Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

PURPOSE: We present final 5-year outcomes of the multicenter randomized sham-controlled trial of a water vapor therapy (Rezum™) for treatment of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia. MATERIALS AND METHODS: A total of 197 subjects >50 years of age with International Prostate Symptom Score ≥13, maximum flow rate ≤15 ml/second and prostate volume 30 to 80 cc were randomized and followed for 5 years. From the control arm of 61 subjects, a subset of 53 subjects requalified and after 3 months received treatment as part of the crossover group and were also followed for 5 years. The total number of vapor treatments to each lobe of the prostate was determined by length of prostatic urethra and included middle lobe treatment per physician discretion. RESULTS: Significant improvement of lower urinary tract symptoms was observed at <3 months post-thermal therapy, remaining durable through 5 years in the treatment group (International Prostate Symptom Score reduced 48%, quality of life increased 45%, maximum flow rate improved 44%, Benign Prostatic Hyperplasia Impact Index decreased 48%). Surgical re-treatment rate was 4.4% with no reports of device or procedure related sexual dysfunction or sustained de novo erectile dysfunction. Results within the crossover group were similar through 5 years. CONCLUSIONS: Minimally invasive treatment with water vapor thermal therapy provides significant and durable symptom relief as well as flow rate improvements through 5 years, with low surgical re-treatment rates and without impacting sexual function. It is a versatile therapy, providing successful treatment to obstructive lateral and middle lobes.

Prostatic arterial embolization for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.

BACKGROUND: A variety of minimally invasive surgical approaches are available as an alternative to transurethral resection of the prostate (TURP) for management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Prostatic arterial embolization (PAE) is a relatively new, minimally invasive treatment approach. OBJECTIVES: To assess the effects of PAE compared to other procedures for treatment of LUTS in men with BPH. SEARCH METHODS: We performed a comprehensive search using multiple databases (The Cochrane Library, MEDLINE, Embase, LILACS, Scopus, Web of Science, and Google Scholar), trials registries, other sources of grey literature, and conference proceedings with no restrictions on language of publication or publication status, up until 25 September 2020. SELECTION CRITERIA: We included parallel-group randomized controlled trials (RCTs), as well as non-randomized studies (NRS, limited to prospective cohort studies with concurrent comparison groups) enrolling men over the age of 40 with LUTS attributed to BPH undergoing PAE versus TURP or other surgical interventions.  DATA COLLECTION AND ANALYSIS: Two review authors independently classified studies for inclusion or exclusion and abstracted data from the included studies. We performed statistical analyses by using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. We used GRADE guidance to rate the certainty of evidence of RCTs and NRSs.  MAIN RESULTS: We found data to inform two comparisons: PAE versus TURP (six RCTs and two NRSs), and PAE versus sham (one RCT). Mean age, IPSS, and prostate volume of participants were 66 years, 22.8, and 72.8 mL, respectively. This abstract focuses on the comparison of PAE versus TURP as the primary topic of interest. PAE versus TURP We included six RCTs and two NRSs with short-term (up to 12 months) follow-up and one RCT with long-term follow-up (13 to 24 months).  Short-term follow-up: based on RCT evidence, there may be little to no difference in urologic symptom score improvement (mean difference [MD] 1.55, 95% confidence interval [CI] -0.40 to 3.50; 369 participants; 6 RCTs; I² = 75%; low-certainty evidence) measured by the International Prostatic Symptom Score (IPSS) on a scale from 0 to 35, with higher scores indicating worse symptoms. There may be little to no difference in quality of life (MD 0.16, 95% CI -0.37 to 0.68; 309 participants; 5 RCTs; I² = 56%; low-certainty evidence) as measured by the IPSS quality of life question on a scale from 0 to 6, with higher scores indicating worse quality of life between PAE and TURP, respectively. While we are very uncertain about the effects of PAE on major adverse events (risk ratio [RR] 0.71, 95% CI 0.16 to 3.10; 250 participants; 4 RCTs; I² = 26%; very low-certainty evidence), PAE may increase re-treatments (RR 3.64, 95% CI 1.02 to 12.98; 204 participants; 3 RCTs; I² = 0%; low-certainty evidence). Based on 18 re-treatments per 1000 men in the TURP group, this corresponds to 47 more (0 more to 214 more) per 1000 men undergoing PAE.   We are very uncertain about the effects on erectile function (MD -0.03, 95% CI -6.35 to 6.29; 129 participants; 2 RCTs; I² = 78%; very low-certainty evidence) measured by the International Index of Erectile Function at 5 on a scale from 1 to 25, with higher scores indicating better function. NRS evidence when available yielded similar results. Based on evidence from NRS, PAE may reduce the occurrence of ejaculatory disorders (RR 0.51, 95% CI 0.35 to 0.73; 260 participants; 1 NRS; low-certainty evidence). Longer-term follow-up: based on RCT evidence, we are very uncertain about the effects of PAE on urologic symptom scores (MD 0.30, 95% CI -3.17 to 3.77; 95 participants; very low-certainty evidence) compared to TURP. Quality of life may be similar (MD 0.20, 95% CI -0.49 to 0.89; 95 participants; low-certainty evidence). We are also very uncertain about major adverse events (RR 1.96, 95% CI 0.63 to 6.13; 107 participants; very low-certainty evidence). We did not find evidence on erectile function and ejaculatory disorders. Based on evidence from NRS, PAE may increase re-treatment rates (RR 1.51, 95% CI 0.43 to 5.29; 305 participants; low-certainty evidence); based on 56 re-treatments per 1000 men in the TURP group. this corresponds to 143 more (25 more to 430 more) per 1000 men in the PAE group.  AUTHORS' CONCLUSIONS: Compared to TURP up to 12 months (short-term follow-up), PAE may provide similar improvement in urologic symptom scores and quality of life. While we are very uncertain about major adverse events, PAE may increase re-treatment rates. We are uncertain about erectile function, but PAE may reduce ejaculatory disorders. Longer term (follow-up of 13 to 24 months), we are very uncertain as to how both procedures compare with regard to urologic symptom scores, but quality of life appears to be similar. We are very uncertain about major adverse events but PAE may increase re-treatments. We did not find longer term evidence on erectile function and ejaculatory disorders. Certainty of evidence for the main outcomes of this review was low or very low, signalling that our confidence in the reported effect size is limited or very limited, and that this topic should be better informed by future research.

