The placebo and nocebo effects in functional urology
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu časopisecké články, přehledy
PubMed
34949831
DOI
10.1038/s41585-021-00545-2
PII: 10.1038/s41585-021-00545-2
Knihovny.cz E-zdroje
- MeSH
- lidé MeSH
- nocebo efekt MeSH
- placebo efekt MeSH
- symptomy dolních močových cest * MeSH
- urologie * MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
A placebo is an inert substance normally used in clinical trials for comparison with an active substance. However, a placebo has been shown to have an effect on its own; commonly known as the placebo effect. A placebo is an essential component in the design of conclusive clinical trials but has itself become the focus of intense research. The placebo effect is partly the result of positive expectations of the recipient on the state of health. Conversely, a nocebo effect is when negative expectations from a substance lead to poor treatment outcomes and/or adverse events. Randomized controlled trials in functional urology have demonstrated the importance of the placebo and nocebo effects across different diseases such as overactive bladder, urinary incontinence, lower urinary tract symptoms and interstitial cystitis/painful bladder syndrome, as well as male and female sexual dysfunction. Understanding the true nature of the placebo-nocebo complex and the scope of its effect in functional urology could help urologists to maximize the positive effects of this phenomenon while minimizing its potentially negative effects.
Department of Urology 2nd Faculty of Medicine Charles University Prague Czech Republic
Department of Urology Comprehensive Cancer Center Medical University of Vienna Vienna Austria
Department of Urology The Jikei University School of Medicine Tokyo Japan
Department of Urology University Medical Center Hamburg Eppendorf Hamburg Germany
Department of Urology University of Texas Southwestern Medical Center Dallas TX USA
Department of Urology Weill Cornell Medical College New York NY USA
European Association of Urology research foundation Arnhem Netherlands
Hourani Center for Applied Scientific Research Al Ahliyya Amman University Amman Jordan
Institute for Urology and Reproductive Health Sechenov University Moscow Russia
Karl Landsteiner Institute of Urology and Andrology Vienna Austria
King Fahad Specialist Hospital Dammam Dammam Saudi Arabia
King Faisal Medical City Abha Saudi Arabia
Research Center for Evidence Based Medicine Tabriz University of Medical Sciences Tabriz Iran
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Stewart-Williams, S. & Podd, J. The placebo effect: dissolving the expectancy versus conditioning debate. Psychol. Bull. 130, 324 (2004). PubMed
McDonald, C. J., Mazzuca, S. A. & McCabe, G. P. Jr How much of the placebo ‘effect’ is really statistical regression? Stat. Med. 2, 417–427 (1983). PubMed
Colloca, L. The placebo effect in pain therapies. Annu. Rev. Pharmacol. Toxicol. 59, 191–211 (2019). PubMed
Aronson, J. Please, please me. BMJ 318, 716 (1999). PubMed PMC
Benedetti, F., Mayberg, H. S., Wager, T. D., Stohler, C. S. & Zubieta, J.-K. Neurobiological mechanisms of the placebo effect. J. Neurosci. 25, 10390–10402 (2005). PubMed PMC
Gaab, J. The placebo and its effects: a psychoneuroendocrinological perspective. Psychoneuroendocrinology 105, 3–8 (2019). PubMed
Evers, A. W. et al. Implications of placebo and nocebo effects for clinical practice: expert consensus. Psychother. Psychosom. 87, 204–210 (2018). PubMed
Ernst, E. & Resch, K. L. Concept of true and perceived placebo effects. BMJ 311, 551–553 (1995). PubMed PMC
Colloca, L. & Barsky, A. J. Placebo and nocebo effects. N. Engl. J. Med. 382, 554–561 (2020). PubMed
Gupta, U. & Verma, M. Placebo in clinical trials. Perspect. Clin. Res. 4, 49 (2013). PubMed PMC
Lipman, J. J. et al. Peak B endorphin concentration in cerebrospinal fluid: reduced in chronic pain patients and increased during the placebo response. Psychopharmacology 102, 112–116 (1990). PubMed
Pollo, A. et al. Expectation modulates the response to subthalamic nucleus stimulation in Parkinsonian patients. Neuroreport 13, 1383–1386 (2002). PubMed
Howick, J. et al. Are treatments more effective than placebos? A systematic review and meta-analysis. PLoS ONE 8, e62599 (2013). PubMed PMC
Howick, J. H. The Philosophy of Evidence-Based Medicine (John Wiley & Sons, 2011).
