Comparing meditative scuba diving versus multisport activities to improve post-traumatic stress disorder symptoms: a pilot, randomized controlled clinical trial.

Background: Post-Traumatic Stress Disorder (PTSD) is a chronic and disabling disease that currently has no fully effective therapeutic solution. Complementary approaches, such as relaxation, sport, or meditation, could be therapeutic aids for symptom reduction. Scuba diving combines sport and mindfulness training and has been found to have a positive effect on chronic stress and PTSD. Objectives: The first objective of this pilot study is to compare the effectiveness of diving associated with mindfulness exercises (the Bathysmed® protocol) with multisport activity in reducing PTSD symptoms. The secondary objective is to compare the impact of the Bathysmed® protocol on mindfulness functioning in the two groups of subjects suffering from PTSD. Method: This proof-of-concept took the form of a controlled randomized clinical trial. The primary endpoint was the severity of PTSD symptoms, measured by the PCL-5 (PTSD Check List) scale. Half of the group were exposed to the Bathysmed® protocol (the experimental condition), and the other half to a non-specific multisport program. Results: Bathysmed® protocol improved PCL-5 scores more than the multisport program but the result was not significant. The protocol was significantly better than the multisport activity in reducing intrusion symptoms of PTSD after one month. Globally, trait mindfulness scores improved up to one month after the course, but the result was not significant. Three months after the course, there was no difference between the two groups with regard to PCL-5 and Freiburg Mindfulness Inventory scores.. Conclusion: Our study demonstrates the value of the Bathysmed® protocol even though it suffers from a lack of power and could only obtain partial but encouraging results. Mindfulness must be practiced over the long term to achieve stable benefits. This probably explains why no differences persisted three months after the course. Further work is needed to confirm the initial results obtained with this pilot study.

Antecedentes:El trastorno de estrés postraumático (TEPT) es una enfermedad crónica e incapacitante que actualmente no tiene solución terapéutica totalmente eficaz. Enfoques complementarios, como relajación, deporte o meditación podrían ser ayudas terapéuticas para la reducción de síntomas. El buceo combina deporte y entrenamiento mindfulness y se ha encontrado que tiene un efecto positivo sobre el estrés crónico y el trastorno de estrés postraumático.Objetivos:El primer objetivo de este estudio piloto es comparar la efectividad del buceo asociado a ejercicios de mindfulness (el protocolo Bathysmed®) con la actividad multideportiva para reducir los síntomas del TEPT. El objetivo secundario es comparar el impacto del protocolo Bathysmed® sobre el funcionamiento de mindfulness en los dos grupos de sujetos que padecen TEPT.Método:Esta prueba de concepto tomó la forma de un ensayo clínico aleatorizado controlado. El criterio de valoración principall fue la gravedad de los síntomas de TEPT, medida por la escala PCL-5 (Lista de chequeo para TEPT). La mitad del grupo estuvo expuesto al protocolo Bathysmed® (la condición experimental), y la otra mitad a un programa multideportivo no específico.Resultados:El protocolo Bathysmed® mejoró las puntuaciones de PCL-5 más que el programa multideportivo, pero el resultado no fue significativo. El protocolo fue significativamente mejor que la actividad multideportiva para reducir los síntomas de intrusión del TEPT luego de un mes. Globalmente, los puntajes de mindfulness de rasgo mejoraron hasta un mes luego del curso, pero el resultado no fue significativo. Tres meses después del curso, no hubo diferencias entre los dos grupos con respecto a las puntuaciones de PCL-5 y FMI (Freiburg Mindfulness Inventory).Conclusión:Nuestro estudio demuestra el valour del protocolo Bathysmed® a pesar de que sufre una falta de poder y solo pudo obtener resultados parciales pero alentadores. Mindfulness debe practicarse durante un largo plazo para alcanzar beneficios estables. Esto probablemente explica por qué no persistieron diferencias tres meses después del curso. Es necesario seguir trabajando para confirmar los resultados iniciales obtenidos con este estudio piloto.

Middle-ear barotrauma after hyperbaric oxygen therapy: a five-year retrospective analysis on 2,610 patients.

Introduction: Hyperbaric oxygen (HBO2) therapy is the use of oxygen or gas mixtures at a pressure above atmospheric pressure for therapeutic purposes. This treatment is used in numerous pathological processes. Its main side effect is middle ear barotrauma (MEB), which represents a great concern for iatrogenic HBO2 therapy. The aim of this work is to describe this adverse event in order to highlight clinical elements that can contribute to its prevention and management. Methods: We conducted a five-year retrospective study from January 2013 to December 2017, where 2,610 patients were selected, in the Hyperbaric Medicine Centre, Sainte- Marguerite Hospital of Marseille, France. Results: 262 patients experienced MEB after HBO2, representing a prevalence of 10.04% and incidence of 0.587%. Their average age was 55 ± 19 years. Women were more affected than men. We have not highlighted a seasonality to this condition. Risk factors were: age older than 55 years, female gender, ear, nose and throat history (cancer, radiotherapy, infections or allergies, malformations or benign tumors), general history (smoking, obstructive breathing disorders, thyroid disorders and obesity), HBO2-approved indications of sudden deafness and delayed wound healing, and altered tympanic mobility on initial examination. Although the benign stages of Haines-Harris classification were the most encountered in our study, MEB was responsible for premature discontinuation of HBO2. Conclusion: MEB is a common condition responsible for many premature discontinuations of HBO2. Its origin is multifactorial, associating non-modifiable and modifiable factors. Better management of this affection will further contribute to making HBO2 a low-risk treatment.

