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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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“A therapeutic benefit of open-label placebo versus no treatment was also recently reported for patients with irritable bowel syndrome in a randomized controlled study (8) and in a pilot study in depression (9).”
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Self-citationHow do they add up? The interaction between the placebo and treatment effect: A systematic review
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“In the other studies, the hypothesis was not tested.(10,25,36,37,47) Statistical meta-analysis of the interaction was not carried out due to lack of available data (means and standard deviation were missing).”
ResultOvercoming disagreement: a roadmap for placebo studies
Blease, C., & Annoni, M. (2019) · Biology & Philosophy · doi:10.1007/s10539-019-9671-5 · Cited by 35
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Self-citationN-acetylcysteine (NAC) for methamphetamine dependence: A randomised controlled trial
McKetin, R., Dean, O. M., Turner, A., Kelly, P. J., Quinn, B., Lubman, D. I., Dietze, P., Carter, G. L., Higgs, P., Sinclair, B., et al. (2021) · EClinicalMedicine · doi:10.1016/j.eclinm.2021.101005 · Cited by 33
Placebo Responses on Cardiovascular, Gastrointestinal, and Respiratory Organ Functions
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Placebo and nocebo effects: from observation to harnessing and clinical application
Tu, Y., Zhang, L., & Kong, J. (2022) · Translational Psychiatry · doi:10.1038/s41398-022-02293-2 · Cited by 34
“Randomized clinical trials of open-label placebos in different conditions, including patients with irritable bowel syndrome [133], cLBP [134], cancer-related fatigue [135], and episodic migraine [136], have demonstrated the therapeutic efficacy of open-label placebos.”
BackgroundPain Response to Open Label Placebo in Induced Acute Pain in Healthy Adult Males
Schneider, T., Luethi, J., Mauermann, E., Bandschapp, O., & Ruppen, W. (2019) · Anesthesiology · doi:10.1097/aln.0000000000003076 · Cited by 34
“Most studies pertaining to open label placebo have been based on providing transparent education about the placebo effect.(17,22,23,27) Schaefer et al.”
BackgroundCzerniak, E., Oberlander, T. F., Weimer, K., Kossowsky, J., & Enck, P. (2020) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2020.00169 · Cited by 36
“, medication labeling (17) or study design (18–20).”
BackgroundStridh, A., Pontén, M., Arver, S., Kirsch, I., Abé, C., & Jensen, K. B. (2020) · JAMA Network Open · doi:10.1001/jamanetworkopen.2020.1423 · Cited by 32
Self-citationOpen-Label Placebo Injection for Chronic Back Pain With Functional Neuroimaging
Ashar, Y. K., Sun, M. M. C., Knight, K., Flood, T. F., Anderson, Z. G., Kaptchuk, T. J., & Wager, T. D. (2024) · JAMA Network Open · doi:10.1001/jamanetworkopen.2024.32427 · Cited by 33
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Open-Label Placebo Treatment: Outcome Expectations and General Acceptance in the Lay Population
Haas, J. W., Rief, W., & Doering, B. K. (2020) · International Journal of Behavioral Medicine · doi:10.1007/s12529-020-09933-1 · Cited by 31
“, irritable bowel syndrome [9], chronic pain [12, 13], allergic rhinitis [14], cancer fatigue [15, 16], and migraines [17].”
BackgroundIs acupuncture a placebo therapy?
Zheng, Y.-C., Yuan, T., & Liu, T. (2014) · Complementary Therapies in Medicine · doi:10.1016/j.ctim.2014.05.005 · Cited by 30
Transcranial magnetic stimulation as a treatment for functional (psychogenic) upper limb weakness
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Design and conduct of confirmatory chronic pain clinical trials
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Can knowledge of Placebo and Nocebo Mechanisms Help Improve Randomized Clinical Trials?