Mangera, A., Chapple, C. R., Kopp, Z. S. & Plested, M. The placebo effect in overactive bladder syndrome. Nat. Rev. Urol. 8, 495 (2011). PubMed
Chvetzoff, G. & Tannock, I. F. Placebo effects in oncology. J. Natl Cancer Inst. 95, 19–29 (2003). PubMed
Kaptchuk, T. J. & Miller, F. G. Placebo effects in medicine. N. Engl. J. Med. 373, 8–9 (2015). PubMed
Bishop, F. L. et al. What techniques might be used to harness placebo effects in non-malignant pain? A literature review and survey to develop a taxonomy. BMJ Open 7, e015516 (2017). PubMed PMC
Beecher, H. K. The powerful placebo. J. Am. Med. Assoc. 159, 1602–1606 (1955). PubMed
Häuser, W., Hansen, E. & Enck, P. Nocebo phenomena in medicine: their relevance in everyday clinical practice. Dtsch. Ärztebl. Int. 109, 459 (2012). PubMed PMC
Kravvariti, E., Kitas, G. D., Mitsikostas, D. D. & Sfikakis, P. P. Nocebos in rheumatology: emerging concepts and their implications for clinical practice. Nat. Rev. Rheumatol. 14, 727–740 (2018). PubMed
Colagiuri, B., Schenk, L. A., Kessler, M. D., Dorsey, S. G. & Colloca, L. The placebo effect: from concepts to genes. Neuroscience 307, 171–190 (2015). PubMed
Fields, H. L. & Levine, J. D. Placebo analgesia — a role for endorphins? Trends Neurosci. 7, 271–273 (1984).
Peciña, M., Heffernan, J., Wilson, J., Zubieta, J. & Dombrovski, A. Prefrontal expectancy and reinforcement-driven antidepressant placebo effects. Transl. Psychiatry 8, 1–11 (2018).
Mostafaei, H. et al. Nocebo response in the pharmacological management of overactive bladder: a systematic review and meta-analysis. Eur. Urol. Focus 7, 1143–1153 (2020). PubMed
Colloca, L. & Miller, F. G. Harnessing the placebo effect: the need for translational research. Philos. Trans. R. Soc. B Biol. Sci. 366, 1922–1930 (2011).
Hróbjartsson, A. & Gøtzsche, P. C. Placebo interventions for all clinical conditions (2010 update). Cochrane Database Syst. Rev. 2010, CD003974 (2010). PMC
Hróbjartsson, A. & Gøtzsche, P. C. Is the placebo powerless? Update of a systematic review with 52 new randomized trials comparing placebo with no treatment. J. Intern. Med. 256, 91–100 (2004). PubMed
Barnett, A. G., Van Der Pols, J. C. & Dobson, A. J. Regression to the mean: what it is and how to deal with it. Int. J. Epidemiol. 34, 215–220 (2005). PubMed
Kienle, G. S. & Kiene, H. The powerful placebo effect: fact or fiction? J. Clin. Epidemiol. 50, 1311–1318 (1997). PubMed
Hróbjartsson, A. & Gøtzsche, P. C. Placebo interventions for all clinical conditions. Cochrane Database Syst. Rev. 2004, CD003974 (2004).
Benedetti, F., Lanotte, M., Lopiano, L. & Colloca, L. When words are painful: unraveling the mechanisms of the nocebo effect. Neuroscience 147, 260–271 (2007). PubMed
Kong, J. et al. A functional magnetic resonance imaging study on the neural mechanisms of hyperalgesic nocebo effect. J. Neurosci. 28, 13354–13362 (2008). PubMed PMC
Nolan, T. The placebo effect in general practice. InnovAiT 12, 404–407 (2019).
Wells, R. E. & Kaptchuk, T. J. To tell the truth, the whole truth, may do patients harm: the problem of the nocebo effect for informed consent. Am. J. Bioeth. 12, 22–29 (2012). PubMed PMC
Tyrer, P., Eilenberg, T., Fink, P., Hedman, E. & Tyrer, H. Health anxiety: the silent, disabling epidemic. BMJ 353, i2250 (2016). PubMed
Planès, S., Villier, C. & Mallaret, M. The nocebo effect of drugs. Pharm. Res. Perspect. 4, e00208 (2016).
Cohen, S. The nocebo effect of informed consent. Bioethics 28, 147–154 (2014). PubMed
Ockene, J. K. et al. Symptom experience after discontinuing use of estrogen plus progestin. JAMA 294, 183–193 (2005). PubMed
Vase, L., Robinson, M. E., Verne, G. N. & Price, D. D. The contributions of suggestion, desire, and expectation to placebo effects in irritable bowel syndrome patients: an empirical investigation. Pain 105, 17–25 (2003). PubMed
Price, D. D. et al. An analysis of factors that contribute to the magnitude of placebo analgesia in an experimental paradigm. Pain 83, 147–156 (1999). PubMed
Benedetti, F., Arduino, C. & Amanzio, M. Somatotopic activation of opioid systems by target-directed expectations of analgesia. J. Neurosci. 19, 3639–3648 (1999). PubMed PMC
Goebel, M. U. et al. Behavioral conditioning of immunosuppression is possible in humans. FASEB J. 16, 1869–1873 (2002). PubMed
Benedetti, F. et al. Conscious expectation and unconscious conditioning in analgesic, motor, and hormonal placebo/nocebo responses. J. Neurosci. 23, 4315–4323 (2003). PubMed PMC
Petrie, K. J. & Rief, W. Psychobiological mechanisms of placebo and nocebo effects: pathways to improve treatments and reduce side effects. Annu. Rev. Psychol. 70, 599–625 (2019). PubMed
Bąbel, P. Classical conditioning as a distinct mechanism of placebo effects. Front. Psychiatry 10, 449 (2019). PubMed PMC
Schedlowski, M., Enck, P., Rief, W. & Bingel, U. Neuro-bio-behavioral mechanisms of placebo and nocebo responses: implications for clinical trials and clinical practice. Pharmacol. Rev. 67, 697–730 (2015). PubMed
Colloca, L. & Finniss, D. Nocebo effects, patient-clinician communication, and therapeutic outcomes. JAMA 307, 567–568 (2012). PubMed PMC
Nestoriuc, Y., Orav, E. J., Liang, M. H., Horne, R. & Barsky, A. J. Prediction of nonspecific side effects in rheumatoid arthritis patients by beliefs about medicines. Arthritis Care Res. 62, 791–799 (2010).
