Meta‐analysis: the effect of supplementation with probiotics on eradication rates and adverse events during Helicobacter pylori eradication therapy
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Summary Background Recent evidence found probiotics could inhibit Helicobacter pylori colonization from both in vitro and in vivo studies. Aim To systematically evaluate whether adding probiotics to anti‐ H. pylori regimens could improve eradication rates and reduce side effects during anti‐ H. pylori treatment. Methods Eligible articles were identified by searches of electronic databases. We included all randomized trials comparing probiotics supplementation to placebo or no treatment during anti‐ H. pylori regimens. Statistical analysis was performed with Review Manager 4.2.8. Subanalysis/Sensitivity analysis was also performed. Results We identified 14 randomized trials ( n = 1671). Pooled H. pylori eradication rates were 83.6% (95% CI = 80.5–86.7%) and 74.8% (95% CI = 71.1–78.5%) for patients with or without probiotics by intention‐to‐treat analysis, respectively, the odds ratio (OR) was 1.84 (95% CI = 1.34–2.54); the occurrence of total side effects were 24.7% (95% CI = 20.0–29.4%) and 38.5% (95% CI = 33.0–44.1%) for groups with or without probiotics, especially for diarrhoea, the summary OR was 0.44 (95% CI = 0.30–0.66). Conclusions Our review suggests that supplementation with probiotics could be effective in increasing eradication rates of anti‐ H. pylori therapy, and could be considered helpful for patients with eradication failure. Furthermore, probiotics show a positive impact on H. pylori therapy‐related side effects.In 459 migraine attacks, information provided to patients (from negative to neutral to positive) modified placebo and medication outcomes in a progressive fashion.
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Μελέτη της πολυπαραγοντικής αναλγησίας στο μετεγχειρητικό πόνο μετά από λαπαροσκοπική χολοκυστεκτομή
Σκοπός:Ο βασικός σκοπός της μελέτης ήταν να ελεγχθεί αν ο συνδυασμός γκαμπαπεντίνης (600mg 4ώρες προεγχειρητικά, 600mg 24ώρες μετά), κεταμίνης (0.3mg/kg πριν την αναισθησία), λορνοξικάμης (8mg πριν την αναισθησία και 8mg/12ώρες) και τοπικής έγχυσης ροπιβακαΐνης (5ml 7.5% στα σημεία εισόδου των trocar) έχει καλύτερη αναλγητική δράση σε σχέση με το καθένα από αυτά τα φάρμακα ξεχωριστά τις πρώτες 24 ώρες μετά από λαπαροσκοπική χολοκυστεκτομή. Δευτερεύων σκοπός ήταν να εξετασθεί αν αυτός συνδυασμός έχει λιγότερες επιπλοκές σχετιζόμενες με την κατανάλωση οπιοειδών.Μέθοδος:Διεξήχθη μία ελεγχόμενη τυχαιοποιημένη μελέτη σε 2 νοσηλευτικά κέντρα. 148 ασθενείς ηλικίας 18-70 ετών κατανεμήθηκαν τυχαία σε 6 ομάδες (28 σε κάθε ομάδα) με τη χρήση λογισμικού: A (γκαμπαπεντίνη/κεταμίνη/λορνοξικάμη/ροπιβακαΐνη), B (γκαμπαπεντίνη/placebo/placebo/placebo), Γ (placebo/κεταμίνη/placebo/placebo), Δ (placebo/placebo/λορνοξικάμη/placebo), E (placebo/placebo/placebo/ροπιβακαΐνη) και ΣΤ (placebo/placebo/placebo/placebo). Μόνο ο κύριος ερευνητής γνώριζε την ομάδα κάθε ασθενούς και παρείχε τα φάρμακα και τα εικονικά φάρμακα σε καλυμμένες προγεμισμένες σύριγγες. Η κύρια έκβαση της μελέτης ήταν η 24ωρη κατανάλωση μορφίνης. Δευτερεύουσες εκβάσεις ήταν η συχνότητα των σχετιζόμενων με τα οπιοειδή επιπλοκών (ναυτία, έμετος, καταστολή, κνησμός και δυσκολία ούρησης).Αποτελέσματα:Μόνο οι ομάδες Α (6.4mg), B (9.46mg) και Δ (9.36mg) είχαν χαμηλότερη κατανάλωση μορφίνης σε σχέση με την ομάδα ελέγχου (20.29mg) (p<0.001, p=0.01 και p=0.008 αντίστοιχα). Η ομάδα Α δε διέφερε από τις ομάδες Β και Δ (p=0.92, p=0.93). Υπήρξε διαφορά μόνο στα επεισόδια ναυτίας και μόνο μεταξύ των ομάδων Α (n=5) και της ομάδας ελέγχου (n=12) (p=0.018). Συμπεράσματα:Ο συνδυασμός γκαμπαπεντίνης, κεταμίνης, λορνοξικάμης, και τοπικής έγχυσης ροπιβακαΐνης δεν έχει ισχυρότερη αναλγητική δράση σε σχέση με μόνη την γκαμπαπεντίνη ή τη λορνοξικάμη μετά από λαπαροσκοπική χολοκυστεκτομή. Ο συνδυασμός μειώνει μόνο τη συχνότητα της μετεγχειρητικής ναυτίας αλλά απαιτούνται μεγαλύτερες μελέτες για την εξαγωγή ασφαλών συμπερασμάτων.
