Summary Background Whether concomitant therapy is superior to bismuth quadruple therapy or 14-day triple therapy for the first-line treatment of Helicobacter pylori infection remains poorly ...understood. We aimed to compare the efficacy and safety of 10-day concomitant therapy, 10-day bismuth quadruple therapy, and 14-day triple therapy in the first-line treatment of H pylori. Methods In this multicentre, open-label, randomised trial, we recruited adult patients (aged >20 years) with H pylori infection from nine medical centres in Taiwan. Patients who had at least two positive tests from the rapid urease test, histology, culture, or serology or who had a single positive13 C-urea breath test for gastric cancer screening were eligible for enrolment. Patients were randomly assigned (1:1:1) to either concomitant therapy (lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg, all given twice daily) for 10 days; bismuth quadruple therapy (bismuth tripotassium dicitrate 300 mg four times a day, lansoprazole 30 mg twice daily, tetracycline 500 mg four times a day, and metronidazole 500 mg three times a day) for 10 days; or triple therapy (lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg, all given twice daily) for 14 days. A computer-generated permuted block randomisation sequence with a block size of 6 was used for randomisation, and the sequence was concealed in an opaque envelope until the intervention was assigned. Investigators were masked to treatment allocation. The primary outcome was the eradication frequency of H pylori with first-line therapy assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov , number NCT01906879. Findings Between July 17, 2013, and April 20, 2016, 5454 patients were screened for eligibility. Of these, 1620 patients were randomly assigned in this study. The eradication frequencies were 90·4% (488/540 95% CI 87·6–92·6) for 10-day bismuth quadruple therapy, 85·9% (464/540 82·7–88·6) for 10-day concomitant therapy, and 83·7% (452/540 80·4–86·6) for 14-day triple therapy in the intention-to-treat analysis. 10-day bismuth quadruple therapy was superior to 14-day triple therapy (difference 6·7% 95% CI 2·7–10·7, p=0·001), but not 10-day concomitant therapy. 10-day concomitant therapy was not superior to 14-day triple therapy. The frequency of adverse events was 67% (358/533) in patients treated with 10-day bismuth quadruple therapy, 58% (309/535) in patients treated with 10-day concomitant therapy, and 47% (252/535) in patients treated with 14-day triple therapy. Interpretation Bismuth quadruple therapy is preferable to 14-day triple therapy in the first-line treatment in the face of rising prevalence of clarithromycin resistance. Concomitant therapy given for 10 days might not be optimum and a longer treatment length should be considered. Funding National Taiwan University Hospital and Ministry of Science and Technology of Taiwan.
Summary Background Whether sequential treatment can replace triple therapy as the standard treatment for Helicobacter pylori infection is unknown. We compared the efficacy of sequential treatment for ...10 days and 14 days with triple therapy for 14 days in first-line treatment. Methods For this multicentre, open-label, randomised trial, we recruited patients (≥20 years of age) with H pylori infection from six centres in Taiwan. Using a computer-generated randomisation sequence, we randomly allocated patients (1:1:1; block sizes of six) to either sequential treatment (lansoprazole 30 mg and amoxicillin 1 g for the first 7 days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 500 mg for another 7 days; with all drugs given twice daily) for either 10 days (S-10) or 14 days (S-14), of 14 days of triple therapy (T-14; lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg for 14 days; with all drugs given twice daily). Investigators were masked to treatment allocation. Our primary outcome was the eradication rate in first-line treatment by intention-to-treat (ITT) and per-protocol (PP) analyses. This trial is registered with ClinicalTrials.gov , number NCT01042184. Findings Between Dec 28, 2009, and Sept 24, 2011, we enrolled 900 patients: 300 to each group. The eradication rate was 90·7% (95% CI 87·4–94·0; 272 of 300 patients) in the S-14 group, 87·0% (83·2–90·8; 261 of 300 patients) in the S-10 group, and 82·3% (78·0–86·6; 247 of 300 patients) in the T-14 group. Treatment efficacy was better in the S-14 group than it was in the T-14 group in both the ITT analysis (number needed to treat of 12·0 95% CI 7·2–34·5; p=0·003) and PP analyses (13·7 8·3–40, p=0·003). We recorded no significant difference in the occurrence of adverse effects or in compliance between the three groups. Interpretation Our findings lend support to the use of sequential treatment as the standard first-line treatment for H pylori infection. Funding National Taiwan University Hospital and National Science Council.