Papadopoulos, D. & Mitsikostas, D. Nocebo effects in multiple sclerosis trials: a meta-analysis. Mult. Scler. J. 16, 816–828 (2010).
He, J., Morales, D. R. & Guthrie, B. Exclusion rates in randomized controlled trials of treatments for physical conditions: a systematic review. Trials 21, 1–11 (2020).
Jensen, J. S., Bielefeldt, A. Ø. & Hróbjartsson, A. Active placebo control groups of pharmacological interventions were rarely used but merited serious consideration: a methodological overview. J. Clin. Epidemiol. 87, 35–46 (2017). PubMed
Faria, V. et al. Do you believe it? Verbal suggestions influence the clinical and neural effects of escitalopram in social anxiety disorder: a randomized trial. EBioMedicine 24, 179–188 (2017). PubMed PMC
Colloca, L., Lopiano, L., Lanotte, M. & Benedetti, F. Overt versus covert treatment for pain, anxiety, and Parkinson’s disease. Lancet Neurol. 3, 679–684 (2013).
Santana, L. & Fontenelle, L. F. A review of studies concerning treatment adherence of patients with anxiety disorders. Patient Prefer. Adherence 5, 427–439 (2011). PubMed PMC
Chaliha, C. & Stanton, S. The ethnic cultural and social aspects of incontinence — a pilot study. Int. Urogynecol. J. 10, 166–170 (1999).
Greville-Harris, M. & Dieppe, P. Bad is more powerful than good: the nocebo response in medical consultations. Am. J. Med. 128, 126–129 (2015). PubMed
van Leeuwen, J. H. S., Castro, R., Busse, M. & Bemelmans, B. L. The placebo effect in the pharmacologic treatment of patients with lower urinary tract symptoms. Eur. Urol. 50, 440–453 (2006). PubMed
Enck, P., Bingel, U., Schedlowski, M. & Rief, W. The placebo response in medicine: minimize, maximize or personalize? Nat. Rev. Drug Discov. 12, 191 (2013). PubMed
Colloca, L., Sigaudo, M. & Benedetti, F. The role of learning in nocebo and placebo effects. Pain 136, 211–218 (2008). PubMed
Mondaini, N. et al. Finasteride 5 mg and sexual side effects: how many of these are related to a nocebo phenomenon? J. Sex. Med. 4, 1708–1712 (2007). PubMed
Many sexual adverse effects of finasteride are attributable to a nocebo effect. Nat. Clin. Pract. Urol. 5, 66–66 (2008).
Walsh, J. J. Old-Time Makers of Medicine: The Story of The Students And Teachers of the Sciences Related to Medicine During the Middle Ages (Good Press, 2019).
Gliedman, L. H., Gantt, W. H. & Teitelbaum, H. A. Some implications of conditional reflex studies for placebo research. Am. J. Psychiatry 113, 1103–1107 (1957). PubMed
Kurland, A. A. The drug placebo — its psychodynamic and conditional reflex action. Behav. Sci. 2, 101–110 (1957).
Pavlov, I. P. & Anrep, G. V. Conditioned Reflexes: an Investigation of the Physiological Activity of the Cerebral Cortex (Oxford University Press, 1927).
Lang, W. & Rand, M. A placebo response as a conditional reflex to glyceryl trinitrate. Med. J. Aust. 1, 12–14 (1969).
Kirsch, I. & Heap, M. Hypnosis: Theory, Research and Application (Routledge, 2017).
Kirsch, I. Response expectancy as a determinant of experience and behavior. Am. Psychol. 40, 1189 (1985).
Kirsch, I. & Weixel, L. J. Double-blind versus deceptive administration of a placebo. Behav. Neurosci. 102, 319 (1988). PubMed
Bąbel, P. et al. How classical conditioning shapes placebo analgesia: hidden versus open conditioning. Pain. Med. 19, 1156–1169 (2018). PubMed
Bąbel, P. et al. Classical conditioning without verbal suggestions elicits placebo analgesia and nocebo hyperalgesia. PLoS ONE 12, e0181856 (2017). PubMed PMC
Manchikanti, L., Giordano, J., Fellows, B. & Hirsch, J. A. Placebo and nocebo in interventional pain management: a friend or a foe-or simply foes. Pain. Phys. 14, E157–E175 (2011).
