Peri- and post-operative outcomes, complications, and functional results amongst different modifications of endoscopic enucleation of the prostate (EEP): a systematic review and meta-analysis.

PURPOSE: To investigate and assess outcomes, complications, and functional results amongst different modifications of endoscopic enucleation of the prostate (EEP). METHODS: We conducted a systematic review and meta-analysis according to the PRISMA checklist. We searched the Medline, Cochrane, and Embase databases. We included only randomised-controlled trials (RCT) comparing modifications of EEPs and assessed the risk of bias (RoB). RESULTS: Seven RCTs were included in the study. Overall, 1266 patients were treated with Holmium laser enucleation of the prostate (HoLEP) and 80 patients with thulium laser vapo-enucleation of the prostate (ThuVEP). The operative time during pulse shape-modified HoLEP was shorter when compared to standard pulse HoLEP (MD 18.08 min, 95% CI 8.11-28.05 min, p = 0.0004). The decrease in haemoglobin was significantly lower for two-lobe HoLEP when compared to three-lobe HoLEP (MD 0.16 g/dl, 95% CI 0.22-0.1 g/dl, p < 0.00001). Virtual Basket (VB) HoLEP showed a smaller haemoglobin decrease when compared to standard pulse HoLEP (1.12 ± 1.78 vs. 2.54 ± 1.23 g/dl, p = 0.03). When directly comparing one- vs. two- vs. three-lobe HoLEP, surgical time (p < 0.001) and enucleation efficiency (p = 0.006) were significantly different and favouring one- and two-lobe HoLEP in the study with the largest patient population included. No significant differences for complications were observed; however, Clavien-Dindo IVa events were reported for two patients. CONCLUSION: All variations of EEP improve symptoms and functional parameters with a low incidence of high-grade complications. One- and two-lobe approaches and pulse shape-modified HoLEP seem to be beneficial in terms of operative time and blood loss.

What is the role of single-stage oral mucosa graft urethroplasty in the surgical management of lichen sclerosus-related stricture disease in men? A systematic review.

PURPOSE: The benefits and harms of the available types of surgical management for lichen sclerosus-related (LS) strictures remain unclear and, thus, clear and robust clinical practice recommendations cannot be given. MATERIALS AND METHODS: To assess the role of single-stage OMGU in the management of LS strictures and explore how its benefits and harms compare with the alternative management options. Medline, Embase and Cochrane controlled trial databases (CENTRAL, CDSR) were systematically searched. Randomized (RCTs) and nonrandomized studies (NRCSs) comparing single-stage OMGU with other surgical management options for LS strictures and single-arm studies on single-stage OMGU were included. Risk of bias (RoB) was assessed. RESULTS: Of the 1912 abstracts identified, 15 studies (1 NRCS and 14 single-arm studies) were included, recruiting in total 649 patients. All studies were at high RoB. In the only NRCS available, stricture-free rate (SFR) for single-stage and staged OMGU was 88% vs 60%, respectively (p = 0.05), at a mean follow-up of 66.5 months. SFR range for single-stage OMGU in single-arm studies was 65-100% (mean/median follow-up, 12-59 months). Single-stage OMGU had low complication rates and beneficial impact on LUTS and QoL. CONCLUSIONS: The present SR highlights the methodological limitations of the available literature. In the absence of adverse local tissue conditions, and taking into consideration benefit-harm balance and surgeon's skills and expertise, single-stage OMGU can be justified in patients with LS strictures.

Nonantibiotic Strategies for the Prevention of Infectious Complications following Prostate Biopsy: A Systematic Review and Meta-Analysis.