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Patients with chronic pain show large placebo effects in clinical trials, and inert pills can lead to clinically meaningful analgesia that can last from days to weeks. Whether the placebo response can be predicted reliably, and how to best predict it, is still unknown. We have shown previously that placebo responders can be identified through the language content of patients because they speak about their life, and their pain, after a placebo treatment. In this study, we examine whether these language properties are present before placebo treatment and are thus predictive of placebo response and whether a placebo prediction model can also dissociate between placebo and drug responders. We report the fine-tuning of a language model built based on a longitudinal treatment study where patients with chronic back pain received a placebo (study 1) and its validation on an independent study where patients received a placebo or drug (study 2). A model built on language features from an exit interview from study 1 was able to predict, a priori, the placebo response of patients in study 2 (area under the curve = 0.71). Furthermore, the model predicted as placebo responders exhibited an average of 30% pain relief from an inert pill, compared with 3% for those predicted as nonresponders. The model was not able to predict who responded to naproxen nor spontaneous recovery in a no-treatment arm, suggesting specificity of the prediction to placebo. Taken together, our initial findings suggest that placebo response is predictable using ecological and quick measures such as language use.
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To examine whether there are gender differences in event-related potential (ERP) responses to painful stimulation after administration of placebo medication; and to investigate whether placebo medication reduces anticipatory stress and if this reduction can explain the placebo analgesic response. Several experimental and clinical studies have shown that males report lower pain compared with females. There are, however, few reports of gender differences in placebo analgesia.All subjects (n = 33; 17 women) participated in both a natural history and a placebo condition. ERPs were evoked by heat pulses with a peak at 52 °C.The results showed that pain unpleasantness and the N2/P2 ERP components were reduced in the placebo condition compared with the natural history condition. Only men displayed placebo responses in pain report and in the P2 component. Anticipatory stress was reduced after placebo administration, and the reduction in anticipatory stress was significantly related to the placebo effect on pain. Regression analyses revealed that the interaction of gender by anticipatory stress was significantly related to the mean placebo response, with men responding with lower stress after placebo medication, and larger placebo responses.A placebo response on pain unpleasantness was observed in men only, and reduced stress after placebo administration was observed in males only. Thus, reduced stress may be a mechanism for placebo responses in pain.