Wager, T. D. et al. Placebo-induced changes in FMRI in the anticipation and experience of pain. Science 303, 1162–1167 (2004). PubMed
Amanzio, M., Benedetti, F., Porro, C. A., Palermo, S. & Cauda, F. Activation likelihood estimation meta-analysis of brain correlates of placebo analgesia in human experimental pain. Hum. Brain Mapp. 34, 738–752 (2013). PubMed
Benedetti, F. Placebo effects: from the neurobiological paradigm to translational implications. Neuron 84, 623–637 (2014). PubMed
Blok, B. F. Central pathways controlling micturition and urinary continence. Urology 59, 13–17 (2002). PubMed
Benedetti, F. Placebo Effects (Oxford University Press, USA, 2014).
Colloca, L., Flaten, M. A. & Meissner, K. Placebo and Pain: from Bench to Bedside (Academic Press, 2013).
Holstege, G. The emotional motor system and micturition control. Neurourol. Urodyn. 29, 42–48 (2010). PubMed
Blok, B. F. & Holstege, G. Direct projections from the periaqueductal gray to the pontine micturition center (M-region). An anterograde and retrograde tracing study in the cat. Neurosci. Lett. 166, 93–96 (1994). PubMed
Yoshimura, N. et al. Therapeutic receptor targets for lower urinary tract dysfunction. Naunyn Schmiedebergs Arch. Pharmacol. 377, 437–448 (2008). PubMed
Andersson, K.-E. & Gratzke, C. in Textbook of the Neurogenic Bladder 95–114 (CRC Press, 2008).
De la Fuente-Fernández, R. et al. Expectation and dopamine release: mechanism of the placebo effect in Parkinson’s disease. Science 293, 1164–1166 (2001). PubMed
de la Fuente-Fernández, R., Schulzer, M. & Stoessl, A. J. Placebo mechanisms and reward circuitry: clues from Parkinson’s disease. Biol. Psychiatry 56, 67–71 (2004). PubMed
Van der Aa, F., Ost, D. & De Ridder, D. J. M. K. Interstitial cells of the bladder: the missing link? BJOG 111, 57–60 (2004). PubMed
Amanzio, M. & Benedetti, F. Neuropharmacological dissection of placebo analgesia: expectation-activated opioid systems versus conditioning-activated specific subsystems. J. Neurosci. 19, 484–494 (1999). PubMed PMC
Levine, J., Gordon, N. & Fields, H. The mechanism of placebo analgesia. Lancet 312, 654–657 (1978).
Benedetti, F. The opposite effects of the opiate antagonist naloxone and the cholecystokinin antagonist proglumide on placebo analgesia. Pain 64, 535–543 (1996). PubMed
Pertwee, R. G. & Fernando, S. R. Evidence for the presence of cannabinoid CB1 receptors in mouse urinary bladder. Br. J. Pharmacol. 118, 2053–2058 (1996). PubMed PMC
Freeman, R. et al. The effect of cannabis on urge incontinence in patients with multiple sclerosis: a multicentre, randomised placebo-controlled trial (CAMS-LUTS). Int. Urogynecol. J. 17, 636–641 (2006).
Vase, L. & Wartolowska, K. Pain, placebo, and test of treatment efficacy: a narrative review. Br. J. Anaesth. 123, e254–e262 (2019). PubMed PMC
Benedetti, F. & Amanzio, M. Mechanisms of the placebo response. Pulm. Pharmacol. Ther. 26, 520–523 (2013). PubMed
Benedetti, F., Amanzio, M., Casadio, C., Oliaro, A. & Maggi, G. Blockade of nocebo hyperalgesia by the cholecystokinin antagonist proglumide. Pain 71, 135–140 (1997). PubMed
Galton, F. Regression towards mediocrity in hereditary stature. J. Anthropol. Inst. Gt. Br. Irel. 15, 246–263 (1886).
Sech, S. M. et al. The so-called “placebo effect” in benign prostatic hyperplasia treatment trials represents partially a conditional regression to the mean induced by censoring. Urology 51, 242–250 (1998). PubMed
Chapple, C. What is new in functional urology? Eur. Urol. Focus. 5, 307–309 (2019). PubMed
Haylen, B. T. et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol. Urodynam. 29, 4–20 (2010).
