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- Alajbeg, Ivan, et al.
(författare)
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Intraoralelectrostimulator for xerostomia relief : along-term, multicenter, open-label, uncontrolled, clinical trial
- 2012
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Ingår i: Oral surgery, oral medicine, oral pathology and oral radiology. - : Elsevier. - 2212-4403 .- 2212-4411. ; 113:6, s. 773-781
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: A previous sham-controlled multinational study demonstrated the short-term efficacy and safety for xerostomia treatment of an intraoral device that delivers electrostimulation to the lingual nerve. The objective of this study was to test the hypothesis that those beneficial effects would be sustained over an 11-month period. STUDY DESIGN: The device was tested on a mixed sample of 94 patients with xerostomia in an open-label, uncontrolled, prospective multicenter trial. Statutory outcome assessments were done at 5th, 8th, and 11th months and analyzed by multiple comparisons. RESULTS: Improvements achieved at month 5 from baseline were sustained throughout the follow-up period for the primary outcome, xerostomia severity, and the secondary outcomes resting whole salivary flow rate, xerostomia frequency, oral discomfort, and difficulties in speech, swallowing, and sleeping. No significant side effects were detected. CONCLUSIONS: The beneficial effects of a removable intraoral electrostimulating device were sustained for an 11-month period.
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| 3. |
- Reveiz, Ludovic, et al.
(författare)
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Stress ulcer, gastritis, and gastrointestinal bleeding prophylaxis in critically ill pediatric patients : a systematic review
- 2010
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Ingår i: Pediatric Critical Care Medicine. - : Lippincott Williams & Wilkins. - 1529-7535 .- 1947-3893. ; 11:1, s. 124-132
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To identify and evaluate the quality of evidence supporting prophylactic use of treatments for stress ulcers and upper gastrointestinal bleeding. Stress ulcers, erosions of the stomach and duodenum, and upper gastrointestinal bleeding are well-known complications of critical illness in children admitted to the pediatric intensive care unit.DATA SOURCES: Studies were identified from the Cochrane Central Register of Controlled Trials, PUBMED; LILACS; Scirus. We also scanned bibliographies of relevant studies.STUDY SELECTION: This systematic review of randomized controlled trials assessed the effects of drugs for stress-related ulcers, gastritis, and upper gastrointestinal bleeding in critically ill children admitted to the pediatric intensive care unit.DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted the relevant data. Most randomized controlled trials were judged as having unclear risk of bias. When pooling two randomized controlled trials, treatment was significantly more effective in preventing upper gastrointestinal bleeding (macroscopic or important bleeding) compared with no treatment (two studies = 300 participants; relative risk, 0.41; 95% confidence interval, 0.19-0.91; I = 12%). Meta-analysis of two studies found no significant difference in death rates among groups (two randomized controlled trials = 132 participants; relative risk, 1.39; 95% confidence interval, 0.70-2.79; I = 4%). The rate of pneumonia was not significantly different when comparing treatment and no treatment in one study. When comparing ranitidine with no treatment, significant differences were found in the proportion of mechanically ventilated children with normal gastric mucosal endoscopic findings by histologic specimens (one randomized controlled trial = 48 participants; relative risk, 3.53; 95% confidence interval, 1.34-9.29). No significant differences were found when comparing different drugs (omeprazole, ranitidine, sucralfate, famotidine, amalgate), doses, or regimens for main outcomes (deaths, endoscopic findings of erosion or ulcers, upper gastrointestinal bleeding, or pneumonia).CONCLUSIONS: Although pooled data of two studies suggested that critically ill pediatric patients may benefit from receiving prophylactic treatment to prevent upper gastrointestinal bleeding, we found that high-quality evidence to guide clinical practice is still limited.
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| 4. |
- Strietzel, Frank P, et al.
(författare)
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Efficacy and safety of an intraoral electrostimulation device for xerostomia relief : A multicenter randomized trial
- 2011
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Ingår i: Arthritis and Rheumatism. - : Wiley. - 0004-3591 .- 1529-0131. ; 63:1, s. 180-190
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The objective of the study was to evaluate the efficacy in treating xerostomia and the safety of an intraoral electrostimulation device, containing stimulating electrodes, an electronic circuit and a power source. The device delivers electrostimulation through the oral mucosa to the lingual nerve, in order to enhance the salivary reflex. Methods: The device was tested on a sample of patients with xerostomia due to Sjögren’s syndrome and other sicca conditions in a prospective randomized multi-center trial consisting of two stages: (I) a double blind, cross-over designed stage to compare the effects of the electrically “active” device with the “sham” device, both used for one month, and (II) a 3- month open label stage to assess the long-term influence of the “active” device. Improvement of xerostomia severity from baseline was the primary outcome. Results: A total of 114 subjects were randomized. In Stage I, “active” device performed better than “sham” for patient-reported xerostomia severity (p<0.002), xerostomia frequency (p<0.05), quality of life impairment (p<0.01) and swallowing difficulty (p<0.02). At the end of Stage II, statistically significant improvements were verified for patient-reported xerostomia severity (p<0.0001), xerostomia frequency (p<0.0001), oral discomfort (p<0.001), speech difficulty (p<0.02) and sleeping difficulty (p<0.001), and for resting salivary flow-rate (p<0.01). Conclusion: Daily use of the device alleviated oral dryness, discomfort and some complications of xerostomia, such as speech and sleeping difficulties, and increased salivary output. The results show a cumulative positive effect of the device over the period of the study, from baseline to the trial’s end.
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