Controversies over the surgical placebo: legal issues and the ethical debate

The debate on controlled surgery trials has had some rather "sensational" repercussions, enlivening the placebo issue. In France, there is a consensus on the ethical conditions necessary for proper protection of individual persons. This consensus has taken on a legal form with the promulgation of the Huriet law. For this reason, all studies and research protocols in medicine and surgery are examined by ethics committees (CCPPRB) who assess the inclusion conditions within the framework of biomedical research and in compliance with the concept that individual participants must be give proper protection. These committees are faced with increasingly complex situations, particularly concerning the pertinence of information give to the participant and the modalities of consent. In France, standard measures were established after a parliamentary debate issuing from a wider public debate. The issue has become a social transaction between biomedical research professionals and the society in general. The international debate over the surgery placebo is an interesting illustration of how mediation institutions, working along the principles of ethical committees, play a key role in social awareness of the ethical issues involved before an innovating practice is initiated. But how legitimate are sensational pieces published in the media, which as is clearly demonstrated with the debate over the surgical placebo, are almost always individual points of view? Shouldn't the debate take into account the contributions of ethical committees which integrate representatives of the social community as well as the importance of a legal framework for individual protection as proposed by the French law? Shouldn't personal points of view be counterbalanced by regularly expressed ethical committee opinions formed after appropriate ethics-oriented discussion going beyond the simple question of "should we do it", a question often dismissed by extreme theoretical arguments that leave unanswered the practical question of "how should we do it"?     

CT-based delineation of lymph node levels and related CTVs in the node-negative neck: DAHANCA, EORTC, GORTEC, NCIC,RTOG consensus guidelines.

BACKGROUND AND PURPOSE: The appropriate application of 3-D CRT and IMRT for HNSCC requires a standardization of the procedures for the delineation of the target volumes. Over the past few years, two proposals--the so-called Brussels guidelines from Grégoire et al., and the so-called Rotterdam guidelines from Nowak et al.--emerged from the literature for the delineation of the neck node levels. Detailed examination of these proposals however revealed some important discrepancies. MATERIALS AND METHODS: Within this framework, the Brussels and Rotterdam groups decided to review their guidelines and derive a common set of recommendations for delineation of neck node levels. This proposal was then discussed with representatives of major cooperative groups in Europe (DAHANCA, EORTC, GORTEC) and in North America (NCIC, RTOG), which, after some additional refinements, have endorsed them. The objective of the present article is to present the consensus guidelines for the delineation of the node levels in the node-negative neck. RESULTS AND CONCLUSIONS: First a short discussion of the discrepancies between the previous Brussels and the Rotterdam guidelines is presented. The general philosophy of the consensus guidelines and the methodology used to resolve the various discrepancies are then described. The consensus proposal is then presented and representative CTVs that are consistent with these guidelines are illustrated on CT sections. Last, the limitations of the consensus guidelines are discussed and some concerns about the direct applications of these guidelines to the node-positive neck and the post-operative neck are described.     

Factors associated with liver biopsy performance in HCV-HIV coinfected injecting drug users with HCV viremia: Results from a five-year longitudinal assessment

The last international consensus conference about hepatitis C virus (HCV) treatment emphasized the importance of treatment for persons coinfected with HCV and human immunodeficiency virus (HIV). As liver biopsy precedes treatment, we aimed to identify factors associated with the performance of liver biopsy among HIV-HCV coinfected drug users during a 5-year follow-up to study their access to HCV treatment. Of the 296 patients followed in the HIV hospital departments of Nice and Marseilles and with retrievable records about HCV diagnosis and care, 166 were eligible for analysis having had detectable HCV RNA at least once during the study period. Overall, 45.2% of patients underwent liver biopsy during follow-up. Using proportional hazard models, predictors of having had a liver biopsy were high social support, complete abstinence from drug injection, and lack of immunosuppression as well as male gender, no history of multiple incarcerations, more recent onset of drug use, and an increase of liver enzyme levels. These results suggest that specific efforts should be devoted to HIV-HCV coinfected drug users to assist with stabilizing these patients to optimize their access to HCV care whenever possible. The MANIF 2000 study group includes C. Boirot, A. D. Bouhnik, M. P. Carrieri, J. P. Cassuto, M. Chesney, P. Dellamonica, P. Dujardin, S. Duran, J. G. Fuzibet, H. Gallais, J. A. Gastaut, G. Lepeu, D. A. Loundou, C. Marimoutou, D. Mechali, J. P. Moatti, J. Moreau, M. Nègre, Y. Obadia, I. Poizot-Martin, C. Pradier, D. Rey, C. Rouzioux, A. Sobel, B. Spire, F. Trémolières, and D. Vlahov.     

Total soluble HLA class I and soluble HLA-G in multiple myeloma and monoclonal gammopathy of undetermined significance.

