Cognitive-behavioral intervention to enhance adherence to antiretroviral therapy: a randomized controlled trial (CCTG 578)

OBJECTIVE: We conducted a randomized, multi-site, controlled trial of a cognitive-behavioral adherence intervention for patients initiating or changing an antiretroviral (ART) regimen. DESIGN: A 3 x 2 factorial design was used with the primary randomization assigning patients (1: 1: 1) to one of two adherence interventions or usual care. METHODS: The five-session adherence interventions consisted of cognitive-behavioral and motivational components, with or without a 2-week pre-treatment placebo practice trial. Intent-to-treat analysis used probability weights and regression tree analysis to account for missing data. RESULTS: A total of 230 patients were randomized; 199 started ART, of whom 74% completed the 48-week study. Electronic monitored adherence outcomes between the two intervention groups did not differ significantly and were thus pooled in analyses. At week 4, 82% of intervention patients had taken at least 90% of their prescribed ART doses, compared with 65% of controls (P < 0.01); this group difference dropped to 12% at week 12 (72 versus 60%; P = 0.15) and 11% at week 24 (66 versus 55%; P = 0.28). Mean adherence in the intervention group was significantly higher than the control group at week 24 (89 versus 81%; P < 0.05) only. There were no group differences with respect to HIV-1 RNA throughout the study. CONCLUSIONS: The effects of the cognitive-behavioral intervention on adherence were modest and transient, and no effects were observed on viral load or CD4 cell count. More robust effects may require a more intense intervention that combines ongoing adherence monitoring and individualized intervention "dosage" that matches the need and performance of each patient.     

Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: A randomized study

Background

Antimicrobial resistance has decreased eradication rates for Helicobacter pylori infection worldwide. A sequential treatment schedule has been reported to be effective, but studies published to date were performed in Italy. We undertook this study to determine whether these results could be replicated in India.

Methods

A randomized, open-labeled, prospective controlled trial comparing sequential vs. standard triple-drug therapy was carried out at Lokmanya Tilak Municipal General Hospital, Mumbai. Two hundred and thirty-one patients with dyspepsia were randomized to a 10-day sequential regimen (40 mg of pantoprazole, 1 g of amoxicillin, each administered twice daily for the first 5 days, followed by 40 mg of pantoprazole, 500 mg of clarithromycin, and 500 mg of tinidazole, each administered twice daily for the remaining 5 days) or to standard 14-day therapy (40 mg of pantoprazole, 500 mg of clarithromycin, and 1 g of amoxicillin, each administered twice daily).

Results

The eradication rate achieved with the sequential regimen was significantly greater than that obtained with the triple therapy. Per-protocol eradication rate of sequential therapy was 92.4 % (95 % CI 85.8–96.1 %) vs. 81.8 % (95 % CI 73.9–87.8 %) (p?=?0.027) for standard drug therapy. Intention-to-treat eradication rates were 88.2 % (95 % CI 80.9–93.0 %) vs. 79.1 % (95 % CI 71.1–85.4 %), p?=?0.029, respectively. The incidence of major and minor side effects between therapy groups was not significantly different (14.6 % in the triple therapy group vs. 23.5 % in sequential group, p?=?0.12). Follow up was incomplete in 3.3 % and 4.7 % patients in standard and sequential therapy groups, respectively. Sequential therapy includes one additional antibiotic (tinidazole) that is not contained in standard therapy.

Conclusions

Sequential therapy was significantly better than standard therapy for eradicating H. pylori infection.     

Heparin therapy: A randomized prospective study

Eighty patients were assigned randomly either to continuous or to intermittent heparin therapy, with control by the Lee-White Clotting Time (LWCT). Major bleeding complications occurred in 7.5 per cent and minor complications in 18 per cent of the entire group. The incidence of major bleeding complications in the continuous group (5 per cent) did not differ significantly from the incidence in the intermittent group (10 per cent). In contrast, bleeding complications were significantly more frequent in patients with soft-tissue trauma due to such procedures as thoracenteses and cut-downs, vascular damage due to other causes, and LWCTs over 35 minutes for 2 consecutive days.The incidence of bleeding complications appear to be the same in patients receiving intermittent as in those receiving continuous heparin therapy. Thoracenteses, cut-downs, and other forms of soft-tissue injury predispose to bleeding complications while laboratory monitoring with the LWCT may help to reduce bleeding complications.     

Disposable-sheath, flexible gastroscope system versus standard gastroscopes: a prospective, randomized trial.

