If paracetamol is "no better than placebo for back pain", why not put it this way: "Placebo is as good as ..." and make every effort to improving physician-patient-relationships (Benedetti 2013).
The term placebo („Placebo Domino in regione vivorum“, Vulgata 114:9) is misleading. E.g. a placebo-control might contain the same adjuvant as the verum-group (Villa 2005/2006).
Our current knowledge of placebo-effects should have scientific implications (Bendetti 2014). We should refrain from shame-surgery or pseudo-placebo-treatments, which are still ethically accepted in Germany under certain conditions (BÄK 2010).
Treatments come with different effects:
Specific (receptor oriented)
Weakly specific (off target: side effect)
Systemic: (e.g. mother-newborn-relationship, health-communication, the art of touching a patient, ...)
RCTs are perfectly designed to measure specific effects. The observation of system-effects might need longer time-periods, different designs (cmRCT? Relton 2010), and other indicators: "quality through the patient’s eyes", less costs for further medications, behavior change, qualitative observations etc.
Systemic effects might also be induced by highly specific devices or chemical products (e.g. adjuvants targeting specific receptors, 3D-“baby-television”-ultrasound, vagus-nerve-stimulation, ...). These products (designed for systemic outcomes) are less controlled than specific interventions.
Homeopathy is a good example to reflect on specific and systemic effects:
The mortality of cholera in the 19th century was ~40%.
Specific standard treatment (blood-letting and fluid restriction) raised the mortality rate to ~60%.
Hahnemann reported far better results, because he diluted the specific effect to absolute zero, eliminated all side effects, let his patients drink, as much as they wanted, talked to them and refrained from bloodletting (Hahnemann 1831). Florence Nightingale went even further and concentrated herself completely on the systemic cure-effect (care without a believe-system).
The problem with homeopathy is that the physician who uses it has to be absolutely convinced that the effect is indeed "specific". His strong belief is than mirrored by the patient, who therefore is convinced that the future will be positive. Therefore homeopathy is a belief-system which might induce systemic effects (and very weak or non-specific effects). It has no “specific” side effects, but surely can cause harm, if a specific standard treatment would work better.
I argue that we should study systemic effects more seriously. There might be even an evolutionary reason why a far too optimistic homo sapiens (Sharot 2011) feels pessimistic when ill, and why he needs someone to care for him, in order to let his nature do the cure (Placebo-Paradox: Humphrey 2012).
If we understand systemic effects better, we might improve health outcomes and use less specific treatments, thereby reducing costs - and the need for overdiagnosis, overtreatment and medicalization.
References
• BÄK 2010: Placebo in der Medizin: www.bundesaerztekammer.de/aerzte/medizin-ethik/projektbezogene-themen/pl...
• Benedetti F: Placebo and the New Physiology of the Doctor-Patient Relationship. Phys Rev 2013, 93(3):1207-46
• Benedetti F: Placebo effects: From the Neurobiological Paradigm to Translational Implications, Neuron 2014, 84: 623-637
• Hahnemann, Heilung von der asiatischen Cholera und Schützung vor derselben, 1831
• Humphrey N et al.: The evolutionary psychologiy of healing: a human success story. Curr Biol. 2012 Sep 11;22(17):R695-8
• Relton C (2010): Rethinking pragmatic randomised controlled trials: introducing the “cohort multiple randomised controlled trial” design, BMJ 2010; 340:c1066340
• Sharot T.: The optimism bias. Curr Biol 2011, 21, R941-945
• Villa LL et al. (2005): Lancet Oncol 2005 6(5):271-8 : „The study had two placebo groups with adjuvant doses of 225 μg or 450 μg for appropriate safety comparisons.“ . Br J Cancer. Dec 4, 2006; 95(11): 1459–66: „The placebo contained the same adjuvant and was visually indistinguishable from vaccine …“
Rapid Response:
Re: A dose of humility
If paracetamol is "no better than placebo for back pain", why not put it this way: "Placebo is as good as ..." and make every effort to improving physician-patient-relationships (Benedetti 2013).
The term placebo („Placebo Domino in regione vivorum“, Vulgata 114:9) is misleading. E.g. a placebo-control might contain the same adjuvant as the verum-group (Villa 2005/2006).
Our current knowledge of placebo-effects should have scientific implications (Bendetti 2014). We should refrain from shame-surgery or pseudo-placebo-treatments, which are still ethically accepted in Germany under certain conditions (BÄK 2010).
Treatments come with different effects:
Specific (receptor oriented)
Weakly specific (off target: side effect)
Systemic: (e.g. mother-newborn-relationship, health-communication, the art of touching a patient, ...)
RCTs are perfectly designed to measure specific effects. The observation of system-effects might need longer time-periods, different designs (cmRCT? Relton 2010), and other indicators: "quality through the patient’s eyes", less costs for further medications, behavior change, qualitative observations etc.
Systemic effects might also be induced by highly specific devices or chemical products (e.g. adjuvants targeting specific receptors, 3D-“baby-television”-ultrasound, vagus-nerve-stimulation, ...). These products (designed for systemic outcomes) are less controlled than specific interventions.
Homeopathy is a good example to reflect on specific and systemic effects:
The mortality of cholera in the 19th century was ~40%.
Specific standard treatment (blood-letting and fluid restriction) raised the mortality rate to ~60%.
Hahnemann reported far better results, because he diluted the specific effect to absolute zero, eliminated all side effects, let his patients drink, as much as they wanted, talked to them and refrained from bloodletting (Hahnemann 1831). Florence Nightingale went even further and concentrated herself completely on the systemic cure-effect (care without a believe-system).
The problem with homeopathy is that the physician who uses it has to be absolutely convinced that the effect is indeed "specific". His strong belief is than mirrored by the patient, who therefore is convinced that the future will be positive. Therefore homeopathy is a belief-system which might induce systemic effects (and very weak or non-specific effects). It has no “specific” side effects, but surely can cause harm, if a specific standard treatment would work better.
I argue that we should study systemic effects more seriously. There might be even an evolutionary reason why a far too optimistic homo sapiens (Sharot 2011) feels pessimistic when ill, and why he needs someone to care for him, in order to let his nature do the cure (Placebo-Paradox: Humphrey 2012).
If we understand systemic effects better, we might improve health outcomes and use less specific treatments, thereby reducing costs - and the need for overdiagnosis, overtreatment and medicalization.
References
• BÄK 2010: Placebo in der Medizin: www.bundesaerztekammer.de/aerzte/medizin-ethik/projektbezogene-themen/pl...
• Benedetti F: Placebo and the New Physiology of the Doctor-Patient Relationship. Phys Rev 2013, 93(3):1207-46
• Benedetti F: Placebo effects: From the Neurobiological Paradigm to Translational Implications, Neuron 2014, 84: 623-637
• Hahnemann, Heilung von der asiatischen Cholera und Schützung vor derselben, 1831
• Humphrey N et al.: The evolutionary psychologiy of healing: a human success story. Curr Biol. 2012 Sep 11;22(17):R695-8
• Relton C (2010): Rethinking pragmatic randomised controlled trials: introducing the “cohort multiple randomised controlled trial” design, BMJ 2010; 340:c1066340
• Sharot T.: The optimism bias. Curr Biol 2011, 21, R941-945
• Villa LL et al. (2005): Lancet Oncol 2005 6(5):271-8 : „The study had two placebo groups with adjuvant doses of 225 μg or 450 μg for appropriate safety comparisons.“ . Br J Cancer. Dec 4, 2006; 95(11): 1459–66: „The placebo contained the same adjuvant and was visually indistinguishable from vaccine …“
Helmut Jäger
Competing interests: No competing interests