Utilisation de la prolothérapie dans le traitement des affections musculosquelettiques chroniques / Use of prolotherapy in the treatment of chronic musculoskeletal disorders

Au Canada, les maladies musculosquelettiques constituent un problème important de santé publique. Nombreuses sont les personnes qui en souffrent et doivent être traitées pour soulager leur douleur et améliorer leur état fonctionnel. Mais rares sont les traitements efficaces et sécuritaires pour les personnes atteintes. Certains suggèrent la prolothérapie comme solution thérapeutique. Cette pratique médicale consiste en l'injection de diverses substances (dextrose, glycérine et phénol) à l'intérieur des ligaments ou des tendons endommagés entraînant une irritation et une inflammation locales et permettant de stimuler la croissance cellulaire et de réparer les tissus. Actuellement, ce traitement n'est pas reconnu au Québec et, afin d'assurer une pratique médicale sécuritaire, le Collège des médecins du Québec a demandé à l'Institut national d'excellence en santé et en services sociaux (INESSS) d'évaluer l'efficacité et l'innocuité de la prolothérapie dans le traitement des douleurs musculosquelettiques chroniques. L'INESSS a retenu treize essais contrôlés randomisés (ECR) ­ dont la qualité varie de mauvaise à très bonne ­ (et cinq études observationnelles) évaluant l'efficacité de la prolothérapie sur différentes affections musculosquelettiques: 1. la lombalgie; 2. la douleur chronique du poignet; 3. l'arthrose des doigts; 4. la tendinite achiléenne; 5. la maladie d'Osgood-Schlatter; 6. l'arthrose du genou; 7. l'épicondylite latérale; 8. la subluxation temporo-mandibulaire. L'analyse des articles nous permet de constater différentes disparités dans cette pratique médicale. La composition des injections de prolothérapie dans les essais contrôlés randomisés semble dépendre des préférences de l'investigateur. Le protocole d'intervention de la prolothérapie est également très variable : il n'y a pas de normalisation pour le nombre de traitements, le nombre de sites, l'intervalle entre les traitements, la durée du traitement et les co-interventions. L'évaluation des articles scientifiques sur la prolothérapie permet à l'INESSS de conclure ce qui suit: -l'identification de la source de la douleur, essentielle dans le traitement des affections musculosquelettiques, et particulièrement des lombalgies, est absente des études; -la prolothérapie telle que pratiquée dans les études analysées n'est pas supérieure à une injection de solution saline sans agent proliférant dans le traitement des lombalgies chroniques; -pour les sept autres applications évaluées seulement dans un ou deux essais contrôlés randomisés chacun, le niveau de preuve ne permet pas de prouver ni de réfuter l'efficacité de la prolothérapie, les données étant trop fragmentaires sur ces sujets; -la prolothérapie peut avoir des conséquences graves s'il y a une injection accidentelle dans l'espace rachidien. L'absence de contrôle du site effectif d'injection par une technique d'imagerie, dans les études recensées, peut expliquer en partie la fréquence observée de ces effets indésirables; - les preuves ne soutiennent pas l'utilisation de la prolothérapie pour les affections musculosquelettiques; -l'absence d'un mécanisme d'action de la prolothérapie démontré expérimentalement ne permet pas, à l'heure actuelle, de justifier la poursuite d'études sur des sujets humains.(AU)

