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: