respectively).There were nosignificant differences in serum DAO,D-lactic acid,and endotoxin levels before and after ERCPbetween the two groups.No adverse effects of mirabilite were observed.CONCLUSIONExternal use of mirabilite reduced the PEP occurrence.It significantly alleviated post-proceduralpain and reduced inflammatory response.Our results favor the external use of mirabilite toprevent PEP in children.

Ulinastatin in the treatment of severe acute pancreatitis:A singlecenter randomized controlled trial

BACKGROUND Severe acute pancreatitis(AP)is one of the most common diseases of the gastrointestinal tract and carries a significant financial burden with high disability and mortality.There are no effective drugs in the clinical management of severe AP,and there is an absence of evidence-based medicine concerning the treatment of severe AP.AIM To explore whether ulinastatin(UTI)can improve the outcome of severe AP.METHODS The present research included patients who were hospitalized in intensive critical care units(ICUs)after being diagnosed with severe AP.Patients received UTI(400000 IU)or placebos utilizing computer-based random sequencing(in a 1:1 ratio).The primary outcome measures were 7-d mortality,clinical efficacy,inflammatory response,coagulation function,infection,liver function,renal function,and drug-related adverse effects were evaluated.RESULTS A total of 181 individuals were classified into two groups,namely,the placebo group(n=90)and the UTI group(n=91).There were no statistically significant differences in baseline clinical data between the two groups.The 7-d mortality and clinical efficacy in the UTI group were remarkably improved compared with those in the placebo group.UTI can protect against hyperinflammation and improve coagulation dysfunction,infection,liver function,and renal function.UTI patients had markedly decreased hospital stays and hospitalization expenditures compared with the placebo group.CONCLUSION The findings from the present research indicated that UTI can improve the clinical outcomes of patients with severe AP and has fewer adverse reactions.

What we have learned from randomized trials of prostate cancer screening

The introduction of prostate-specific antigen （PSA） for prostate cancer screening in the late 1980s led to an epidemic of prostate cancer, particularly in developed countries. However, the first valid reports from randomized controlled trials on the efficacy of screening were not published until 2009. Men in the screening group in the European Randomized Study of Screening for Prostate Cancer were 20% less likely than those in the control group to die from prostate cancer. The absolute difference was only 0.7/1000, implying that over 1400 men needed to be screened to prevent one prostate cancer death. Screening was also associated with a 70% increased risk for being diagnosed with prostate cancer. The American Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial found no survival benefit for screening. Results were not conclusive because a substantial proportion of study subjects had previously undergone PSA testing, over half of the control group had PSA testing, follow-up was relatively short, and fewer than 100 subjects died from prostate cancer. Balancing the potential survival benefit from screening is the risk of overdiagnosis--finding cancers that would not otherwise cause clinical problems^and the risk of treatment complications, including urinary, sexual and bowel dysfunction. Prostate cancer screening efforts would benefit from improved biomarkers, which more readily identify clinically important cancers. Cancer control efforts might also need to include chemoprevention, though currently available agents are controversial. In the meantime, oatients need to be supoorted in achievine informed decisions on whether to be screened for orostate cancer.

S-1 in the treatment of pancreatic cancer

S-1 is an oral 5-fluorouracil(5-FU) prodrug,which is designed to improve the antitumor activity of 5-FU by inhibiting dihydropyrimidine dehydrogenase,the key enzyme of 5-FU catabolism.Recently,two important studies on the clinical use of S-1 for pancreatic cancer have been reported from Japan.In the first study(GEST study),S-1 demonstrated non-inferiority to gemcitabine(GEM) in overall survival(OS) for metastatic or locally advanced pancreatic cancer,but combination chemotherapy with GEM and S-1 did not show superiority to GEM in OS.In the second study(JASPAC-01 study),S-1 showed superiority to adjuvant chemotherapy with GEM in OS in patients with resected pancreatic cancer.In addition to GEM,S-1 is now regarded as the key drug in the management of pancreatic cancer in Japan.To date,many studies have investigated the effectiveness of S-1 in various settings,such as first-line chemotherapy for metastatic or locally advanced pancreatic cancer,second-line chemotherapy after GEM failure,and chemoradiotherapy for locally advanced disease.In this review,we focus on recent clinical trials of S-1-based chemotherapy for advanced pancreatic cancer.