Musculoskeletal disorders represent a major public health problem in Canada. Many people are affected and require long-term treatments in order to relieve their pain and improve their functional status. Many of these treatments have doubtful or unknown effectiveness and safety, among which prolotherapy has been suggested as a therapeutic option. Prolotherapy consists in injecting various substances (dextrose, glycerin and phenol) into painful ligaments or tendons, with the theory that this would lead to local irritation, inflammation and stimulation of cell growth and tissue repair. Currently, this treatment is not recognized in Québec. Concerned with the safety of the public, the Collège des médecins du Québec has asked the Institut national d'excellence en santé et en services sociaux (INESSS) to evaluate the efficacy and safety of prolotherapy in the treatment of chronic musculoskeletal pain. INESSS selected 13 randomized controlled trials (RCTs) whose quality ranges from poor to very good (and five observational studies) that evaluated the efficacy of prolotherapy in different musculoskeletal conditions: 1) low back pain; 2) wrist pain; 3) finger osteoarthritis; 4) Achilles tendinosis; 5) Osgood-Schlatter disease; 6) knee osteoarthritis; 7) lateral epicondylosis; and 8) temporomandibular joint subluxation. The analysis of information provided by these studies revealed great variations with this medical procedure. For instance, the content of the prolotherapy injections in the randomized clinical trials seemed to depend on the investigator's preferences rather than on the diagnosis. Variations in treatment protocols were observed with the number of treatments, the number of sites, the interval between treatments, the duration of treatment or the co-interventions, signaling an evident lack of standardization. From the evaluation of the scientific evidence on prolotherapy, INESSS concludes: • that the origin of the pain, essential in determining a diagnosis and treatment plan when treating musculoskeletal conditions, is not mentioned in any of these studies; -that prolotherapy, as performed in the studies that were analyzed, is not superior to injecting a saline solution with no proliferative agent (placebo) for treating chronic low back pain; -that for the other seven applications of interest, each of which was evaluated in only one or two randomized controlled trials, the level of evidence does not support or refute the efficacy of prolotherapy, information being too fragmentary at this time; -that prolotherapy can have serious consequences, particularly in low-back pain patients with accidental injection into the spinal canal, as prolotherapy has not been performed in clinical studies under any type of medical imaging guidance; -that the balance between potential benefits and risks does not support the use of prolotherapy for musculoskeletal conditions; -that continuing to conduct studies on prolotherapy involving human subjects can be considered unethical given that there is an absence of scientific basis to the alleged mechanism of action for prolotherapy which remain speculative at best.(AU)

Summary: Indications for positron­emission tomography (pet): a brief update

The purpose of this report is to provide an initial response to various questions concerning the expansion of the clinical indications for positron-emission tomography (PET) and PET-CT1 in oncology and for other types of diseases with regard to the current practice in Québec. A targeted literature review identified 28 health technology assessments and systematic reviews on this topic published between 2004 and 2010, from which information concerning PET clinical indications was extracted. These indications were placed in two categories: the initial indications (diagnostic characterization and tumour initial staging) and follow-up indications (evaluation of treatment response, disease progression, and evaluation of recurrences). In twelve cancers, initial and follow-up indications are accepted both in the literature and in Québec, with a low potential for expanding indications based on nuances or specificities that cannot be discussed in the context of this report. A potential expansion of the indications accepted in Québec was identified for six cancers, for two of which there is an international consensus, namely, glioma for the initial indications and gastrointestinal stromal tumours for both initial and follow-up indications. The other indications are the subject of debate because of a lack of interpretable evidence (kidney cancer for the initial indications and pancreatic cancer for the follow-up indications); emerging, thanks to the large number of recent studies (thyroid cancer for the initial indications); or included in another category (unspecified brain cancer placed together with glioma). With regard to non-oncological indications, only chronic osteomyelitis and prosthesis-related infections could constitute new, emerging indications. As for the utility of PET in planning radiotherapy treatments, this question could not be resolved because of a lack of evidence. This is an emerging and mainly experimental field, and there is presently no systematic review of the available data. The current research mainly concerns technical issues specific to each cancer. The Unité d'évaluation des technologies et des modes d'intervention en santé (UETMIS) at the Centre hospitalier universitaire de Québec (CHUQ) is analyzing now the literature on this new technological application and its potential use in Québec. In conclusion, the range of new or expanded indications for PET in relation to those currently accepted in Québec remains fairly limited. However, PET is a rapidly evolving technology, and its combined use with other technologies such as magnetic resonance imaging, is opening development prospects for new clinical applications. Following an agreement with the Ministère de la Santé et des Services sociaux, it was agreed that the most concerned professional associations with PET would be consulted to check if the results of this update on the indications accurately reflect the current state of knowledge and their application in Québec clinical practice. The minutes of the meetings are presented in Appendix E, and the main points are summarized in Section 5.