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Altered Placebo and Drug Labeling Changes the Outcome of Episodic Migraine Attacks
Open accessAbstract
In 459 migraine attacks, information provided to patients (from negative to neutral to positive) modified placebo and medication outcomes in a progressive fashion.
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“In a clinical setting, it has been demonstrated that either or both placebo (positive expectancy of pain relief) and nocebo effects (negative expectancy of increased pain) influence the effectiveness of medical treatment (Kam-Hansen et al., 2014; Pollo et al., 2001).”
From Distinct neural representations of placebo and nocebo effects (2015) · cites this paper as Kam-Hansen et al., 2014
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“…treatment (other) No treatment Between subjects 16/16 Patients undergoing dental surgery Acute procedural pain (postoperative pain) 1 3 postintervention# Kam-Hansen et al. (2014)39 Verbal suggestion referring to placebo or active treatment (oral) Control treatment Within subjects 120 Patients…”
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“For instance, inert treatments presented as costly to patients tend to be more effective than treatments that patients know are less expensive.(14,23) Social learning–observing first-hand the effects of a treatment on others–also greatly contributes to the formation of placebo responses.”
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The Insula: A “Hub of Activity” in Migraine
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“can reduce chronic and acute pain (ie, back pain and episodic migraine) and cancer-related fatigue.(6,16,37) So far, studies on”
BackgroundPredictors of the placebo analgesia response in randomized controlled trials of chronic pain
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Self-citationOpen-label placebo vs double-blind placebo for irritable bowel syndrome: a randomized clinical trial
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MethodResultSelf-citationTreatment as usual and routine care in research and clinical practice
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“However, placebo effects induced via this process do not require explicit cognitive control, nor are they be immediately affected by new information. the treatment is chemically inert (Kam-Hansen et al., 2014; Kaptchuk et al., 2010).”
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Are Blue Pills Better Than Green? How Treatment Features Modulate Placebo Effects
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Opposite effects of the same drug
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Clinical Use of Placebo Effects in Patients With Pain Disorders
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“…to excellent clinical results for patients with chronic pain (Carvalho et al., 2016; Klinger et al., 2017), idiopathic and neuropathic pain (Petersen et al., 2014, 2012; Vase et al., 2014), migraine (Kam-Hansen et al., 2014), and knee osteoarthritis (Gollub et al., 2018; Tetreault et al., 2016).”
BackgroundKatz, N. P., Dworkin, R. H., North, R. B., Thomson, S., Eldabe, S. S., Hayek, S. M., Kopell, B. H., Markman, J. D., Rezai, A. R., Taylor, R. S., et al. (2021) · Pain · doi:10.1097/j.pain.0000000000002204 · Cited by 74
“balanced information in all available sources, including company websites, internet postings about the clinical trial, informed consent documents, patient education materials, and verbal descriptions and body language.(76,81) Interactions should be scripted to the extent possible to minimize the risk of bias.”
BackgroundOpen-label placebo clinical trials: is it the rationale, the interaction or the pill?
Blease, C., Bernstein, M. H., & Locher, C. (2019) · BMJ Evidence-Based Medicine · doi:10.1136/bmjebm-2019-111209 · Cited by 71
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Nocebo effects can make you feel pain
Colloca, L. (2017) · Science · doi:10.1126/science.aap8488 · Cited by 67
Egorova, N., Yu, R., Kaur, N., Vangel, M., Gollub, R. L., Dougherty, D. D., Kong, J., & Camprodon, J. A. (2015) · Pain · doi:10.1097/j.pain.0000000000000163 · Cited by 63
“desirable and their interaction with treatment produces better results compared with treatment only.(26) At the same time, nocebo effects are mostly harmful and related to anxiety.”
Response to placebo in clinical epilepsy trials—Old ideas and new insights
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Athletes Intending to Use Sports Supplements Are More Likely to Respond to a Placebo
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“Research has shown that placebo effects can be initiated via verbal instructions (creating an expectation of a drug; (28)) and/or via repeat exposure to a drug with a subsequent placebo intervention mirroring the action of that drug (9).”
BackgroundSchaffer, J. T., Hunter, B. R., Ball, K. M., & Weaver, C. S. (2015) · Annals of Emergency Medicine · doi:10.1016/j.annemergmed.2014.12.012 · Cited by 62
Klinger, R., Kothe, R., Schmitz, J., Kamping, S., & Flor, H. (2017) · Pain · doi:10.1097/j.pain.0000000000000977 · Cited by 67
Informed consent and clinical trials: where is the placebo effect?
