The placebo response in myasthenia gravis assessed by quantitative myasthenia gravis score: A meta‐analysis

Frisaldi, Elisa; Shaibani, Aziz; Vollert, Jan; Ferrero, Bruno; Carrino, Roberta; Ibraheem, Hayan Dhamer; Vase, Lene

doi:10.1002/mus.26469

Cited by 9 publications

(9 citation statements)

References 68 publications

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“…These responses, however, would require the inclusion of an untreated control group in the trial to be accounted for as placebo/nocebo effects. Some of these clinical conditions include myasthenia gravis (MG) 114 and painful diabetic neuropathy (PDN). 115 Placebo and drug responses in MG trials, as assessed by means of the Quantitative Myasthenia Gravis scores assigned by neurologists, have been shown to be small and moderate, respectively.…”

Section: Discussionmentioning

confidence: 99%

Placebo and nocebo effects and mechanisms associated with pharmacological interventions: an umbrella review

Frisaldi,

Shaibani,

Benedetti

et al. 2023

BMJ Open

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ObjectivesThis review aimed to summarise the existing knowledge about placebo and nocebo effects associated with pharmacological interventions and their mechanisms.DesignUmbrella review, adopting the Assessment of Multiple Systematic Reviews 2 tool for critical appraisal.Data sourcesMEDLINE/PubMed, Scopus, Web of Science, PsycINFO, Cochrane Central Register of Controlled Trial were searched in September 2022, without any time restriction, for systematic reviews, narrative reviews, original articles. Results were summarised through narrative synthesis, tables, 95% CI.Outcome measuresMechanisms underlying placebo/nocebo effects and/or their effect sizes.ResultsThe databases search identified 372 studies, for a total of 158 312 participants, comprising 41 systematic reviews, 312 narrative reviews and 19 original articles. Seventy-three per cent of the examined systematic reviews were of high quality.Our findings revealed that mechanisms underlying placebo and/or nocebo effects have been characterised, at least in part, for: pain, non-noxious somatic sensation, Parkinson’s disease, migraine, sleep disorders, intellectual disability, depression, anxiety, dementia, addiction, gynaecological disorders, attention-deficit hyperactivity disorder, immune and endocrine systems, cardiovascular and respiratory systems, gastrointestinal disorders, skin diseases, influenza and related vaccines, oncology, obesity, physical and cognitive performance. Their magnitude ranged from 0.08 to 2.01 (95% CI 0.37 to 0.89) for placebo effects and from 0.32 to 0.90 (95% CI 0.24 to 1.00) for nocebo effects.ConclusionsThis study provides a valuable tool for clinicians and researchers, identifying both results ready for clinical practice and gaps to address in the near future.FundingUniversità Cattolica del Sacro Cuore, Milan, Italy with the ‘Finanziamento Ponte 2022’ grant.PROSPERO registration numberCRD42023392281.

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Section: Discussionmentioning

confidence: 99%

Placebo and nocebo effects and mechanisms associated with pharmacological interventions: an umbrella review

Frisaldi,

Shaibani,

Benedetti

et al. 2023

BMJ Open

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“…Quantitative score of MG (QMG score) was used to score the severity of the disease of MG patients [14]. There are 13 items on the QMG scale, with a total score of 39 points.…”

Section: Methodsmentioning

confidence: 99%

Correlation of Vitamin D3 with the Expression of RORγt and Foxp3 mRNAs in the Peripheral Blood of Myasthenia Gravis Patients

Huang

Xu³

2020

Neuroimmunomodulation

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Objectives: to investigate the expression levels of 1,25(OH)2D3 in the peripheral blood from patients with myasthenia gravis (MG) and to correlate levels with retinoid-related orphan receptor γt (RORγt) and forkhead or winged-helix transcription factor 3 (Foxp3) mRNA expression. Methods: Sixty-seven patients with MG were enrolled in the experimental group, and 50 normal subjects were selected as the control group. The expression levels of 1,25(OH)2D3 and RORγt and Foxp3 mRNAs were measured in the serum of the 2 patient groups and the relationship between factors were correlated with the severity score of MG. The relationship between the levels of 1,25(OH)2D3 and the relative expressions of RORγt and Foxp3 mRNAs was determined. Results: There were no differences between groups regarding patient’s baseline data. 1,25(OH)2D3 and RORγt and Foxp3 mRNAs are differentially expressed in the MG group and the control group (p < 0.05). QMG score is negatively correlated with the expression level of peripheral blood 1,25(OH)2D3 and Foxp3 mRNA (r = −0.797, −0.543; p < 0.01) and positively correlated with the relative expression level of RORγt mRNA (r = 0.539; p < 0.01). 1,25(OH)2D3 expression level was negatively correlated with the relative expression of RORγt mRNA (r = −0.559; p < 0.01) and positively correlated with the relative expression of Foxp3 mRNA (r = 0.390; p < 0.01). Conclusions: The levels of 1,25(OH)2D3 were shown to be lower in patients with MG compared to normal controls. The observed low levels of 1,25(OH)2D3 may lead to changes in the expression of RORγt and Foxp3 mRNAs involved in MG.

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“…Regarding the placebo group, only 4 of 13 participants displayed more positive than negative comments for postintervention domain, suggesting little positive effect on this group. Those positive reports maybe due to the placebo effect, which was recently studied in NMD [48,49]. Together, qualitative and data transformation results suggested a positive trend regarding the effect of NAC in this context.…”

Section: Discussionmentioning

confidence: 66%

Understanding Symptoms in RYR1-Related Myopathies: A Mixed-Methods Analysis Based on Participants’ Experience

Peris

Cosgrove

Chrismer

et al. 2020

Patient

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Background In rare diseases such as ryanodine receptor 1-related myopathies (RYR1-RM), health-related quality of life (HRQoL) measures are critically important so clinicians and researchers can better understand what symptoms are most important to participants, with the ultimate goal of finding tangible solutions for them. Objectives The main objective of this study was to characterize symptoms in individuals with RYR1-RM to inform future research. A secondary objective of this study was to analyze positive and negative sentiments regarding symptoms and treatment effects post N-acetylcysteine (NAC) administration in individuals with RYR1-RM. Methods The study used a mixed-methods design applying methodological triangulation. Qualitative data were collected via semi-structured interviews at three visits to characterize symptoms in individuals with RYR1-RM and to analyze treatment effects. Qualitative data were then transformed into quantitative results to measure the frequency with which each symptom was mentioned by participants. Results A total of 12 symptoms were identified as areas of interest to participants with RYR1-RM, highlighting fatigue and weakness as key symptoms. Data transformation categorized more than 1000 citations, reporting a greater number of positive comments for postintervention interviews than for baseline and preintervention visits and that NAC group participants stated more positive comments regarding treatment effect than did the placebo group. Conclusions We present a comprehensive characterization of symptoms in RYR1-RM and how those symptoms influence HRQoL. Furthermore, the introduction of mixed methods may be a valuable way to better understand patient-centered data in rare diseases to support affected individuals in coping with their symptoms.

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The placebo response in myasthenia gravis assessed by quantitative myasthenia gravis score: A meta‐analysis

Cited by 9 publications

References 68 publications

Placebo and nocebo effects and mechanisms associated with pharmacological interventions: an umbrella review

Placebo and nocebo effects and mechanisms associated with pharmacological interventions: an umbrella review

Correlation of Vitamin D3 with the Expression of RORγt and Foxp3 mRNAs in the Peripheral Blood of Myasthenia Gravis Patients

Understanding Symptoms in RYR1-Related Myopathies: A Mixed-Methods Analysis Based on Participants’ Experience

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