Improvement cues of lesion absorption using the adjuvant therapy of traditional Chinese medicine Qinbudan tablet for retreatment pulmonary tuberculosis with standard anti-tuberculosis regimen.

BACKGROUND: China is the second highest pulmonary tuberculosis (PTB) burden country worldwide. However, retreatment of PTB has often developed resistance to at least one of the four first-line anti-TB drugs. The cure rate (approximately 50.0-73.3%) and management of retreatment of PTB in China needs to be improved. Qinbudan decoction has been widely used to treat PTB in China since the 1960s. Previously clinical studies have shown that the Qinbudan tablet (QBDT) promoted sputum-culture negative conversion and lesion absorption. However, powerful evidence from a randomized controlled clinical trial is lacking. Therefore, the aim of this study was to compare the efficacy and safety of QBDT as an adjunct therapy for retreatment of PTB. METHODS: We conducted a multicenter, randomized, double-blind, placebo-controlled clinical trial in China. People diagnosed with PTB were enrolled who received previous anti-TB treatment from April 2011 to March 2013. The treatment group received an anti-TB regimen and QBDT, and the control group was administered an anti-TB regimen plus placebo. Anti-TB treatment options included isoniazid, rifampicin, pyrazinamide, ethambutol, streptomycin for 2 months (2HRZES), followed by isoniazid, rifampicin, ethambutol for 6 months (6HRE), daily for 8 months. Primary outcome was sputum-culture conversion using the MGIT 960 liquid medium method. Secondary outcomes included lung lesion absorption and cavity closure. Adverse events and reactions were observed after treatment. A structured questionnaire was used to record demographic information and clinical symptoms of all subjects. Data analysis was performed by SPSS 25.0 software in the full analysis set (FAS) population. RESULTS: One hundred eighty-one cases of retreatment PTB were randomly divided into two groups: the placebo group (88 cases) and the QBDT group (93 cases). A total of 166 patients completed the trial and 15 patients lost to follow-up. The culture conversion rate of the QBDT group and placebo group did not show a noticeable improvement by using the covariate sites to correct the rate differences (79.6% vs 69.3%; rate difference = 0.10, 95% confidence interval (CI): - 0.02-0.23; F = 2.48, P = 0.12) after treatment. A significant 16.6% increase in lesion absorption was observed in the QBDT group when compared with the placebo group (67.7% vs 51.1%; rate difference = 0.17, 95% CI: 0.02-0.31; χ2 = 5.56, P = 0.02). The intervention and placebo group did not differ in terms of cavity closure (25.5% vs 21.1%; rate difference = 0.04, 95% CI: - 0.21-0.12; χ2 = 0.27, P = 0.60). Two patients who received chemotherapy and combined QBDT reported pruritus/nausea and vomiting. CONCLUSIONS: No significant improvement in culture conversion was observed for retreatment PTB with traditional Chinese medicine plus standard anti-TB regimen. However, QBDT as an adjunct therapy significantly promoted lesion absorption, thereby reducing lung injury due to Mycobacterium tuberculosis infection. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov, NCT02313610.