PURPOSE: We identify which nonantibiotic strategies could reduce the risk of infectious complications following prostate biopsy. MATERIALS AND METHODS: We performed a literature search on MEDLINE®, Embase® and the Cochrane Database for randomized controlled trials (inception to May 2020) assessing nonantibiotic interventions in prostate biopsy. Primary outcome was pooled infectious complications (fever, sepsis and symptomatic urinary tract infection) and secondary outcome was hospitalization. Cochrane risk of bias tool and GRADE approach were used to assess the bias and the certainty of evidence. The study protocol was registered with PROSPERO (CRD42015026354). RESULTS: A total of 90 randomized controlled trials (16,941 participants) were included in the analysis, with 83 trials being categorized into one of 10 different interventions. Transperineal biopsy was associated with significantly reduced infectious complications as compared to transrectal biopsy (RR 0.55, 95% CI 0.33-0.92, p=0.02, I2=0%, 1,330 participants, 7 studies). Rectal preparation with povidone-iodine was also shown to reduce infectious complications (RR 0.50, 95% CI 0.38-0.65, p <0.000001, I2=27%, 1,686 participants, 8 studies) as well as hospitalization (RR 0.38, 95% CI 0.21-0.69, p=0.002, I2=0%, 620 participants, 4 studies). We found no difference in infectious complications/hospitalization for 6 other interventions, ie number of biopsy cores, periprostatic nerve block, number of injections for periprostatic nerve block, needle guide type, needle type and rectal preparation with enema. In 2 interventions (needle diameter, rectal preparation with chlorhexidine) meta-analysis was not possible. Finally, 7 studies had unique interventions. The certainty of evidence was rated as low/very low for all interventions. CONCLUSIONS: Transperineal biopsy significantly reduces infectious complications compared to transrectal biopsy and should therefore be preferred. If transrectal biopsy is performed, rectal preparation with povidone-iodine is highly recommended. The other investigated nonantibiotic strategies did not significantly influence infection and hospitalization after prostate biopsy.

Targeted therapy for metastatic renal cell carcinoma.