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The Effect of Temporal Information on Placebo Analgesia and Nocebo Hyperalgesia
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Orthognathic Surgery as a Treatment for Temporomandibular Disorders
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“The expectations of the patient, doctor’s attention and empathy, type and scope of the education about themeasure or kind and form of applying the placebo are included herein (see also Table 3) [98], [112].”
BackgroundResultInfluentialYennurajalingam, S., Azhar, A., Lu, Z., Rodriguez, A. J., Arechiga, A. B., Guerra-Sanchez, M., Stanton, P. A., Andersen, C. R., Urbauer, D. L., & Bruera, E. D. (2022) · The Oncologist · doi:10.1093/oncolo/oyac184 · Cited by 26
Are Children the Better Placebo Analgesia Responders? An Experimental Approach
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Systems Pharmacogenomics – Gene, Disease, Drug and Placebo Interactions: A Case Study in COMT
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Self-citationA comparison of open-label and deceptive placebo analgesia in a healthy sample
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Self-citationTranslating knowledge on placebo and nocebo effects into clinical practice
Caliskan, E. B., Bingel, U., & Kunkel, A. (2024) · PAIN Reports · doi:10.1097/pr9.0000000000001142 · Cited by 27
Placebo and Active Treatment Additivity in Placebo Analgesia: Research to Date and Future Directions
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“…M anuscript A uthor M anuscript A uthor M anuscript The time course of the treatment relative to outcome assessment was reported in most studies and varied between 13.5 min and 4 h (Aslaksen et al., 2015; Atlas et al., 2012; Berna et al., 2017; Butcher & Carmody, 2012; Kam-Hansen et al., 2014).”
BackgroundMethodResultInfluentialEgan, P. M., Clarkson, J. J., & Hirt, E. R. (2014) · Journal of Experimental Social Psychology · doi:10.1016/j.jesp.2014.11.006 · Cited by 26
“Furthermore, these types of expectancy effects are obtained in myriad domains, ranging from sleep recovery (Draganich & Erdal, 2014) to cardiovascular improvement (Crum & Langer, 2007; Stoate, Wulf, & Lewthwaite, 2012) to pain alleviation (Kam-Hansen et al., 2014) to hunger satiation (Crum, Corbin, Brownell, & Salovey…”
BackgroundAssessing the Impact of Expectations in Cognitive Training and Beyond
Denkinger, S., Spano, L. P., Bingel, U., Witt, C. M., Bavelier, D., & Green, C. S. (2021) · Journal of Cognitive Enhancement · doi:10.1007/s41465-021-00206-7 · Cited by 26
Placebo effects in obesity research
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“Collectively, PRFs may promote improved outcomes even when participants do not receive a bioactive treatment and regardless of whether they are aware of this (3-5).”
Self-citationJustice for Placebo: Placebo Effect in Clinical Trials and Everyday Practice
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“…led to significant analgesia in response to conditioned thermal pain, which also generalized to unconditioned mechanical pain. which could lead to reductions in medication doses, shorter treatment durations, increased patient safety, fewer side e ff ects, and even reduced costs [33,45,49].”
Role of placebo effects in pain and neuropsychiatric disorders
Belcher, A. M., Ferré, S., Martinez, P. E., & Colloca, L. (2017) · Progress in Neuro-Psychopharmacology and Biological Psychiatry · doi:10.1016/j.pnpbp.2017.06.003 · Cited by 25
“Several such experiments have yielded positive results on conditions such as irritable bowel syndrome (Kaptchuk et al., 2010), chronic low back pain (Carvalho et al., 2016), migraine headache (Kam-Hansen et al., 2014), allergic rhinitis (Schaefer et al., 2016) and depression (Kelley et al., 2012).”
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Shi, Y., Cui, S.-Y., Zeng, Y., Huang, S., Cai, G., Yang, J., & Wu, W. (2021) · Frontiers in Behavioral Neuroscience · doi:10.3389/fnbeh.2021.696577 · Cited by 25
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“…studies have shown that OLP in addition to treatment as usual (TAU) can improve outcomes, for instance in irritable bowel syndrome, 25,29 episodic migraine, 23 and CBP. 7,27 Given OLP’s tolerability and safety, these findings indicate that they can have clinically relevant short-term benefits.”