Neoadjuvant therapy for resectable pancreatic cancer

The use of neoadjuvant therapies has played a major role for borderline resectable and locally advanced pancreatic cancers(PCs). For this group of patients, preoperative chemotherapy or chemoradiation has increased the likelihood of surgery with negative resection margins and overall survival. On the other hand, for patients with resectable PC, the main rationale for neoadjuvant therapy is that the overall survival with current strategies is unsatisfactory. There is a consensus that we need new treatments to improve the overall survival and quality of life of patients with PC. However, without strong scientific evidence supporting the theoretical advantages of neoadjuvant therapies, these potential benefits might turn out not to be worth the risk of tumors progression while waiting for surgery. The focus of this paper is to provide the readers an overview of the most recent evidence on this subject.

Electroacupuncture for abdominal pain relief in patients with acute pancreatitis:A three-arm randomized controlled trial

Background: Electroacupuncture(EA) may reduce the severity of acute pancreatitis(AP) and provide additional pain relief in patients with chronic pancreatitis. However, the ability of EA to relieve pain in patients with AP has not been well documented.Objective: This study was undertaken to compare the pain-relieving effects of EA and conventional treatment in patients with AP.Design, setting, participants and interventions: This study was conducted using a randomized, controlled,three-arm, parallel-group and multi-center design. Patients diagnosed with AP were randomly and equally assigned to EA1, EA2 or control groups. All participants received conventional standard-of-care therapy for AP. Local EA alone was administered in EA1, and local plus distal EA was given in EA2.Local EA included two abdominal acupoints, while distal EA included twelve peripheral acupoints. EA groups underwent one session of EA daily for 4 days(days 1–4), or until pain was resolved or discharged.Main outcome measures: The primary outcome measure was the change in the visual analogue scale(VAS;0–100) pain score between baseline and day 5.Results: Eighty-nine participants were randomized into EA1, EA2 and control groups, and 88(EA1, 30;EA2, 29;control, 29) were included in the full-analysis set. VAS score change(median [interquartile range]) on day 5 was(12.3 ± 22.5) in the EA1 group,(10.3 ± 21.5) in the EA2 group, and(8.9 ± 15.2) in the control group. There were not significant differences in the change in VAS score among treatments(P = 0.983). However, time to food intake was significantly shorter in the EA group(EA1 + EA2) than in the control group(median 2.0 days vs 3.0 days), with a hazard ratio of 0.581(P = 0.022;95% CI,0.366–0.924). No significant adverse events occurred.Conclusion: EA treatment did not significantly reduce pain after 4 days of treatment in patients with AP-associated abdominal pain but significantly reduced time to first food intake.

Oxaliplatin plus irinotecan vs irinotecan as second-line treatment in pancreatic cancer patients:a randomized–controlled open-label Phase II study

Background:Limited second-line therapeutic options are available for metastasis pancreatic cancer(mPC).We aimed to explore the efficacy and safety of oxaliplatin plus irinotecan(IROX)in mPC patients.Methods:This is an open-label,Phase 2,randomized study of mPC patients(aged 18–75 years)who failed when using gemcitabine plus S-1 as first-line therapy.Block randomization with a block size of four was used to randomly assign patients(1:1)between October 2015 and December 2017 to receive either IROX(oxaliplatin 85mg/m2 and irinotecan 160mg/m2)or irinotecan monotherapy(irinotecan 180mg/m^(2))until disease progression,unacceptable adverse events,or consent withdrawal.The primary end point was overall survival,and the secondary end points were progression-free survival,overall response rate,and adverse event rate.Results:A total of 74 patients were enrolled in this study,including 44 males and 30 females,with an average age of 61 years.The median overall survival was 10.2 and 6.7 months(adjusted hazard ratio[HR],0.7;95%confidence interval[CI],0.4–1.2;P=0.20)and the median progression-free survival was 5.1 and 2.3 months(adjusted HR,0.4;95%CI,0.2–0.6;P<0.01)in the IROX group and irinotecan group,respectively.The overall response rates were 18.4%(7/38)in the IROX group and 5.5%(2/36)in the irinotecan group(P=0.06).Grade 3–4 adverse events occurred in 34%(13/38)of patients in the IROX group and 19%(7/36)of patients in the irinotecan group(P=0.15).Conclusions:IROX had no significant survival benefit over irinotecan monotherapy in our study.However,IROX reduced the risk of disease progression by 60%,with acceptable toxicity.

Effect of electrically stimulating acupoint, Zusanli(ST 36), on patient’s recovery after laparoscopic colorectal cancer resection: a randomized controlled trial

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.

