A Randomized Control Trial of Dexketoprofen/Vitamin B (Thiamine, Pyridoxine and Cyanocobalamin) Fixed-Dose Combination in Post-Traumatic Grade I-II Cervical Sprains.

Autor: Delgado-García P; IMACEN S.A. de C.V., Chihuahua, Mexico., Alcocer-Herrera JB; INBIOMEDyC Queretaro, Santiago de Querétaro, Mexico., Urenda-Quezada A; Traumatology Area of Mediadvance Clinical S.A.P.I. de C.V., Chihuahua, Mexico., Alonso-Martinez MD; Centro de Investigacion Clinica de Mexico, S. de R.L. de C.V. Morelia, Michoacan, Mexico., Bautista-Mendoza MA; Department of Traumatology and Orthopedics, Sanatorio Alcocer Pozo S.A. de C.V., Santiago de Querétaro, Mexico., Romero-Antonio Y; Research and Development Department of Laboratorios Silanes, S.A. de C.V., Av. De las Palmas No. 340, 3rd floor, Lomas de Chapultepec, Miguel Hidalgo, 11000, Mexico City, Mexico., Mora-Villalobos JC; Research and Development Department of Laboratorios Silanes, S.A. de C.V., Av. De las Palmas No. 340, 3rd floor, Lomas de Chapultepec, Miguel Hidalgo, 11000, Mexico City, Mexico., Sander-Padilla JG; Research and Development Department of Laboratorios Silanes, S.A. de C.V., Av. De las Palmas No. 340, 3rd floor, Lomas de Chapultepec, Miguel Hidalgo, 11000, Mexico City, Mexico., Rios-Brito KF; Research and Development Department of Laboratorios Silanes, S.A. de C.V., Av. De las Palmas No. 340, 3rd floor, Lomas de Chapultepec, Miguel Hidalgo, 11000, Mexico City, Mexico., Rodríguez-Vazquez IC; Research and Development Department of Laboratorios Silanes, S.A. de C.V., Av. De las Palmas No. 340, 3rd floor, Lomas de Chapultepec, Miguel Hidalgo, 11000, Mexico City, Mexico., González-Canudas J; Research and Development Department of Laboratorios Silanes, S.A. de C.V., Av. De las Palmas No. 340, 3rd floor, Lomas de Chapultepec, Miguel Hidalgo, 11000, Mexico City, Mexico. jogonzalez@silanes.com.mx.; IMSS-Centro Médico Nacional Siglo XXI, Mexico City, Mexico. jogonzalez@silanes.com.mx.
Jazyk: angličtina
Zdroj: Clinical drug investigation [Clin Drug Investig] 2024 Jun; Vol. 44 (6), pp. 413-424. Date of Electronic Publication: 2024 Jun 06.
DOI: 10.1007/s40261-024-01370-2
Abstrakt: Background: Musculoskeletal disorders are an important cause of work absence. Clinical practice guidelines recommend nonsteroidal anti-inflammatory drugs (NSAIDs) for grade I-II cervical sprains. The combination of thiamine + pyridoxine + cyanocobalamin vitamins has been used, alone and in combination with NSAIDs, for pain and inflammation in musculoskeletal disorders.
Objective: The objective of this study was to demonstrate the analgesic synergy of dexketoprofen, and the combination of vitamins thiamine + pyridoxine + cyanocobalamin in a fixed-dose combination (FDC) for the treatment of acute pain caused by grade I-II cervical sprains.
Methods: We conducted a multicentre, prospective, randomized, double-blind, phase IIIb clinical study comparing two treatment groups: (1) dexketoprofen 25 mg/vitamin B (thiamine 100 mg, pyridoxine 50 mg and cyanocobalamin 0.50 mg) in an FDC (two or more active ingredients combined in a single dosage form) versus (2) dexketoprofen 25 mg monotherapy (single drug to treat a particular disease), one capsule or tablet orally, every 8 h for 7 days. Final mean, average change, and percentage change in pain perception (measured using a visual analogue scale [VAS]) were compared with baseline between groups. A p value < 0.05 was considered statistically significant. Analyses were conducted using SPSS software, v.29.0.
Results: A statistically significant reduction in pain intensity was observed from the third day of treatment with the FDC compared with monotherapy (- 3.1 ± - 1.5 and - 2.6 ± - 1.1 cm, respectively) measured using the VAS (p = 0.011). Regarding the degree of disability, using the Northwick Park Neck Pain Questionnaire (NPQ), statistical difference was observed for the final measurement (7.5%, interquartile range [IQR] 2.5, 10.5; vs. 7.9%, IQR 5.0, 13.8; p = 0.028). A lower proportion of adverse events was reported when using the FDC.
Conclusions: The FDC of dexketoprofen/thiamine + pyridoxine + cyanocobalamin vitamins demonstrated superior efficacy and a better safety profile compared with dexketoprofen monotherapy for pain treatment in patients with grade I-II cervical sprains.
Clinical Trials Registration: NCT05001555, registered 29 July 2021 ( https://clinicaltrials.gov/study/NCT05001555 ).
(© 2024. The Author(s).)
Databáze: MEDLINE
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