Working with patients’ treatment expectations – what we can learn from homeopathy
Wilhelm, M., Hermann, C., Rief, W., Schedlowski, M., Bingel, U., & Winkler, A. (2024) · Frontiers in Psychology · doi:10.3389/fpsyg.2024.1398865 · Cited by 23
Deceptive but not open label placebos attenuate motion-induced nausea
Barnes, K., Yu, A., Josupeit, J., & Colagiuri, B. (2019) · Journal of Psychosomatic Research · doi:10.1016/j.jpsychores.2019.109808 · Cited by 22
Basedau, H., Ornello, R., Matteis, E. D., Bolortsetseg, D., Kadyrova, B., Vurallı, D., Боженко, М. І., Azizova, I., Bitsadze, N., Eralieva, E., et al. (2023) · Cephalalgia · doi:10.1177/03331024231218392 · Cited by 22
“One study even demonstrated that the magnitude of a clinical effect can be significantly influenced by the simple labelling of a placebo as an active treatment and vice versa, highlighting the importance of expectancy in therapeutic success rates of medication (19).”
BackgroundPlacebo effects in spider phobia: an eye-tracking experiment
Gremsl, A., Schwab, D., Höfler, C., & Schienle, A. (2018) · Cognition & Emotion · doi:10.1080/02699931.2017.1422698 · Cited by 21
“Kam-Hansen et al., 2014). Taken together, this eye-tracking study showed that a placebo was able to change visual avoidance of spiders; it seemed to increase the willingness for a controlled and prolonged confrontation. The overall time spent on the spider pictures positively correlated with placebo-related symptom re…”
BackgroundInfluentialAntonelli, M., & Donelli, D. (2018) · Health & Social Care in the Community · doi:10.1111/hsc.12681 · Cited by 22
Providing open-label placebos remotely—A randomized controlled trial in allergic rhinitis
Κube, T., Hofmann, V. E., Glombiewski, J. A., & Kirsch, I. (2021) · PLoS ONE · doi:10.1371/journal.pone.0248367 · Cited by 22
“However, research has demonstrated that placebos being honestly prescribed to patients (so called “open-label placebos” = OLPs) can lead to symptom reduction in irritable bowel syndrome [5], chronic back pain [6, 7], migraine [8], cancer-related fatigue [9, 10], attention-deficit hyperactivity disorder [11, 12], depre…”
BackgroundSelf-citationFriesen, P., & Dionne, É. (2022) · Science & Technology Studies · doi:10.23987/sts.110291 · Cited by 21
Drug‐Placebo Additivity in Randomized Clinical Trials
Hall, K. T., & Loscalzo, J. (2019) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.1626 · Cited by 23
“In a study of the effects of labeling in migraine, Kam-Hansen et al.(25) labeled verum and placebo Maxalt, as “placebo,” “Maxalt,” or “Maxalt or placebo.”
BackgroundSondermann, W., Jockenhöfer, F., Dissemond, J., Pfaar, O., Bingel, U., & Schedlowski, M. (2021) · Dermatology · doi:10.1159/000513445 · Cited by 22
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“studies related to pain have been performed to this day [130,133,153].”