Efficacy and safety of Yiqi Huoxue Jiedu decoction for the treatment of advanced epithelial ovarian cancer patients: a double-blind randomized controlled clinical trial

OBJECTIVE:To further evaluate the complementary effect of Yiqi Huoxue Jiedu decoction(YHJD)on patients with advanced epithelial ovarian cancer(EOC).METHODS:All 330 enrolled participants diagnosed with stageⅢc EOC were randomly divided into two groups that received YHJD or a placebo.The primary end point was health-related quality of life(HRQL)measured by the functional assessment of cancer therapy-ovary cancer(FACT-O)questionnaire.The secondary end point was progression-free survival(PFS).RESULTS:A total of 299 participants completed the trial with 153 and 146 in YHJD and control groups,respectively.After 6 months of treatment,YHJD increased physical wellbeing(PWB),functional wellbeing(FWB),additional concerns(AC),and the trial outcome index(TOI)(P<0.05)by various degrees compared with the baseline.YHJD also had notable advantages over the placebo at 3 and 6 months in terms of PWB,FWB,AC(P<0.05),and TOI(P<0.01).In addition,YHJD had a significant advantage in terms of PFS compared with the placebo(21 vs18 months,P<0.05).No adverse events were reported.CONCLUSION:YHJD is an effective and safe choice as a complementary therapy to improve HRQL and prolong PFS of stageⅢc EOC patients.

Zhengyuan capsule(正元胶囊)for the treatment of cancer-related fatigue in lung cancer patients undergoing operation:a study protocol for a randomized controlled trial

OBJECTIVE: To evaluate the efficacy and safety of Zhengyuan capsule(正元胶囊) when treating Cancer-related fatigue(CRF) in lung cancer patients undergoing surgical operation.METHODS/DESIGN: This is a single-center, double-blinded, prospective, and randomized controlled trial in the Department of Integrated Chinese and Western Medicine, Shanghai Chest Hospital Shanghai Jiao Tong University, Shanghai. Eligible participants will be randomly allocated into two groups: a treatment group receiving an 8-week Zhengyuan capsule regimen therapy and a control group receiving an 8-week placebo capsule regimen therapy. Evaluation will be carried out at four timelines: the participants' screening period, baseline period, the middle of the intervention period,and the end of the intervention period. The primary outcome assessment is fatigue scoring using the Cancer Fatigue Scale(CFS) measurement system.Secondary measurements include fatigue severity assessment using the Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF) measurement system, Traditional Chinese Medicine syndrome pattern differentiation, levels of immunologic indicators(TNF-α, IL-6, IL-1, T lymphocytes subsets and B lymphocyte subsets), patient's pulmonary function, performance status scale(PS),self-rating scale of sleep(SRSS), and adverse events(AEs).DISCUSSION: The trial results can provide efficacy and safety data of Zhengyuan capsule when treating CRF in clinic. The data can also be imported into the management and treatment guidelines for CRF in lung cancer patients undergoing operation throughout China.

Effect of Aidi injection plus chemotherapy on gastric carcinoma:a Meta-analysis of randomized controlled trials

OBJECTIVE: To conduct a Meta-analysis of studies on the effect of Aidi injectioncombined with chemotherapy versus chemotherapy alone in the treatment of gastric cancer(GC).METHODS: Nine electronic databases and six gray literature databases were comprehensively searcheduntil April 20,2013. Two reviewers independently selected and assessed included trialsaccording to the inclusion and exclusion criteria. The risk of bias tool from the Cochrane Handbook version 5.1.0was used to assess trial quality. All calculations were performed using Review Manager 5.0.RESULTS: Thirty-two studies including 1927 participants met the inclusion criteria,most of which were low quality. Compared with chemotherapy alone,Aidi injection plusthe same chemotherapy significantly improved the effective rate [OR = 1.52,95% CI(1.24,1.86),P < 0.0001],clinical beneficial rate [OR = 1.77,95% CI(1.33,2.36),P < 0.0001],and quality of life [OR = 3.02,95% CI(2.39,3.82),P <0.000 01]. There was a significant improvement in nausea and vomiting incidence [OR = 0.34,95%CI(0.24,0.47),P < 0.000 01],diarrhea [OR = 0.47,95%CI(0.33,0.69),P < 0.000 01],leukopenia( 3,0.51),P = 0.05],hemⅢ-ogⅣ)[OR = 0.34,95%CI(0.2lobin decrease(thromⅢ-boⅣ) [OR = 0.42,95%CI(0.18-1.00),P = 0.05],cytopenia(4],and Ⅲ-damⅣ) [OR = 0.46,95%CI(0.22,0.96),P = 0.0age to liver function [OR = 0.36,95%CI(0.24,0.54),P < 0.000 01].CONCLUSION: Aidi injection combined with chemotherapy significantly improved the clinical effect of chemotherapy,reducing the incidence of adverse events. Use of the CONSORT statement for randomized controlled trials is recommended for stricter reporting.

