title: B-vitamin mixture improves the analgesic effect of diclofenac in patients with osteoarthritis: a double blind study.
abstract: According to the high consumption of the mixture of B vitamins and diclofenac in several countries, this combination has constituted a frequently used option in pain therapy from inflammatory origin. Although the evidence obtained from inflammatory pain animal models has shown the existence of analgesic synergy between diclofenac and the B vitamins mixture, the corresponding clinical evidence is scarce. A double-blind, randomized clinical trial study was designed to characterize the analgesic effect and safety of diclofenac and B vitamins against diclofenac alone in patients with severe osteoarthritis. Forty eight patients programmed to total knee arthroplasty with a pain level ≥7 in a 1-10 cm visual analogue scale were allocated to receive a single intramuscular injection of sodium diclofenac (75 mg) alone or combined with thiamine (100 mg), pyridoxine (100 mg) and cyanocobalamin (5 mg), and the pain level was evaluated during 12 h post-injection. Diclofenac+B vitamins mixture showed a superior analgesic effect during the assessed period and also a better assessment of the pain relief perception by patients than diclofenac alone. This study constitutes a clinical support on the improvement of the analgesic effect of diclofenac by B vitamins in patients with osteoarthritis programmed to total knee arthroplasty, as a clinical model of inflammatory pain.
authors.affiliation: Hospital de Ortopedia Magdalena de las Salinas, Instituto Mexicano del Seguro Social, Mexico City, Mexico.
authors.forename: M C
authors.initials: MC
authors.lastname: Magaña-Villa
authors.forename: H I
authors.initials: HI
authors.lastname: Rocha-González
authors.forename: C
authors.initials: C
authors.lastname: Fernández del Valle-Laisequilla
authors.forename: V
authors.initials: V
authors.lastname: Granados-Soto
authors.forename: J
authors.initials: J
authors.lastname: Rodríguez-Silverio
authors.forename: F J
authors.initials: FJ
authors.lastname: Flores-Murrieta
authors.forename: M C
authors.initials: MC
authors.lastname: Carrasco-Portugal
authors.forename: J G
authors.initials: JG
authors.lastname: Reyes-García
mesh_terms: D000368:Aged; D000700:Analgesics / Q000494:pharmacology*; D004008:Diclofenac / Q000009:adverse effects / Q000494:pharmacology*; D004311:Double-Blind Method; D004357:Drug Synergism; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D014803:Vitamin B Complex / Q000494:pharmacology*
chemical_list: D000700:Analgesics; D014803:Vitamin B Complex; D004008:Diclofenac