Efficacy and safety of twice daily sustained-release paracetamol formulation for osteoarthritis pain of the knee or hip: a randomized, double-blind, placebo-controlled, twelve-week study

Abstract

Improvement in WOMAC pain, physical function and stiffness subscales from treatment with SR paracetamol BID versus placebo in subjects with knee or hip OA was not significant. SR paracetamol BID demonstrated significant improvements in GPAOA, PGART, and high-responder rate. High placebo response may have contributed to lack of statistical separation on some outcomes. All interventions were generally well tolerated.

Pharmacological Management of Osteoarthritis With a Focus on Symptomatic Slow-Acting Drugs

“…A 12-week randomized, double-blind, placebo-controlled study of paracetamol twice a day in patients with hip and/or knee OA demonstrated no decrease in the severity of pain and stiffness and no improvement of joint function. 27 Also, long-term administration of paracetamol is associated with a higher risk in mortality and toxicity events in cardiovascular system, gastrointestinal (GI) system, and kidneys. 28…”

“…Paracetamol is readily available as a nonprescription drug; however, because of safety concerns and little evidence of its efficacy, paracetamol is used as needed for the initial treatment of OA. A 12-week randomized, double-blind, placebo-controlled study of paracetamol twice a day in patients with hip and/or knee OA demonstrated no decrease in the severity of pain and stiffness and no improvement of joint function 27 . Also, long-term administration of paracetamol is associated with a higher risk in mortality and toxicity events in cardiovascular system, gastrointestinal (GI) system, and kidneys 28 …”

Study of a Standardized Plant Extract Used as an Anti-Inflammatory Drug to Reduce Joint Pain

“…In his studies (2015) Cohrane [20] identified the importance of physical exercise in improving pain and functional status in patients diagnosed with knee osteoarthritis. , hypothesis confirmed by Fransen et al (21) The guidelines recommend the practice of the physical exercise to patients with knee osteoarthritis (even if the results are beneficial in the short term, up to 6 months) [1] and the use of non-steroidal anti-inflammatory drugs used locally and not orally due to reactions that may occur at the digestive tract level, cardiovascular and renal [22,23,24,25]. The recommendations of ACR/EULAR (The American College of Rheumatology/ The European League Against Rheumatism) indicate the combination of pharmacological and non-pharmacological treatment to ensure optimal results in the treatment of the knee [26,27,28].…”