Blease, C., Bishop, F. L., & Kaptchuk, T. J. (2017) · BMJ · doi:10.1136/bmj.j463 · Cited by 61
Self-citationSurgical treatment of migraine headaches
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Harnessing the Placebo Effect in Pediatric Migraine Clinic
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Placebo effects in osteoarthritis: implications for treatment and drug development
Neogi, T., & Colloca, L. (2023) · Nature Reviews Rheumatology · doi:10.1038/s41584-023-01021-4 · Cited by 61
Nocebo vs. Placebo: The Challenges of Trial Design in Analgesia Research
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“41 Thus, each patient was tested in seven conditions: one control condition, placebo with each of the three suggestions, and the active drug with each of the three suggestions.”
InfluentialDoes training general practitioners result in more shared decision making during consultations?
Sanders, A., Bensing, J. M., Essed, M. A. L. U., Magnée, T., de Wit, N. J., & Verhaak, P. F. M. (2016) · Patient Education and Counseling · doi:10.1016/j.pec.2016.10.002 · Cited by 54
Esch, T., & Stefano, G. B. (2022) · Frontiers in Integrative Neuroscience · doi:10.3389/fnint.2022.913573 · Cited by 64
“The results from studies published by Kam-Hansen et al. (2014) and Kaptchuk et al. (2010) suggested that the placebo effect exists even in studies involving ‘‘open-label treatments’’ (i.e., when the patient is informed that he or she will be taking a drug with no active ingredients).”
ResultThe role of patient beliefs in open-label placebo effects.
Leibowitz, K. A., Hardebeck, E. J., Goyer, J. P., & Crum, A. J. (2019) · Health Psychology · doi:10.1037/hea0000751 · Cited by 59
“…of other conditions, including attention-deficit-hyperactivity disorder (ADHD), allergic rhinitis, migraines, and back pain (Carvalho et al., 2016; Kam-Hansen et al., 2014; Sandler & Bodfish, 2008; Sandler, Glesne, & Bodfish, 2010; Schaefer, Harke, & Denke, 2016; Schaefer, Sahin, & Berstecher,…”
Flowers, K. M., Patton, M. E., Hruschak, V., Fields, K. G., Schwartz, E., Zeballos, J., Kang, J. D., Edwards, R. R., Kaptchuk, T. J., & Schreiber, K. L. (2021) · Pain · doi:10.1097/j.pain.0000000000002185 · Cited by 55
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Unsolved, Forgotten, and Ignored Features of the Placebo Response in Medicine
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Placebo and nocebo responses in drug trials of epilepsy
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Placebo Analgesia in Rodents: Current and Future Research
Keller, A., Akintola, T., & Colloca, L. (2018) · International Review of Neurobiology · doi:10.1016/bs.irn.2018.02.001 · Cited by 45
“…Robinson, Verne, & Price, 2003, 2005), idiopathic and neuropathic pain (Petersen et al., 2012, 2014; Vase, Petersen, & Lund, 2014), low back pain (Carvalho et al., 2016; Hashmi et al., 2012), migraine (Kam-Hansen et al., 2014), and knee osteoarthritis (Gollub et al., 2018; Tetreault et al., 2016).”
BackgroundContextually Aided Recovery (CARe): a scientific theory for innate healing
Newell, D., Lothe, L. R., & Raven, T. J. L. (2017) · Chiropractic & Manual Therapies · doi:10.1186/s12998-017-0137-z · Cited by 49
Placebo Improvement in Pharmacologic Treatment of Menopausal Hot Flashes
Freeman, E. W., Ensrud, K. E., Larson, J. C., Guthrie, K. A., Carpenter, J. S., Joffe, H., Newton, K. M., Sternfeld, B., & LaCroix, A. Z. (2015) · Psychosomatic Medicine · doi:10.1097/psy.0000000000000143 · Cited by 45
“Other data show that placebos given after active drug treatment maintained the active drug outcome with reduced adverse effects (9).”
