title: To evaluate efficacy and safety of fixed dose combination of aceclofenac + paracetamol + thiocolchicoside (acenac-MR) in the treatment of acute low back pain.
abstract: Low back pain is very common complaint in all age groups. Paracetamol, non-steroidal anti-inflammatory drugs and muscle relaxants are commonly prescribed in combination for the treatment of back pain. The aim of the study was to evaluate efficacy and safety of fixed dose combination of aceclofenac + paracetamol + thiocolchicoside (acenac-MR) in the treatment of acute low back pain. Thirty-five patients, age being 18 to 76 years suffering from acute low back pain were enrolled in the study. Study drug acenac-MR tablet, (Medley pharmaceutical, Mumbai) containing aceclofenac 100 mg + thiocolchicoside 4 mg + paracetamol 500 mg was prescribed twice daily for a duration of 7 days. Intensity of pain was evaluated at the start of the therapy and on day 3 and day 7 with the help of visual analogue scale. Mobility assessment in low back patients was evaluated at the start of the therapy and on day 3 and day 7. A simple graduated bar (0 value at floor) evaluated hand-to-floor distance. Tolerability and efficacy was evaluated based on the global assessment by the investigator based on a 3-point scale marked as excellent/good/poor. There were 20 males and 10 females who were included for final analysis, 5 patients lost to follow-up. Intensity of pain at rest (p< or =0.0014 at day 3, p< or =0.0001 at day 7), during movement (p< or =0.0001 at day 3, p< or =0.0001 at day 7) and at night (p< or =0.0001 at day 3, p< or =0.0001 at day 7) was significantly reduced by acenac-MR compared to baseline. The mobility assessment revealed a statistically significant improvement in hand-to-floor distance on the 3rd (< or =0.0001) and 7th day (< or =0.0001) as compared to baseline with acenac-MR. As per investigators' assessment about efficacy of trial drug, 70% of patients reported excellent, 26.66 % good and 3.33 % reported poor efficacy. As per investigators' assessment about tolerability, 60 % of patients reported excellent, 36.66 % good and 3.33 % reported poor tolerability. None of the patients discontinued the therapy due to side-effects. Result of this study showed that aceclofenac + thiocolchicoside + paracetamol significantly reduced intensity of pain and improve the mobility of the patients.
authors.affiliation: Navjeevan Hospital, Amravati 444602.
authors.forename: Govind
authors.initials: G
authors.lastname: Lahoti
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D003078:Colchicine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004008:Diclofenac / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D004008:Diclofenac; D000082:Acetaminophen; C056498:aceclofenac; D003078:Colchicine; C004280:thiocolchicoside