Coyne, K. S. et al. National community prevalence of overactive bladder in the United States stratified by sex and age. Urology 77, 1081–1087 (2011). PubMed
Irwin, D. E. et al. Understanding the elements of overactive bladder: questions raised by the EPIC study. BJU Int. 101, 1381–1387 (2008). PubMed
Stewart, W. et al. Prevalence and burden of overactive bladder in the United States. World J. Urol. 20, 327–336 (2003). PubMed
Milsom, I. et al. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 87, 760–766 (2001). PubMed
Eapen, R. S. & Radomski, S. B. Review of the epidemiology of overactive bladder. Res. Rep. Urol. 8, 71 (2016). PubMed PMC
Andersson, K.-E. The overactive bladder: pharmacologic basis of drug treatment. Urology 50, 74–84 (1997). PubMed
Robinson, D. & Cardozo, L. Managing overactive bladder. Climacteric 22, 250–256 (2019). PubMed
Yamaguchi, O. et al. Randomized, double-blind, placebo- and propiverine-controlled trial of the once-daily antimuscarinic agent solifenacin in Japanese patients with overactive bladder. BJU Int. 100, 579–587 (2007). PubMed
Shin, D. G. et al. Mirabegron as a treatment for overactive bladder symptoms in men (MIRACLE study): efficacy and safety results from a multicenter, randomized, double-blind, placebo-controlled, parallel comparison phase IV study. Neurourol. Urodyn. 38, 295–304 (2019). PubMed
Cruz, F. et al. Efficacy and safety of onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity: a randomised, double-blind, placebo-controlled trial. Eur. Urol. 60, 742–750 (2011). PubMed
Mostafaei, H. et al. Placebo response in patients with oral therapy for overactive bladder: a systematic review and meta-analysis. Eur. Urol. Focus https://doi.org/10.1016/j.euf.2021.02.005 (2021). PubMed DOI
Sand, P. K., Dmochowski, R. R., Reddy, J. & van der Meulen, E. A. Efficacy and safety of low dose desmopressin orally disintegrating tablet in women with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J. Urol. 190, 958–964 (2013). PubMed
Johnson, T. M. et al. Changes in nocturia from medical treatment of benign prostatic hyperplasia: secondary analysis of the Department of Veterans Affairs Cooperative Study Trial. J. Urol. 170, 145–148 (2003). PubMed
Blaivas, J. G. et al. Overactive bladder phenotypes: development and preliminary data. Can. J. Urol. 28, 10699–10704 (2021). PubMed
Herschorn, S., Chapple, C. R., Snijder, R., Siddiqui, E. & Cardozo, L. Could reduced fluid intake cause the placebo effect seen in overactive bladder clinical trials? Analysis of a large solifenacin integrated database. Urology 106, 55–59 (2017). PubMed
Baines, G., Araklitis, G., Flint, R., Robinson, D. & Cardozo, L. What affects the placebo effect? Eur. J. Obstet. Gynecol. Reprod. Biol. 246, 134–137 (2020). PubMed
Avery, J. C., Braunack-Mayer, A. J., Stocks, N. P., Taylor, A. & Duggan, P. Psychological Perspectives in Urinary Incontinence: a Metasynthesis (OA Women’s Health, 2013).
Irwin, D. E., Kopp, Z. S., Agatep, B., Milsom, I. & Abrams, P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 108, 1132–1138 (2011). PubMed
Milsom, I. & Gyhagen, M. The prevalence of urinary incontinence. Climacteric 22, 217–222 (2019). PubMed
Mostafaei, H. et al. Prevalence of female urinary incontinence in the developing world: a systematic review and meta-analysis — a report from the Developing World Committee of the International Continence Society and Iranian Research Center for Evidence Based Medicine. Neurourol. Urodyn. 39, 1063–1086 (2020). PubMed
Wilson, L., Brown, J. S., Shin, G. P., Luc, K.-O. & Subak, L. L. Annual direct cost of urinary incontinence. Obstet. Gynecol. 98, 398–406 (2001). PubMed
Ganz, M. L. et al. Economic costs of overactive bladder in the United States. Urology 75, 526–532 (2010). PubMed
D’Ancona, C. et al. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol. Urodyn. 38, 433–477 (2019). PubMed
Abrams, P. et al. 6th International Consultation on Incontinence. Recommendations of the International Scientific Committee: evaluation and treatment of urinary incontinence, pelvic organ prolapse and faecal incontinence. Neurourol. Urodyn. 37, 2271–2272 (2018). PubMed
Yalcin, I. & Bump, R. C. The effect of previous treatment experience and incontinence severity on the placebo response of stress urinary incontinence. Am. J. Obstet. Gynecol. 191, 194–197 (2004). PubMed
Klarskov, N., Darekar, A., Scholfield, D., Whelan, L. & Lose, G. Effect of fesoterodine on urethral closure function in women with stress urinary incontinence assessed by urethral pressure reflectometry. Int. Urogynecol. J. 25, 755–760 (2014). PubMed