BACKGROUND: Endoscopically transmitted infections due to inadequate disinfection are rare but well-recognized complications. A new prototype of a flexible, fiberoptic endoscope has been developed that uses a disposable sheath to cover and protect all working surfaces of the endoscope from contamination. The present study investigated the function, reprocessing, and hygienic status of this endoscope system in comparison with standard systems. METHODS: In a prospective, randomized trial, 100 upper endoscopic procedures (50 standard, 50 sheathed) were performed. Analog rating scales were used to evaluate endoscopic performance and reprocessing. Reprocessing time, procedure duration, insertion depth, total instrument downtime, and problems occurring during the procedure were recorded. Microbiologic swabs were obtained from each endoscope. RESULTS: Mean procedure duration was slightly longer with the sheathed system than with standard endoscope (9.9 vs. 8.4 min). Set up and reprocessing times, however, were significantly shorter with the Endosheath (8.9 vs. 48.4 min with the standard endoscope). The disposable-sheath endoscope system permits the rate of performance of procedures to be increased by a factor of up to 3.0. Both endoscopists and reprocessing personnel preferred the standard endoscope. No post-procedure sheath leakage or rupture was seen. CONCLUSION: Our results suggest that the "disposable endoscope" may have important advantages in terms of decreased instrument turn-around time and potentially improved safety.     

Carbenicillin-trimethoprim/sulfamethoxazole versus carbenicillin-gentamicin as empiric therapy of infection in granulocytopenic patients: A prospective,randomized, double-blind study

The results of therapy with carbenicillin plus trimethoprim-sulfamethoxazole (C-T/S) were compared to those obtained with carbenicillin plus gentamicin (C-G) in a prospective double-blind study of empiric antibiotic therapy in granulocytopenic patients. Patients were stratified into two groups: favorable-prognosis, group 1 (carcinoma, lymphoma, multiple myeloma), or unfavorable-prognosis, group 2 (acute leukemia, bone marrow transplantation), based on anticipated duration of granulocytopenia. Over-all, empiric antibiotic trials were more often successful (P = 0.004) in group 1 (55 of 62 patients or 89 per cent) than in group 2 (42 of 64 patients, 66 per cent). Within group 1, there was a favorable outcome in 30 of 32 (94 per cent) C-T/S trials and in 25 of 30 (83 per cent) C-G trials (P = 0.25); within group 2, there was a favorable outcome in 23 of 30 (77 per cent) C-T/S trials and in 19 of 34 (56 per cent) C-G trials (P = 0.14). Combined results in both groups indicated a higher proportion of favorable outcome in C-T/S trials (53 of 62, 85 per cent) than in C-G trials (44 of 64, 69 per cent). Further analysis (Mantel-Haenszel test) showed the over-all difference in outcome to be significant (P = 0.049), but the general applicability of this result may be limited by the rather low incidence of gram-negative bacterial infections in this study. There was no difference between the treatment regimens in antibiotic toxicity, and serious superinfection occurred only in group 2 patients (21 per cent of trials), equally divided between treatment arms. Initial protocol dosing achieved target plasma levels of trimethoprim (3 to 8 μg/ml) or gentamicin (4 to 10 μg/ml) in 57 of 68 (84 per cent) C-T/S trials compared to 21 of 60 (35 per cent) C-G trials.     

Whole-gut irrigation versus enema in elective colorectal surgery: A prospective,randomized study

Whole-gut irrigation was compared with conventional mechanical bowel preparation in a prospective, randomized study. All 100 patients had a combination of ampicillin and metronidazole during and after colorectal surgery. Patients' complaints were equally frequent during the two preparations and were severe in 15 per cent. Gastric position of the tube for irrigation resulted in severe complaints in 3 of 26 patients and in the duodenal position, in severe complaints in five of 24. The time for irrigation was shorter than that for conventional preparation. Deep wound infections were equally frequent after irrigation (3/46) and conventional preparation (4/47). Seven patients were excluded, since no bowel resection had been performed. Collapse of the small and large intestine, as evaluated blindly during surgery, was more frequent after irrigation (P<0.05). Anastomotic leaks after left side resections were less frequent in patients with collapse of the small (P<0.001) and large (P<0.05) intestine. Five leakages among 29 patients after conventional preparation in contrast to one among 22 after whole-gut irrigation favor the latter, even if this difference did not reach statistical significance (0.05<P<0.10), since anastomotic leakage is lethal in a high number of patients.     

COMBAT--conventional versus multisite pacing for bradyarrhythmia therapy: rationale of a prospective randomized multicenter study

COMBAT is a prospective, multicenter, randomized, blinded clinical study, with crossover design. The main objective is the comparative evaluation of atrio-biventricular versus conventional atrioventricular stimulation (atrio and right ventricle) in patients with heart failure and bradycardia as the primary indication for pacemaker implantation. After successful atrio-biventricular system implantation, patients will be randomized into two groups: group A--atrioventricular conventional pacing and group B--atrio-biventricular pacing. Both groups will be programmed in DDD mode with AV delay optimized by echocardiogram. After 3 months, New York Heart Association functional class, ventricular arrhythmia density and complexity, echocardiography outcomes, 6-min hall walk distance, quality of life and peak oxygen consumption will be assessed in all patients. Then, all patients will crossover to the other pacing regimen, with an additional AV delay adjustment by echo. Patients will be followed up for another 3 months at the end of which all evaluations will be repeated. Patients will then crossover back to their original pacing regimen for a further 3 months. At the end of this 9-month period, patients will be reprogrammed according to their optimal pacing regime. In an extended follow-up, patient survival will be evaluated after 24 months of the optimal pacing therapy.     