BACKGROUND: Several comparative randomised controlled trials (RCTs) have been performed including combinations of tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors since the publication of a Cochrane Review on targeted therapy for metastatic renal cell carcinoma (mRCC) in 2008. This review represents an update of that original review. OBJECTIVES: To assess the effects of targeted therapies for clear cell mRCC in patients naïve to systemic therapy. SEARCH METHODS: We performed a comprehensive search with no restrictions on language or publication status. The date of the latest search was 18 June 2020. SELECTION CRITERIA: We included randomised controlled trials, recruiting patients with clear cell mRCC naïve to previous systemic treatment. The index intervention was any TKI-based targeted therapy. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the included studies and extracted data for the primary outcomes: progression-free survival (PFS), overall survival (OS) and serious adverse events (SAEs); and the secondary outcomes: health-related quality of life (QoL), response rate and minor adverse events (AEs). We performed statistical analyses using a random-effects model and rated the certainty of evidence according to the GRADE approach. MAIN RESULTS: We included 18 RCTs reporting on 11,590 participants randomised across 18 comparisons. This abstract focuses on the primary outcomes of select comparisons. 1. Pazopanib versus sunitinib Pazopanib may result in little to no difference in PFS as compared to sunitinib (hazard ratio (HR) 1.05, 95% confidence interval (CI) 0.90 to 1.23; 1 study, 1110 participants; low-certainty evidence). Based on the control event risk of 420 per 1000 in this trial at 12 months, this corresponds to 18 fewer participants experiencing PFS (95% CI 76 fewer to 38 more) per 1000 participants. Pazopanib may result in little to no difference in OS compared to sunitinib (HR 0.92, 95% CI 0.80 to 1.06; 1 study, 1110 participants; low-certainty evidence). Based on the control event risk of 550 per 1000 in this trial at 12 months, this corresponds to 27 more OSs (95% CI 19 fewer to 70 more) per 1000 participants. Pazopanib may result in little to no difference in SAEs as compared to sunitinib (risk ratio (RR) 1.01, 95% CI 0.94 to 1.09; 1 study, 1102 participants; low-certainty evidence). Based on the control event risk of 734 per 1000 in this trial, this corresponds to 7 more participants experiencing SAEs (95% CI 44 fewer to 66 more) per 1000 participants. 2. Sunitinib versus avelumab and axitinib Sunitinib probably reduces PFS as compared to avelumab plus axitinib (HR 1.45, 95% CI 1.17 to 1.80; 1 study, 886 participants; moderate-certainty evidence). Based on the control event risk of 550 per 1000 in this trial at 12 months, this corresponds to 130 fewer participants experiencing PFS (95% CI 209 fewer to 53 fewer) per 1000 participants. Sunitinib may result in little to no difference in OS (HR 1.28, 95% CI 0.92 to 1.79; 1 study, 886 participants; low-certainty evidence). Based on the control event risk of 890 per 1000 in this trial at 12 months, this would result in 29 fewer OSs (95% CI 78 fewer to 8 more) per 1000 participants. Sunitinib may result in little to no difference in SAEs (RR 1.01, 95% CI 0.93 to 1.10; 1 study, 873 participants; low-certainty evidence). Based on the control event risk of 705 per 1000 in this trial, this corresponds to 7 more SAEs (95% CI 49 fewer to 71 more) per 1000 participants.  3. Sunitinib versus pembrolizumab and axitinib Sunitinib probably reduces PFS as compared to pembrolizumab plus axitinib (HR 1.45, 95% CI 1.19 to 1.76; 1 study, 861 participants; moderate-certainty evidence). Based on the control event risk of 590 per 1000 in this trial at 12 months, this corresponds to 125 fewer participants experiencing PFS (95% CI 195 fewer to 56 fewer) per 1000 participants. Sunitinib probably reduces OS (HR 1.90, 95% CI 1.36 to 2.65; 1 study, 861 participants; moderate-certainty evidence). Based on the control event risk of 880 per 1000 in this trial at 12 months, this would result in 96 fewer OSs (95% CI 167 fewer to 40 fewer) per 1000 participants. Sunitinib may reduce SAEs as compared to pembrolizumab plus axitinib (RR 0.90, 95% CI 0.81 to 1.02; 1 study, 854 participants; low-certainty evidence) although the CI includes the possibility of no effect. Based on the control event risk of 604 per 1000 in this trial, this corresponds to 60 fewer SAEs (95% CI 115 fewer to 12 more) per 1000 participants.  4. Sunitinib versus nivolumab and ipilimumab Sunitinib may reduce PFS as compared to nivolumab plus ipilimumab (HR 1.30, 95% CI 1.11 to 1.52; 1 study, 847 participants; low-certainty evidence). Based on the control event risk of 280 per 1000 in this trial at 30 months' follow-up, this corresponds to 89 fewer PFSs (95% CI 136 fewer to 37 fewer) per 1000 participants. Sunitinib reduces OS (HR 1.52, 95% CI 1.23 to 1.89; 1 study, 847 participants; high-certainty evidence). Based on the control event risk 600 per 1000 in this trial at 30 months, this would result in 140 fewer OSs (95% CI 219 fewer to 67 fewer) per 1000 participants. Sunitinib probably increases SAEs (RR 1.37, 95% CI 1.22 to 1.53; 1 study, 1082 participants; moderate-certainty evidence). Based on the control event risk of 457 per 1000 in this trial, this corresponds to 169 more SAEs (95% CI 101 more to 242 more) per 1000 participants. AUTHORS' CONCLUSIONS: Based on the low to high certainty of evidence, several combinations of immune checkpoint inhibitors appear to be superior to single-agent targeted therapy in terms of PFS and OS, and with a favourable AE profile. Some single-agent targeted therapies demonstrated a similar or improved oncological outcome compared to others; minor differences were observed for AE within this group. The certainty of evidence was variable ranging from high to very low and all comparisons were based on single trials.

What are the unmet supportive care needs of men affected by penile cancer? A systematic review of the empirical evidence.

PURPOSE: To systematically evaluate evidence regarding the unmet supportive care needs of men affected by penile cancer and their partners to create a holistic model of care and inform clinical practice guidelines. METHODS: We searched CINAHL, MEDLINE, PsychINFO, Embase, and the Cochrane Library (CCRT and CDSR) controlled trials databases and clinicaltrial.gov from 1990 to April 2020. This review was reported according to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. RESULTS: 18 articles were included, reporting the results from 17 studies. Included reports used qualitative (seven studies) and survey (ten studies). Across these studies, men reported that the diagnosis and subsequent treatment of penile cancer affected physical, psychological and sexual well-being with each facet impacting and being intertwined with the other at varying degrees. There was varying complexity of unmet needs in men and partners pre-surgery, post-surgery and into survivorship. CONCLUSIONS: Moderate evidence exists that men affected by penile cancer experience a range of unmet supportive care needs across the international literature. Further work to evaluate the impact of penile cancer on partners is required.

Efficacy of soluble fibre, antispasmodic drugs, and gut-brain neuromodulators in irritable bowel syndrome: a systematic review and network meta-analysis.

