Eligibility criteria for Menopausal Hormone Therapy (MHT): a position statement from a consortium of scientific societies for the use of MHT in women with medical conditions. MHT Eligibility Criteria Group.

This project aims to develop eligibility criteria for menopausal hormone therapy (MHT). The tool should be similar to those already established for contraception A consortium of scientific societies coordinated by the Spanish Menopause Society met to formulate recommendations for the use of MHT by women with medical conditions based on the best available evidence. The project was developed in two phases. As a first step, we conducted 14 systematic reviews and 32 metanalyses on the safety of MHT (in nine areas: age, time of menopause onset, treatment duration, women with thrombotic risk, women with a personal history of cardiovascular disease, women with metabolic syndrome, women with gastrointestinal diseases, survivors of breast cancer or of other cancers, and women who smoke) and on the most relevant pharmacological interactions with MHT. These systematic reviews and metanalyses helped inform a structured process in which a panel of experts defined the eligibility criteria according to a specific framework, which facilitated the discussion and development process. To unify the proposal, the following eligibility criteria have been defined in accordance with the WHO international nomenclature for the different alternatives for MHT (category 1, no restriction on the use of MHT; category 2, the benefits outweigh the risks; category 3, the risks generally outweigh the benefits; category 4, MHT should not be used). Quality was classified as high, moderate, low or very low, based on several factors (including risk of bias, inaccuracy, inconsistency, lack of directionality and publication bias). When no direct evidence was identified, but plausibility, clinical experience or indirect evidence were available, "Expert opinion" was categorized. For the first time, a set of eligibility criteria, based on clinical evidence and developed according to the most rigorous methodological tools, has been defined. This will provide health professionals with a powerful decision-making tool that can be used to manage menopausal symptoms.
Competing Interests: Declaration of competing interest In the past 3 years the following have received grant support from: Laura Baquedano: Organon, Theramex Joaquín Calaf: None declared Pluvio Coronado: MSD, Shionogi, Adventia, Procare, Abex Esther De la Viuda: Adamed, Bayer, Exeltis, Effik, Gedeon Ritcher, MSD, Organon, Procare Health Iberia, Sandoz, Shionogi, Teva, Theramex Plácido Llaneza: None declared Nicolás Mendoza: Astellas Pharma, Shionogi Verónica Nieto: None declared Borja Otero: Exeltis Spain Isabel María Ramírez: Exeltis, MSD, Pfizer Sonia Sánchez: Gynea-Kern, Shionogi, Theramex, Organon, Isdin, Lacer, Uriach, Dermolab Visitación Álvarez: None declared Leire Andraca: None declared Camil Castelo-Branco: Shionogi Europe Marta Correa: None declared José Luis Doval: Exeltis María Fasero: MSD, Organon, Theramex, Shionoghi Gabriel Fiol: MSD Ana Isabel Gómez: None declared María de los Ángeles Gómez: Theramex, Gedeon Richter y Exeltis Silvia González: Isdin, MSD, Shionogi, Lacer Misericordia Guinot: None declared Sonia Herrero: None declared Eva María Iglesias: Astellas Pharma, Shionoghi and Lacer Ana Rosa Jurado: Astellas Pharma, Bayer, Stada, Exeltis, Shionogi, MSD Iñaki Lete: Organon, Adamed España, Gedeon Ritcher Daniel María Lubián: Shionogi, Exeltis and Adamed Milagros Martínez: Shionoggi, Khern-Pharma Aníbal Nieto: None declared Laura Nieto: None declared Milagros Pedreira: None declared Ezequiel Pérez-Campos: Exeltis María Jesús Plá: None declared Jesús Presa: Theramex, Adamed Laboratorios, Kern Pharma Francisco Quereda: Theramex, Shionoghi, Lacer, Gedeon Richter, Amgen, MSD Miriam Ribes: Procareh Beatriz Roca: Organon Pablo Romero: None declared Antonio Sánchez: None declared Ana Santaballa: None declared Amparo Santamaría: None declared Iván Sola: None declared Francisco Tahones: None declared Zully Benítez: None declared Teresa Bombas: None declared María Jesús Cancelo: Shionogi Europe Antonio Cano: Astellas, Theramex and Italfarmaco Néstor C Garello: None declared Andrea R Genazzani: None declared Dimitrios G Goulis: None declared Luis R Hernández: None declared Santiago Palacios: Arkochim, Bayer Healthcare, Exeltis, Gedeon Richter, Novo Nordisk, Procare Health, Serelys, Mithra, Lacer, Sandoz Rafael Sánchez Borrego: Seid SA, Lacer SA, Shionogi Slu, Exeltis, Astellas Tommaso Simoncini: None declared
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