Safety, tolerability and potential efficacy of injection of autologous adipose-derived stromal vascular fraction in the fingers of patients with systemic sclerosis: an open-label phase I trial.

BACKGROUND: In patients with systemic sclerosis (scleroderma, SSc), impaired hand function greatly contributes to disability and reduced quality of life, and is insufficiently relieved by currently available therapies. Adipose tissue-derived stromal vascular fraction (SVF) is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune diseases. We aimed to measure for the first time the safety, tolerability and potential efficacy of autologous SVF cells local injections in patients with SSc with hand disability. METHODS: We did an open-label, single arm, at one study site with 6-month follow-up among 12 female SSc patients with Cochin Hand Function Scale score >20/90. Autologous SVF was obtained from lipoaspirates, using an automated processing system, and subsequently injected into the subcutaneous tissue of each finger in contact with neurovascular pedicles. Primary outcome was the number and the severity of adverse events related to SVF-based therapy. Secondary endpoints were changes in hand disability and fibrosis, vascular manifestations, pain and quality of life from baseline to 2 and 6 months after cell therapy. FINDINGS: All enrolled patients had surgery, and there were no dropouts or patients lost to follow-up. No severe adverse events occurred during the procedure and follow-up. Four minor adverse events were reported and resolved spontaneously. A significant improvement in hand disability and pain, Raynaud's phenomenon, finger oedema and quality of life was observed. INTERPRETATION: This study outlines the safety of the autologous SVF cells injection in the hands of patients with SSc. Preliminary assessments at 6 months suggest potential efficacy needing confirmation in a randomised placebo-controlled trial on a larger population. FUNDING: GFRS (Groupe Francophone de Recherche sur la Sclérodermie). CLINICAL TRIALS NUMBER: NCT01813279.

Clinical trials and E-health: impact of new information technology applied to clinical trials (including source data-medical records) and to human and drug research.

Within the last few years, new technology has come to play an important part in our professional and private daily environment. Healthcare has not escaped this progressive mutation with computers reaching the bedside. Clinical research has also shown growing interest in these new tools available to the clinical investigator, the patient, as well as to specialist departments for diagnosis and follow-up of patients, and to the different professions in clinical research. If the use of new technology seems to make life easier, by centralizing data or by simplifying data-sharing between different teams, it is still a matter of private data which must remain reliable, confidential and secure, whether it is being used in ordinary healthcare or in academic or industrial research. The aim of the round table was to estimate the impact of new information technology applied to clinical trials (including source data-medical records) and to human and drug research. First, an inventory was made of the development of these new technologies in the healthcare system. The second point developed was identification of expected benefits in order to issue guidelines for their good use and hazard warnings in clinical trials. Finally, the impact of these new technologies on the investigator as well as the project manager was analysed.

On chikungunya acute infection and chloroquine treatment.

In recent issues, the efficacy of chloroquine (and the dosage that may be used) in the treatment of acute chikungunya infections was discussed. We have conducted a double-blind placebo-controlled randomized trial on the French Reunion Island (Indian Ocean), in which 27 patients received chloroquine and 27 patients received a placebo treatment. The chloroquine treatment consisted of 600 mg at day 1, 600 mg at days 2 and 3, and 300 mg at days 4 and 5. No significant difference between groups could be identified regarding the duration of febrile arthralgia or the decrease of viremia between day 1 and day 3. However, at day 200, patients who received chloroquine complained more frequently of arthralgia than those who received placebo (p < 0.01). In conclusion, our results suggest that there is currently no justification for the use of chloroquine to treat acute chikungunya infections.

End-of-dose akinesia after a single intravenous infusion of the dopaminergic agonist piribedil in Parkinson's disease patients: a pharmacokinetic/pharmacodynamic, randomized, double-blind study.

This randomized, double-blind trial was designed to define the possible relationship between piribedil plasma concentrations and the decrease of the Unified Parkinson's Disease Rating Scale (UPDRS) motor score or the switch from off to on state after single intravenous infusion. Ten fluctuating patients with idiopathic Parkinson's disease (PD) received escalating doses of piribedil (2-16 mg) and placebo. Starting from 2 mg, piribedil was effective in reducing the motor deficit (UPDRS, motor score) including akinesia at the first evaluation time point of 15 minutes, and in reversing off state of 7 of 10 patients. The doses were equally effective, although the effect was more sustained with the highest dose of 16 mg. Piribedil was well tolerated up to a 16-mg dose and pharmacokinetics were linear up to the 16-mg dose. Plasma levels of piribedil were not correlated to the motor score improvement or switch from off-->on. In conclusion, a short single infusion of piribedil at 2 to 16 mg was safe and effective in improving motor symptoms, including akinesia, of fluctuating PD patients.