High‐dose spironolactone lacks effectiveness in treatment of fibromyalgia (RCT)

Böhm, Ruwen; Westermann, Paul; Gleim, Martin; Cascorbi, Ingolf; Grünewald, Matthias; Herdegen, Thomas; Ohnesorge, Henning

doi:10.1002/ejp.1784

Cited by 5 publications

(3 citation statements)

References 51 publications

(75 reference statements)

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“…Little is known about the impact of these drugs alone or in combination with estrogens—which is how they would typically be taken for gender transition—on chronic pain. Spironolactone in isolation has been reported to decrease inflammatory pain-related behavior in male mice ( 161 ) and neuropathic pain-related behavior in rats ( 162 ), but it did not alter fibromyalgia pain in women ( 163 ), or pain in human osteoarthritis patients of either sex ( 164 ). Research is needed to determine whether combined estrogens + anti-androgens are likely to affect chronic pain in preoperative vs. postoperative trans individuals.…”

Section: Hormone Replacement Therapy (Hrt) In Adultsmentioning

confidence: 99%

Pain mechanisms in the transgender individual: a review

Anger,

Case,

Baranowski

et al. 2024

Front. Pain Res.

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Specific AimProvide an overview of the literature addressing major areas pertinent to pain in transgender persons and to identify areas of primary relevance for future research.MethodsA team of scholars that have previously published on different areas of related research met periodically though zoom conferencing between April 2021 and February 2023 to discuss relevant literature with the goal of providing an overview on the incidence, phenotype, and mechanisms of pain in transgender patients. Review sections were written after gathering information from systematic literature searches of published or publicly available electronic literature to be compiled for publication as part of a topical series on gender and pain in the Frontiers in Pain Research.ResultsWhile transgender individuals represent a significant and increasingly visible component of the population, many researchers and clinicians are not well informed about the diversity in gender identity, physiology, hormonal status, and gender-affirming medical procedures utilized by transgender and other gender diverse patients. Transgender and cisgender people present with many of the same medical concerns, but research and treatment of these medical needs must reflect an appreciation of how differences in sex, gender, gender-affirming medical procedures, and minoritized status impact pain.ConclusionsWhile significant advances have occurred in our appreciation of pain, the review indicates the need to support more targeted research on treatment and prevention of pain in transgender individuals. This is particularly relevant both for gender-affirming medical interventions and related medical care. Of particular importance is the need for large long-term follow-up studies to ascertain best practices for such procedures. A multi-disciplinary approach with personalized interventions is of particular importance to move forward.

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Section: Hormone Replacement Therapy (Hrt) In Adultsmentioning

confidence: 99%

Pain mechanisms in the transgender individual: a review

Anger,

Case,

Baranowski

et al. 2024

Front. Pain Res.

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“…Esse antagonista reversível do receptor mineralocorticóide e do receptor androgênico atrai o interesse farmacoterapêutico pelos papéis patogênicos que esses respectivos receptores possuem em doenças de origem neuropsiquiátrica. No entanto, em estudo recente foi demonstrado que uma dose de 200 mg (considerada alta) ao longo de 4 semanas não tem o poder de alterar os sintomas da fibromialgia em mulheres adultas, além de causar diminuição transitória da taxa de filtração glomerular e aumento do potássio sérico entre 2 e 4 semanas, sendo seu uso não recomendado no tratamento dessa condição (Böhm et al, 2021).…”

Section: Tratamento Medicamentosounclassified

Avanços na abordagem terapêutica da fibromialgia: uma revisão integrativa

Souza

Silva

Pereira

et al. 2022

RSD

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A fibromialgia (FM) é uma síndrome caracterizada como um distúrbio sistêmico complexo, a qual afeta milhões de pessoas em todo o mundo, levando ao aumento do uso de terapias não farmacológicas, como medidas terapêuticas com menos efeitos colaterais e com o intuito de uma abordagem mais efetiva da FM. O presente estudo de revisão buscou avaliar novos avanços na abordagem terapêutica da fibromialgia, documentados por meio de estudos clínicos e randomizados. Trata-se de uma pesquisa de revisão integrativa realizada por meio da base de dados PubMed, que levou em consideração os seguintes critérios de inclusão: ensaios clínicos e testes controlados e aleatórios; artigos publicados no último ano que possuíam texto completo disponível e que abordassem o tratamento da fibromialgia. Foi observado que a prática de fortalecimento muscular central, alongamento e de vibração do corpo inteiro se mostrou benéfica na melhora da qualidade de vida, assim como intervenções em grupo que possuem enfoque no autocuidado e na educação em neurociência da dor. Terapias intervencionistas como a estimulação transcraniana por corrente contínua demonstraram divergências quanto à eficácia do método, e uma dieta de substituição com o trigo Khorasan resultou em melhora geral dos sintomas gastrointestinais vistos em pacientes com fibromialgia. Espironolactona e alopurinol se mostraram ineficazes, diferente da suplementação de vitamina B6 e magnésio, ambas relacionadas com melhora da dor e redução do estresse, respectivamente, em pacientes com fibromialgia. Dessa forma, novos estudos que possibilitem a compreensão efetiva de tais modalidades terapêuticas no manejo da fibromialgia são sugeridos pelos autores.

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“…Ordinal outcomes are frequently used in clinical practice and biomedical research, in order to make decisions and outcome assessments more patient‐centered. Examples include the visual analog scale (VAS; e.g., Kristensen et al., 2021; Lange et al., 2021) and quality of life (QOL) questionnaires (e.g., SF‐36, Böhm et al., 2021), just to name a few. From a statistical perspective, these outcomes should not be analyzed using classical parametric methods, because they are purely ordinal, which renders location‐shift effect measures inappropriate.…”

Section: Introductionmentioning

confidence: 99%

A neutral comparison of statistical methods for analyzing longitudinally measured ordinal outcomes in rare diseases

et al. 2023

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Ordinal data in a repeated measures design of a crossover study for rare diseases usually do not allow for the use of standard parametric methods, and hence, nonparametric methods should be considered instead. However, only limited simulation studies in settings with small sample sizes exist. Therefore, starting from an Epidermolysis Bullosa simplex trial with the above‐mentioned design, a rank‐based approach using the R package nparLD and different generalized pairwise comparisons (GPC) methods were compared impartially in a simulation study. The results revealed that there was not one single best method for this particular design, because a trade‐off exists between achieving high power, accounting for period effects, and for missing data. Specifically, nparLD as well as the unmatched GPC approaches do not address crossover aspects, and the univariate GPC variants partly ignore the longitudinal information. The matched GPC approaches, on the other hand, take the crossover effect into account in the sense of incorporating the within‐subject association. Overall, the prioritized unmatched GPC method achieved the highest power in the simulation scenarios, although this may be due to the specified prioritization. The rank‐based approach yielded good power even at a sample size of , whereas the matched GPC method could not control the type I error.

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High‐dose spironolactone lacks effectiveness in treatment of fibromyalgia (RCT)

Abstract: This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Cited by 5 publications

References 51 publications

Pain mechanisms in the transgender individual: a review

Pain mechanisms in the transgender individual: a review

Avanços na abordagem terapêutica da fibromialgia: uma revisão integrativa

A neutral comparison of statistical methods for analyzing longitudinally measured ordinal outcomes in rare diseases

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