This review raises questions as to the efficacy of local anesthetic sympathetic blockade as treatment of CRPS. Its efficacy is based mainly on case series. Less than one third of patients obtained full pain relief. The absence of control groups in case series leads to an overestimation of the treatment response that can explain the findings.
Purpose: Racotumomab-alum is an anti-idiotype vaccine targeting the NeuGcGM3 tumor-associated ganglioside. This clinical trial was conducted to provide a preliminary estimate of efficacy and safety of racotumomab as switch maintenance for patients with advanced non-small cell lung cancer (NSCLC).Experimental design: Patients with stage IIIb/IV NSCLC who have at least stable disease after first-line chemotherapy were randomized 1:1 to racotumomab-alum (5 immunizations every 2 weeks and reimmunizations every 4 weeks) or placebo. Treatment was administered beyond progressive disease, until severe performance status worsening or toxicity. At progression, only five patients per group received further anticancer therapy. The primary endpoint was overall survival (OS).Results: One-hundred and seventy-six patients were randomized to racotumomab-alum (n ¼ 87) and placebo (n ¼ 89). Median OS was 8.23 and 6.80 months, respectively [HR, 0.63; 95% confidence interval (CI), 0.46-0.87; P ¼ 0.004]. Median progression-free survival (PFS) in vaccinated patients was 5.33 versus 3.90 months for placebo (HR, 0.73; 95% CI 0.53-0.99; P ¼ 0.039). The most common adverse events in the racotumomab-alum arm were burning and pain at the injection site, bone pain, and asthenia. A high antibody response of IgM and IgG isotype against the NeuGcGM3 ganglioside was obtained. Hyperimmune sera were able to specifically recognize and kill the NeuGcGM3-expressing L1210 cell line. Patients who developed anti-NeuGcGM3 antibodies capable to bind and kill 30% L1210 cells showed longer median survival times.Conclusions: Switch maintenance with racotumomab-alum is an effective and a well-tolerated treatment option for patients with advanced NSCLC. Clin Cancer Res; 20(14); 3660-71. Ó2014 AACR.
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AimAssess the association of flossing with periodontitis.Materials and MethodsThis was a cross‐sectional study using the National Health and Nutrition Examination Survey (NHANES) years 2011‐2014. We used three categories of flossing: 0–1, 2–4 and ≥5 days in the past week and the CDC definition of periodontitis. We calculated odds ratios controlling for age, gender, smoking, drinking, income and dentist visits.ResultsA total of 6939 adult subjects were included, 35% flossed ≤1 time a week, and 40% had periodontitis. After adjustment, the odds of periodontitis were 17% lower for subjects who flossed >1 time a week than for subjects who flossed less often (odds ratio=0.83, 95% CI 0.72–0.97). A dose response was not observed. Men were twice as likely as women to have periodontitis. Younger subjects, non‐smokers and subjects with the highest incomes had lower odds of having periodontitis.ConclusionsFlossing was associated with a modestly lower prevalence of periodontitis. Older age, being male, smoking, low income and less frequent dental visits were associated with a higher prevalence of periodontitis. Flossing 2–4 days a week could be as beneficial as flossing more frequently. This is a cross‐sectional study so a causal relation between flossing and periodontitis cannot be established.
To assess the association of probiotics with depression, a large population-based cross-sectional study was conducted. National Health and Nutrition Examination Survey adult participants from 2005 through 2012 were included. Exposure was defined as having consumed any probiotic food or supplement on any of the interview days. Subjects were classified as depressed if Patient Health Questionnaire scores were ≥10. Of the 18,019 subjects included, 14.11% consumed probiotics. Unadjusted analysis suggested that subjects who consumed probiotics had lower odds of depression (OR=0.58, 95% CI=0.45-0.75). After adjustment for characteristics associated with depression and probiotic exposure, the effect was attenuated (OR=0.82, 95% CI=0.61-1.1) and no longer significant. Use of probiotics is not associated with lower rates of depression in this national sample.
BackgroundTreatment for depressive disorders often requires subsequent interventions. Patients who do not respond to antidepressants have treatment‐resistant depression (TRD). Predicting who will develop TRD may help healthcare providers make more effective treatment decisions. We sought to identify factors that predict TRD in a real‐world setting using claims databases.MethodsA retrospective cohort study was conducted in a US claims database of adult subjects with newly diagnosed and treated depression with no mania, dementia, and psychosis. The index date was the date of antidepressant dispensing. The outcome was TRD, defined as having at least three distinct antidepressants or one antidepressant and one antipsychotic within 1 year after the index date. Predictors were age, gender, medical conditions, medications, and procedures 1 year before the index date.ResultsOf 230,801 included patients, 10.4% developed TRD within 1 year. TRD patients at baseline were younger; 10.87% were between 18 and 19 years old versus 7.64% in the no‐TRD group, risk ratio (RR) = 1.42 (95% confidence interval [CI] 1.37–1.48). TRD patients were more likely to have an anxiety disorder at baseline than non‐TRD patients, RR = 1.38 (95% CI 1.35–1.14). At 3.68, fatigue had the highest RR (95% CI 3.18–4.25). TRD patients had substance use disorders, psychiatric conditions, insomnia, and pain more often at baseline than non‐TRD patients.ConclusionTen percent of subjects newly diagnosed and treated for depression developed TRD within a year. They were younger and suffered more frequently from fatigue, substance use disorders, anxiety, psychiatric conditions, insomnia, and pain than non‐TRD patients.
BackgroundDepression that does not respond to antidepressants is treatment‐resistant depression (TRD). TRD definitions include assessments of treatment response, dose and duration, and implementing these definitions in claims databases can be challenging. We built a data‐driven TRD definition and evaluated its performance.MethodsWe included adults with depression, ≥1 antidepressant, and no diagnosis of mania, dementia, or psychosis. Subjects were stratified into those with and without proxy for TRD. Proxies for TRD were electroconvulsive therapy, deep brain, or vagus nerve stimulation. The index date for subjects with proxy for TRD was the procedure date, and for subjects without, the date of a randomly selected visit. We used three databases. We fit decision tree predictive models. We included number of distinct antidepressants, with and without adequate doses and duration, number of antipsychotics and psychotherapies, and expert‐based definitions, 3, 6, and 12 months before index date. To assess performance, we calculated area under the curve (AUC) and transportability.ResultsWe analyzed 33,336 subjects with no proxy for TRD, and 3,566 with the proxy. Number of antidepressants and antipsychotics were selected in all periods. The best model was at 12 months with an AUC = 0.81. The rule transported well and states that a subject with ≥1 antipsychotic or ≥3 antidepressants in the last year has TRD. Applying this rule, 15.8% of subjects treated for depression had TRD.ConclusionThe definition that best discriminates between subjects with and without TRD considers number of distinct antidepressants (≥3) or antipsychotics (≥1) in the last year.
Placebo response is influenced by the pain syndrome evaluated. These differences should be considered when evaluating novel compounds for the treatment of neuropathic pain conditions.
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