BackgroundLangford, D. J., Lou, R., Sheen, S., Amtmann, D., Colloca, L., Edwards, R. R., Farrar, J. T., Katz, N. P., McDermott, M. P., Reeve, B. B., et al. (2022) · Journal of Pain · doi:10.1016/j.jpain.2022.12.011 · Cited by 21
More than consent for ethical open-label placebo research
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“While the mean age of patients in the previous studies ranged between 40 and 60 years (23, 25, 30, 58), our results”
ResultEffectiveness of Conditioned Open-label Placebo With Methadone in Treatment of Opioid Use Disorder
Belcher, A. M., Cole, T. O., Massey, E. C., Billing, A. S., Wagner, M. A., Wooten, W., Epstein, D. H., Hoag, S. W., Wickwire, E. M., Greenblatt, A. D., et al. (2023) · JAMA Network Open · doi:10.1001/jamanetworkopen.2023.7099 · Cited by 19
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The beneficial effect of positive treatment expectations on pharmacological migraine prophylaxis
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“Finally, studies also show that the contingent features of placebo treatments such as taste, color, size, or invasiveness can also modulate the effect (Branthwaite and Cooper, 1981; De Craen et al., 1996; Kaptchuk et al., 2008; Kam-Hansen et al., 2014; Faasse et al., 2016; Berna et al., 2017).”
BackgroundChen, J. A., Vijapura, S., Papakostas, G. I., Parkin, S. R., Kim, D. J. H., Cusin, C., Baer, L., Clain, A. J., D, M. F. M., & Mischoulon, D. (2014) · Asian Journal of Psychiatry · doi:10.1016/j.ajp.2014.12.002 · Cited by 19
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“Previous RCTs on open medication [34, 50, 51] investigated patient–clinician communication as a contextual factor and its additional impact on analgesic outcomes [38, 52–55].”
BackgroundUnderstanding placebo effects: Implications for nursing practice
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Eliminating Opioids from Breast Conserving Surgery: Perioperative Pain Management Pathway
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Surgical treatment for migraine: Time to fight against the knife
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Effects of Open-Label Placebos on State Anxiety and Glucocorticoid Stress Responses
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Can insights from placebo and nocebo mechanisms studies improve the randomized controlled trial?
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Narrative Medicine Meets Planetary Health: Mindsets Matter in the Anthropocene
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Headache research in 2014: advancing migraine therapy
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“The placebo effect in migraineurs is known to influence their improvement in symptoms and that response may be exaggerated with PFO closure [24,25].”
BackgroundColloca, L. (2020) · International review of neurobiology · doi:10.1016/bs.irn.2020.04.001 · Cited by 15
Nocebo, Aufklärung und Arzt-Patienten-Kommunikation
Hansen, E., Zech, N., & Benson, S. (2020) · Der Nervenarzt · doi:10.1007/s00115-020-00963-4 · Cited by 16
No open-label placebo effect in insomnia? Lessons learned from an experimental trial
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What Placebos Teach Us about Health and Care
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The Therapeutic Value of the Relationship for Placebo Effects and Other Healing Practices
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Placebos as a Source of Agency: Evidence and Implications
Friesen, P. (2019) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2019.00721 · Cited by 19
Erpelding, N., Evans, K., Lanier, R. K., Elder, H., & Katz, N. P. (2020) · Clinical Journal of Pain · doi:10.1097/ajp.0000000000000873 · Cited by 14
The role of positive information provision in open‐label placebo effects
Barnes, K., Babbage, E., Barker, J. M., Jain, N., & Faasse, K. (2023) · Applied Psychology Health and Well-Being · doi:10.1111/aphw.12444 · Cited by 12
Remotely Provided Open-Label Placebo Reduces Frequency of and Impairment by Allergic Symptoms
Κube, T., Kirsch, I., Glombiewski, J. A., Witthöft, M., & Bräscher, A. (2022) · Psychosomatic Medicine · doi:10.1097/psy.0000000000001110 · Cited by 13
Self-citationExpectancy Effect in Three Mind-Body Clinical Trials
Hicks, M., Hanes, D. A., & Wahbeh, H. (2016) · Journal of Evidence-Based Complementary & Alternative Medicine · doi:10.1177/2156587216652572 · Cited by 16
ZAFONTE, R. D., Fregni, F., Bergin, M. J. G., Goldstein, R., Boudreau, N., Monge, I., Luz, M., Frazier, J., & Giacino, J. T. (2019) · Brain Injury · doi:10.1080/02699052.2019.1677941 · Cited by 13
“Expectations and labelling may significantly influence perceived efficacy in those with chronic disorders (31).”
