Traumeel S for pain relief following hallux valgus surgery: a randomized controlled trial.

BACKGROUND: In spite of recent advances in post-operative pain relief, pain following orthopedic surgery remains an ongoing challenge for clinicians. We examined whether a well known and frequently prescribed homeopathic preparation could mitigate post-operative pain. METHOD: We performed a randomized, double blind, placebo-controlled trial to evaluate the efficacy of the homeopathic preparation Traumeel S in minimizing post-operative pain and analgesic consumption following surgical correction of hallux valgus. Eighty consecutive patients were randomized to receive either Traumeel tablets or an indistinguishable placebo, and took primary and rescue oral analgesics as needed. Maximum numerical pain scores at rest and consumption of oral analgesics were recorded on day of surgery and for 13 days following surgery. RESULTS: Traumeel was not found superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial, however a transient reduction in the daily maximum post-operative pain score favoring the Traumeel arm was observed on the day of surgery, a finding supported by a treatment-time interaction test (p = 0.04). CONCLUSIONS: Traumeel was not superior to placebo in minimizing pain or analgesic consumption over the 14 days of the trial. A transient reduction in the daily maximum post-operative pain score on the day of surgery is of questionable clinical importance. TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov. # NCT00279513.

Combining longitudinal discriminant analysis and partial area under the ROC curve to predict non-response to treatment for hepatitis C virus.

A longitudinal discriminant analysis is applied to build predictive models based on repeated measurements of serum hepatitis C virus RNA. These models are evaluated through the partial area under the receiver operating curve index (PA index) and, the final selection of the best model is based on cross-validated estimates of the PA index. Models are compared by building 95% bootstrap confidence interval for the difference in PA index between two models. Data from a randomised trial, in which chronic HCV patients were enrolled, are used to illustrate the application of the proposed method to predict treatment outcome.

Effect of Traumeel S on cytokine profile in a cecal ligation and puncture (CLP) sepsis model in rats.

BACKGROUND: Sepsis results in significant morbidity and mortality, with current treatment options limited with respect to efficacy as well as safety. The complex homeopathic remedy Traumeel S has been shown to have both anti-inflammatory and immunostimulatory effects in the in vitro setting. OBJECTIVES: The objective was to explore the effects of Traumeel S in an in vivo setting, using a cecal ligation and puncture (CLP) sepsis model in rats, evaluating the effects of the medication on cytokine activity. DESIGN: Sepsis was induced in 30 rats using accepted CLP methodology. Following the procedure, rats were randomly allocated to receive an intraperitoneal injection of either Traumeel S (n=15) or normal saline (n=15). At 6 hours post-CLP, serum cytokines (interleukin [IL]-1ß, tumor necrosis factor-α, IL-6, and IL-10) were evaluated. RESULTS: IL-1ß levels were significantly higher in the treatment group (p=0.03) with no significant differences found between the groups with respect to the other cytokines tested. CONCLUSIONS: In contrast to in vitro studies, Traumeel significantly increased IL-1ß levels in an in vivo model, without influencing other cytokines. IL-1ß is a proinflammatory cytokine that has been shown to have a protective effect in the CLP rat model. Further research is warranted to examine this finding, as well as its clinical implications.

HCV-specific T-cell response in relation to viral kinetics and treatment outcome (DITTO-HCV project).

BACKGROUND & AIMS: The second slope of viral decline induced by interferon treatment has been suggested to be influenced mainly by the hepatitis C virus (HCV)-specific T-cell response; however, this hypothesis needs to be validated by results derived from experimental studies. METHODS: To address this issue, the HCV-specific T-cell response of 32 genotype-1-infected patients of the 270 patients enrolled in the dynamically individualized treatment of hepatitis C infection and correlates of viral/host dynamics phase III, open-label, randomized, multicenter trial was studied in relation to viral kinetics and treatment outcome. RESULTS: Greater proliferative responses by HCV-specific CD8 cells were found before treatment in patients with a fast viral decline and with a sustained viral response. However, no significant improvement of HCV-specific CD8 responses was observed in the first weeks of therapy in both rapid viral responder and non-rapid viral responder patients. A mild enhancement of proliferative T-cell responses and a partial restoration of the cytotoxic T-cell potential was expressed only late during treatment, likely favored by HCV clearance. CONCLUSIONS: Early restoration of an efficient T-cell response does not seem to be an essential requirement for a rapid viral decline in the first weeks of treatment. However, patients presenting a better HCV-specific CD8 cell proliferative potential at baseline are more likely to present a rapid and sustained viral response. Therefore, future treatment protocols should consider the development of strategies aimed at improving HCV-specific T-cell responses.