Blaganje, M. et al. Non-ablative Er: YAG laser therapy effect on stress urinary incontinence related to quality of life and sexual function: a randomized controlled trial. Eur. J. Obstet. Gynecol. Reprod. Biol. 224, 153–158 (2018). PubMed
Li, J. et al. The role of duloxetine in stress urinary incontinence: a systematic review and meta-analysis. Int. Urol. Nephrol. 45, 679–686 (2013). PubMed
Parish, S. J. et al. Toward a more evidence-based nosology and nomenclature for female sexual dysfunctions — part II. J. Sex. Med. 13, 1888–1906 (2016). PubMed
Laumann, E. O., Paik, A. & Rosen, R. C. Sexual dysfunction in the United States: prevalence and predictors. JAMA 281, 537–544 (1999). PubMed
Basson, R. et al. Report of the international consensus development conference on female sexual dysfunction: definitions and classifications. J. Urol. 163, 888–893 (2000). PubMed
Bradford, A. & Meston, C. Correlates of placebo response in the treatment of sexual dysfunction in women: a preliminary report. J. Sex. Med. 4, 1345–1351 (2007). PubMed PMC
Modelska, K. & Cummings, S. Female sexual dysfunction in postmenopausal women: systematic review of placebo-controlled trials. Am. J. Obstet. Gynecol. 188, 286–293 (2003). PubMed
Weinberger, J. M. et al. Female sexual dysfunction and the placebo effect: a meta-analysis. Obstet. Gynecol. 132, 453–458 (2018). PubMed
Wiegel, M., Meston, C. & Rosen, R. The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J. Sex. Marital. Ther. 31, 1–20 (2005). PubMed
Bradford, A. & Meston, C. M. Behavior and symptom change among women treated with placebo for sexual dysfunction. J. Sex. Med. 8, 191–201 (2011). PubMed
Bradford, A. Listening to placebo in clinical trials for female sexual dysfunction. J. Sex. Med. 10, 451–459 (2013). PubMed
DeRogatis, L. R. & Burnett, A. L. The epidemiology of sexual dysfunctions. J. Sex. Med. 5, 289–300 (2008). PubMed
Gur, S. et al. Update on drug interactions with phosphodiesterase-5 inhibitors prescribed as first-line therapy for patients with erectile dysfunction or pulmonary hypertension. Curr. Drug Metab. 14, 265–269 (2013). PubMed
Swearingen, D., Nehra, A., Morelos, S. & Peterson, C. A. Hemodynamic effect of avanafil and glyceryl trinitrate coadministration. Drugs Context 2013, 212248 (2013). PubMed PMC
De Araujo, A. C. et al. The management of erectile dysfunction with placebo only: does it work? J. Sex. Med. 6, 3440–3448 (2009). PubMed
Seidman, S. N., Roose, S. P., Menza, M. A., Shabsigh, R. & Rosen, R. C. Treatment of erectile dysfunction in men with depressive symptoms: results of a placebo-controlled trial with sildenafil citrate. Am. J. Psychiatry 158, 1623–1630 (2001). PubMed
Mulhall, J. P., Carlsson, M., Stecher, V. & Tseng, L.-J. Predictors of erectile function normalization in men with erectile dysfunction treated with placebo. J. Sex. Med. 15, 866–872 (2018). PubMed PMC
Stridh, A. et al. Placebo responses among men with erectile dysfunction enrolled in phosphodiesterase 5 inhibitor trials: a systematic review and meta-analysis. JAMA Netw. Open 3, e201423–e201423 (2020). PubMed PMC
Melnik, T. & Abdo, C. H. Psychogenic erectile dysfunction: comparative study of three therapeutic approaches. J. Sex. Marital. Ther. 31, 243–255 (2005). PubMed
Faasse, K., Martin, L. R., Grey, A., Gamble, G. & Petrie, K. J. Impact of brand or generic labeling on medication effectiveness and side effects. Health Psychol. 35, 187 (2016). PubMed
Konkle, K. S. et al. Comparison of an interstitial cystitis/bladder pain syndrome clinical cohort with symptomatic community women from the RAND Interstitial Cystitis Epidemiology study. J. Urol. 187, 508–512 (2012). PubMed
Nigro, D. A. et al. Associations among cystoscopic and urodynamic findings for women enrolled in the Interstitial Cystitis Data Base (ICDB) Study. Urology 49, 86–92 (1997). PubMed
Nickel, J. C. Interstitial cystitis: characterization and management of an enigmatic urologic syndrome. Rev. Urol. 4, 112 (2002). PubMed PMC
Nickel, J. C. & Moldwin, R. FDA BRUDAC 2018 Criteria for Interstitial Cystitis/Bladder Pain Syndrome Clinical Trials: future direction for research. J. Urol. 200, 39–42 (2018). PubMed
Hunner, G. L. A rare type of bladder ulcer in women; report of cases. Boston Med. Surgical J. 172, 660–664 (1915).
Hanno, P. International Consultation on IC-Rome, September 2004/Forging an International Consensus: progress in painful bladder syndrome/interstitial cystitis. Int. Urogynecol. J. 16, S2 (2005).