Aquablation of the prostate for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.

BACKGROUND: New, minimally invasive surgeries have emerged as alternatives to transurethral resection of the prostate (TURP) for the management of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Aquablation is a novel, minimally invasive, water-based therapy, combining image guidance and robotics for the removal of prostatic tissue. OBJECTIVES: To assess the effects of Aquablation for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia. SEARCH METHODS: We performed a comprehensive search using multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Web of Science, and LILACS), trials registries, other sources of grey literature, and conference proceedings published up to 11 February 2019, with no restrictions on the language or status of publication. SELECTION CRITERIA: We included parallel-group randomised controlled trials (RCTs) and cluster-RCTs, as well as non-randomised observational prospective studies with concurrent comparison groups in which participants with BPH who underwent Aquablation. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion at each stage, and undertook data extraction and 'Risk of bias' and GRADE assessments of the certainty of the evidence. We considered review outcomes measured up to and including 12 months after randomisation as short-term and beyond 12 months as long-term. MAIN RESULTS: We included one RCT with 184 participants comparing Aquablation to TURP. The mean age and International Prostate Symptom Score were 65.9 years and 22.6, respectively. The mean prostate volume was 53.2 mL. We only found short-term data for all outcomes based on a single randomised trial.Primary outcomesUp to 12 months, Aquablation likely results in a similar improvement in urologic symptom scores to TURP (mean difference (MD) -0.06, 95% confidence interval (CI) -2.51 to 2.39; participants = 174; moderate-certainty evidence). We downgraded the evidence certainty by one level due to study limitations. Aquablation may also result in similar quality of life when compared to TURP (MD 0.27, 95% CI -0.24 to 0.78; participants = 174, low-certainty evidence). We downgraded the evidence certainty by two levels due to study limitations and imprecision. Aquablation may result in little to no difference in major adverse events (risk ratio (RR) 0.84, 95% CI 0.31 to 2.26; participants = 181, very low-certainty evidence) but we are very uncertain of this finding. This would correspond to 15 fewer major adverse events per 1000 participants (95% CI 64 fewer to 116 more). We downgraded the evidence certainty by one level for study limitations and two levels for imprecision.Secondary outcomesUp to 12 months, Aquablation may result in little to no difference in retreatments (RR 1.68, 95% CI 0.18 to 15.83; participants = 181, very low-certainty evidence) but we are very uncertain of this finding. This would correspond to 10 more retreatments per 1000 participants (95% CI 13 fewer to 228 more). We downgraded the evidence certainty by one level due to study limitations and two levels for imprecision.Aquablation may result in little to no difference in erectile function as measured by International Index of Erectile Function questionnaire Erectile Function domain compared to TURP (MD 2.31, 95% CI -0.63 to 5.25; participants = 64, very low-certainty evidence), and may cause slightly less ejaculatory dysfunction than TURP, as measured by Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MD 2.57, 95% CI 0.60 to 4.53; participants = 121, very low-certainty evidence). However, we are very uncertain of both findings. We downgraded the evidence certainty by two levels due to study limitations and one level for imprecision for both outcomes.We did not find other prospective, comparative studies comparing Aquablation to TURP or other procedures such as laser ablation, enucleation, or other minimally invasive therapies. AUTHORS' CONCLUSIONS: Based on short-term (up to 12 months) follow-up, the effect of Aquablation on urological symptoms is probably similar to that of TURP (moderate-certainty evidence). The effect on quality of life may also be similar (low-certainty evidence). We are very uncertain whether patients undergoing Aquablation are at higher or lower risk for major adverse events (very low-certainty evidence). We are very uncertain whether Aquablation may result in little to no difference in erectile function but offer a small improvement in preservation of ejaculatory function (both very low-certainty evidence). These conclusions are based on a single study of men with a prostate volume up to 80 mL in size. Longer-term data and comparisons with other modalities appear critical to a more thorough assessment of the role of Aquablation for the treatment of LUTS in men with BPH.

Efficacy and safety of prostate artery embolization for benign prostatic hyperplasia: an observational study and propensity-matched comparison with transurethral resection of the prostate (the UK-ROPE study).