Background Abelmoschus manihot , a single medicament of traditional Chinese medicine, has been widely used to treat kidney disease. This is the first randomized controlled clinical trial to assess ...its efficacy and safety in patients with primary glomerular disease. Study Design Prospective, open-label, multicenter, randomized, controlled, clinical trial. Setting & Participants From May 2010 to October 2011, a total of 417 patients with biopsy-proven primary glomerular disease from 26 hospitals participated in the study. Interventions A manihot in the form of a huangkui capsule, 2.5 g, 3 times per day; losartan potassium, 50 mg/d; or combined treatment, a huangkui capsule at 2.5 g 3 times per day, was combined with losartan potassium, 50 mg/d. The duration of intervention was 24 weeks. Outcomes & Measurements The primary outcome was change in 24-hour proteinuria from baseline after treatment. Change in estimated glomerular filtration rate (eGFR) from baseline after treatment was a secondary outcome. The 24-hour proteinuria was measured every 4 weeks and eGFR was measured at 0, 4, 12, and 24 weeks. Results Mean baseline urine protein excretion was 1,045, 1,084, and 1,073 mg/d in the A manihot , losartan, and combined groups, respectively, and mean eGFR was 108, 106, and 106 mL/min/1.73 m2 , respectively. After 24 weeks of treatment, mean changes in proteinuria were protein excretion of −508, −376, and −545 mg/d, respectively ( P = 0.003 for A manihot vs losartan and P < 0.001 for the combined treatment vs losartan). Mean eGFR did not change significantly. The incidence of adverse reactions was not different among the 3 groups ( P > 0.05), and there were no severe adverse events in any group. Limitations Results cannot be generalized to those with nephrotic syndrome or reduced eGFR. Conclusions A manihot is a promising therapy for patients with primary kidney disease (chronic kidney disease stages 1-2) with moderate proteinuria.
Background Extracorporeal membrane oxygenation (ECMO) has been utilized for patients in critical condition, such as those with life-threatening respiratory failure or postcardiotomy cardiogenic ...shock. This study analyzed the outcomes of patients treated with ECMO and identified the relationship between prognosis and the Acute Kidney Injury Network (AKIN) scores obtained at pre-ECMO support (AKIN 0-hour ); and at post-ECMO support 24 hours (AKIN 24-hour ) and 48 hours (AKIN 48-hour ). Methods This study reviewed the medical records of 102 critically ill patients on ECMO support at a specialized intensive care unit at a tertiary care university hospital between March 2002 and January 2008. Demographic, clinical, and laboratory variables were retrospectively collected as survival predicators. Results The overall mortality rate was 57.8%. The most common condition requiring ECMO support was cardiogenic shock. Goodness-of-fit was good for AKIN 0-hour , AKIN 24-hour , and AKIN 48-hour criteria. The AKIN 0-hour , AKIN 24-hour , and AKIN 48-hour scoring systems also had excellent areas under the receiver operating characteristic curve (0.804 ± 0.046, 0.811 ± 0.045, and 0.858 ± 0.040, respectively). Furthermore, multiple logistic regression analysis indicated that AKIN 48-hour , age, and Glasgow Coma Scale score on the first day of intensive care unit admission were independent risk factors for hospital mortality. Finally, cumulative survival rates at 6-month follow-up after hospital discharge differed significantly ( p < 0.05) for AKIN 48-hour stage 0 versus AKIN 48-hour stages 1, 2, and 3; and AKIN 48-hour stage 1 and 2 versus AKIN 48-hour stage 3. Conclusions During ECMO support, the AKIN 48-hour scoring system proved to be a reproducible evaluation tool with excellent prognostic abilities for these patients.