BackgroundMindfulness Meditation Modulates Pain Through Endogenous Opioids
Sharon, H., Maron-Katz, A., Ben Simon, E., Flusser, Y., Hendler, T., Tarrasch, R., & Brill, S. (2016) · The American Journal of Medicine · doi:10.1016/j.amjmed.2016.03.002 · Cited by 44
Deceptive and Nondeceptive Placebos to Reduce Pain
Κube, T., Rief, W., Vivell, M.-B., Schäfer, N. L., Vermillion, T., Körfer, K., & Glombiewski, J. A. (2019) · Clinical Journal of Pain · doi:10.1097/ajp.0000000000000781 · Cited by 48
The Ethics of Placebo Effects in Clinical Practice and Research
Annoni, M. (2018) · International review of neurobiology · doi:10.1016/bs.irn.2018.07.031 · Cited by 45
Schaefer, M., Denke, C., Harke, R., Olk, N., Erkovan, M., & Enge, S. (2019) · Scientific Reports · doi:10.1038/s41598-019-49466-6 · Cited by 44
What can be done to control the placebo response in clinical trials? A narrative review
Evans, K., Colloca, L., Peciña, M., & Katz, N. P. (2021) · Contemporary Clinical Trials · doi:10.1016/j.cct.2021.106503 · Cited by 44
How can placebo effects best be applied in clinical practice? A narrative review
Bystad, M. K., Wynn, R., & Bystad, C. (2015) · Psychology Research and Behavior Management · doi:10.2147/prbm.s75670 · Cited by 48
Placebo Effects and the Ethics of Therapeutic Communication: A Pragmatic Perspective
Annoni, M., & Miller, F. G. (2016) · Kennedy Institute of Ethics journal · doi:10.1353/ken.2016.0004 · Cited by 45
“In a recent study by Kam-Hansen et al. (2014), 66 patients with recurring migraine headaches were randomized using a 2 × 3 balanced-placebo design.”
MethodSchmitz, J., Müller, M., Stork, J., Eichler, I., Zöllner, C., Flor, H., & Klinger, R. (2019) · Psychotherapy and Psychosomatics · doi:10.1159/000501385 · Cited by 44
Healing in a Social Context: The Importance of Clinician and Patient Relationship
Wampold, B. E. (2021) · Frontiers in Pain Research · doi:10.3389/fpain.2021.684768 · Cited by 45
“As discussed earlier, placebo effects, most likely due to expectancies, can be created without face-to-face interactions (32, 33), say by written information.”
BackgroundOpen-label placebo for chronic low back pain: a 5-year follow-up
Carvalho, C., Pais, M., Cunha, L., Rebouta, P., Kaptchuk, T. J., & Kirsch, I. (2020) · Pain · doi:10.1097/j.pain.0000000000002162 · Cited by 40
Self-citationAn update on behavioral treatments in migraine - current knowledge and future options
Kropp, P., Meyer, B., Meyer, W., & Dresler, T. (2017) · Expert Review of Neurotherapeutics · doi:10.1080/14737175.2017.1377611 · Cited by 37
Parental Attitudes About Placebo Use in Children
Faria, V., Kossowsky, J., Petkov, M. P., Kaptchuk, T. J., Kirsch, I., Lebel, A., & Borsook, D. (2016) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2016.10.018 · Cited by 37
Self-citationThe Placebo Effect in Cardiology: Understanding and Using It
Sheldon, R. S., & Opie, M. (2017) · Canadian Journal of Cardiology · doi:10.1016/j.cjca.2017.09.017 · Cited by 54
Metadata
- Authors
- Kam-Hansen, S., Jakubowski, M., Kelley, J. M., Kirsch, I., Hoaglin, D. C., Kaptchuk, T. J., & Burstein, R.
- Affiliations
- Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.
- Beth Israel Deaconess Medical Center (US)
- IC Independent Consulting (Australia) (AU)
- Corresponding author
- Kaptchuk, Ted J.
- Burstein, Rami
- Venue
- Science Translational Medicine
- Published
- 2014-01-08
- Volume
- 6
- Issue
- 218
- Pages
- 218ra5-218ra5
- ISSN
- 1946-6234 (ISSN-L)
- 1946-6242
- PMC
- PMC4005597
- OpenAlex
- W2169836118
- Cited by
- 399
- References
- 22
- Citations by year
- 2026: 11 · 2025: 26 · 2024: 21 · 2023: 26 · 2022: 28 · 2021: 38 · 2020: 47 · 2019: 38 · 2018: 42 · 2017: 36 · 2016: 27 · 2015: 29 · 2014: 29
- FWCI
- 22.49
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Science Translational Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Neurological Disorders and Stroke (R01NS069847, R37NS079678)
- National Center for Complementary and Integrative Health (K24AT004095)
- Topics
- Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
- Health Sciences › Medicine › Clinical Neurology › Migraine and Headache Studies
- Health Sciences › Medicine › Complementary and alternative medicine › Acupuncture Treatment Research Studies
- Keywords
- episodic migraine, placebo effect, drug labeling, rizatriptan, patient information, analgesia
- MeSH terms
- Drug Labeling, Humans, Migraine Disorders, Pain Measurement, Placebos, Triazoles, Tryptamines, Treatment Outcome, Endpoint Determination
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