BACKGROUND: Although novel therapies for irritable bowel syndrome (IBS) continue to be developed, many doctors rely on more established, traditional therapies as first-line or second-line treatment options. These therapies include soluble fibre (eg, ispaghula husk), antispasmodic drugs, peppermint oil, and gut-brain neuromodulators (including tricyclic antidepressants, selective serotonin reuptake inhibitors, or α-2-δ calcium channel subunit ligands). However, the relative efficacy of traditional treatments in patients with IBS is unclear because there have been few head-to-head randomised controlled trials (RCTs). We aimed to compare and rank the efficacy of traditional therapies in patients with IBS to help inform clinical decisions. METHODS: For this systematic review and network meta-analysis, we searched MEDLINE, Embase, Embase Classic, and the Cochrane Central Register of Controlled Trials from inception to week 2 of August 2019; ClinicalTrials.gov for unpublished trials or supplementary data published up to Aug 18, 2019; and gastroenterology conference proceedings for study abstracts published between 2001 and Aug 18, 2019. We included RCTs that compared any of these treatments with each other (head-to-head trials) or with placebo, in which the efficacy of soluble fibre, antispasmodic drugs, peppermint oil, or gut-brain neuromodulators was assessed in adults (aged at least 18 years) with IBS of any subtype after 4-12 weeks of treatment. Only RCTs reporting a dichotomous assessment of overall response to therapy, in terms of either improvement in global IBS symptoms or improvement in abdominal pain, were included. The efficacy and safety of all treatments were reported as a pooled relative risk (RR) with 95% CIs to summarise the effect of each comparison tested, and treatments were ranked according to their P-score. FINDINGS: Our search identified 5863 references, of which 81 were screened for eligibility. 51 RCTs with data from 4644 patients were eligible for inclusion in our analysis, but only 13 of these trials were at low risk of bias. Based on an endpoint of failure to achieve improvement in global IBS symptoms at 4-12 weeks, peppermint oil capsules were ranked first for efficacy (RR 0·63, 95% CI 0·48-0·83, P-score 0·84) and tricyclic antidepressants were ranked second (0·66, 0·53-0·83, P-score 0·77). For failure to achieve an improvement in global IBS symptoms at 4-12 weeks, there were no significant differences between active treatments after direct or indirect comparisons. For failure to achieve improvement in abdominal pain at 4-12 weeks, tricyclic antidepressants were ranked first for efficacy (0·53, 0·34-0·83, P-score 0·87); however, this result was based on data from only four RCTs involving 92 patients. For failure to achieve an improvement in abdominal pain, none of the active treatments showed superior efficacy upon indirect comparison. Tricyclic antidepressants were more likely than placebo to lead to adverse events (1·59, 1·26-2·06, P-score 0·16). INTERPRETATION: In this network meta-analysis of RCTs of soluble fibre, antispasmodic drugs, peppermint oil, and gut-brain neuromodulators for IBS, few of which were judged as being at a low risk of bias, peppermint oil was ranked first for efficacy when global symptoms were used as the outcome measure, and tricyclic antidepressants were ranked first for efficacy when abdominal pain was used as the outcome measure. However, because of the lack of methodological rigour of some RCTs analysed in our study, there is likely to be considerable uncertainty around these findings. In addition, because treatment duration in most included trials was 4-12 weeks, the long-term relative efficacy of these treatments is unknown. FUNDING: None.

Benefits and Harms of Electrical Neuromodulation for Chronic Pelvic Pain: A Systematic Review.

CONTEXT: Patients with chronic pelvic pain (CPP) may have pain refractory to conventional pain management strategies. Neuromodulation could provide relief of pain. OBJECTIVE: To evaluate the benefits and harms of neuromodulation for CPP. EVIDENCE ACQUISITION: A comprehensive search of EMBASE, PUBMED, and SCOPUS was performed for the entire database to January 2018. Studies were selected, data were extracted, and quality was assessed by two independent reviewers. A meta-analysis was used to combine randomized controlled trials (RCTs); otherwise, a narrative analysis was used. EVIDENCE SYNTHESIS: After screening 1311 abstracts, 36 studies including eight RCTs were identified, enrolling 1099 patients. Studies covered a broad range in terms of phenotypes of CPP and methods of neuromodulation. A meta-analysis was possible for percutaneous tibial nerve stimulation and transcutaneous electrical nerve stimulation, which showed improvement in pain. Only narrative synthesis was possible for other modalities (sacral nerve stimulation, spinal cord stimulation, intravaginal electrical stimulation, and pudendal nerve stimulation) which appeared to reduce pain in patients with CPP. Treatments generally improved quality of life but with variable reporting of adverse events. Many studies showed high risks of bias and confounding. CONCLUSIONS: While electrical neuromodulation may improve symptoms in CPP, further work is needed with high-quality studies to confirm it. PATIENT SUMMARY: Neuromodulation may be useful in reducing pain and improving quality of life in patients with chronic pelvic pain, but more research is needed.