BackgroundPlacebos in clinical practice: an ethical overview
Annoni, M., & Miller, F. G. (2014) · Douleur et Analgésie · doi:10.1007/s11724-014-0400-1 · Cited by 13
Nocebo and Placebo Effects and Their Implications in Psychotherapy
Rief, W., & Wilhelm, M. (2024) · Psychotherapy and Psychosomatics · doi:10.1159/000540791 · Cited by 13
Niazi, S. K. (2024) · Healthcare · doi:10.3390/healthcare12222314 · Cited by 14
“A recent study published in Science Translational Medicine [3] tested how people reacted to migraine pain medication to show that the placebo was 50% as effective as the analgesic drug once the participants were told that the tested drug could reduce pain.”
Medrea, I., Christie, S. N., Tepper, S. J., Thavorn, K., & Hutton, B. (2022) · Headache The Journal of Head and Face Pain · doi:10.1111/head.14283 · Cited by 13
Bandak, E., Overgaard, A., Kristensen, L. E., Ellegaard, K., Guldberg–Møller, J., Bartholdy, C. R., Hunter, D. J., Altman, R. D., Christensen, R., Bliddal, H., et al. (2021) · Trials · doi:10.1186/s13063-020-04952-5 · Cited by 12
Informed Consent: Hints From Placebo and Nocebo Research
Colloca, L. (2015) · The American Journal of Bioethics · doi:10.1080/15265161.2015.1074314 · Cited by 12
“One of the drugs used was Maxalt (10-mg rizatriptan), which has been proven to provide relief of pain from headaches.”
BackgroundMethodInfluentialTowards an account of the placebo effect: a critical evaluation alongside current evidence
Friesen, P. (2020) · Biology & Philosophy · doi:10.1007/s10539-019-9733-8 · Cited by 11
Strategies to minimize placebo effects in research investigations
Rodrigues, F. B., & Ferreira, J. J. (2020) · International review of neurobiology · doi:10.1016/bs.irn.2020.04.002 · Cited by 11
Effect of a bioconverted product of Lotus corniculatus seed on the axillary microbiome and body odor
Kim, M., Tagele, S. B., Jo, H., Kim, M., Jung, Y., Park, Y.-J., So, J.-H., Kim, H. J., Kim, H. J., Lee, D., et al. (2021) · Scientific Reports · doi:10.1038/s41598-021-89606-5 · Cited by 13
van Middendorp, H., Berende, A., Vos, F. J., ter Hofstede, H. J. M., Kullberg, B. J., & Evers, A. W. M. (2021) · Clinical Rheumatology · doi:10.1007/s10067-021-05760-1 · Cited by 10
Auriculotherapy for reducing chronic spinal pain in health workers: a clinical trial
Morais, B. X., Munhoz, O. L., Moreira, C. H. C., Kurebayashi, L. F. S., Lopes, L. F. D., & Magnago, T. S. B. D. S. (2023) · Revista Latino-Americana de Enfermagem · doi:10.1590/1518-8345.6641.3954 · Cited by 11
Montecchi-Palmer, M., Wu, M., Rolando, M., Lau, C., Quinones, V. L. P., & Dana, R. (2023) · Ophthalmology and Therapy · doi:10.1007/s40123-023-00720-1 · Cited by 10
A Conversation with … Ted J. Kaptchuk, Expert in Placebo Effects
Leopold, S. S. (2021) · Clinical Orthopaedics and Related Research · doi:10.1097/corr.0000000000001824 · Cited by 10
Fife, D., Cepeda, M. S., Baseman, A. S., Richards, H. M., Hu, P., Starr, H. L., & Sena, A. G. (2018) · PLoS ONE · doi:10.1371/journal.pone.0193453 · Cited by 10
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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