Radiofrequency versus conventional diathermy Milligan-Morgan hemorrhoidectomy: a prospective, randomized study

Background  

In the past decade, several new surgical tools have revived the hope for an improved technique to treat radically hemorrhoids with less postoperative pain. Among these radiofrequency (RF), excisional surgery seems to be safe, fast, and accompanied by less postoperative pain. The aim of this study was to evaluate and compare RF (ligasure TM) to conventional diathermy Milligan-Morgan hemorrhoidectomy (MMH).     

Helicobacter pylori eradication: a randomized prospective study of triple therapy versus triple therapy plus lactoferrin and probiotics

OBJECTIVES: Helicobacter pylori is causally associated with gastritis and peptic ulcer diseases. Recent data (meta-analysis) have demonstrated that triple therapy with amoxicillin, clarithromycin, and a proton pump inhibitor has an eradication rate of only 74-76% and new therapeutic protocols may be necessary. The aim of this study was to examine whether adding bovine lactoferrin (bLf) and probiotics (Pbs) to the standard triple therapy for H. pylori infection could improve the eradication rate and reduce side effects. METHODS: H. pylori infection was diagnosed in 206 patients: in 107 based on an upper endoscopy exam and a rapid urease test, and in 99 by means of the H. pylori stool antigen-test and the C(13) urea breath test (C(13) UBT). The patients were randomized into two groups: 101 patients (group A) underwent standard triple eradication therapy (esomeprazole, clarithromycin, amoxicillin), while 105 patients (group B) underwent a modified eradication therapy (standard triple eradication therapy plus bLf and Pb). Successful eradication therapy was defined as a negative C(13) UBT 8 wk after completion of the treatment. Results were evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis. Data were evaluated and considered positive when P<0.05. RESULTS: At the end of the study 175/206 patients showed negative C(13) UBT results. According to intention-to-treat analysis, the infection was eradicated in 73/101 patients from Group A and in 93/105 from Group B. PP analysis showed 73/96 patients from Group A and 93/101 from Group B to have been successfully treated. More patients from group A than from group B reported side effects from their treatment (P<0.05). CONCLUSIONS: The results of our study suggest that the addition of bLf and Pbs could improve the standard eradication therapy for H. pylori infection--bLf serving to increase the eradication rate and Pbs to reduce the side effects of antibiotic therapy.     

Pacing of the interventricular septum versus the right ventricular apex: A prospective, randomized study

BackgroundLeft ventricular (LV) function may be impaired by right ventricular (RV) apical pacing. The interventricular septum is an alternative pacing site, but randomized data are limited. Our aim was to compare ejection fraction (EF) resulting from pacing the interventricular septum versus the RV apex.MethodsRV lead implantation was randomized to the apex or the mid-septum. LVEF and RVEF were determined at baseline and after 1 and 4 years by radionuclide angiography.ResultsWe enrolled 59 patients, of whom 28 were randomized to the apical group and 31 to the septal group, with follow-up available in 47 patients at 1 year and 33 patients at 4 years. LVEF in the apical and in the septal groups was 55 ± 8% vs. 46 ± 15% (p = 0.021) at 1 year and 53 ± 12% vs. 47 ± 15% (p = 0.20) at 4 years. Echocardiography confirmed a mid-septal lead position in only 54% of patients in the septal group, with an anterior position in the remaining patients. In the septal group, LVEF decreased significantly in patients with an anterior RV lead (? 10.0 ± 7.7%, p = 0.003 at 1 year and ? 8.0 ± 9.5%, p = 0.035 at 4 years), but not in patients who had a mid-septal lead. Left intraventricular dyssynchrony was significantly increased in case of an anterior RV lead. RVEF was not significantly impaired by RV pacing, regardless of RV lead position.ConclusionsPacing at the RV septum confers no advantage in terms of ventricular function compared to the apex. Furthermore, inadvertent placement of the RV lead in an anterior position instead of the mid-septum results in reduced LV function.     

