Placebo and other psychological interactions in headache treatment

We present a theory according which a headache treatment acts through a specific biological effect (when it exists), a placebo effect linked to both expectancy and repetition of its administration (conditioning), and a non-specific psychological effect. The respective part of these components varies with the treatments and the clinical situations. During antiquity, suggestions and beliefs were the mainstays of headache treatment. The word placebo appeared at the beginning of the eighteenth century. Controversies about its effect came from an excessive interpretation due to methodological bias, inadequate consideration of the variation of the measure (regression to the mean) and of the natural course of the disease. Several powerful studies on placebo effect showed that the nature of the treatment, the associated announce, the patients’ expectancy, and the repetition of the procedures are of paramount importance. The placebo expectancy is associated with an activation of pre-frontal, anterior cingular, accumbens, and periacqueducal grey opioidergic neurons possibly triggered by the dopaminergic meso-limbic system. In randomized control trials, several arms design could theoretically give information concerning the respective part of the different component of the outcome and control the natural course of the disease. However, for migraine and tension type headache attacks treatment, no three arm (verum, placebo, and natural course) trial is available in the literature. Indirect evidence of a placebo effect in migraine attack treatment, comes from the high amplitude of the improvement observed in the placebo arms (28% of the patients). This figure is lower (6%) when using the harder criterium of pain free at 2 h. But these data disregard the effect of the natural course. For prophylactic treatment with oral medication, the trials performed in the last decades report an improvement in 21% of the patients in the placebo arms. However, in these studies the duration of administration was limited, the control of attacks uncertain as well as the evolution of the co-morbid psycho-pathology. Considering the reviews and meta-analysis of complex prophylactic procedures, it must be concluded that their effect is mostly linked to a placebo and non-specific psychological effects. Acupuncture may have a slight specific effect on tension type headache, but not on migraine. Manual therapy studies do not exhibit difference between manipulation, mobilization, and controls; touch has no proven specific effect. A comprehensive efficacy review of biofeedback studies concludes to a small specific effect on tension type headache but not on migraine. A review of behavioral treatment conclude to an interesting mean improvement but did not demonstrated a specific effect with the exception of a four arm study including a pseudo meditation control group. Expectation-linked placebo, conditioning, and non-specific psychological effects vary according clinical situations and psychological context; likely low in RCT, high after anempathic medical contact, and at its maximum with a desired charismatic healer. The announcements of doctors strongly influence the beliefs of patients, and in consequence their pain and anxiety sensibilities; this modulates the amplitude of the placebo and the non-specific psychological effects and is therefore a major determinant of the therapeutic success. Furthermore, any repetitive contact, even through a placebo, may interfere positively with the psychopathological co-morbidity. One has to keep in mind that the non-specific psychological interactions play a major role in the improvement of the majority of the headache sufferers

Informing participants of allocation to placebo at trial closure: postal survey.

Objectives To assess whether and how investigators of placebo controlled randomised trials inform participants of their treatment allocation at trial closure and to assess barriers to feedback. Design Postal survey With a semistructured questionnaire. Participants All investigators who published a placebo controlled randomised trial in 2000 in five leading medical journals, and a random sample of 120 trials listed in the national research register database. Main outcome measures Number of investigators who informed participants of their treatment allocation at trial closure, methods for delivering the information, and barriers to unmasking treatment. Results 45% of investigators informed either,all or most participants of their treatment allocation, and 55% did not inform any participant or only informed those who asked. The main reasons for not informing participants were that the investigators never considered this option (40%) or to avoid biasing results at study follow up (24%). Conclusion Further research is required to examine sensitive ways to communicate treatment information to trial participants

Towards a Holistic Framework of Cancer Related Fatigue: Qualitative Data on the Experience of Embodiment in Breast Cancer Survivors

Cancer Related Fatigue (CRF) is one of the most common and detrimental side effects of cancer treatment. Despite its increasing prevalence and severity CRF remains dismissed by the majority of clinicians. One reason for the apparent gap between clinical need and clinical undertaking is the penchant towards reductionist accounts of the disorder: a tendency to discount the interface between the lived experience of sufferers and the multi-dimensional etiology of CRF as it manifests adversely on a day-to-day basis. We undertook semi-structured interviews with 13 Breast cancer survivors suffering from CRF and then subsequently coded their responses using Team Based Qualitative Analysis. We focused most specifically on shifts in embodied awareness that accompanied our participant’s experience of CRF. Our analysis revealed multiple dimensions of the social and bodily underpinnings of fatigue. Most relevantly we found a consistent change in the reported capacity for awareness of bodily sensations. This shift in awareness appeared to be directly connected to the experience of CRF and a newfound, “respect” for the needs of the body. Furthermore, we found that many of the practices that were described as helpful in alleviating fatigue were oriented around eliciting a sense of embodied awareness, examples being: dance, yoga, and shamanic ritual. This relationship with bodily sensations existed in conjunction with the anxiety and trauma that arose as a result of cancer treatment. Our analysis suggests that the quality of awareness and relationship to bodily experience in CRF is a functionally relevant component of the disorder and should be considered as an experiential target moving forward