Review
Medicine, General & Internal
Morton E. Tavel
Summary: The placebo effect refers to improvements in illnesses or subjective symptom reduction caused by interventions with no known physical effects, while the nocebo effect refers to undesirable symptoms or illnesses following interventions with no known physical effects, and it may play a role in chronic illnesses without objective confirmation. Both placebo and nocebo effects are powerful and must be understood by practitioners and researchers in clinical medicine. Individual caregivers can apply these principles to modify patient care outcomes.
AMERICAN JOURNAL OF MEDICINE
(2022)
Article
Pharmacology & Pharmacy
Fabrizio Benedetti, Martina Amanzio, Fabio Giovannelli, Karen Craigs-Brackhahn, Aziz Shaibani
Summary: This study revealed that participants who read a list of possible adverse events before receiving a placebo treatment reported more adverse events compared to those who did not read the list. Moreover, increased activity in the hypothalamic-pituitary-adrenal axis and higher state anxiety scores were observed in those who reported multiple adverse events, indicating a potential neuroendocrine mechanism following placebo administration.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2021)
Review
Biochemistry & Molecular Biology
Ratna Shree Sharma, Johannes Pallua, Michael Schirmer
Summary: This meta-analysis examines the occurrence of adverse events in the placebo arms of double-blind, randomized, placebo-controlled studies in rheumatoid arthritis. The results show that patients in the placebo arms reported adverse events such as nausea and hepatobiliary disorders at similar rates to those in the verum arms. It is important for patients to be aware that adverse events can still occur even with placebo medication.
Article
Psychology, Multidisciplinary
Carina Schlintl, Anne Schienle
Summary: The study showed that written information can influence the occurrence of reported placebo/nocebo side effects. Additionally, information about the provider's optimistic personality was associated with a lower frequency of reported adverse side effects.
FRONTIERS IN PSYCHOLOGY
(2021)
Article
Psychology, Multidisciplinary
Monika K. Heller, Sarah C. E. Chapman, Rob Horne
Summary: In clinical trials, patients often report more side-effects when receiving placebo, and medication beliefs and other psychological factors can predict the detection and attribution of side-effects.
ANNALS OF BEHAVIORAL MEDICINE
(2022)
Article
Medicine, General & Internal
Ingmar Schaefer, Jan Hendrik Oltrogge, Yvonne Nestoriuc, Claire V. Warren, Stefanie Brassen, Maximilian Blattner, Dagmar Luehmann, Alexandra Tinnermann, Martin Scherer, Christian Buechel
Summary: Concerns about adverse effects can affect the uptake of COVID-19 vaccination. Research suggests that positive and negative expectations prior to vaccination are associated with systemic adverse effects. Understanding these associations can improve clinician-patient interactions and public vaccine campaigns.
Review
Oncology
Sandy Simon, Katherine E. Francis, Janene E. Dalrymple, Val Gebski, Sarah J. Lord, Michael Friedlander, Chee Khoon Lee
Summary: Non-drug-related adverse events are common in ovarian cancer patients in maintenance therapy RCTs. Potential explanations include the nocebo effect, residual toxicities from previous treatment, or underlying disease.
EUROPEAN JOURNAL OF CANCER
(2022)
Review
Medicine, General & Internal
Julia W. Haas, Friederike L. Bender, Sarah Ballou, John M. Kelley, Marcel Wilhelm, Franklin G. Miller, Winfried Rief, Ted J. Kaptchuk
Summary: This systematic review and meta-analysis found that significantly more adverse events (AEs) were reported in the vaccine groups compared with the placebo groups, but the rates of reported AEs in the placebo arms were still substantial. Public vaccination programs should take into account the high rates of AEs in placebo arms.
Review
Immunology
F. L. Bender, W. Rief, M. Wilhelm
Summary: This study investigated the solicited adverse events reported in placebo groups following seasonal influenza vaccination. The results showed significant effect sizes of proportions for solicited adverse events, indicating substantial nocebo responses after vaccination. This highlights the importance of addressing fear of side effects to reduce vaccine hesitancy.
