Honest placebo: good medicine against cancer -related tiredness?

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This article is part of the ONCOLOGY SELLOUSE 2019 magazine for naturopathy. Read the full edition here. Reference zhou es, Halle Kt, Michaud al, et al. Open label placebo reduces fatigue for cancer survivors: a randomized study. Support Care Cancer. 2019; 27 (6): 2179-2187. Study objective Evaluation of the effect of a blind placebo on cancer-related fatigue (CRF) for cancer survivors and assessment, whether personality traits or a genetic variation of the dopamine degradation (Catechol-o-methyltransferase) influence the placebo reaction Designed study with participants that either an open placebo group (i.e. h. The participants were aware that they received a placebo) or a control group without treatment participants were participants forty cancer survivors, all of whom have no indication of a ...
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This article is part of the ONCOLOGY SELLOUSE 2019 of magazine for naturopathy . Read the full edition here.

reference

zhou es, Halle Kt, Michaud al, et al. Open label placebo reduces fatigue for cancer survivors: a randomized study. Support-Care Cancer . 2019; 27 (6): 2179-2187.

Study goal

Assessment of the effect of a consistently placebos on cancer-related fatigue (CRF) for cancer survivors and assessment, whether personality traits or a genetic variation of dopamine degradation (Catechol-o-methyltransferase) influence the placebo reaction

draft

randomized study with participants who either were assigned to an open placebo group (i.e. the participants were given a placebo) or a control group without treatment

participant

Forty cancer survivors, all of whom had no indication of an active illness, were at least 6 months after the treatment, <43 achieved on the Functional Assessment of Chronic Illness Therapy-Fatigue (Facit-F) and were not treated or examined for any other medical cause of fatigue. The average age of the participants was 47.3 years (range 22-74) and most goods married (62.5 %), non-Hispanic white (87.5 %) women (92.5 %), in which breast cancer was diagnosed on average (55 %). 9.3 years ago.

Intervention

on day 1 of the study, all participants filled 7 questionnaires (Facit-F, SF-12, POMS-SF, GLTEQ, BIDR-7, LOT-R and the Subjective Significance Questionnaire) and emitted a saliva sample for genetic tests. The participants then met with a test doctor for a 15-minute study discussion, in which the test doctor explained both the justification of the study and earlier evidence that pointed out that placebo can improve fatigue. At the end of this discussion, the participants opened a sealed envelope on which their study assignment was given (either open-label placebo [OLP] or non-treatment control). The OLP participants received 120 placebo pills with the instruction to take 2 pills twice a day for 22 days.

On the 8th day of the study, all participants repeated 3 questionnaires (Facit-F, GLTEQ and the Subjective Significance Questionnaire). The OLP participants were reminded and encouraged to continue taking their placebo pills.

On day 22 of the study, all participants repeated 5 questionnaires (Facit-F, SF-12, POMS-SF, GLTEQ and the questionnaire for subjective significance). No data were collected after day 22.

study parameters evaluated

  • Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue (Facit-F)
  • physical and psychological health: short form-12 (SF-12)
  • mood disorder: Profile of Mood States-short form (Poms-SF)
  • Exercise participation: Godin Leisure Time Exercise Questionnaire (glteq)
  • Tendency to react to socially desired: Balanced Inventory of Desirable Responding version 7 (BIDR-7)
  • generalized optimism: life orientation test revised (Lot-R)
  • Subjective fatigue and general quality of life: questionnaires for subjective significance
  • Catechol-o-methyltransferase (COMT) SNPS RS4680 and RS4818: Gentests

primary result measurements

It was assumed that differences in the results of the questionnaire reflect the influence of placebo.

important knowledge

olp significantly improved the CRF, which is reflected in changes in the FACIT-F scores between day 1 and 8 and day 1 and 22.

Changes to the FACIT-F scores not significantly correlated with dimensions for socially desirable reactions (BIDR-7) or generalized optimism (LOT-R), which indicates that a general tendency to expect the best or to present itself in the best light is no personality that is connected to the reaction of OLP.

It can be expected that the successful treatment of cancer -related fatigue improves the quality of life of the patient and possibly also improves their survival.

The OLP reaction differed significantly based on the COMT RS4818 genotype, which indicates that the dopamine system could play a role.

The questionnaires SF-12, POMS-SF and GLTEQ showed no significant difference between OLP and control.

The questionnaire for subjective significance showed a significant subjective improvement in tiredness and the general quality of life in response to OLP on day 8, but not on day 22.

practice implications

CNI is defined as "a stressful, persistent, subjective feeling of physical, emotional and/or cognitive fatigue or exhaustion in connection with cancer and/or cancer treatment that is not proportional to the latest activities".

Although this academic definition is describing in the technical sense, it does not convey a real feeling for the effects of CNI on humans. Nothing is comparable to the words of real patients who share their own experiences: "It is not an exhaustion. I am exhausted. I have never had such fatigue. It is not a work fatigue or emotional exhaustion. It is very different."

cni naturally differs from exhaustion, which is perceived as part of daily life. It is not clearly associated with physical exertion, is not relieved by calm or sleep and includes additional manifestations such as apathy, cognitive dysfunction, emotional instability and general weakness.

Formal estimates of the prevalence of CNI range from 4 % to 91 %, depending on the type of cancer examined and the evaluation methods used. 3 A recent estimate suggests that 45 % of cancer patients that undergo treatment and 29 % of the cancer survivors have a non-trivial CNI for years Existing long -term problem).

CNI is one of the most common concerns reported by cancer patients and can affect the activities of everyday life and quality of life so much that it is classified as more stressful than other cancer -related symptoms such as depression, nausea and pain. Predict. 7.8 Therefore it can be expected that the successful treatment of CNI improves the quality of life of the patient and possibly also improves their survival.

The current treatment options for CNI include movement, mining body approaches, psychosocial interventions and pharmaceutical therapy. 9 It can be strongly argued that movement is the most effective of these treatment options.

The present results of Zhou et al. can be helpful in this regard. You confirm the results of a similar study from 2018 independently and position OLP as an interesting treatment option for CNI. 13 You can also use OLP to be used to support patients in implementing a therapeutic exercise program. While Zhou et al. No statistically significant evidence found that OLP helped the patient to increase their physical activity, it is not inappropriately to assume that a longer period of time would increase this probability. It was documented that placebo effects last up to 12 months and represent a valid option for patients. Finally, the approach of the doctor is probably important when implementing OLP in clinical practice. Zhou et al. Was very consciously towards the participants and presented information, encouragement and support. "Faith activation" could be an important element for the success of placebo in clinical practice.

restrictions

This study is

by the predominant proportion of female participants (92.5 %) and the short duration of studies (22 days). Further studies in a more diverse group of subjects with longer intervention are required.

FAZIT

Even with open administration, the subjective cancer -related tiredness improved in comparison to no treatment for cancer survivors.

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