Patients with cancer use low-molecular-weight fucoidan (LMF) as a supplement to therapy. However, most studies of LMF are in vitro or conducted using animals. Concurrent chemoradiotherapy (CCRT) is ...the gold standard for locally advanced rectal cancer (LARC). This study investigated the quality of life (QoL) and clinical outcomes of patients with LARC taking LMF as a supplement to neoadjuvant CCRT. This was a double-blind, randomized, placebo-controlled study. The sample comprised 87 patients, of whom 44 were included in a fucoidan group and 43 were included in a placebo group. We compared their QoL scores and clinical outcomes before treatment, and at 1 month, 2 months, and 3 months posttreatment. Pretreatment and posttreatment gut microbiota differences were also compared. Although enhanced physical well-being (PWB) at 2 months and 3 months posttreatment in the fucoidan group were observed (both P < .0125), the improvements of the Functional Assessment of Cancer Therapy for Patients with Colorectal Cancer (FACT-C) were nonsignificant (all P > .0125). Skin rash and itching and fatigue were less common in the fucoidan group (both P < .05). Posttreatment, the genus Parabacteroides was significantly more common in the gut microbiota of the fucoidan group. LMF administration improved the QoL, skin rash and itching, fatigue, and gut microbiota composition of the patients with LARC receiving CCRT.
Clinical Trial Registration: NCT04342949
Background Acute respiratory distress syndrome (ARDS) is a life-threatening medical condition. Extracorporeal membrane oxygenation (ECMO) is a salvage therapy for patients with ARDS and refractory ...hypoxia. This study compared the characteristics and outcomes of ARDS patients who did or did not receive ECMO matched with Acute Physiology and Chronic Health Evaluation II (APACHE II) score and age. Methods This retrospective, case-control study enrolled patients with ARDS admitted to the intensive care unit of a tertiary referral hospital between January 2007 and December 2012. Overall, 216 patients with ARDS—81 receiving ECMO (ECMO group) and 135 not receiving ECMO (non-ECMO group)—were enrolled in this study. Patients were paired when the difference in their APACHE II scores was within 3 points and their age difference was 3 years. In total, 126 patients could not be matched and were thus excluded. Eventually, of the 90 patients with ARDS enrolled in this study, 45 ECMO group patients were matched with 45 non-ECMO group patients. The demographic data, reasons for intensive care unit admission, and laboratory variables were evaluated. Results The primary etiology of ARDS was infection (72.2%). The APACHE II score and age-matched group receiving ECMO therapy had higher inhospital survival rates. Moreover, the patients receiving ECMO therapy had significantly lower 6-month mortality rates than did the non-ECMO group. Conclusions Patients with ARDS who received ECMO treatment had higher inhospital survival rates than did those with a similar disease severity and at a similar age who did not receive ECMO.
Background: Pancreatic cancer is a difficult-to-treat cancer with a late presentation and poor prognosis. Some patients seek traditional Chinese medicine (TCM) consultation. We aimed to investigate ...the benefits of complementary Chinese herbal medicine (CHM) among patients with pancreatic cancer in Taiwan. Methods: We included all patients with pancreatic cancer who were registered in the Taiwanese Registry for Catastrophic Illness Patients Database between 1997 and 2010. We used 1:1 frequency matching by age, sex, the initial diagnostic year of pancreatic cancer, and index year to enroll 386 CHM users and 386 non-CHM users. A Cox regression model was used to compare the hazard ratios (HRs) of the risk of mortality. The Kaplan-Meier curve was used to compare the difference in survival time. Results: According to the Cox hazard ratio model mutually adjusted for CHM use, age, sex, urbanization level, comorbidity, and treatments, we found that CHM users had a lower hazard ratio of mortality risk (adjusted HR = 0.67, 95% CI = 0.56-0.79). Those who received CHM therapy for more than 90 days had significantly lower hazard ratios of mortality risk than non-CHM users (90- to 180-day group: adjusted HR = 0.56, 95% CI = 0.42-0.75; >180-day group: HR = 0.33, 95% CI = 0.24-0.45). The survival probability was higher for patients in the CHM group. Bai-hua-she-she-cao (Herba Oldenlandiae; Hedyotis diffusa Spreng) and Xiang-sha-liu-jun-zi-tang (Costus and Chinese Amomum Combination) were the most commonly used single herb and Chinese herbal formula, respectively. Conclusions: Complementary Chinese herbal therapy might be associated with reduced mortality among patients with pancreatic cancer. Further prospective clinical trial is warranted.
