Elly Pichardo, MD.
Facultad de Ciencias de la Salud, Pontificia Universidad Catolica Madre y Maestra. Santiago, Dominican Republic
Tatiana Liborio-Kimura, DDS, PhD.
Department of Pathology and Legal Medicine. Federal University of Amazonas. Manaus, AM, Brazil.
Maria del Pilar Estrella Caballero
Universidad San Martin de Porres. Lima, Peru.
Vahid Nouri Kandany, MD
Universidad Autónoma de Santo Domingo.Centro de investigación Biomédicas y Clínicas. Santiago, Dominican Republic.
Lucas Augusto Pepe Mena
Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo. SP/Brazil.
Edson Santos Ferreira Filho, MD.
Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo. SP/Brazil.
Eduardo Dytz Almeida, MD, MSc.
Instituto de Cardiologia do Rio Grande do Sul. Porto Alegre, Brazil.
Ana Isabel Sanchez-Barbero, MD.
Facultad de Ciencias de la Salud, Pontificia Universidad Javeriana Cali/ Centro Medico Imbanaco de Cali. Cali, Colombia.
Susan Benedict Navia
Replimune. MA,USA.
Alberto Durán-Peña, MD.
Service de Neurologie. Hôpital de la Pitié Salpêtrière, Paris France.
Khalid Ali S S Al-Karbi, MD.
Primary Health Care Corporation, Qatar.
Marianne Zelniker, MD.
Dr. Husek, Kliniken Schmieder Heidelberg, Odense University Hospital, St. Josef Hospital, Svendborg Sygehus.
Diego Greatti Vaz da Silva, MD.
AC Camargo Cancer Center, SP/Brazil.
Mariane Schäffer Castro
Universidade La Salle, RS/Brazil.
Cassiano Ricardo de Oliveira Berto
Eurofarma Laboratórios S.A, SP/Brazil
Clarissa Medeiros, MD.
Hospital Pérola Byington in São Paulo and Maternity Hospital Interlagos. SP/Brazil.
Danielli Matsuura, MD.
Instituto do Câncer do Estado de São Paulo, SP/Brazil
Daniel Eduardo Carvajal-Hausdorf, MD.
Clinica Alemana. Facultad de Medicina Universidad del Desarrollo. Santiago, Chile
Carlos Augusto Rossetti
Faculdade Israelita de Ciências da Saúde Albert Einstein, SP/Brazil.
Camelia Tang Qian Ying, MD.
Department of Hand and Reconstructive Microsurgery, Tan Tock Seng Hospital. Singapore.
Bruno Soares Rocha Calabria, MD.
Centro de quimioterapia Unimed Campinas, City Campinas. Hospital dos Fornecedores de Cana de Piracicaba: Piracicaba, Hospital S˜ão Francisco : Americana, São Paulo, BR
Gustavo de Almeida, MD.
Associação Brasileira de Medicina Legal e Perícia Médica Senado Federal, Brasilia, DF/Brazil.
Kamran Mushtaq
Department of Gastroenterology, Hamad Medical Corporation, Doha/Qatar.
Ana Luisa Soares Neves, MD
Hospital Evangelico de Belo Horizonte. Belo Horizonte, Brasil.
Gustavo Costa Nascimento de Carvalho
Escola Bahiana de Medicina e Saúde Pública. Brazil.
Ahmed Abdallah Ahmed Abdallah
Hamad Medical Corporation, Qatar.
Ahmed Doomi, MBBS, CABNS, FEBNS, FRCS
Neurosurgery department, Hamad Medical Corporation, Doha - Qatar
Matteo Guidetti
“Aldo Ravelli” Research Center for Neurotechnology & Experimental Brain Therapeutics, Department of Health Sciences, University of Milan, Milan, Italy.
Eladio Radhames Perez Antonio
Instituto Tecnologico de Santo Domingo, Dominican Republic.
Sachin Thakuji Thigale
Northeastern University, Novartis Institutes for BioMedical Research Inc.
Pedro Oliveira, DDM, MD, PhD.
Universidade de Lisboa Faculdade de Medicina: Lisboa, Lisboa, PT and Egas Moniz Cooperativa de Ensino Superior CRL: Caparica, Setúbal, PT.
Arturo Tamayo, MD, FAHA, MSc.
Assistant Professor of Neurology, Rady Max School of Medicine , University of Manitoba. Winnipeg Canada.
Denise Saretta Schwartz, DVM, MSc, PhD.
Faculdade de Medicina Veterinária e Zootecnia (FMVZ), Universidade de São Paulo, SP/Brazil
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.