OBJECTIVES: To assess the efficacy and safety of prostate artery embolization (PAE) for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) and to conduct an indirect comparison of PAE with transurethral resection of the prostate (TURP). PATIENTS AND METHODS: As a joint initiative between the British Society of Interventional Radiologists, the British Association of Urological Surgeons and the National Institute for Health and Care Excellence, we conducted the UK Register of Prostate Embolization (UK-ROPE) study, which recruited 305 patients across 17 UK urological/interventional radiology centres, 216 of whom underwent PAE and 89 of whom underwent TURP. The primary outcomes were International Prostate Symptom Score (IPSS) improvement in the PAE group at 12 months post-procedure, and complication data post-PAE. We also aimed to compare IPSS score improvements between the PAE and TURP groups, using non-inferiority analysis on propensity-score-matched patient pairs. The clinical results and urological measurements were performed at clinical sites. IPSS and other questionnaire-based results were mailed by patients directly to the trial unit managing the study. All data were uploaded centrally to the UK-ROPE study database. RESULTS: The results showed that PAE was clinically effective, producing a median 10-point IPSS improvement from baseline at 12 months post-procedure. PAE did not appear to be as effective as TURP, which produced a median 15-point IPSS score improvement at 12 months post-procedure. These findings are further supported by the propensity score analysis, in which we formed 65 closely matched pairs of patients who underwent PAE and patients who underwent TURP. In terms of IPSS and quality-of-life (QoL) improvement, there was no evidence of PAE being non-inferior to TURP. Patients in the PAE group had a statistically significant improvement in maximum urinary flow rate and prostate volume reduction at 12 months post-procedure. PAE had a reoperation rate of 5% before 12 months and 15% after 12 months (20% total rate), and a low complication rate. Of 216 patients, one had sepsis, one required a blood transfusion, four had local arterial dissection and four had a groin haematoma. Two patients had non-target embolization that presented as self-limiting penile ulcers. Additional patient-reported outcomes, pain levels and return to normal activities were very encouraging for PAE. Seventy-one percent of PAE cases were performed as outpatient or day cases. In contrast, 80% of TURP cases required at least 1 night of hospital stay, and the majority required 2 nights. CONCLUSION: Our results indicate that PAE provides a clinically and statistically significant improvement in symptoms and QoL, although some of these improvements were greater in the TURP arm. The safety profile and quicker return to normal activities may be seen as highly beneficial by patients considering PAE as an alternative treatment to TURP, with the concomitant advantages of reduced length of hospital stay and need for admission after PAE. PAE is an advanced embolization technique demanding a high level of expertise, and should be performed by experienced interventional radiologists who have been trained and proctored appropriately. The use of cone-beam computed tomography is encouraged to improve operator confidence and minimize non-target embolizations. The place of PAE in the care pathway is between that of drugs and surgery, allowing the clinician to tailor treatment to individual patients' symptoms, requirements and anatomical variation.

Hyperbaric oxygen for late sequelae of carbon monoxide poisoning enhances neurological recovery: case report.

Neuropsychiatric sequelae have been reported in 15%-45% of survivors of carbon monoxide (CO) poisoning. Hyperbaric oxygen (HBO2) therapy reduces the incidence of cognitive and neurological a dysfunction. The efficacy of providing HBO2 beyond the first one to two days after initial insult is unknown. However, some evidence exists for the benefit of this treatment. We report on treating a patient 14 months after CO injury, who responded with markedly improved neurologic status. A 27-year-old scholar was found comatose due to CO poisoning (carboxyhemoglobin = 31.7%). He received five acute HBO2 treatments. After discharge, he developed chorea, Parkinsonism, dystonia, memory loss, slowed processing speed and verbal fluency, leaving him disabled. After the patient reached a clinical plateau, HBO2 was tried again at 90 minutes at 2.4 ATA plus air breaks. Neuropsychological testing was performed at baseline and after each 20 HBO2 cycles, five of which were performed during the period from 14-22 months after CO exposure. After the first 20 treatments, Parkinsonism and dystonia improved. After 40 sessions, further improvements were seen on mental speed, verbal fluency, and fine motor movements. The outcome following 100 treatments was that the patient regained independence, including the ability to drive and to become gainfully employed. Our case calls into question the concept that HBO2 therapy has no role during the chronic phase of CO brain injury. Randomized clinical trials should be considered to evaluate the therapeutic efficacy of HBO2 in patients with neurological sequelae following CO injury.

Peri-mitral atrial flutter: personalized ablation strategy based on arrhythmogenic substrate.