Article
Psychology, Multidisciplinary
Nina Zech, Leoni Scharl, Milena Seemann, Michael Pfeifer, Ernil Hansen
Summary: The effects of suggestions on respiratory muscle strength were evaluated in this study. The results showed that different suggestions had significant impacts on respiratory muscle strength, with expiratory force being more affected than inspiratory force. Women showed stronger reactions to the suggestions.
FRONTIERS IN PSYCHOLOGY
(2022)
Article
Clinical Neurology
Christian P. Cheung, Mathura T. Thiyagarajah, Haben Y. Abraha, Celina S. Liu, Krista L. Lanctot, Alex J. Kiss, Mahwesh Saleem, Ari Juda, Anthony J. Levitt, Ayal Schaffer, Amy H. Cheung, Mark Sinyor
Summary: This study found that among patients receiving active treatment in antidepressant trials, drug-drug trials had lower rates of adverse events compared to other designs. However, there were no significant differences in adverse event rates across different designs for patients receiving placebo.
JOURNAL OF AFFECTIVE DISORDERS
(2021)
Article
Anesthesiology
Lingling Weng, Kaya J. Peerdeman, Delia Della Porta, Antoinette I. M. van Laarhoven, Andrea W. M. Evers
Summary: Placebo and nocebo effects can influence pain perception but may not have the same impact on itch. The study suggests that these effects may generalize within the pain modality but not across different sensory modalities.
Article
Chemistry, Multidisciplinary
Yair Sharav, Yaron Haviv, Michael Tal
Summary: The purpose of this study was to investigate the effects of placebo and nocebo under hypnotic analgesia in lowly and highly hypnotizable subjects. Placebo and nocebo effects were studied through verbal expectation and conditioning in 12 lowly and 12 highly hypnotizable subjects under hypnosis. The results showed that placebo-produced analgesia differed significantly from nocebo-produced hyperalgesia in lowly hypnotizable subjects. However, no difference was detected between placebo and nocebo effects in highly hypnotizable subjects. The study suggests that combining placebo intervention with hypnotic analgesia can significantly improve pain relief regardless of hypnotic susceptibility.
APPLIED SCIENCES-BASEL
(2023)
Article
Psychology, Multidisciplinary
Stefanie H. Meeuwis, Henriet van Middendorp, Dieuwke S. Veldhuijzen, Andrea W. M. Evers
Summary: Placebo and nocebo effects are mediated by expectation in an open-label context, but not in a closed-label context. Ignorance of bodily signals may moderate the direct effects of nocebo suggestions, and behavioral activation system may modulate the effects of suggestions on itch through expectation. Other interindividual differences showed limited impact on placebo and nocebo responding in itch.
FRONTIERS IN PSYCHOLOGY
(2021)
Article
Psychology, Multidisciplinary
Katia Mattarozzi, Arianna Bagnis, Joanna Klosowska, Przemyslaw Babel, Valeria Cremonini, Alessandra De Palma, Arianna Fabbri, Elisa Farinella, Lucrezia Puccini, Vittorio Sambri, Simona Semprini, Paolo Maria Russo
Summary: This study highlights the role of psychological influences in triggering and amplifying the adverse effects of the COVID-19 vaccine (i.e., nocebo effects). Fear, beliefs, and expectations about the COVID-19 vaccine, trust in health and scientific institutions, and stable personality traits were measured in 315 adult Italian citizens (145 men) during the 15-min waiting time after vaccination. The occurrence and severity of 10 potential adverse effects were assessed 24 hr later. Nonpharmacological variables predicted nearly 30% of the severity of the vaccine's adverse effects. Expectations are important determinants of adverse effects from vaccines, and the results of the path analyses show that these expectations stem primarily from people's vaccine beliefs and attitudes, which can be changed. Implications for increasing vaccine acceptability and limiting the nocebo effect are discussed.
PSYCHOLOGICAL SCIENCE
(2023)
Article
Geriatrics & Gerontology
E. Kravvariti, M. Kotsani, D. D. Mitsikostas, P. P. Sfikakis
Summary: Several factors, such as psychological disorders, neurodegenerative diseases, and chronic pain, may increase susceptibility to the nocebo effect in older adults. However, under-representation in clinical trials, the complexity of geriatric patient care, and the lack of validated tools for assessing susceptibility and preventive efforts hinder research on nocebo effects in this population.