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Objective The aim of this analysis was to perform a meta-analysis evaluating gender difference of delayed healing risk in patients with venous leg ulcers. Methods We searched the PubMed and Web of Knowledge from their inception to 4 July 2015. The meta-analysis of pooled odds ratio and 95% confidence interval for venous leg ulcers healing risk were calculated. Results Twelve studies with 4453 patients were included in the meta-analysis. The pooled odds ratio for healing rate stratified by gender was 1.055 (95% CI 0.955–1.165; Z = 1.05, p = 0.292) by fix-effects model. The Begg's test (z = 2.67, p = 0.007), the Egger's test (t = 4.00, p = 0.003), and asymmetric funnel plot suggested there was significant publication bias. Subgroup analysis showed the pooled odds ratios were 1.048 (95% CI 0.945–1.162; Z = 0.88, p = 0.376) in prospective studies and 1.439 (95% CI 0.757–2.736; Z = 1.11, p = 0.266) in retrospective studies. Sensitivity analyses by only pooled adjusted odds ratios showed the pooled odds ratio was 1.049 (95% CI 0.946–1.163; Z = 0.91, p = 0.365), which indicated the results of meta-analysis were robust. Meta-regression analysis showed the healing rate odds ratio stratified by gender was not related with healing rate (t = 0.73, p = 0.484). Conclusion Our meta-analysis indicates that no gender difference existed for delayed healing in venous leg ulcers. Our results may be also useful in developing a risk score for failure of venous leg ulcers to heal.
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Fear of pain (FOP) and its effect on placebo analgesia was investigated. It was hypothesized that FOP should interfere with placebo-mediated pain inhibition and result in weaker placebo responding in pain intensity, pain unpleasantness, stress, and event-related potentials to contact heat pain. Thirty-three subjects participated in a balanced 2 condition (natural history, placebo)×3 test (pretest, posttest 1, posttest 2) within-subject design, tested on 2 separate days. FOP was measured by the Fear of Pain Questionnaire and subjective stress by the Short Adjective Check List. Placebo effects were found on reported pain unpleasantness and N2 and P2 amplitudes. FOP was related to reduced placebo responding in pain unpleasantness, but this was only evident for the subjects who received the placebo condition on day 1. Subjects who received the placebo condition on day 1 experienced more pretest stress than those who received the placebo condition on day 2 (ie, reversed condition order), and this explained the interaction effect on placebo responding. FOP was related to reduced placebo responding on P2 amplitude, whereas placebo responding on N2 amplitude was unaffected by FOP. Higher placebo responses on N2 and P2 amplitudes were both related to higher placebo analgesic magnitude in pain unpleasantness. In conclusion, increased FOP was found to reduce subjective and electrophysiological placebo analgesic responses.
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Many clinical trials, including those in pediatric populations, use a placebo arm for medical conditions for which there are readily available therapeutic interventions. Several short-term efficacy trials of antihypertensive medications performed in response to Food and Drug Administration–issued written requests have used a placebo arm; whether the use of a placebo arm is safe in children with hypertension is unknown. We sought to define the rates of adverse events in 10 short-term antihypertensive trials to determine whether these trials resulted in increased risk to pediatric patients receiving placebo. We combined patient-level data from 10 antihypertensive efficacy trials performed in pediatric patients that were submitted to the Food and Drug Administration from 1998 to 2005. We determined the number and type of all of the adverse events reported during the placebo-controlled portion of the clinical trials and compared these numbers between the patients who received placebo and those who received active drug. Among the 1707 children in the 10 studies, we observed no differences in the rates of adverse events reported between the patients who received placebo and those who received active drug. Only 5 patients suffered a serious adverse event during the trials; none were thought by the investigators to be related to study drug, and only 1 occurred in a patient receiving placebo. Short-term exposure to placebo in pediatric trials of antihypertensive medications appears to be safe.
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A previous meta-analysis of clinical analgesic trial studies showed generally low magnitudes of placebo analgesia (N. Engl. J. Med. 344 (2001) 1594). However, as studies included in their analysis used only placebo as a control condition, we conducted two meta-analyses, one in which 23 studies used only placebo as a control condition, and one in which 14 studies investigated placebo analgesic mechanisms. Magnitudes of placebo analgesic effects were much higher in the latter (mean effect size=0.95) as compared to the former (mean effect size=0.15) and were significantly different (P=0.003). This difference as well as differences in effect sizes within studies of placebo mechanisms may be parsimoniously explained by differences in expected pain levels produced by placebo suggestions and by conditioning. Furthermore, some of the studies of placebo analgesic mechanisms indicate that the magnitude of placebo analgesia is higher when the placebo analgesic effect is induced via suggestion combined with conditioning than via suggestion alone or conditioning alone. Based on these findings, we suggest that placebo analgesic effects are most optimally conceptualized in terms of perception of the placebo agent, and therefore a new definition of placebo response is proposed.
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