Bipolar versus monopolar transurethral resection of the prostate for lower urinary tract symptoms secondary to benign prostatic obstruction.

BACKGROUND: Transurethral resection of the prostate (TURP) is a well-established surgical method for treatment of men with lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO). This has traditionally been provided as monopolar TURP (MTURP), but morbidity associated with MTURP has led to the introduction of other surgical techniques. In bipolar TURP (BTURP), energy is confined between electrodes at the site of the resectoscope, allowing the use of physiological irrigation medium. There remains uncertainty regarding differences between these surgical methods in terms of patient outcomes. OBJECTIVES: To compare the effects of bipolar and monopolar TURP. SEARCH METHODS: A comprehensive systematic electronic literature search was carried out up to 19 March 2019 via CENTRAL, MEDLINE, Embase, ClinicalTrials.gov, PubMed, and WHO ICTRP. Handsearching of abstract proceedings of major urological conferences and of reference lists of included trials, systematic reviews, and health technology assessment reports was undertaken to identify other potentially eligible studies. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials (RCTs) that compared monopolar and bipolar TURP in men (> 18 years) for management of LUTS secondary to BPO. DATA COLLECTION AND ANALYSIS: Two independent review authors screened the literature, extracted data, and assessed eligible RCTs for risk of bias. Statistical analyses were undertaken according to the statistical guidelines presented in the Cochrane Handbook for Systematic Reviews of Interventions. The quality of evidence (QoE) was rated according to the GRADE approach. MAIN RESULTS: A total of 59 RCTs with 8924 participants were included. The mean age of included participants ranged from 59.0 to 74.1 years. Mean prostate volume ranged from 39 mL to 82.6 mL. Primary outcomes BTURP probably results in little to no difference in urological symptoms, as measured by the International Prostate Symptom Score (IPSS) at 12 months on a scale of 0 to 35, with higher scores reflecting worse symptoms (mean difference (MD) -0.24, 95% confidence interval (CI) -0.39 to -0.09; participants = 2531; RCTs = 16; I² = 0%; moderate certainty of evidence (CoE), downgraded for study limitations), compared to MTURP. BTURP probably results in little to no difference in bother, as measured by health-related quality of life (HRQoL) score at 12 months on a scale of 0 to 6, with higher scores reflecting greater bother (MD -0.12, 95% CI -0.25 to 0.02; participants = 2004; RCTs = 11; I² = 53%; moderate CoE, downgraded for study limitations), compared to MTURP. BTURP probably reduces transurethral resection (TUR) syndrome events slightly (risk ratio (RR) 0.17, 95% CI 0.09 to 0.30; participants = 6745; RCTs = 44; I² = 0%; moderate CoE, downgraded for study limitations), compared to MTURP. This corresponds to 20 fewer TUR syndrome events per 1000 participants (95% CI 22 fewer to 17 fewer). Secondary outcomes BTURP may carry a similar risk of urinary incontinence at 12 months (RR 0.20, 95% CI 0.01 to 4.06; participants = 751; RCTs = 4; I² = 0%; low CoE, downgraded for study limitations and imprecision), compared to MTURP. This corresponds to four fewer events of urinary incontinence per 1000 participants (95% CI five fewer to 16 more). BTURP probably slightly reduces blood transfusions (RR 0.42, 95% CI 0.30 to 0.59; participants = 5727; RCTs = 38; I² = 0%; moderate CoE, downgraded for study limitations), compared to MTURP. This corresponds to 28 fewer events of blood transfusion per 1000 participants (95% CI 34 fewer to 20 fewer). BTURP may result in similar rates of re-TURP (RR 1.02, 95% CI 0.44 to 2.40; participants = 652; RCTs = 6; I² = 0%; low CoE, downgraded for study limitations and imprecision). This corresponds to one more re-TURP per 1000 participants (95% CI 19 fewer to 48 more). Erectile function as measured by the International Index of Erectile Function score (IIEF-5) at 12 months on a scale from 5 to 25, with higher scores reflecting better erectile function, appears to be similar (MD 0.88, 95% CI -0.56 to 2.32; RCTs = 3; I² = 68%; moderate CoE, downgraded for study limitations) for the two approaches. AUTHORS' CONCLUSIONS: BTURP and MTURP probably improve urological symptoms, both to a similar degree. BTURP probably reduces both TUR syndrome and postoperative blood transfusion slightly compared to MTURP. The impact of both procedures on erectile function is probably similar. The moderate certainty of evidence available for the primary outcomes of this review suggests that there is no need for further RCTs comparing BTURP and MTURP.