Previous studies have reported that increased high-sensitive C-reactive protein (hs-CRP) levels are associated with an inflammatory state. This study investigated the association among hs-CRP, ...substrate properties, and long-term clinical outcomes after catheter ablation of atrial fibrillation (AF). A total of 137 patients with AF (54 ± 13 years) who underwent mapping and catheter ablation were included. The hs-CRP was measured before the first ablation procedure. The substrate properties (initiating triggers, biatrial mean voltage, and high-frequency sites) of the 2 atria and long-term outcome were investigated in patients in the low hs-CRP group (<75%, 2.92 mg/L) and high hs-CRP group (>75%, 2.92 mg/L). Patients with a higher hs-CRP were associated with an increased number of identified nonpulmonary vein ectopies (34.4% vs 17%, p = 0.034), lower mean left atrial (LA) voltage (1.72 ± 0.73 vs 1.92 ± 0.72 Hz, p = 0.045), and higher-frequency sites in the left atrium (71% vs 37%, p = 0.027). After a median follow-up period of 15 months, the single-procedure success rate (72% vs 53%, p = 0.008) and final success rate after multiple procedures (94% vs 81%, p = 0.02) were higher in the low hs-CRP group. In a multivariable regression model adjusted for other potential covariates, hs-CRP level (p = 0.021) and LA diameter (p = 0.032) were independent predictors of recurrence. In conclusion, baseline CRP levels before the first AF ablation procedure had an independent prognostic value in predicting long-term recurrence. Patients with a high hs-CRP level were associated with an abnormal LA substrate and high incidence of nonpulmonary vein AF sources.
Background Extracorporeal membrane oxygenation (ECMO) has been utilized for patients in critical condition, including life-threatening respiratory failure and postcardiotomy cardiogenic shock. This ...study analyzed the outcomes of patients with acute respiratory distress syndrome (ARDS) treated by ECMO and identified the relationship between prognosis and urine output (UO) obtained on the first day of ECMO support. Methods This study reviewed the medical records of 81 ARDS patients after ECMO support on a specialized cardiovascular surgery intensive care unit of a tertiary care university hospital between May 2006 and December 2011. Demographic, clinical, and laboratory variables were retrospectively collected as survival predictors. Results The overall mortality rate was 55.5%. A multiple logistic regression analysis indicated that the Acute Physiology and Chronic Health Evaluation II (APACHE II) score, mean arterial pressure, platelet count, and UO on day 1 of ECMO support were independent risk factors for hospital mortality. By using the areas under the receiver operating characteristic (AUROC) curve, UO obtained on the first day of ECMO support demonstrated good discriminative power (AUROC 0.754 ± 0.056, p < 0.001). Urine output had the best discriminative power, the best Youden index, and the highest overall correctness of prediction. Cumulative survival rates at the 6-month follow-up differed significantly ( p < 0.001) for UO 1,432 mL or greater on day 1 of ECMO support versus those with UO less than 1,432 mL on day 1 of ECMO support. Conclusions In ARDS patients receiving ECMO support, UO obtained on the first day of ECMO support showed good prognostic ability in predicting hospital mortality.
This report is the second analysis of a prospective randomized trial to investigate the impact of (18)F-fluorodeoxyglucose positron emission tomography (FDG-PET) on cervical cancer patients with ...enlarged pelvic lymph nodes identified by magnetic resonance imaging.
Patients with newly diagnosed cervical cancer with enlarged pelvic lymph nodes but free of enlarged para-aortic lymph nodes (PALN) were eligible. Patients were randomized to receive either pretreatment FDG-PET (PET arm) or not (control arm). The whole pelvis was the standard irradiation field for all patients except those with FDG-avid extrapelvic findings.
In all, 129 patients were enrolled. Pretreatment PET detected extrapelvic metastases in 7 patients. No new patient experienced treatment failure during the additional 4-year follow-up period. There were no significant differences between the PET arm and the control arm regarding overall survival, disease-free survival, and freedom from extrapelvic metastasis. In the control arm, 8 of 10 patients with PALN relapse had limited extrapelvic nodal failures; their 5-year disease-specific survival was 34.3%. By contrast, only 1 of 5 patients with PALN relapse in the PET arm experienced such limited failures; their 5-year survival rate was 0%.
Although the pretreatment detection of PALN did not translate into survival benefit, it indeed decreased the need for extended-field concurrent chemoradiation therapy.
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