有氧运动改善化疗期间乳腺癌患者体质及生活质量研究:一项随机对照试验

背景蒽环类药物是乳腺癌基础化疗药物之一,但化疗常伴随着体质改变如体脂增加和心肺功能下降,胃肠道反应和骨髓抑制等毒副作用,影响患者的生活质量。目前关于运动改善以上毒副作用的研究结果不一致,有待进一步研究。临床上,应用运动处方改善乳腺癌患者以上化疗毒副作用的效果和安全性需要进一步探究。目的探究有氧运动改善蒽环类药物化疗期间乳腺癌患者体质和生活质量的效果及有氧运动的安全性。方法本研究是一项随机对照试验,纳入2022年3月—2023年1月在北京市朝阳区三环肿瘤医院接受蒽环类药物化疗方案的44例成年女性乳腺癌患者为研究对象,随机分为运动组(23例)与对照组(21例),对照组患者在化疗结束后提供个性化运动指导。运动组患者在化疗住院期间在康复师监督下进行锻炼,在家时通过患者自我监督和试验人员远程监督进行个性化运动干预。在化疗前后收集主要结局指标,包括体质和生活质量,记录胃肠道反应、骨髓抑制的发生次数、严重程度及运动相关不良事件。以化疗前数据为协变量,采用协方差分析比较两组体质情况和生活质量情况。结果本研究干预、随访过程中共流失4例,最终纳入40例患者(运动组21例,对照组19例)。运动干预期间未观察到严重不良事件。运动干预期间,患者平均依从性为81.8%;每次运动时长的平均依从性为91.9%;运动强度平均依从性为92.5%。化疗后,运动组体脂重、体脂百分比、内脏脂肪面积、腰围、腰臀比低于对照组,惯用手握力、相对峰值摄氧量(VO_(2)peak)高于对照组(P<0.05)。化疗后运动组患者功能性障碍发生率(7/20)低于对照组(12/16)(χ^(2)=5.707,P=0.017)。化疗后运动组生理状况、情感状况、附加得分低于对照组,功能状况得分高于对照组(P<0.05)。化疗后对照组生理状况分数(P<0.001)、运动组功能状况分数(P=0.017)高于化疗前。对照组和运动组患者分别共接受了84例次和94例次蒽环类药物化疗,对照组分别发生了84例次胃肠道反应和71次骨髓抑制,运动组分别发生了54例次胃肠道反应和45例次骨髓抑制,两组患者胃肠道反应和骨髓抑制发生情况比较,差异有统计学意义(P<0.05)。结论在蒽环类药物化疗期间进行有氧运动可以改善乳腺癌患者的体质和生活质量,且有监督的有氧运动是安全的。

3D-CRT中采用二程计划对局部晚期食管癌患者V20及放射性肺炎的影响

目的探讨局部晚期食管癌适形放疗中采用二程计划对V20(肺接受>20 Gy照射的体积占全肺体积百分比)和放射性肺炎(radioactive pneumonia,RP)的影响。方法 40例局部晚期食管癌患者,随机分为一次计划放疗组20例(A组)和二程计划放疗组20例(B组),所有患者均接受三维适形放疗,诱导化疗前行首次CT定位,A组制定全程适形计划,给予处方剂量66 Gy,B组放疗剂量达到46 Gy后,行第2次CT定位,将2次CT图像融合,制定后程适形计划,给予处方剂量20 Gy,总处方剂量66 Gy。计算并比较两组放疗计划中V20、放疗结束3月内RP发生情况。结果 40例患者中RP发生率为22.5%(9/40),其中A组7例(35.0%),B组2例(10.0%),二次定位双侧肺V20差异有统计学意义(P<0.05),双侧肺平均受照剂量差异无统计学意义(P>0.05)。结论在局部晚期食管癌适形放疗中,宜采用分程放疗,从而降低肺受量,降低放射性肺损伤的发生率。