Benefits of Empiric Nutritional and Medical Therapy for Semen Parameters and Pregnancy and Live Birth Rates in Couples with Idiopathic Infertility: A Systematic Review and Meta-analysis.

CONTEXT: Empiric use of medical and nutritional supplements to improve semen parameters and pregnancy rates in couples with idiopathic infertility has reached global proportions, although the evidence base for their use in this setting is controversial. OBJECTIVE: We systematically reviewed evidence comparing the benefits of nutritional and medical therapy on pregnancy rates and semen parameters in men with idiopathic infertility. EVIDENCE ACQUISITION: A literature search was performed using MEDLINE, Embase, LILACS, and the Cochrane Library (searched from January 1, 1990 to September 19, 2017). using the methods detailed in the Cochrane Handbook. Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to assess the certainty of evidence. EVIDENCE SYNTHESIS: The literature search identified 5663 citations, and after screening of abstracts and full texts, 61 studies (59 randomised controlled trials and two nonrandomised comparative studies) were included. Pooled results demonstrated that pentoxyfylline, coenzyme Q10, L-carnitine, follicle-stimulating hormone, tamoxifen, and kallikrein all resulted in improvements in semen parameters. Individual studies identified several other medical and nutritional therapies that improved semen parameters, but data were limited to individual studies with inherent methodological flaws. There were limited data available on live birth and pregnancy rates for all interventions. The GRADE certainty of evidence for all outcomes was very low mainly owing to methodological flaws and inconsistencies in study design. Some outcomes were also downgraded owing to imprecision of results. CONCLUSIONS: There is some evidence that empiric medical and nutritional supplements may improve semen parameters. There is very limited evidence that empiric therapy leads to better live birth rates, spontaneous pregnancy, or pregnancy following assisted-reproductive techniques. However, the findings should be interpreted with caution as there were some methodological flaws, as a number of studies were judged to be either at high or unclear risk of bias for many domains. PATIENT SUMMARY: This review identified several medical and nutritional treatments, such as pentoxyfylline, coenzyme Q10, L-carnitine, follicle-stimulating hormone, tamoxifen, and kallikrein, that appear to improve semen parameters. However, there are limited data suggesting improvements in pregnancy and live birth rates. The lack of evidence can be attributed to methodological flaws in studies and the low number of pregnancies reported.

Fecal microbiota transplantation for Clostridium difficile infection: systematic review and meta-analysis.