Aims: The aim of this study is to characterize the arrhythmogenic substrate for peri-mitral atrial flutter (PMAFL), thereby determining a personalized ablation strategy to treat PMAFL. Methods and results: Thirty-six consecutive PMAFL patients (mean age: 63.8 ± 11.3, 23 males) underwent detailed three-dimensional electroanatomic mapping in left atrium (LA). The LA was divided into septal-anterior wall (SAW), posterior inferior wall (PIW), and mitral isthmus (MI) region, respectively. Ablation strategy was determined based on the endocardial bipolar voltage map. Based on electrophysiological substrates, 10, 17, and 9 cases were classified into iatrogenic, spontaneous, and no-substrate PMAFL, respectively. The mean voltage in SAW was significantly lower in spontaneous PMAFL (iatrogenic: 1.07 ± 0.66 mV; spontaneous: 0.65 ± 0.44 mV; no-substrate: 1.60 ± 0.53 mV, P <0.001), while iatrogenic PMAFL patients had the lowest voltage in MI (0.51 ± 0.23 mV vs. 1.55 ± 0.78 mV, 1.61 ± 0.56 mV, P <0.001). No low-voltage or slow conduction zone was found in the no-substrate PMAFL group. Fifteen spontaneous PMAFLs were successfully terminated by modified septal-anterior (9/10) or conventional anterior ablation line (6/7). Eight iatrogenic PMAFLs (8/10) were terminated by reinforcing the previous ablation areas. Cardioversion without PMAFL ablation was done in no-substrate PMAFL patients. After a median follow-up of 12 (7-39) months, two spontaneous PMAFL patients received redo procedures for recurrence due to "gap" conduction. Conclusions: The ablation strategy for PMAFL patients should be based on the arrhythmogenic substrate, but not the indiscriminate MI ablation. No-substrate PMAFLs during AF ablation could be monitored after cardioversion and might not need further ablation.

Dynamics of cinacalcet use and biochemical control in hemodialysis patients: a retrospective New-user cohort design.

BACKGROUND: Cinacalcet is used to treat secondary hyperparathyroidism among hemodialysis patients. Large-scale epidemiologic studies describing patterns of cinacalcet use, effects on parathyroid hormone (PTH), calcium, and phosphorous levels, and predictors of discontinuation have not been previously reported. METHODS: This retrospective cohort study used a clinical database of a large U.S. dialysis provider (2007-2010) merged with administrative data from the United States Renal Data System. Among new users of cinacalcet with Medicare coverage, trends in PTH, calcium, and phosphorus were measured in 30-day intervals following cinacalcet initiation. RESULTS: Seventeen thousand seven hundred sixty-three eligible initiators contributed 111,047 30-day follow-up intervals. Of these, 56 % discontinued cinacalcet by month 4. Of those discontinuing, 76.3 % reinitiated. Mean values of PTH, calcium, and phosphorus decreased to recommended levels within 4 months following initiation. Proximal PTH levels < 150 pg/mL were associated with discontinuation: HR = 1.23 (95 % CI: 1.12, 1.36), whereas low calcium (< 7.5 mg/dL) was suggestive of an association, HR = 1.09 (95 % CI 0.91, 1.32). Being in the Part D gap period increased discontinuation risk: HR = 1.09 (95 % CI: 1.03, 1.16). Low-income subsidy status decreased discontinuation risk: HR = 0.77 (95 % CI 0.69, 0.86). Predictors of reinitiation included low-income subsidy, HR = 1.32 (95 % CI 1.22, 1.43); higher albumin level, HR = 1.23 (95 % CI 1.10, 1.36) and higher calcium level, HR = 1.26 (95 % CI 1.19, 1.33). CONCLUSIONS: Substantial and expected declines in laboratory values occurred following cinacalcet initiation. Early discontinuation and reinitiation of cinacalcet were common and may have occurred for clinical and economic reasons.

Delayed repeat enemas are safe and cost-effective in the management of pediatric intussusception.