食管癌首程放疗后局部复发患者应用3DCRT的疗效及放射性损伤

目的探讨食管癌首程放疗后局部复发患者应用三维适形放射治疗（3-dimensional conformal radiation therapy,3DCRT）的疗效及放射性损伤。方法选取50例食管癌首程放疗后局部复发患者,随机分为观察组和对照组,每组25例。给予观察组3DCRT治疗（50-64 Gy）,对照组常规再放疗治疗（运用60Co或10 Mv-X线对食管复发病灶三野行体外照射,达30 Gy后用后装治疗机行腔内治疗,总照射剂量40-60 Gy。）,比较两组患者的临床疗效、1-3年生存情况、不良反应及放射性损伤情况。结果观察组治疗的有效率高于对照组（76.0%vs 48.0%,P〈0.05）,恶化率低于对照组（4.0%vs 12.0%,P〈0.05）。观察组患者的1、2、3年生存率均明显比对照组高（68.0%、28.0%、16.0%vs 40.0%、16.0%、4.0%,P〈0.05）。观察组患者各项不良反应及放射性损伤的发生率均比对照组低（均P〈0.05）。结论食管癌首程放疗后局部复发患者应用3DCRT的疗效显著,且放射性损伤发生率低。

Clinical efficacy and safety evaluation of Buzhongyiqi pills(补中益气丸)on appetite improvement in patients with colorectal cancer receiving chemotherapy:a pilot randomized cross-over clinical trial

OBJECTIVE: To evaluate the clinical efficacy and safety of Buzhongyiqi pills(BZYQP, 补中益气丸) in improving the appetite of patients with colorectal cancer(CRC) receiving chemotherapy. TRIAL DESIGN: A pilot, randomized, single-blind crossover clinical trial was conducted on diagnosed stage II-IV CRC patients receiving chemotherapy. METHODS: Patients were randomly assigned to either the BZYQP-placebo or placebo-BZYQP groups. The BZYQP-placebo group received BZYQP for 1-2 d before the first cycle of chemotherapy and continued until the end of the third cycle. A 7-day washout followed, after which they received a placebo until the end of the sixth cycle. The placebo-BZYQP group followed the opposite treatment order. The oral dose of BZYQP and placebo was ten pills three times daily. A total of 12 visit points were scheduled in this study, with each visit point carried out before and after each of the six cycles of chemotherapy. The Simplified Nutrition Appetite Questionnaire(SNAQ), the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30, version 3.0), and the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE, V5.0) were used to evaluate patient appetite, quality of life, and drug safety. RESULTS: Totally 62 patients completed the study, and baseline characteristics were balanced between the BZYQP-placebo and placebo-BZYQP groups. The primary outcome, as assessed by SNAQ scores, demonstrates a statistically significant difference between the two groups during the first three cycles of chemotherapy, with the mean SNAQ score of the BZYQP-placebo group consistently higher than that of the placebo-BZYQP group from V1(P < 0.001). After the washout period, the SNAQ score of the BZYQP-placebo group decreased from V7, and the difference in SNAQ scores between the two groups gradually became more significant after the intersection at V9. Secondary outcomes showed that during the first three cycles of chemotherapy, the BZYQP-placebo group had significantly lower scores in physical, role, emotional, cognitive, and social functioning domains, as well as in fatigue, loss of appetite, and diarrhea symptoms, compared to the placebo-BZYQP group(P < 0.001). Scores for physical, role, emotional, cognitive, and social functioning in the BZYQP-placebo group remained lower(P < 0.05) at V11. The chemotherapy-induced adverse events(AEs) in the BZYQP-placebo group were significantly lower than those in the placebo-BZYQP group at V5, mainly in nausea and vomiting(9.1% vs 62.1%, P < 0.001), diarrhea(12.1% vs 44.8%, P = 0.004), and anemia(15.2% vs 41.4%, P = 0.021). No drugrelated events were reported in this study. CONCLUSION: BZYQP is feasible and safe to effectively improve the appetite of patients with CRC receiving chemotherapy and help them with better quality of life.

Is endoscopic papillary balloon dilatation really a risk factor for post-ERCP pancreatitis?

