Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease.

BACKGROUND: The endoscopic radiofrequency procedure (Stretta) has been used for more than a decade to treat patients with gastroesophageal reflux disease (GERD). However, the efficacy of the procedure in improving objective and subjective clinical endpoints needs to be further established. AIM: To determine the efficacy of the Stretta procedure in treating patients with GERD, using a systematic review and meta-analysis of controlled and cohort studies. METHODS: We conducted a systematic search of the PubMed and Cochrane databases for English language clinical studies of the Stretta procedure, published from inception until May 2016. Randomized controlled trials (RCTs) and cohort studies that included the use of the Stretta procedure in GERD patients were included. A generalized inverse weighting was used for all outcomes. Results were calculated by both fixed effects and random effects model. RESULTS: Twenty-eight studies (4 RCTs, 23 cohort studies, and 1 registry) representing 2468 unique Stretta patients were included in the meta-analysis. The (unweighted) mean follow-up time for the 28 studies was 25.4 [14.0, 36.7] months. The pooled results showed that the Stretta reduced (improved) the health-related quality of life score by -14.6 [-16.48, -12.73] (P < 0.001). Stretta also reduced (improved) the pooled heartburn standardized score by -1.53 [-1.97, -1.09] (P < 0.001). After Stretta treatment, only 49% of the patients using proton pump inhibitors (PPIs) at baseline required PPIs at follow-up (P < 0.001). The Stretta treatment reduced the incidence of erosive esophagitis by 24% (P < 0.001) and reduced esophageal acid exposure by a mean of -3.01 [-3.72, -2.30] (P < 0.001). Lower esophageal sphincter (LES) basal pressure was increased post Stretta therapy by a mean of 1.73 [-0.29, 3.74] mmHg (P = NS). CONCLUSIONS: The Stretta procedure significantly improves subjective and objective clinical endpoints, except LES basal pressure, and therefore should be considered as a viable alternative in managing GERD.

Measurement of Lens Autofluorescence Can Distinguish Subjects With Diabetes From Those Without.

Lens autofluorescence is increased in patients with diabetes mellitus, but clinical application has been limited by the lack of an instrument suitable for routine clinical use. We investigate possible uses of a new scanning confocal biomicroscope (1) to identify subjects with undiagnosed type 2 diabetes and (2) as a marker for the progression of diabetes. One hundred seventy-eight subjects self-reported as normal and 53 subjects physician-diagnosed with diabetes or prediabetes were recruited. Measurements were collected using a ClearPath DS-120 Lens Fluorescence Biomicroscope calibrated with standards traceable to National Institute of Standards and Technology (NIST). Fluorescence intensities were corrected for age by subtracting the value expected from a regression of intensity versus age for normal subjects. This "fluorescence deviation" showed progressively higher values for normal, prediabetes, type 2 diabetes, and type 1 diabetes and a high degree of predictability of diabetes diagnosis. A receiver operating characteristics curve was used to determine sensitivity and specificity for prediction of diabetes type 2. At a fluorescence deviation of 2500, a sensitivity of 67% at 94% specificity was observed detection of type 2 diabetes. The progressively higher fluorescence deviations are consistent with the physiological mechanisms of accumulation of fluorescent advanced glycation end products as the subject ages. The sensitivity and specificity performance of the lens autofluorescence test for type 2 diabetes is comparable to the performance of glucose threshold tests. The statistically significant difference between fluorescence deviations of normal and type 2 diabetes supports the feasibility of lens autofluorescence to screen subjects for undiagnosed type 2 diabetes. Ophthalmic practices are points of care at which there may be a public health benefit for screening patients for undiagnosed diabetes.

Simultaneous noninvasive clinical measurement of lens autofluorescence and rayleigh scattering using a fluorescence biomicroscope.

BACKGROUND: Lens autofluorescence increases with the age of the subject, and the fluorophores responsible are associated with cataract, retinopathy, and other complications of diabetes. We built a scanning confocal lens fluorescence biomicroscope suitable for routine clinical measurement of lens autofluorescence and light scattering and report data from 127 healthy subjects. METHOD: The fluorescence biomicroscope focuses a beam of light from a blue light-emitting diode on the lens and measures fluorescent green light and blue scattered light using a sensitive silicon photomultiplier. The system includes a target fixation light and a video camera for alignment and automatic pupil tracking. Under software control, a volume of measurement is scanned from behind the posterior lens capsule, through the lens to the aqueous humor, and then back again. Software computes the average ratio of lens autofluorescence to scattered light in the central portion of the lens. Self-reported healthy nondiabetic subjects were examined by an optometrist; if their eyes were healthy and without significant cataract, they were entered into the study. RESULTS: Valid lens autofluorescence data were collected from 127 subjects between 21 and 70 years of age. A linear model for lens autofluorescence intensity with age was highly statistically significant, and the improvement in fit for higher-order polynomial models was not statistically significant. The ratio of lens autofluorescence to light scatter was also calculated; regression analysis showed significant curvature for the relationship of the fluorescence ratio to age, so a nonlinear model was used to estimate the mean ratio of autofluorescence to scatter and its prediction intervals as a function of age. CONCLUSIONS: Our observation of a strongly significant linear regression of fluorescence intensity with age of the subjects agrees with the results from previous studies, as does a nonlinear model for the fluorescence ratio. The fluorescence biomicroscope enables the clinician to identify patients with fluorescence ratio significantly higher than expected for their age.

Generation of an artificial skin construct containing a non-degradable fiber mesh: a potential transcutaneous interface.

Generation of a stable interface between soft tissues and biomaterials could improve the function of transcutaneous prostheses, primarily by minimizing chronic infections. We hypothesized that inclusion of non-biodegradable biomaterials in an artificial skin substrate would improve integration of the neodermis. In the present study, we compared the biocompatibility of an experimental substrate, consisting of collagen and glycosylaminoglycans, with commercially available artificial skin of similar composition. By utilizing a mouse excisional wound model, we found that the source of collagen (bovine tendon versus hide), extent of injury and wound contraction were critical determinants of inflammation and neodermis formation. Reducing the extent of injury to underlying muscle reduced inflammation and improved remodeling; the improved conditions allowed the detection of a pro-inflammatory effect of hide-derived collagen. To eliminate the complication of wound contraction, subsequent grafts were performed in guinea pigs and showed that inclusion of carbon fibers or non-degradable sutures resulted in increased foreign body response (FBR) and altered remodeling. On the other hand, inclusion of a polyester multi-stranded mesh induced a mild FBR and allowed normal neodermis formation. Taken together, our observations suggest that non-degradable biomaterials can be embedded in an artificial skin construct without compromising its ability to induce neodermis formation.