Open mesh versus non-mesh repair of groin hernia meta-analysis of randomized trials leased on individual patient data

Abstract Background. The EU Hernia Trialists Collaboration was established to provide reliable evaluation of newer methods of groin hernia repair. It involved 70 investigators in 20 countries. Materials and methods. Twenty eligible trials (5016 participants) of open mesh vs. non-mesh groin hernia repair were identified. Meta-analysis was performed using raw individual patient data where possible. Results. Fewer hernia recurrences were reported after mesh repair. There were no clear differences between mesh and non-mesh groups in complications. Overall, those in the mesh groups had a shorter hospital stay, quicker return to usual activities and less frequent persisting pain, but individual trial results varied. Conclusions. The review provides strong evidence that open mesh repair is associated with a reduction in the risk of recurrence of between 50% and 75%. There is also some evidence of quicker recovery and of lower rates of persisting pain following open mesh repair. Electronic Publication     

ENTERAL VERSUS PARENTERAL NUTRITION AFTER OESOPHAGOGASTRIC SURGERY: A PROSPECTIVE RANDOMIZED COMPARISON

Background: There appears to be an emerging consensus that early postoperative nutritional support benefits the high-risk patient by decreasing septic morbidity, maintaining immunocompetence and improving wound healing. Enteral nutrition via a feeding jejunostomy has been associated with serious complications, with a reported mortality rate as high as 10%. while total parenteral nutrition has also been associated with a wide variety of complications. Methods: Ninety-seven patients undergoing oesophagectomy or gastrectomy underwent pre-operative nutritional assessment and were randomized to receive either total parenteral nutrition (47 patients) or enteral nutrition (50 patients). Results: There was no significant difference in the number of catheter-related complications between the two groups, but 9 (45%) patients in the total parenteral nutrition group had major morbidity (potentially fatal in two patients) requiring active intervention. Conclusions: This study demonstrates enteral nutrition to be safe and associated with mainly reversible minor complications. It is probable that immediate postoperative enteral feeding conserves the gut's integrity. Whether this leads to a reduction in postoperative septic complications has not been demonstrated by this study although there appears to be a trend in this direction, supporting the concept of enteral feeding as ‘primary therapy’. This can be safely, simply and economically achieved using a feeding jejunostomy placed at the time of surgery.     

Absence of effects of prolonged simvastatin therapy on nocturnal sleep in a large randomized placebo-controlled study

1It has been suggested that lipophilic HMG CoA reductase inhibitors, like lovastatin and simvastatin, may cause sleep disturbance. 2Six hundred and twenty-one patients at increased risk of coronary heart disease were randomized in a single centre to receive 40 mg daily simvastatin, 20 mg daily simvastatin or matching placebo. To assess the effects of prolonged use of simvastatin on nocturnal sleep quality and duration, a sleep questionnaire was administered to 567 patients (95% of 595 survivors) at an average of 88 weeks (range: 44–129 weeks) after randomization. 3The main outcome measures were sleep-related problems and use of sleep-enhancing medications reported during routine study follow-up visits, and responses to the sleep questionnaire about changes in sleep duration and about various sleep events during the preceding month. 4No differences were observed between the treatment groups in the frequency of sleep-related problems reported, in the proportion of follow-up visits at which such problems were reported, or in the use of sleep-enhancing medications. The numbers who stopped study treatment were similar in the different treatment groups, and no patient stopped principally because of insomnia. In response to the sleep questionnaire, there were no significant differences between the treatment groups in reports of various sleep events during the preceding month, except that slightly fewer patients allocated simvastatin reported waking often. No differences in sleep duration were observed. 5This placebo-controlled trial does not indicate any adverse effects of prolonged treatment with simvastatin on systematically sought measures of sleep disturbance.     

Phase I trial of the polyelectrolyte carbetimer administered i.v. once every four weeks

Summary Carbetimer, a new synthetic low molecular weight polyelectrolyte with a novel structure displayed antitumor activiy in a number of animal tumor model systems and in vitro investigations. Based on these findings it was brought to a phase I clinical trial in patients with advanced malignant disease after failure of conventional treatment or with no conventional treatment available. Forty-eight patients received 98 courses. The schedule was a one hour i.v. infusion every four weeks. The starting dose was 180 mg/m² and dose escalation was performed according to a modified Fibonacci formula up to 16,690 mg/m². At least three patients were treated at each dose level and each patient was eligible to receive repeat courses at the same dose, until progressive disease or dose-limiting toxicity intervened. No hematological toxicity was encountered. Some adverse effects such as reversible proteinuria, hypercalcaemia, pain at infusion site, nausea and vomiting and fatigue were seen partly in a dose-related manner but did not represent the maximum tolerated dose (MTD). The limiting toxicity at the highest dose level of 16,690 mg/m² consisted of ocular symptoms (light flashes) accompanied by a modest decrease of blood pressure and nausea or vomiting during a one hour infusion. 16,690 mg/m²/1 hour was considered the MTD. There were four deaths on study, all considered diseaserelated. Fourteen patients had stable disease for more than two courses, which, however, could also be explained by the natural course of disease. No clear-cut antitumor responses were noted in our study center.The recommended dose for phase II trials derived from our results is 12,550 mg/m²/2 hours. However, with regard to experiences in other phase I studies, the subsequent phase II studies will be performed with a dose of 6,500 mg/m².     