Alcohol intake in relation to body mass index and waist-to-hip ratio: the importance of type of alcoholic beverage.

OBJECTIVE: Alcohol consumption may play a role in the development of obesity but the relationship between alcohol and weight is still unclear. The aim of our study was to assess the cross-sectional association of intakes of total alcohol and of specific alcoholic beverages (wine, beer and spirits) with waist-to-hip ratio (WHR) and body mass index (BMI) in a large sample of adults from all over France. DESIGN: Cross-sectional. SETTING: Participants were free-living healthy volunteers of the SU.VI.MAX study (an intervention study on the effects of antioxidant supplementation on chronic diseases). SUBJECTS: For 1481 women aged 35-60 years and 1210 men aged 45-60 years, intakes of total alcohol and specific alcoholic beverages were assessed by six 24-hour dietary records. BMI and WHR were measured during a clinical examination the year after. RESULTS: A J-shaped relationship was found between total alcohol consumption and WHR in both sexes and between total alcohol consumption and BMI in men only (P<0.05). The same relationships were observed with wine (P<0.05); men and women consuming less than 100 g day(-1) had a lower BMI (men only) and WHR than non-drinkers or those consuming more. Spirits consumption was positively associated with BMI (linear regression coefficient beta=0.21, 95% confidence interval (CI): 0.09-0.34 and beta=0.22, 95% CI: 0.06-0.39 for men and women, respectively) and WHR (beta=0.003, 95% CI: 0.001-0.005 and beta=0.003, 95%CI: 0.0002-0.006) in both sexes in a linear fashion. No relationship between beer consumption and BMI or WHR was found. CONCLUSION: If confirmed in longitudinal studies, our results indicate that consumption of alcoholic beverages may be a risk factor for obesity.

International, multicenter, randomized, controlled study comparing dynamically individualized versus standard treatment in patients with chronic hepatitis C.

BACKGROUND/AIMS: The aim of this study was to increase virologic response rates by individualized treatment according to the early virologic response. METHODS: Serum HCV-RNA was frequently quantified in patients with chronic hepatitis C (n=270) treated with peginterferon alfa-2a (180 microg/week) and ribavirin (1000-1200 mg/day). After 6 weeks patients were classified as rapid (RVR), slow (SPR), flat (FPR), or null responders (NUR) and randomized within each viral kinetic class to continue therapy either with an individualized or standard regimen. Individualized therapy comprised peginterferon monotherapy (48 weeks) or shorter combination therapy (24 weeks) for RVR, triple therapy with histamine (1 mg/day) (48 weeks) or prolonged combination therapy (72 weeks) for SPR, triple therapy for FPR, and high-dose peginterferon (360 microg/week) plus ribavirin for NUR patients. RESULTS: Patients were categorized as RVR (n=171), SPR (n=65), FPR (n=10), or NUR (n=22). Overall end-of-treatment and sustained virologic response rates were 77 and 60% in the individualized and 77 and 66% in the standard treatment arm, respectively. Histamine in addition to peginterferon and ribavirin and high-dose peginterferon plus ribavirin did not improve virologic response rates in patients with FPR and NUR, respectively. CONCLUSIONS: An improvement in virologic efficacy was not achieved with the available individualized treatment options.

Could measuring of perceived risk among general practitioners have helped anticipate the French BSE crisis?

In October of 2000, a second BSE crisis caught French public authorities unprepared and caused a collapse in beef consumption as well as considerable political turmoil. Data collected between May and July, 2000, among a group of general practitioners (GPs), while national consumption of beef was back to pre-BSE levels, paradoxically showed high latent risk perception, suggesting a new crisis was possible or likely.