Efficacy of high-dissolution turmeric-sesame formulation for pain relief in adult subjects with acute musculoskeletal pain compared to acetaminophen: A randomized controlled study

Medicine (Baltimore). 2020 Jul 10;99(28):e20373. doi: 10.1097/MD.0000000000020373.

Abstract

Background: Acetaminophen (paracetamol) is one of the most commonly used over-the-counter for pain relief. Management of acute pain with plant-based nutrients has remained suboptimal due to an absence of data supporting acute relief of pain. In the present study, it was hypothesized that high-dissolution liquid treatment of black sesame extract oil, Curcuma longa and Boswellia serrata may provide pain relief in people with acute musculoskeletal pain as quickly as acetaminophen.

Methods: In this randomized active controlled open label study, 88 healthy subjects with acute musculoskeletal pain were randomized to receive treatment capsule (Rhuleave-K; 1,000 mg/d) or 1,000 mg/d acetaminophen for 7 days. Change in pain intensity and pain relief at first 6 hours, 3 days, and 7 days were measured. The onset of analgesia was measured by perceptible pain relief and meaningful pain relief. Other measures were McGill Pain Questionnaire and Patient Global Impression Change.

Results: The treatment formulation resulted in average magnitude of pain relief comparable to the acetaminophen. Sixty-six percent of subjects in the treatment group reported positive response in pain relief (≥50% max TOTPAR; total pain relief) after 6 hours, compared to 73% of control. Seventy-three percent of subjects on treatment were considered positive responders, compared to 80% in the control group. The average time of onset of analgesia was 1 hour for the treatment group, versus 0.83 hour for control. At the end of day 3 and 7, there was significant improvement (P < .001 for day 3 and day 7) in the pain condition of treatment group and was comparable to control (P = .436 for day 3 and P = .529 for day 7). The total McGill Pain score showed significant reduction in pain with the treatment irrespective of the pain intensity statistically equal (P = .468) to control. Both the groups were equal in providing sensory pain relief (P = .942), but the treatment was 8.57 times significantly better (P = .027) than acetaminophen in reducing the unpleasantness and emotional aspects (affective domain) involved with acute pain.

Conclusion: The results showed that the treatment used in the study may act as a natural, fast acting, and safe alternative for acute pain relief comparable to acetaminophen.

Publication types

  • Equivalence Trial

MeSH terms

  • Adult
  • Antioxidants / therapeutic use*
  • Boswellia
  • Curcuma
  • Humans
  • Middle Aged
  • Musculoskeletal Pain / drug therapy*
  • Phytotherapy*
  • Plant Extracts / therapeutic use*
  • Sesame Oil / therapeutic use*
  • Sesamum
  • Treatment Outcome

Substances

  • Antioxidants
  • Plant Extracts
  • Sesame Oil
  • turmeric extract