OBJECTIVES: The clinical and economic burden of Clostridium difficile infection (CDI) is significant. Recurrent CDI management has emerged as a major challenge with suboptimal response to standard therapy. Fecal microbiota transplantation (FMT) has been used as a treatment to reconstitute the normal microbial homeostasis and break the cycle of antibiotic agents that may further disrupt the microbiome. Given the lack of randomized-controlled trials (RCTs) and limitations in previous systematic reviews, we aimed to conduct a systematic review with robust methods to determine the efficacy and safety profile of FMT in CDI. METHODS: An electronic search was conducted using MEDLINE (1946-March 2012), EMBASE (1974-March 2012) and Cochrane Central Register of Controlled Trials (2012). The search strategy was not limited by language. Abstract data were excluded and only completed studies that underwent the full, rigorous peer-review process were included. Studies that used FMT via any delivery modality for laboratory or endoscopically proven CDI with clinical resolution as primary outcome were included. A sample size of 10 or more patients was a further criterion. Elements of the Centre for Reviews and Dissemination checklist and the National Institute of Clinical Excellence quality assessment for case series checklist were employed to determine study quality. Eligibility assessment and data extraction were performed by two independent researchers. Both unweighted pooled resolution rates (UPR) and weighted pooled resolution rates (WPR) were calculated with corresponding 95% confidence intervals (CI) for overall studies, as well as predefined subgroups. RESULTS: Eleven studies with a total of 273 CDI patients treated with FMT were identified; no RCTs were found as none have been published. Two-hundred and forty-five out of 273 patients experienced clinical resolution (UPR 89.7%; WPR 89.1% (95% CI 84 to 93%)). There was no statistically significant heterogeneity between studies (Cochran Q test P=0.13, I(2)=33.7%). A priori subgroup analysis suggested that lower gastrointestinal FMT delivery (UPR 91.4%; WPR 91.2% (95% CI 86 to 95%)) led to a trend towards higher clinical resolution rates than the upper gastrointestinal route (UPR 82.3%; WPR 80.6% (95% CI 69-90%)) (proportion difference of WPR was 10.6% (95% CI -0.6 to 22%)). No difference in clinical outcomes was detected between anonymous vs. patient selected donors. There were no reported adverse events associated with FMT and follow-up was variable from weeks to years. CONCLUSIONS: FMT holds considerable promise as a therapy for recurrent CDI but well-designed, RCTs and long-term follow-up registries are still required. These are needed to identify the right patient, efficacy and safety profile of FMT before this approach can be widely advocated.

[Study on moxa sticks burning temperature-time-space curves].

OBJECTIVE: To study the burning characteristics of moxa stick. METHODS: A self-designed moxa stick burning temperature measuring device, which was assembled with ALTEC intelligence digital setter and SJ-600 thermocouple, was used to conduct next four experiences: 1) embedding a thermocouple inside a moxa stick to measure peak burning temperature; 2) pulling a thermocouple embedded in the moxa stick at the proper rate to detect combustion stability; 3) elucidating temperature distribution of transverse section by measuring the temperature in the center, radius midpoint and lateral; 4) drawing temperature-time-space curves by pulling the thermocouples in the former three observation points. RESULTS: The experiment indicated that the burning temperature peak of three-year moxa stick (Hubei Herbal Medicine St. Qichun Technology Co., Ltd.) was 848 degrees C which had good combustion stability. Furthermore, the temperature in the center, radius midpoint and lateral of transverse section were 843 degrees C, 731 degrees C and 410 degrees C, respectively, and its burning temperature-time-space curves was drawn, which showed the real-time burning temperature and the peak burning temperature and were regarded as ultimate indice to integrate the formers. CONCLUSION: The measuring system elaborately reflecting the burning features of moxa stick may provide reference for manufacture industry of moxa stick quality criteria for its convenience and accuracy.

Recent safety concerns with proton pump inhibitors.

There have been recent concerns about the safety of proton pump inhibitors (PPIs). We focus here on 3 specific concerns-the possible interaction between PPIs and clopidogrel, the postulated link between PPI use and fractures, and the possibility that long-term PPI use might lead to hypomagnesemia. There is evidence for an in vitro interaction between clopidogrel and at least some PPIs. The Food and Drug Administration (FDA) has warned against the use of certain PPIs by patients on clopidogrel. However, a randomized controlled trial that compared clopidogrel alone with the combination of clopidogrel and omeprazole found no increase in adverse cardiovascular outcomes and a reduction in the rate of adverse gastrointestinal outcomes attributable to omeprazole. PPI use may be a weak risk factor for certain fractures, but the quality of evidence is relatively poor and there is a strong possibility of confounding. The mechanism whereby PPI use might increase fracture risk is unknown. Currently, no additional measures concerning calcium supplementation or bone mineral density monitoring are recommended for patients on a PPI. The FDA has suggested monitoring serum magnesium levels in patients on PPI therapy. The mechanism and frequency of PPI-induced hypomagnesemia are unclear. PPI treatment should not be withheld from patients who genuinely require it, but the PPI should be taken in the lowest effective dose and only for as long as clinically indicated. The same is, of course, true for all medicines. The benefits of PPI therapy greatly outweigh the risks.