Endoscopic papillary balloon dilatation(EPBD) is useful for decreasing early complications of endoscopic retrograde cholangio-pancreatography(ERCP), including bleeding, biliary infection, and perforation, but it is generally avoided in Western countries because of a relatively high reported incidence of post-ERCP pancreatitis(PEP). However, as the efficacy of endoscopic papillary largeballoon dilatation(EPLBD) becomes widely recognized, EPBD is attracting attention. Here we investigate whether EPBD is truly a risk factor for PEP, and seek safer and more effective EPBD procedures by reviewing past studies. We reviewed thirteen randomised control trials comparing EPBD and endoscopic sphincterotomy(EST) and ten studies comparing direct EPLBD and EST. Three randomized controlled trials of EPBD showed significantly higher incidence of PEP than EST, but no study of EPLBD did. Careful analysis of these studies suggested that longer and higher-pressure inflation of balloons might decrease PEP incidence. The paradoxical result that EPBD with small-calibre balloons increases PEP incidence while EPLBD does not may be due to insufficient papillary dilatation in the former. Insufficient dilatation could cause the high incidence of PEP through the use of mechanical lithotripsy and stress on the papilla at the time of stone removal. Sufficient dilation of the papilla may be useful in preventing PEP.

Effect of precut sphincterotomy on post-endoscopic retrograde cholangiopancreatography pancreatitis:A systematic review and meta-analysis

AIM: To conduct a systemic review and meta-analysis to investigate the role of early precut technique. Multiple randomized controlled trails (RCTs) have reported conflicting results of the early precut sphincterotomy.

Effectiveness of nonsteroidal anti-inflammatory drugs in prevention of post-ERCP pancreatitis:A meta-analysis

AIM: To investigate the effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). METHODS: Two independent reviewers searched Pub Med (1966 to October 2013), Embase (1984 to October 2013) and the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 4, 2013) for relevant randomized controlled trials (RCTs) studying the effectiveness of prophylactic NSAID administration in the prevention of PEP. Using the Cochrane Collaboration Handbook, meta-analyses were conducted to evaluate the overall effect of NSAIDs in preventing the incidences of PEP and moderate to severe pancreatitis. RESULTS: Eight RCTs were identified from the literature search and included 1883 patients that underwent ERCP, with 971 patients in the NSAID group and 912 patients in the placebo group. Sixty-nine out of 971 (7.11%) patients developed PEP in the NSAID group in comparison to 143 out of 912 (15.68%) patients in the placebo group. The pooled RR of PEP incidence with prophylactic NSAID administration was 0.43 (95%CI: 0.33-0.56), which demonstrates that NSAID administration after ERCP significantly reduced the incidence of PEP when compared to the placebo group (P < 0.0001). Subgroup analysis was performed and revealed that the presence (NSAID group) or absence (placebo group) of NSAIDs had no significant effect on the development of moderate to severe pancreatitis (RR = 0.79, 95%CI: 0.52-1.18). Moreover, the administration of NSAIDs as a rectal suppository (RR = 0.35, 95%CI: 0.26-0.48; P < 0.0001) was more effective than oral administration (RR = 0.97, 95%CI: 0.53-1.80) or through infusion (RR = 0.43, 95%CI: 0.12-1.54). CONCLUSION: NSAIDs effectively reduce the incidence of PEP but not of moderate to severe pancreatitis. (C) 2014 Baishideng Publishing Group Inc. All rights reserved.

Testing the feasibility and effects of a self-management support intervention for patients with cancer and their family caregivers to reduce pain and related symptoms (ANtiPain): Study protocol of a pilot study

Despite effective treatment options, more than 40% of cancer patients receive inadequate pain management. Our previous pilot study resulted in substantial adaptations of a cancer pain self-management intervention, the German PRO-Self? Plus Pain Control Program originally developed in the United States. This program will be implemented into clinical practice at the Medical Center-University of Freiburg. The purpose of this multiple methods pilot study is to test the implementation regarding feasibility and effects in clinical practice. In a randomized, wait-list controlled pilot study, adult oncology in-patients of a palliative care consultation service with pain >3/10 will be recruited. The intervention will be performed by a specialized advanced practice nurse with an in-hospital visit and, after discharge, via phone calls and visits. The follow-up will be personalized according to a clinical algorithm that factors in pain intensity, satisfaction with pain management, and patient adherence. The intervention includes structured and tailored components and is based on three key strategies: information, skill building and nurse coaching. The specific aims of this study are threefold: 1) to test the feasibility of the study and intervention procedures;2) to establish effect sizes of main outcome variables (e.g. decrease pain intensity, reduce the number of patients with pain as main symptom) for subsequent power calculation;3) to explore participants’ experiences with pain self-management support and their view of burden and benefit from study participation in a qualitative substudy. During the study period, which includes three data collection time points (T0 before, T1 one week and T2 six weeks after discharge), data will be collected via field notes of study nurses and questionnaires of patients. The results of this pilot study will build the basis for a larger comparative effectiveness study in which long term outcomes of a cancer pain self-management intervention in clinical practice will be evaluated.