BACKGROUND/PURPOSE: The purpose of the study is to compare outcomes between delayed repeat enema (DRE) and immediate surgery (IS) in children with ileocolic intussusception who fail initial enema reduction. METHODS: Retrospective cohort study of children <6 years-of-age from 2008 to 2012 in the Pediatric Health Information System (PHIS) database. Outcomes measured were bowel resection, length of stay (LOS), and adjusted hospital costs (AHC). RESULTS: 4980 of 6889 (72.3%) children with intussusception were discharged without operation following a single successful enema. 1407 of 1909 (73.7%) remaining patients underwent IS while 502 (26.3%) had a DRE. Bowel resection was required in 372 of 1407 (26.4%) patients in IS group compared to 59 of 502 (11.8%) in the DRE group (p<0.001). The number of patients needed to treat by DRE to prevent a bowel resection was 7. In multivariable analysis, the IS patients had a 2.5 times greater likelihood of undergoing bowel resection than the DRE patients (adjusted odds ratio [OR] 2.50, 95% confidence interval [CI] 1.83-3.41, p<0.001). The DRE group had a mean LOS of 3.2 days (95% CI 2.9-3.6) and mean AHC of $9205 (95% CI $7673-$10,735). The IS group had a longer LOS (4.4days, 95% CI 4.0-4.8, p≤0.001) and higher AHC ($14,422, 95% CI $12,631-$16,214, p<0.001). CONCLUSION: Delayed repeat enemas for ileocolic intussusception increase the success of nonoperative reduction, decrease the rate of bowel resection and reduce mean hospital length of stay and costs.

The utility of inpatient rebound bilirubin levels in infants readmitted after birth hospitalization for hyperbilirubinemia.

BACKGROUND AND OBJECTIVES: There are few data evaluating the role of inpatient rebound bilirubin levels in the management of infants readmitted after their birth hospitalization for indirect hyperbilirubinemia. The goal of the present study was to evaluate the clinical utility of inpatient rebound bilirubin levels within this patient population. METHODS: A retrospective cohort study was conducted of 226 infants readmitted after their birth hospitalization for indirect hyperbilirubinemia. Data from 130 infants with rebound bilirubin levels drawn at a mean of 6.1±2.4 hours after discontinuation of phototherapy were compared with data from 96 infants without rebound bilirubin levels. The primary outcome was readmission to the hospital, and secondary outcomes included length of stay and discharge time. A subgroup analysis compared characteristics of children who required repeat phototherapy versus those who did not. RESULTS: Overall, 5 of 130 patients from the rebound group were readmitted compared with 4 of 96 patients from the no-rebound group (P=.98). Length of stay was significantly longer for patients with rebound bilirubin levels (27.7 vs 23.2 hours; P=.001). Patients with bilirubin levels lowered to ≤14 mg/dL were less likely to receive repeat phototherapy than those with levels>14 mg/dL (2 of 129 vs 12 of 97; P=.001). CONCLUSIONS: Early inpatient rebound bilirubin levels do not successfully predict which patients will require hospital readmission for repeat phototherapy. Children with bilirubin levels lowered to ≤14 mg/dL with phototherapy are unlikely to receive repeat phototherapy.

Clinical observations of sequential therapy with Chinese medicine and hysteroscopic mechanical stimulation of the endometrium in infertile patients with repeated implantation failure undergoing frozen-thawed embryo transfer.

OBJECTIVES: To investigate the clinical effect of sequential therapeutic intervention Yupei Qisun [compensating for weakness by invigorating Kidney (Shen) and Spleen (Pi) in advance] in Chinese medicine (CM) and hysteroscopic endometrial mechanical stimulation on the treatment of infertile patients with repeated implantation failure (RIF); and to study the differences in patients' endometrial thickness and type on the day of embryo transfer, serum hormone levels on embryo transfer day and clinical pregnancy outcomes. METHODS: In the clinical study, 168 frozen-thawed embryo transfer (FET) cycles for couples with RIF conforming to the research protocol were randomly divided into three groups: a CM group with 56 cycles (CM combined with FET), a hysteroscopy group with 55 cycles (hysteroscopic endometrial mechanical stimulation), and a control group with 57 cycles (conventional FET). Differences in endometrial thickness on the embryo transfer day, levels of serum estradiol (E2) and progesterone (P) on the embryo transfer day, the E2/P ratio on the embryo transfer day, biochemical and clinical pregnancy rates, implantation rate, abnormal pregnancy rate and other indices were compared among the three groups. RESULTS: Endometrial thickness, E2 and P levels, and the E2/P ratio on embryo transfer day and other factors had no significant differences among groups. The biochemical pregnancy, clinical pregnancy, and implantation rates of the CM and hysteroscopy groups were significantly higher than the control group (P<0.05), and there were no significant differences between these two groups. The abnormal pregnancy rate had no significant difference among the three groups. CONCLUSIONS: Sequential therapy of Yupei Qisun could significantly improve the clinical outcomes of rif-fet cycles, being equivalent to hysteroscopic endometrial mechanical stimulation, and provided a reliable method to treat such infertile couples.

Reasons for interruption of anti-tubercular treatment among the retreatment patients in category II of RNTCP in Chandigarh, north India.