Doggweiler, R. et al. A standard for terminology in chronic pelvic pain syndromes: a report from the chronic pelvic pain working group of the International Continence Society. Neurourol. Urodyn. 36, 984–1008 (2017). PubMed
Berry, S. H. et al. Prevalence of symptoms of bladder pain syndrome/interstitial cystitis among adult females in the United States. J. Urol. 186, 540–544 (2011). PubMed PMC
Parsons, C. L. et al. The prevalence of interstitial cystitis in gynecologic patients with pelvic pain, as detected by intravesical potassium sensitivity. Am. J. Obstet. Gynecol. 187, 1395–1400 (2002). PubMed
Sant, G. R. Etiology, pathogenesis, and diagnosis of interstitial cystitis. Rev. Urol. 4, S9 (2002). PubMed PMC
Foster, H. E. et al. Effect of amitriptyline on symptoms in treatment naive patients with interstitial cystitis/painful bladder syndrome. J. Urol. 183, 1853–1858 (2010). PubMed PMC
van Ophoven, A., Vonde, K., Koch, W., Auerbach, G. & Maag, K. P. Efficacy of pentosan polysulfate for the treatment of interstitial cystitis/bladder pain syndrome: results of a systematic review of randomized controlled trials. Curr. Med. Res. Opin. 35, 1495–1503 (2019). PubMed
Nickel, J. C. et al. Pentosan polysulfate sodium for treatment of interstitial cystitis/bladder pain syndrome: insights from a randomized, double-blind, placebo controlled study. J. Urol. 193, 857–862 (2015). PubMed
Bosch, P. C. Examination of the significant placebo effect in the treatment of interstitial cystitis/bladder pain syndrome. Urology 84, 321–326 (2014). PubMed
Kuo, H. C., Jiang, Y. H., Tsai, Y. C. & Kuo, Y. C. Intravesical botulinum toxin‐A injections reduce bladder pain of interstitial cystitis/bladder pain syndrome refractory to conventional treatment–a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. Neurourol. Urodyn. 35, 609–614 (2016). PubMed
Pinto, R. A. et al. Intratrigonal onabotulinumtoxinA improves bladder symptoms and quality of life in patients with bladder pain syndrome/interstitial cystitis: a pilot, single center, randomized, double-blind, placebo controlled trial. J. Urol. 199, 998–1003 (2018). PubMed
Lai, H. H. Clinical trials: placebo effects in interstitial cystitis/bladder pain syndrome. Nat. Rev. Urol. 11, 494 (2014). PubMed
Coyne, K. S. et al. The prevalence of lower urinary tract symptoms (LUTS) in the USA, the UK and Sweden: results from the Epidemiology of LUTS (EpiLUTS) study. BJU Int. 104, 352–360 (2009). PubMed
Kupelian, V. et al. Prevalence of lower urinary tract symptoms and effect on quality of life in a racially and ethnically diverse random sample: the Boston Area Community Health (BACH) Survey. Arch. Intern. Med. 166, 2381–2387 (2006). PubMed
Martin, S. A., Haren, M. T., Marshall, V. R., Lange, K. & Wittert, G. A. Prevalence and factors associated with uncomplicated storage and voiding lower urinary tract symptoms in community-dwelling Australian men. World J. Urol. 29, 179–184 (2011). PubMed
Abrams, P. et al. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology 61, 37–49 (2003). PubMed
Gratzke, C. et al. EAU guidelines on the assessment of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur. Urol. 67, 1099–1109 (2015). PubMed
Brasure, M. et al. Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: A Review (Agency for Healthcare Research and Quality 2016).
Meng, J. et al. Age, height, BMI and FBG predict prostate volume in ageing benign prostatic hyperplasia: evidence from 5285 patients. Int. J. Clin. Pract. 73, e13438 (2019).
Zhang, W. et al. Prevalence of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) in China: results from the China Health and Retirement Longitudinal Study. BMJ Open 9, e022792 (2019). PubMed PMC
Vuichoud, C. & Loughlin, K. R. Benign prostatic hyperplasia: epidemiology, economics and evaluation. Can. J. Urol. 22, 1–6 (2015). PubMed
Sorokin, I., Schatz, A. & Welliver, C. Placebo medication and sham surgery responses in benign prostatic hyperplasia treatments: implications for clinical trials. Curr. Urol. Rep. 16, 73 (2015). PubMed
Barry, M. J. et al. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients? J. Urol. 154, 1770–1774 (1995). PubMed
McConnell, J. D. et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N. Engl. J. Med. 349, 2387–2398 (2003). PubMed
Kirby, R. S. et al. Efficacy and tolerability of doxazosin and finasteride, alone or in combination, in treatment of symptomatic benign prostatic hyperplasia: the Prospective European Doxazosin and Combination Therapy (PREDICT) trial. Urology 61, 119–126 (2003). PubMed
Lepor, H. et al. The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. N. Engl. J. Med. 335, 533–540 (1996). PubMed
Byrnes, C. A. et al. Efficacy, tolerability, and effect on health-related quality of life of finasteride versus placebo in men with symptomatic benign prostatic hyperplasia: a community-based study. Clin. Ther. 17, 956–969 (1995). PubMed
Nickel, J. C. et al. Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECT study). PROscar Safety Plus Efficacy Canadian Two year Study. CMAJ 155, 1251 (1996). PubMed PMC
Nickel, J. Placebo therapy of benign prostatic hyperplasia: a 25-month study. Canadian PROSPECT Study Group. Br. J. Urol. 81, 383–387 (1998). PubMed
Roehrborn, C. G. et al. The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the LIFT Study. J. Urol. 190, 2161–2167 (2013). PubMed
Porst, H. et al. Efficacy and safety of tadalafil 5 mg once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: subgroup analyses of pooled data from 4 multinational, randomized, placebo-controlled clinical studies. Urology 82, 667–673 (2013). PubMed
Regadas, R. P. et al. Urodynamic effects of the combination of tamsulosin and daily tadalafil in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: a randomized, placebo-controlled clinical trial. Int. Urol. Nephrol. 45, 39–43 (2013). PubMed
Eredics, K., Madersbacher, S. & Schauer, I. A relevant midterm (12 months) placebo effect on lower urinary tract symptoms and maximum flow rate in male lower urinary tract symptom and benign prostatic hyperplasia — a meta-analysis. Urology 106, 160–166 (2017). PubMed
Zimmern, P. Medical treatment modalities for lower urinary tract symptoms: what are the relevant differences in randomised controlled trials? Eur. Urol. 38, 18–24 (2000). PubMed
Enck, P. & Klosterhalfen, S. Does sex/gender play a role in placebo and nocebo effects? Conflicting evidence from clinical trials and experimental studies. Front. Neurosci. 13, 160 (2019). PubMed PMC
Vambheim, S. M. & Flaten, M. A. A systematic review of sex differences in the placebo and the nocebo effect. J. Pain. Res. 10, 1831 (2017). PubMed PMC
Liccardi, G. et al. Evaluation of the nocebo effect during oral challenge in patients with adverse drug reactions. J. Investig. Allergol. Clin. Immunol. 14, 104–107 (2004). PubMed
Colloca, L., Pine, D. S., Ernst, M., Miller, F. G. & Grillon, C. Vasopressin boosts placebo analgesic effects in women: a randomized trial. Biol. Psychiatry 79, 794–802 (2016). PubMed
Siegel, S. Drug tolerance, drug addiction, and drug anticipation. Curr. Direct Psychol. Sci. 14, 296–300 (2005).