Clinical and microbiological effects of daily brushing with either NaF or SnF2 gels in subjects with fixed or removable dental prostheses

61 adults, with fixed or removable dental protheses, completed a 6-month double-blind trial comparing the clinical and microbial effects of brushing twice daily with either 0.22% NaF or 0.4% SnF2. Those subjects brushing with SnF2 had less gingivitis and fewer bleeding sites for both "total teeth" and "abutment teeth". Plaque scores between groups were only statistically different for the "abutment teeth". The microbial parameters, salivary S. mutans and subgingival plaque total CFU, were significantly reduced in the SnF2 group. In both treatment groups, there was a reduction over the course of the study in the number of subjects with recoverable A. actinomycetemcomitans and black pigmented bacteroides, yet there was no difference between groups.     

Guided tissue regeneration in the treatment of furcation defects in mandibular molars

The present investigation was designed to evaluate the regenerative potential of the periodontal tissues in degree III furcation defects at mandibular molars using a treatment procedure based on the principle of guided tissue regeneration. The patient sample included 21 patients, 26-65 years of age, who presented periodontal lesions in the right and left molar regions including "through and through" furcation defects. After an initial examination, each patient was subjected to a series of full-mouth scaling and root planing. 2-3 months later, they were recalled for a baseline examination. The furcation-involved molars were randomly assigned in each patient to either a test or a control treatment procedure. The test procedure included the elevation of muco-periosteal flaps at the buccal and lingual aspects of the molars. Granulation tissue was removed and the exposed root surfaces were debrided and planed. The width and the height of the entrance openings to the furcation defects were assessed. A teflon membrane was adjusted to cover the entrances to the defects (buccal and lingual) and was retained in the manner described by Pontoriero et al. (1988). The flaps were repositioned on the outer surface of the membrane and secured by sutures which were removed after 10 days. Following surgery, the patients were instructed to rinse the mouth twice daily for 4 weeks with chlorhexidine gluconate. The membranes were removed after a healing period of 1-2 months. A surgical procedure identical to the test procedure was performed in the control tooth regions with the exception of the placement of membranes.(ABSTRACT TRUNCATED AT 250 WORDS)     

Efficacy and tolerability of estraderm MX, a new estradiol matrix patch

Objectives: To assess the efficacy and tolerability of a new matrix patch delivering 0.05 mg estradiol per day (Estraderm MX 50) in postmenopausal women with moderate to severe postmenopausal symptoms. Methods: A multicenter, double-blin, randomized, between-patient, placebo controlled trial in 109 postmenopausal women was carried out. Patches were applied twice weekly for 12 weeks. Patients were assessed at 4, 8 and 12 weeks of treatment. The primary efficacy variable was change from baseline in mean number of moderate to severe hot flushes (including night sweats) per 24 h during the last 2 weeks of treatment. Other variables included Kupperman Index, local and systemic tolerability. Plasma concentrations of estradiol (E2), estrone (E1) and estrone sulfate (E1S) were determined before and after treatment. Results: Estraderm MX was significantly superior to placebo (P < 0.001) in reducing mean number of moderate to severe hot flushes (including night sweats) per 24 h after 4, 8 and 12 weeks of treatment. The estimate of treatment group differences after 12 weeks was 4.2 hot flushes (95% confidence interval: 2.6–5.5). Estraderm MX also significantly reduced Kupperman Index at all time points compared to placebo (P < 0.001). Estraderm MX induced increases in mean E2, E1 and E1S plasma levels as expected (E2: baseline 2.7 pg/ml, 12 weeks 38.9 pg/ml; E1: baseline 18.8 pg/ml, 12 weeks 41.6 pg/ml; E1S: baseline 235.6 pg/ml, 12 weeks 765.1 pg/ml). Overall rates of adverse experiences were similar for Estraderm MX and placebo. The number of patients reporting skin irritation was low and similar in both groups. Conclusions: Estraderm MX 50, a new matrix patch, offers an effective and well tolerated dosage form for transdermal delivery of 0.05 mg E2 per day.     

Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter,randomized, double-blind,double-dummy,active-controlled,non-inferiority trial

Background/Purpose

Nemonoxacin is a novel nonfluorinated quinolone with excellent in vitro activity against most pathogens in community-acquired pneumonia (CAP), especially Gram-positive isolates. The purpose of this study was to assess the efficacy and safety of nemonoxacin compared with levofloxacin in patients with CAP.

Oral Sodium Cromoglycate Treatment of Atopic Dermatitis Related to Food Allergy

Thirty-two children and two adults with chronic atopic dermatitis related to food allergy entered this double-blind crossover study comparing oral sodium cromoglycate (200–1600 mg/24 h) with placebo. Each treatment period comprised 6 weeks: 1 weeks on elimination diet, and 2 weeks on a normal. i.e. unrestricted diet. The diagnosis of food allergy was made after clinical improvement with elimination diet and relapse after challenge. Overall analysis of skin symptoms evaluated by means of clinical assessments and diary cards, opinions of treatment, and use of concomitant medication gave no evidence of any difference between sodium cromoglycate and placebo. Unusual symptoms were reported by 18 patients. In one case the patient was withdrawn during the sodium cromoglycate period because of side effects. The majority of symptoms with both treatments were stomach problems. Overall analysis of the laboratory data gave no significant differences between treatments.