Article
Urology & Nephrology
Lazaros Tzelves, Ioannis Glykas, Charalampos Fragkoulis, Dimos-Dimitrios Mitsikostas, Andreas Skolarikos, Blayne Welk, Athanasios Dellis
Summary: The Greek version of the NBSS questionnaire was found to be a valid and reliable instrument for assessing neurogenic bladder symptoms in Greek patients with multiple sclerosis. The questionnaire exhibited high internal consistency and test-retest reliability for overall scores and subdomains. A moderate correlation was also observed between the NBSS quality of life question and the MusiQoL questionnaire.
WORLD JOURNAL OF UROLOGY
(2021)
Letter
Respiratory System
Vasiliki-Kalliopi Bournia, Oliver Distler, Evrydiki Kravvariti, Dimos Mitsikostas, Petros P. Sfikakis
EUROPEAN RESPIRATORY JOURNAL
(2021)
Editorial Material
Clinical Neurology
Dimos D. Mitsikostas, Michael A. Moskowitz
Summary: Post-traumatic headache, while common, is still not well understood and managed effectively. Recent research has found a link between calcitonin gene-related peptide and the trigeminovascular system, opening up new possibilities for understanding the pathophysiology and improving treatment outcomes for this disorder.
NATURE REVIEWS NEUROLOGY
(2021)
Article
Urology & Nephrology
I. Glykas, Ch Fragkoulis, D. D. Mitsikostas, A. Papatsoris, I. Mitsogiannis, G. Papadopoulos, A. Skolarikos, I. Gkialas, K. Ntoumas, A. Dellis
Summary: The study evaluated and compared the efficacy and safety of treating MS patients with LUTD using a b3 agonist (mirabegron) or anticholinergics. Both treatments showed improvement in LUTD symptoms without statistical differences between the two groups.
WORLD JOURNAL OF UROLOGY
(2021)
Review
Chemistry, Medicinal
Panagiotis Gklinos, Dimos D. Mitsikostas
Summary: Galcanezumab is a promising novel treatment for migraine prophylaxis, significantly reducing migraine headaches and headache-related disability by targeting the CGRP pathway. Further research is needed to evaluate its efficacy in treatment-resistant migraine and establish its long-term safety profile.
Review
Pharmacology & Pharmacy
Theodoros Mavridis, Marianthi Breza, Christina Deligianni, Dimos D. Mitsikostas
Summary: Currently, the medical management of cluster headache remains poor, with ongoing clinical trials offering potential valuable evidence for future treatments. Further improvements in clinical trial design could help advance therapeutic options for CH.
EXPERT OPINION ON PHARMACOTHERAPY
(2021)
Review
Medicine, General & Internal
Messoud Ashina, Dawn C. Buse, Hakan Ashina, Patricia Pozo-Rosich, Mario F. P. Peres, Mi Ji Lee, Gisela M. Terwindt, Rashmi Halker Singh, Cristina Tassorelli, Thien Phu Do, Dimos D. Mitsikostas, David W. Dodick
Summary: Migraine is a highly disabling neurological disorder affecting over 1 billion people worldwide. Treatment options include pharmacological and non-pharmacological therapies. Building a personalized treatment plan and exploring emerging mechanism-based treatments are crucial for effective management.
Article
Medicine, General & Internal
Sait Ashina, Dimos D. Mitsikostas, Mi Ji Lee, Nooshin Yamani, Shuu-Jiun Wang, Roberta Messina, Hakan Ashina, Dawn C. Buse, Patricia Pozo-Rosich, Rigmor H. Jensen, Hans-Christoph Diener, Richard B. Lipton
Summary: Tension-type headache is the most prevalent neurological disorder characterized by recurrent headaches of mild to moderate intensity, bilateral location, and no aggravation by routine physical activity. The mainstay of treatment is pharmacological therapy, with recommended preventive treatments including certain medications and non-pharmacological therapies. Despite the widespread prevalence and associated disability, little progress has been made in the field of tension-type headache due to lack of attention and resource allocation.
