Naproxen, paracetamol and pamabrom versus paracetamol, pyrilamine and pamabrom in primary dysmenorrhea: a randomized, double-blind clinical trial.
BACKGROUND
Dysmenorrhea is caused by the discharge of prostaglandins into the uterine tissue; therefore, non-steroidal anti-inflammatory drugs (NSAIDs) are the established initial therapy for dysmenorrhea. Dysmenorrhea therapy may include the administration of drug monotherapy or combination therapy. However, clinical scientific evidence on the efficacy of medications with two or three drugs combined is scarce or nonexistent.


OBJECTIVE
To evaluate and compare the efficacy and safety of two oral fixed-dose combinations for the relief of the symptoms of primary dysmenorrhea among Mexican women. One of the combinations is widely used in Mexico (paracetamol, pyrilamine and pamabrom) and the selected comparison was a medication with naproxen sodium, paracetamol and pamabrom based on the pathophysiology of primary dysmenorrhea.


METHODS
This was a single-centre, double blind, experimental, parallel group, randomized trial. Female patients with primary dysmenorrhea, older than 17 years and with pain intensity greater than 45 mm on a visual analogue scale, were included. The patients were then randomized to receive tablets with naproxen sodium, paracetamol and pamabrom or tablets with paracetamol, pyrilamine and pamabrom for one menstrual cycle. Patient evaluations of symptomatology and pain intensity were recorded throughout one menstrual period. Descriptive and inferential statistical analyses were utilized.


RESULTS
An intention-to-treat population of 91 women, with a mean age of 21.3 ± 3.2 years, received paracetamol, pyrilamine and pamabrom tablets, and 98 participants, with a mean age of 21.0 ± 3.2 years, received naproxen sodium, paracetamol and pamabrom tablets. The participants assessments of pain on the Visual Analogue Scale during the menstrual cycle demonstrated a significant reduction in both treatment groups (p<0.05). There is no significant difference in efficacy between both groups (p>0.05).


CONCLUSIONS
The results showed that both drug combinations were not different in reducing dysmenorrheic pain. Likewise, both treatments were well tolerated. Therefore, both treatments may be used for the treatment of primary dysmenorrhea.
Área Académica de Medicina del Instituto de Ciencias de la Salud de la Universidad Autónoma del Estado de Hidalgo, Pachuca, Hidalgo, México. Address: Área Académica de Medicina del Instituto de Ciencias de la Salud, Universidad Autónoma Del Estado de Hidalgo, Eliseo Ramírez Ulloa 400, Colonia Doctores, Pachuca, Hidalgo, México. Email: mario_i_ortiz@hotmail.com.
Mario I
MI
Ortiz
Universidad del Futbol y Ciencias del Deporte, San Agustín Tlaxiaca, Hidalgo, México.
Gabriela
G
Murguía-Cánovas
Área Académica de Medicina del Instituto de Ciencias de la Salud de la Universidad Autónoma del Estado de Hidalgo, Pachuca, Hidalgo, México.
Laura C
LC
Vargas-López
Laboratorios Liomont S.A. de C.V. Ciudad de México, México.
Rodolfo
R
Silva
Biokinetics, S.A. de C.V., Ciudad de México, México.
Mario
M
González-de la Parra
D000082:Acetaminophen / Q000008:administration & dosage* / Q000009:adverse effects; D000293:Adolescent; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000009:adverse effects; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D004412:Dysmenorrhea / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008800:Mexico; D009288:Naproxen / Q000008:administration & dosage* / Q000009:adverse effects; D010147:Pain Measurement; D011412:Propanolamines / Q000008:administration & dosage* / Q000009:adverse effects; D011738:Pyrilamine / Q000008:administration & dosage* / Q000009:adverse effects; D013607:Tablets; D013806:Theophylline / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D055815:Young Adult
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D011412:Propanolamines; D013607:Tablets; D000082:Acetaminophen; D009288:Naproxen; D013806:Theophylline; D011738:Pyrilamine; C069987:pamabrom
 pamabrom;  paracetamol;  primary dysmenorrhea;  pyrilamine; naproxen