Weimer, K., Colloca, L. & Enck, P. Age and sex as moderators of the placebo response — an evaluation of systematic reviews and meta-analyses across medicine. Gerontology 61, 97–108 (2015). PubMed
Cumming, G. Understanding the New Statistics: Effect Sizes, Confidence Intervals, and Meta-Analysis (Routledge, 2013).
Tufanaru, C. What’s in a name: ‘significant’ results? JBI Evid. Synth. 13, 1–3 (2015).
Rai, S. K., Yazdany, J., Fortin, P. R. & Aviña-Zubieta, J. A. Approaches for estimating minimal clinically important differences in systemic lupus erythematosus. Arthritis Res. Ther. 17, 143 (2015). PubMed PMC
Copay, A. G., Subach, B. R., Glassman, S. D., Polly, D. W. Jr & Schuler, T. C. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J. 7, 541–546 (2007). PubMed
Wyrwich, K. W., Tierney, W. M. & Wolinsky, F. D. Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J. Clin. Epidemiol. 52, 861–873 (1999). PubMed
Jacobson, N. S., Follette, W. C. & Revenstorf, D. Psychotherapy outcome research: methods for reporting variability and evaluating clinical significance. Behav. Ther. 15, 336–352 (1984).
Jacobson, N. S., Follette, W. C. & Revenstorf, D. Toward a standard definition of clinically significant change. Behav. Ther. 17, 308–311 (1986).
Black, N. et al. Consensus development methods: a review of best practice in creating clinical guidelines. J. Health Serv. Res. Policy 4, 236–248 (1999). PubMed
McKenna, H. P. The Delphi technique: a worthwhile research approach for nursing? J. Adv. Nurs. 19, 1221–1225 (1994). PubMed
Lim, R., Liong, M. L., Lim, K. K., Leong, W. S. & Yuen, K. H. The minimum clinically important difference of the International Consultation on Incontinence Questionnaires (ICIQ-UI SF and ICIQ-LUTSqol). Urology 133, 91–95 (2019). PubMed
Fuller, T. W., Ristau, B. T., Tepe, S. M. & Benoit, R. M. Characterizing clinically meaningful changes in lower urinary tract symptoms using the American Urological Association symptom index. Urology 115, 139–143 (2018). PubMed
Barsky, A. J., Saintfort, R., Rogers, M. P. & Borus, J. F. Nonspecific medication side effects and the nocebo phenomenon. JAMA 287, 622–627 (2002). PubMed
Petrie, K. J., Cameron, L. D., Ellis, C. J., Buick, D. & Weinman, J. Changing illness perceptions after myocardial infarction: an early intervention randomized controlled trial. Psychosom. Med. 64, 580–586 (2002). PubMed
Kaptchuk, T. J. et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 336, 999–1003 (2008). PubMed PMC
Petrie, K. J. et al. Effect of providing information about normal test results on patients’ reassurance: randomised controlled trial. BMJ 334, 352 (2007). PubMed PMC
Eikelboom, R. & Stewart, J. Conditioning of drug-induced physiological responses. Psychol. Rev. 89, 507 (1982). PubMed
Brody, H. The lie that heals: the ethics of giving placebos. Ann. Intern. Med. 97, 112–118 (1982). PubMed
Schaefer, M., Sahin, T. & Berstecher, B. Why do open-label placebos work? A randomized controlled trial of an open-label placebo induction with and without extended information about the placebo effect in allergic rhinitis. PLoS ONE 13, e0192758 (2018). PubMed PMC
Blease, C., Colloca, L. & Kaptchuk, T. J. Are open-label placebos ethical? Informed consent and ethical equivocations. Bioethics 30, 407–414 (2016). PubMed PMC
Charlesworth, J. E. et al. Effects of placebos without deception compared with no treatment: a systematic review and meta‐analysis. J. Evid. Based Med. 10, 97–107 (2017). PubMed