NATURE REVIEWS DISEASE PRIMERS
(2021)
Article
Pharmacology & Pharmacy
Christina Deligianni, Dimos D. Mitsikostas, Messoud Ashina
Summary: This review found no safety and tolerability concerns related to the use of erenumab in migraine treatment. The most common adverse events were local skin reactions and constipation, but there were no severe adverse events or frequent events leading to treatment discontinuation. Overall, treatment with erenumab was well tolerated.
EXPERT OPINION ON DRUG SAFETY
(2021)
Article
Clinical Neurology
Timothy J. Steiner, Rigmor Jensen, Zaza Katsarava, Lars Jacob Stovner, Derya Uluduz, Latifa Adarmouch, Mohammed Al Jumah, Ali M. Al Khathaami, Messoud Ashina, Mark Braschinsky, Susan Broner, Jon H. Eliasson, Raquel Gil-Gouveia, Juan B. Gomez-Galvan, Larus S. Gudmundsson, Akbar A. Herekar, Nfwama Kawatu, Najib Kissani, Girish Baburao Kulkarni, Elena R. Lebedeva, Matilde Leonardi, Mattias Linde, Otgonbayar Luvsannorov, Youssoufa Maiga, Ivan Milanov, Dimos D. Mitsikostas, Teymur Musayev, Jes Olesen, Vera Osipova, Koen Paemeleire, Mario F. P. Peres, Guiovanna Quispe, Girish N. Rao, Ajay Risal, Elena Ruiz de la Torre, Deanna Saylor, Mansoureh Togha, Sheng-Yuan Yu, Mehila Zebenigus, Yared Zenebe Zewde, Jasna Zidverc-Trajkovic, Michela Tinelli
Summary: The current focus of headache services in most countries is on specialist care, when in fact, most headache disorders could be effectively treated in educationally supported primary care. The high demand for headache care is the biggest challenge to reform, and placing headache services in primary care with educational support can effectively address this issue. The structured headache services model presented by experts is adaptable and cost-effective, but requires further formal economic analysis to validate its efficiency.
JOURNAL OF HEADACHE AND PAIN
(2021)
Review
Clinical Neurology
Anna K. Eigenbrodt, Hakan Ashina, Sabrina Khan, Hans-Christoph Diener, Dimos D. Mitsikostas, Alexandra J. Sinclair, Patricia Pozo-Rosich, Paolo Martelletti, Anne Ducros, Michel Lanteri-Minet, Mark Braschinsky, Margarita Sanchez del Rio, Oved Daniel, Aynur Ozge, Ayten Mammadbayli, Mihails Arons, Kirill Skorobogatykh, Vladimir Romanenko, Gisela M. Terwindt, Koen Paemeleire, Simona Sacco, Uwe Reuter, Christian Lampl, Henrik W. Schytz, Zaza Katsarava, Timothy J. Steiner, Messoud Ashina
Summary: Migraine is a common but often under-diagnosed and under-treated condition. The Consensus Statement provides guidelines for diagnosis and management, emphasizing the importance of patient education and patient-centered care.
NATURE REVIEWS NEUROLOGY
(2021)
Review
Chemistry, Medicinal
Theodoros Mavridis, Christina Deligianni, Georgios Karagiorgis, Ariadne Daponte, Marianthi Breza, Dimos D. Mitsikostas
Summary: Now is the age of monoclonal antibody use in neurology, especially in the treatment of headaches. Monoclonal antibodies targeting the CGRP and PACAP pathways have shown promising results in migraine prevention, with a need for further research on the PACAP pathway for pain transmission mechanisms.
Meeting Abstract
Clinical Neurology
D. Mitsikostas
EUROPEAN JOURNAL OF NEUROLOGY
(2021)
Meeting Abstract
Pharmacology & Pharmacy
Dimos D. Mitsikostas, Andrzej Dekundy, Michael Althaus, Astrid Scheschonka, Fernando Pagan, Joseph Jankovic