INTRODUCTION: More re-treatment TB patients are notified in India than any other country in the world, and default among this group is a serious public health problem. Adherence to the long course of TB treatment is a complex, dynamic phenomenon with a wide range of factors impacting on treatment taking behaviour. The main aim of the study was to study the basic clinical and demographic profile of the defaulters and the reasons for discontinuation of treatment among these retreatment patients in category II of RNTCP. METHODS: A longitudinal study was designed and the patients registered under RNTCP category II from June 2010 to December 2011 at various centres in Chandigarh formed the study cohort. Out of total 607 patients registered during this period under category II of RNTCP in Chandigarh, 545 consented to participate in the study. These were followed up to September 2012 till the completion of treatment. 32 patients among the registered 545 defaulted from the treatment during the period. These patients were traced in the community and information regarding reasons for interruption and barriers to treatment was obtained from them using a pre-structured pre-tested questionnaire. Data were analysed using SPSS 18 statistical software package. RESULTS: 32(5.9%) patients defaulted from the treatment under RNTCP category II. 29(90.6%) were pulmonary patients while 3(9.4%) were extra-pulmonary patients. 46.9% of the defaulters were in the age group of 20-35 years, followed by 31.3% in the age group of 36-50 years. 21.9% went to traditional healers for cure while 12.5% tried herbal medicine during the treatment. 25% (eight) patients did not have faith on the DOTS treatment. Most common side effects of treatment complained by the patients were GI upset (62.5%), fatigue (59.4%), drowsiness (34.4%) and itching (31.3%). 46.8% believed that ATT induced side-effects were the main reason for treatment interruption. Maximum treatment interruption was seen at the end of the third month (31.3%). CONCLUSIONS: Maximum interruptions were found to occur by end of third month of ATI. AT" induced side-effects were the main reason for treatment interruption. Efforts need to be made to improve the pre-treatment counselling, increase proportion of patients treated by community-based DOTS providers, repeated health education to the patients emphasizing the need to continue treatment.

Comorbidity in heart failure. Results of the Spanish RICA Registry.

BACKGROUND: We sought to identify the comorbidities associated with heart failure (HF) in a non-selected cohort of patients, and its influence on mortality and rehospitalization. DESIGN AND METHODS: Data were obtained from the 'Registro de Insuficiencia Cardiaca' (RICA) of the Spanish Society of Internal Medicine. The registry includes patients prospectively admitted in Internal Medicine units for acute HF. Variables included in Charlson Index (ChI) were collected and analysed according to age, gender, left ventricular ejection fraction (LVEF) and Barthel Index. The primary end point of study was the likelihood of rehospitalization and death for any cause during the year after discharge. RESULTS: We included 2051 patients, mean age 78 and 53% females. LVEF was ⩾ 50% in 59.1% of the cohort. There was a high degree of dependency as measured by Barthel Index (14.8 % had an index ≤ 60). Mean ChI was 2.91 (SD ± 2.4). The most frequent comorbidities included in ChI were diabetes mellitus (44.3%), chronic renal impairment (30.8%) and chronic obstructive pulmonary disease (COPD) (27.4%). Age, myocardial infarction, peripheral artery disease, dementia, COPD, chronic renal impairment and diabetes with target-organ damage were all identified as independent prognostic factors for the combined end point of rehospitalization and death at 1 year. However, if multivariate analysis was done including ChI, only this remained as an independent prognostic factor for the combined end point (P < 0.001). CONCLUSIONS: HF is a comorbid condition. ChI is a simple and feasible tool for estimating the burden of comorbidities in such population. We believe that a holistic approach to HF would improve prognosis and the relief the pressure exerted on public health services.

Patterns of practice in palliative radiotherapy for painful bone metastases: impact of a regional rapid access clinic on access to care.

PURPOSE: External beam radiotherapy (RT) is commonly indicated for the palliation of symptomatic bone metastases, but there is evidence of underutilization of this treatment modality in palliative care for cancer populations. This study was conducted to investigate factors that influenced the use of palliative RT services at a regional comprehensive cancer center. METHODS AND MATERIALS: A cohort of patients with radiographically confirmed bone metastases and first-time users of palliative RT between 2003 and 2005 was retrospectively reviewed from the time of initial diagnosis of bone metastases to death or last follow-up. Type of radiation treatment service provider used (rapid access or routine access) and patient-, tumor-, and treatment-related factors were analyzed for their influences on the number of treatment courses given over the duration of disease. RESULTS: A total of 887 patients received 1,354 courses of palliative RT for bone metastases at a median interval of 4.0 months between courses. Thirty-three percent of patients required more than one RT course. Increased age and travel distance reduced the likelihood and number of treatment courses, while service through a rapid access clinic was independently associated with an increase in subsequent use of palliative RT. CONCLUSIONS: A rapid access service model for palliative RT facilitated access to RT. Travel distance and other factors remained substantial barriers to use of palliative RT services. The pattern of practice suggests an unmet need for symptom control in patients with bone metastases.

