ESCAPE pain trial - The effects of Curcumin in pain relief in women diagnosed with primary dysmenorrhea: A triple blinded, placebo-controlled, phase II, randomized clinical trial protocol.
Year: 2020
Type: article
Study design: Study Protocol
Abstract: Introduction: Primary dysmenorrhea affects many women, being a major cause of absenteeism and reduced productivity at work and at school. Although non-steroidal anti-inflammatory drugs (NSAIDs) are a good treatment option, up to 18% of women show no response or present allergic reactions and adverse events. Curcumin has antispasmodic, antinociceptive, and both specific and nonspecific anti-inflammatory effects, with good tolerability and safety. To date, no previous trial involving curcumin and dysmenorrhea pain has been performed. Therefore, our main goal is to assess the efficacy of curcumin for pain relief among women with primary dysmenorrhea, along with determining curcumin’s adverse effects and tolerability profile.Methods: A phase II, single-center, randomized, triple-blinded, placebo-controlled, parallel-group, superiority trial to evaluate the effect of curcumin (500 mg/12h) in pain reduction in women (18 to 35-year-old) with primary dysmenorrhea. A first cycle will be used for a passive, observational run-in phase. A sample of 108 participants (54 per group) is necessary to detect a 30% difference in pain sensitivity between groups assessed by visual analogue scale (VAS). Secondary outcomes include side effects, Cox Menstrual Symptom Scale (CMSS), and use of rescue drugs for pain relief. Discussion: Clinical evidence has shown analgesic and anti-inflammatory effects of curcumin and in view of dysmenorrhea’s physiopathology being related to those mechanisms targeted by curcumin, we hypothesize its use could represent an innovative and effective therapy to reduce the severity of this disease and its symptoms. Keywords: primary dysmenorrhea, Curcumin, pain relief, Visual Analogue Scale, Cox Menstrual Symptom Scale.
Authors: Facultad de Ciencias de la Salud, Pontificia Universidad Catolica Madre y Maestra. Santiago, Dominican Republic, Elly Pichardo, Tatiana Liborio-Kimura, Maria del Pilar Estrella Caballero, Vahid Nouri Kandany, Lucas Augusto Pepe Mena, Edson Santos Ferreira Filho, Eduardo Dytz Almeida, Ana Isabel Sanchez-Barbero, Susan Benedict Navia, Alberto Durán-Peña, Khalid Ali S S Al-Karbi, Marianne Zelniker, Diego Greatti Vaz da Silva, Mariane Schäffer Castro, Cassiano Ricardo de Oliveira Berto, Clarissa Medeiros, Danielli Matsuura, Daniel Eduardo Carvajal-Hausdorf, Carlos Augusto Rossetti, Camelia Tang Qian Ying, Bruno Soares Rocha Calabria, Gustavo de Almeida, Kamran Mushtaq, Ana Luisa Soares Neves, Gustavo Costa Nascimento de Carvalho, Ahmed Abdallah Ahmed Abdallah, Ahmed Doomi, Matteo Guidetti, Eladio Radhames Perez Antonio, Sachin Thakuji Thigale, Pedro Oliveira, Arturo Tamayo, Denise Saretta Schwartz
Institutions: Pontificia Universidad Católica Madre y Maestra, Universidade Federal do Amazonas, Universidad de San Martín de Porres, Universidad Autónoma de Santo Domingo, Universidade de São Paulo, Fundação Universitária de Cardiologia, Pontificia Universidad Javeriana, Replimune Group, Inc. (United States), Pitié-Salpêtrière Hospital, Primary Health Care, Odense University Hospital, Svendborg Sygehus, AC Camargo Hospital, Universidade La Salle, Eurofarma (Brazil), Hospital da Mulher São Paulo, Instituto do Câncer do Estado de São Paulo, Universidad del Desarrollo, Clínica Alemana, Tan Tock Seng Hospital, Federal Senate, Hamad Medical Corporation, Escola Bahiana de Medicina e Saúde Pública, University of Milan, Instituto Tecnológico de Santo Domingo, Northeastern University, Novartis Institutes for BioMedical Research, University of Lisbon, Egas Moniz - Cooperativa de Ensino Superior Crl, University of Manitoba
Language: English
Subfield: Molecular Medicine
Domain: Life Sciences
Open Access status: diamond
OpenAlex ID: W3048696992