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There is a belief that Sports and Exercise Medicine (SEM) is a unique aspect of medical practice because sports physicians care for elite athletes, and athletes are different. This situation can result in the use of unproven therapies which are then justified on the basis that elite athletes need to be at the “cutting edge” of medical treatment in order to return to play as rapidly as possible. In more established fields of medicine, the use of such unproven therapy would lead to considerable professional criticism.1
The concept that “cutting edge” treatment means the integration of anecdotal treatments into conventional sports medicine needs to be addressed urgently. We argue that not only is this approach flawed but that it will limit the development of an evidence base in SEM, is ethically questionable and will ultimately undermine the credibility of the specialty.2 3
Evidence-based medicine, with all its limitations, is a vital component of good clinical practice and enhances patient confidence in medicine. Good clinical practice demands that we search for, and develop, evidence for benefit and safety and then select treatment options according to the best evidence available. For the speciality of SEM, to ignore established evidence-based approaches to medical practice is simply unacceptable in the modern era.
A recent editorial in the Journal by a group of experienced clinicians argued that an unproven injection therapy for acute muscle strains should be considered “an important part of the landscape of management options”. This statement was based on expert opinion supported by a stated endorsement from “thousands of patients”.4 The injection therapy to which this recommendation referred was a combination of Traumeel S, Actovegin and a local anaesthetic.
The approval of a new pharmaceutical product in medicine follows a tried and tested process overseen by the Food and Drug Administration (FDA) in the USA and Medicines and Health Care Products Regulatory Agency5 in the UK. This process can sometimes take years to fully satisfy the regulatory concerns with regard to efficacy, safety and risk profile of new drugs. The editorial under discussion advocating this unproven form of therapy admitted that the current human evidence for Traumeel S (a substance containing 12 botanical substances including Belladona and Arnica) would be insufficient to gain approval by governmental regulatory bodies such as the FDA.4
The second component of this proposed injection therapy is Actovegin, which is a deproteinised haemodialysate manufactured from calf blood. The drug was placed on the International Olympic Committee (IOC) list of banned drugs in 2000, in part because of concern about the use of this agent by professional cycling teams; however, the IOC subsequently softened its stance due to uncertainty surrounding its ergogenic potential.6 In theory, this particular agent may still be subject to current World Anti-Doping Agency (WADA) sanctions, as the use of intravenous administration for this agent is a prohibited method under the current code. There also have been reports of severe anaphylactic reactions to this substance when administered parenterally.7
Local anaesthetic is also included in this mixture, as a treatment for muscular injury; yet, there is published data to support the myotoxicity of local anaesthetic in this setting.8 Indeed, it is used in laboratory animal models of muscle injury to cause muscle fibre necrosis.9 Without an understanding of the basic science at work, practitioners cannot hope to understand what they are administering to a patient or indeed the potential to do harm.
The editorial cites a study comparing Traumeel S and Actovegin to autologous conditioned serum injections for muscle injury.10 Although this was a small study and used no placebo control group, the serum injections were found to be significantly better than the Traumeel S/Actovegin combination. Rather than support a treatment with some degree of scientific evidence, the editorial authors did not recommend this alternative approach on the basis that this treatment was likely to be banned by WADA.
Recent debate at the British Association of Sports and Exercise Medicine Spring Meeting3 suggested that physicians felt under pressure by the athlete to use Traumeel S, and it was proposed by a few that the onus was on “science” to disprove this therapy rather than the burden of proof being on those who seek to use it. This is wholly at odds with the practice of medicine in other medical specialties and raises the question of the validity of informed consent in these cases. We must resist pressures, which may compromise our standing as rational, safe, evidence-based clinicians worthy of specialist status. To do any less compromises our standing as a specialty.11
The treatment of soft tissue injuries is frustrating both in terms of available means to intervene effectively and the timescales involved in recovery and return to sport. We are right to look to advance the boundaries of treatment and certainly should look at those practicing in ways different from ourselves.4 SEM has a wonderful opportunity and a responsibility to drive research agendas in regard to the medical injuries of both elite athletes as well as the general population.
If advocates of an alternative treatment can demonstrate its efficacy and safety, the treatment automatically becomes part of orthodox medicine and can thus be recommended. We should take care not to be driven into providing unproven and potentially unsafe treatments because of pressure from coaches and players to try anything to expedite a return to sport.
It is argued that few researchers examine such injuries outside of our SEM “world”, but that is patently untrue.12,–,16 17 There is considerable work in basic science, pathology, exercise physiology and pharmacology to support a scientific approach to the development of treatments and clinical practice. It is the lack of drive in SEM to engage in basic science that limits our progress at the “cutting edge” of sports medicine rather than an unwillingness of the established scientific community to study issues relevant to our specialty.
Elite athletes are a vulnerable group often happy to accept at face value a treatment purported to expedite their return to play for a variety of factors. In the dependent relationship that may exist between the team doctor and athlete, particular attention has to be given to whether the doctor's ethical responsibility to fully inform has been discharged. In the UK, General Medical Council guidance on the duties of a doctor states “A Doctor must be satisfied there is a sufficient evidence base for off-license prescribing, and patients must be given sufficient information about those delivering the medication to be in a position to give informed consent”.18
SEM should be at the “cutting edge” of medicine; the specialty consists of an energetic, enthusiastic group of clinicians driven to enhance the health and performance of patients. There is a wealth of basic science pertaining to exercise, and we need to encourage the specialty to develop an evidence-based approach to the development and assessment of new treatment. Otherwise, we risk the very status the specialty has striven to achieve.
Competing interest None.
Provenance peer review Not commissioned; not externally peer reviewed.
Patient consent Not obtained.