Psychopathology among cannabis-dependent treatment seekers and association with later substance abuse treatment.

We determined the proportion of psychiatric treatments for disorders not due to substance use among a cohort of subjects (n = 3,114) seeking treatment for cannabis dependence. Data were retrieved from Danish treatment registers. Cases were compared with a representative sample, which was randomly selected from the general population according to age and gender (n = 15,570). Cannabis users were followed, and reentry into substance abuse treatment was used as an outcome deploying Cox regression analysis. The proportion of treatment for all psychiatric disorders was much higher among cases than among controls: schizophrenia (odds ratio [OR] = 7.9; 95% confidence interval [95% CI] = 6.1-10.2), bipolar disorders (OR = 4.9; 95% CI = 2.8-8.5), other affective disorders (OR = 7.6; 95% CI = 6.1-9.5), and personality disorders (OR = 17.3; 95% CI = 14.5-20.5). All in all, 40.7% of cases, compared with 5.2% of controls, had received psychiatric treatment (OR = 12.5; 95% CI = 11.3-13.8). A history of psychiatric treatment was associated with increased rates of reentry into substance abuse treatment, in general (OR = 1.35; 95% CI = 1.20-1.53), specifically for cannabis (OR = 1.26; 95% CI = 1.07-1.48) and opioid (OR = 1.56; 95% CI = 1.23-1.99) dependence. This is the first study to show that the proportion of psychiatric treatment is much elevated among subjects seeking treatment for cannabis dependence, and that a history of psychiatric problems is associated with higher rates of reentry into substance abuse treatment.

Restorative treatment and use of local anesthesia in free and subsidized public dental services in Helsinki, Finland.

Our aim was to evaluate restorative treatment and the use of local anesthetics in free and subsidized public dental care in Helsinki, Finland. Public dental clinics are open to all patients under the age of 36, and to some specific groups above that age. Patients up to age 19 receive all treatment free of charge and others at highly subsidized rates. Data were collected in May 2001 during a maximum 2-week period covering all public dental clinics in Helsinki. A one-page questionnaire was sent to all dentists (n = 140) in clinical fields. The data requested included the patient's gender and year of birth, and details on restorations: which tooth and which surfaces were filled, the reason for placement or replacement, the material used, and use of local anesthetic. The response rate was 96%. Of all restorations (n = 3057) placed, 14% were in primary teeth and in permanent teeth: 17% in premolars, 17% in incisors, and 52% in molars; the restorative material most often used was composite resin (69%). Glass-ionomer/compomers dominated in the primary teeth. Local anesthetic was used least (35%) in patients under 13 years of age. Replacements of restorations accounted for 10% of all in the free service (under 20 years of age) and 46% in subsidized dental care (20 and older). The major reasons for replacement were secondary caries (41%) and fractured or lost restoration (40%).

Epidemiological evaluation of the outcomes of nonsurgical root canal treatment in a large cohort of insured dental patients.

Selected outcomes following initial nonsurgical root canal treatment (NSRCT) procedures were retrospectively assessed using an insurance company database of 110,766 nonsurgical root canal procedures that were completed by endodontists and their referring general dentists. A subset of 44,613 cases, with a minimum required follow-up time of 2 yr, showed incidences of extraction, retreatment and periradicular surgery equal to 5.56%, 2.47%, and 1.41%, respectively. The incidence of subsequent extraction increased with patient age. Teeth that were not restored after root canal therapy were significantly more likely to undergo extraction than restored teeth. Although the practice pattern for endodontists consisted of a significantly higher proportion of molars (48% more; p < 0.001) and a smaller proportion of anterior teeth (43% less; p < 0.001) than general dentists, both groups of providers had comparable rates of untoward events. These data strongly support the hypothesis that the specialist practice provides similar rates of clinical success compared with other providers, even when treating significantly more complex NSRCT cases. Overall, 94.44% of nonsurgical root canal treated teeth remained functional over an average follow-up time of 3.5 yr. These results are an important indication of the benefits of endodontic treatment when provided in an integrated health care delivery system of endodontists and their referring general dentists.