Erratum to: Prospective randomized trial comparing short-term antibiotic therapy versus standard therapy for acute uncomplicated sigmoid diverticulitis

Purpose  

To date, the standard therapy used for acute episodes of uncomplicated sigmoid diverticulitis has been a 7–10-day antibiotic treatment regimen. Thanks to the development of highly potent, broad-spectrum antibiotics such as ertapenem, the question arises as to whether the duration of treatment of acute uncomplicated sigmoid diverticulitis can be reduced by using highly effective antibiotics.     

Concomitant versus sequential therapy for the treatment of Helicobacter pylori infection: a Greek randomized prospective study

Objective: The objective of this study is to compare, in Greece, a region with >20% local resistance to clarithromycin, the efficacy rates of the concomitant versus the sequential H. pylori eradication therapy. Materials and methods: Our prospective randomized study included 364 patients with newly diagnosed H. pylori infection, randomized to receive a 10-day concomitant or 10-day sequential therapy. Treatment outcome was assessed by C¹³-urea breath test at least 4 weeks after therapy. Intention to treat (ITT) and per protocol (PP) analysis of the eradication rates were performed. Secondary end points included patient compliance and safety. Results: The concomitant therapy group achieved statistically significant higher eradication rates when compared with the sequential treatment group, both in the ITT and in the PP analysis (84.6% versus 70.9%, p?=?0.002, and 90.6% versus 78.1%, p?=?0.001, respectively), after adjusting for age, gender, smoking status, and the presence or not of ulcer and/or non-ulcer dyspepsia. Both groups displayed excellent compliance rates (99.5% for the concomitant therapy group and 96.2% for the sequential therapy group, p?=?0.067). Regarding treatment safety, major adverse events that led to the discontinuation of both regimens were few, with no statistical difference between the two groups (7.0% for the concomitant therapy group and 2.9% for the sequential therapy group). Conclusions: Concomitant therapy led to statistically significant higher eradication rates over sequential therapy. Both therapies showed excellent compliance and an acceptable safety profile. The 10-day quadruple concomitant scheme should be the adopted for first-line H. pylori eradication in Greece.     

Antiviral therapy of varicella-zoster virus infection in immunocompromised children — A prospective randomized study of aciclovir versus brivudin

Summary Both aciclovir and brivudin are effective in the treatment of immunocompromised children with varicella-zoster virus infection. To determine which drug is preferable, a prospective randomized trial aciclovir vs. brivudin was conducted. Forty-three immunocompromised children were randomly assigned to receive aciclovir intravenously at a dose of 1,500 mg/m|22|0/d and brivudin orally at a dose of 15 mg/kg/d, respectively. Twenty-two patients were treated with aciclovir and 21 with brivudin. In all children the general status improved within two days. The eruption of new lesions stopped within one to five days, fever stopped within one to nine days, complete remission occurred within five to six days after introduction of the virustatic therapy. There was no difference in therapeutic efficacy between aciclovir and brivudin. Two children in each group did not respond to the medication. No myelo-, hepato- and nephrotoxic side effects due to aciclovir or brivudin were observed. All obviously immunocompromised children with varicella or zoster may be treated with aciclovir or brivudin.

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Antivirale Therapie von Varicella-Zoster-Virus-Infektionen bei immuninsuffizienten Kindern — eine randomisierte Studie Aciclovir versus Brivudin

Zusammenfassung Aciclovir und Brivudin sind hochwirksame Medikamente für die Behandlung von immuninsuffizienten Kindern mit Varicella-Zoster-Virus-Krankheiten. In einer prospektiven randomisierten Studie Aciclovir versus Brivudin an immundefizienten Kindern erfolgte eine klinische Prüfung mit der Frage, inwieweit eines der beiden Virustatika bevorzugt angewendet werden kann. Aciclovir wurde als Kurzinfusion in einer Dosierung von 1500 mg/m₂ KOF/d und Brivudin per os in einer Dosierung von 15 mg/kg/d verordnet. 43 Kinder erhielten eine antivirale Therapie, 22 mit Aciclovir und 21 mit Brivudin. Nach Therapiebeginn besserte sich der Allgemeinzustand der Patienten innerhalb von zwei Tagen. Die Entwicklung der Effloreszenzen sistierte innerhalb von ein bis fünf Tagen. Die Entfieberung trat nach ein bis neun Tagen ein, und in der Regel war die Varicella-Zoster- Virus-Infektion nach fünf bis sechs Tagen abgeklungen. Unterschiede in der therapeutischen Wirksamkeit zwischen beiden Virustatika wurden nicht registriert. In jeder Behandlungsgruppe gab es jeweils zwei Therapieversager. Myelo-, hepato- und nephrotoxische Nebenwirkungen im Zusammenhang mit der virustatischen Behandlung traten nicht auf. Deshalb kann zusammenfassend festgestellt werden, daß immuninsuffiziente Kinder mit Varizellen oder Zoster gleichermaßen mit Aciclovir oder Brivudin behandelt werden können.