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Other Guidelines
The role of complementary and alternative medicine in the
management of early breast cancer: Recommendations of the European Society of
Mastology (EUSOMA)
Current and future status of research into the efficacy of CAM
The popularity of CAM is illustrated by the fact that large numbers of patients
subscribe to it. In part, this might be a result of the unmet needs described
above, or simply by the 'feel-good' factor the therapies might induce, which is
another expression of the same. However, of greater concern is the suspicion
that some proponents of CAM are offering interventions that claim to influence
the natural history of the disease. The medical profession is entitled to
remain sceptical about some of the claims, but needs to remain circumspect
about claims that do not depend on conceptual models that are incompatible with
the modern understanding of life sciences. For example many active anti-cancer
agents, such as the vinca alkaloids and the taxanes, were developed from
botanicals. Whether the outcome measure is for the patient to feel better or to
develop better research, methodology exists that is sufficient to evaluate all
types of interventions in an evenhanded way, irrespective of the provenance of
the therapy being tested.
In the broadest terms there are three categories of research
design involving cancer patients. 'Qualitative research', which attempts to
capture the individual patient's experience, to understand their needs and to
develop hypothetical solutions to their problems. Phase I/II trials look for
methods and dose of delivery and evidence of 'activity' of an investigational
drug against a measurable tumour parameter. Finally, the randomised controlled
trial (RCT) is set up to establish effectiveness, efficiency, harm/benefit
trade-off and health economics related to the clinical use of an
investigational drug. The RCT is sufficiently robust to cope with the
extraordinary variability and unpredictability of breast cancer and to measure
the outcomes of simple or complex interventions. The properly designed and
conducted RCT can control for case mix, selection bias, observer bias and
placebo effect, and is sufficiently malleable largely to accommodate the needs
of CAM. For example, if the CAM intervention is aimed at improving quality of
life or patients' satisfaction, then these can be defined as primary endpoints
and measured by one or more of the many psychometric instruments that have
already been validated. If the primary endpoint is not already covered by one
of the instruments, for example in the spiritual domain, then it should be the
responsibility of its proponents to develop a new instrument. Another problem
that has to be accommodated concerns the individualisation of treatment, which
is often judged an important component of CAM. Here again, an elegant design
would allow randomisation of the 'individualised' intervention against a
non-individualised 'one size fits all' treatment.
So far there is no persuasive evidence from RCTs that CAM
interventions favourably influence the natural history of breast cancer. In
contrast, a number of CAM interventions aimed at improving symptoms or quality
of life are backed up by reasonably good evidence, e.g. acupuncture for nausea,
aromatherapy for anxiety, exercise for fatigue, music therapy for quality of
life, relaxation therapies for stress
[2].
Finally, as much as it is the responsibility of proponents of CAM
critically to evaluate their favoured treatments, the medical profession has a
responsibility to mentor, encourage and provide the infrastructure for this
type of research.
The National Cancer Research Institute (NCRI) in the UK has now
established such a process that works via two study groups: the Psycho-Social
Study Group (NCRI PSOSG) and the CAM study group (NCRI CAMSG).
Recommendation 5
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There can be only one standard for the evaluation of
interventions to improve the length and quality of survival of patients with
breast cancer irrespective of the type and origin of the treatments. Modern
scientific methodology can accommodate both simple and complex interventions
with outcome measures that are meaningful to the patient herself.
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Modules/lectures about evidence-based CAM should be added to the
curricula
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