Serum beta2-microglobulin, the light chain of the HLA class I molecular complex, remains one of the best survival prognostic factors in multiple myeloma, but other HLA class I molecules might be of interest in monoclonal gammopathies. In this study, we evaluate total soluble HLA class I (HLA-Is) and soluble HLA-G (HLA-Gs) in 103 patients with newly diagnosed multiple myeloma, 30 patients with monoclonal gammopathy of undetermined significance (MGUS), and 30 healthy subjects, studying their prognostic value in multiple myeloma. In multiple myeloma patients, HLA-Is and HLA-Gs median values were 0.8 microg/mL and 28 ng/mL, respectively. Median HLA-Is concentration was higher in stage II and III multiple myeloma patients than in stage I multiple myeloma, MGUS, and control patients. Median HLA-Gs was significantly lower in healthy controls than in MGUS and multiple myeloma patients. A high level of HLA-Is (> or =2.1 microg/mL) was predictive of short survival (P = 0.017). For each given level of beta2-microglobulin, the relative risk of death was higher for patients with HLA-Is > or = 2.1 microg/mL than in patients with a lower level (P = 0.047). HLA-Gs, a marker of monoclonal gammopathy, was of no prognostic value, but the addition of HLA-Is to beta2-microglobulin produced an efficient prognostic score (P < 0.0001). HLA-Is is a new marker of multiple myeloma tumor load and provides additional survival prognostic information to beta2-microglobulin.     

Quantitative variability in the biodistribution and in toxinokinetic studies of the three main alpha toxins from the Androctonus australis hector scorpion venom.

Scorpion stings represent a medical problem in numerous countries. The scorpion Androctonus australis hector produces three alpha toxins (Aah I to III), which are responsible for most of the lethality in mammals. These toxins act on sodium channel and do not cross-react immunologically. We used RIA and ELISA to measure the concentrations of these three toxins in plasma, urine and different organs after i.v. and s.c. injections of water extracts of venoms in rabbits or mice. In both animals, the toxins rapidly appeared in plasma after s.c. injection as it was previously described for the whole venom. However, the toxins disappeared from the blood more quickly than did other main components of the venom. Thus, serotherapy must be initiated immediately to prevent the toxin from reaching its target. We also detected the toxins in urine, kidneys, heart and lungs, but not in the brain. However, the concentration of Aah II was always lower than that of Aah I. Analysis of five samples of venom collected in different areas of southern Tunisia showed that a large polymorphism exists for the three toxins. This is yet another difficulty for serotherapy as there is no cross-antigenicity between them.     

Mycoplasma genitalium,an agent of reemerging sexually transmitted infections

M. genitalium is a reemerging microorganism, responsible for sexually transmissible infections (STIs), with prevalence which varies depending on the country and population group studied. We report here M. genitalium prevalence among the specimens received for STI diagnosis in our routine microbiological laboratory in the university hospital in Marseille, France. We tested 4 624 samples from 3 793 patients using qPCR for M. genitalium, C. trachomatis, N. gonorrheae, T. pallidum. Of these samples, 528 (13.6%) patients were tested positive for at least one pathogen and 126 (3.3%) were positive for M. genitalium. M. genitalium is the second most prevalent micro‐organism detected in women after C. trachomatis (10.4%) and the third most prevalent in men after C. trachomatis (5.1%) and N. gonorrhoeae (4.4%). We observed no significant differences between the prevalence of M. genitalium in vaginal, urethral and urine specimens (p = 0.9). Prevalence of M. genitalium is significantly higher in patients aged between 10–30 years (4.1%) compared to those aged between 30 and 50 years (2.7%) (p = 0.02, RR = 1.54 [1.06–2.24]) and patients over 50 years of age (1.1%) (p = 0.003, RR= 3.98 [1.47–10.8]). M. genitalium is a common agent of STI, therefore we suggest that this micro‐organism should be systematically tested during chronic, recurrent, or antibiotic resistant genital infections and in populations at high‐risk of STIs.     

Real-Time PCR Quantification of Methanobrevibacter oralis in Periodontitis

A real-time PCR assay developed to quantify Methanobrevibacter oralis indicated that its inoculum significantly correlated with periodontitis severity (P = 0.003), despite a nonsignificant difference in prevalence between controls (3/10) and patients (12/22) (P = 0.2, Fisher test). The M. oralis load can be used as a biomarker for periodontitis.     

EFFECTS OF CONVERSATIONAL HYPNOSIS ON RELATIVE PARASYMPATHETIC TONE AND PATIENT COMFORT DURING AXILLARY BRACHIAL PLEXUS BLOCKS FOR AMBULATORY UPPER LIMB SURGERY:A Quasiexperimental Pilot Study

This two-center quasiexperimental pilot study was to determine the effect of conversational hypnosis on patient comfort and parasympathetic tone, which may represent a quantitative measure of hypnotic depth, during regional anesthesia. The patients received conversational hypnosis in one center and oral premedication in the other. The patients’ subjective comfort (0-10 rating scale) and objective parasympathetic tone, as assessed by the Analgesia/Nociception Index (ANI), were measured before and after regional anesthesia. The parasympathetic tone and comfort scores evidenced a significantly greater increase in the hypnosis patients than in controls. These findings suggest that using conversational hypnosis during regional anesthesia may be followed by a subjective increase in patient comfort and an objective increase in parasympathetic tone, monitored by ANI.     

Daniel Widlöcher,l’expert et le conseiller au ministère de la Santé

Former Minister of Health of president François Mitterrand, Edmond Hervé pays homage to Daniel Widlöcher for his contribution as ministerial consultant to the history of psychiatry policy in the eighties, precisely, with the creation of Mental Disease Commission in 1983 whose mission was to prepare a best articulation between public and private organisation of health in France.