Bioavailable turmeric extract for knee osteoarthritis: a randomized, non-inferiority trial versus paracetamol

Abstract

Background To compare the efficacy and safety of bioavailable turmeric extract versus paracetamol in patients with knee osteoarthritis (OA). Methods In this randomized, non-inferiority, controlled clinical study, patients of knee OA were randomized to receive bioavailable turmeric extract (BCM-95®) 500 mg capsule two times daily or paracetamol 650 mg tablet three times daily for 6 weeks. The primary outcome measure was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. The secondary outcome measures were WOMAC total, WOMAC stiffness, and WOMAC physical function scores. Responder analysis of individual patients at different levels (≥ 20%, ≥ 50%, and ≥ 70%) for WOMAC score was calculated. TNF alpha and CRP levels were evaluated and adverse events (AE) were also recorded. Results Seventy-one and seventy-three knee OA patients, respectively in bioavailable turmeric extract and paracetamol groups, completed the study. Non-inferiority (equivalence) test showed that WOMAC scores were equivalent in both the groups (p value < 0.05) in all the domains within the equivalence limit defined by effect size (Cohen’s d) of 0.5 whereas CRP and TNF-α were better reduced with turmeric extract than paracetamol. After 6 weeks of treatment, WOMAC total score, pain, stiffness, and function scores got a significant improvement of 23.59, 32.09, 28.5, and 20.25% respectively with turmeric extract. In the turmeric extract group, 18% of patients got more than 50% improvement and 3% of patients got more than 70% improvement in WOMAC pain and function/stiffness score and none of the patients in the paracetamol group met the criteria. CRP and TNF-α got significantly reduced (37.21 and 74.81% respectively) in the turmeric extract group. Adverse events reported were mild and comparatively less in the turmeric extract group (5.48%) than in the paracetamol group (12.68%). Conclusion The results of the study suggest that bioavailable turmeric extract is as effective as paracetamol in reducing pain and other symptoms of knee osteoarthritis and found to be safe and more effective in reducing CRP and TNF-α. Trial registration Clinical Trials Registry – India CTRI/2017/02/007962. Registered on 27 February 2017

An Investigation into the Effects of a Curcumin Extract (Curcugen®) on Osteoarthritis Pain of the Knee: A Randomised, Double-Blind, Placebo-Controlled Study

“…In a comparative study with the NSAID, diclofenac, 4 weeks of curcumin supplementation lowered the secretion of COX-2 by monocytes in synovial fluid at similar levels to diclofenac [ 39 ]. In another comparative drug trial, 8-weeks of curcumin supplementation reduced concentrations of CRP and TNF-α, whereas paracetamol administration did not affect these markers [ 40 ]. However, in another OA study, compared to the placebo, 6 weeks of curcumin supplementation did not significantly alter the ESR or concentrations of IL-4, IL-6, CRP, TNF-α [ 41 ].…”

Improving Curcumin Bioavailability: Current Strategies and Future Perspectives

“…Two clinical trials assessed the effectiveness of a curcumin-essential oil complex in the management of knee OA compared to common drugs, such as diclofenac or paracetamol. Together, these studies revealed that co-administration of 500 mg of BCM-95 ® CG plus 50 mg of diclofenac twice a day (group 1, 71 patients) compared to administration of 50 mg of diclofenac twice a day alone (group 2, 69 patients), as well as the administration of 500 mg of BCM-95 ® CG twice a day (73 patients) or 650 mg of paracetamol three times a day (71 patients), not only significantly improved knee OA symptoms, but reduced the gastrointestinal (GI) side effects related to NSAIDs treatment and the need of other analgesics, thus suggesting a good alternative treatment option [79,80]. Control: unformulated curcumin; ND: not detected; AUC: area under the drug concentration-time curve; NA: not applicable; a mean ± standard error of mean; b mean; c mean ± standard deviation; d no reported standard deviation or error; e results in mg/mL; 1 AUC 0-3 ; 2 AUC 0-6 ; 3 AUC 0-8 ; 4 AUC 0-12 ; 5 AUC 0-24 ; 6 AUC 0-48 ; 7 AUC 0-∞ .…”

Ingredients of a Natural Oral Nutritional Supplement and Their Role in the Treatment of Osteoarthritis

“…According to the World Health Organization (WHO), it is projected that approximately more than 130 million will be affected by OA, and more than 40 million people will be severely disabled by the disease. 7 This is also because of the medical advances that are increasing the average life expectancy. 8 Women have a higher prevalence of OA than men.…”

“… 8 Women have a higher prevalence of OA than men. 7 Osteoarthritis, especially knee OA, has been proven to impair the physical functions and worsens the overall quality of life.…”

“…If patients continue to have pain, opioids are indicated as a second-line therapy. 7 At this point, there are no definitive cures established for the disease, 11 and the aforementioned medications such as NSAIDs and paracetamol help primarily with symptomatic relief and do not have a clear effect on disease prevention. 7 In addition, long-term use of these medications can lead to hepatic, gastrointestinal (GI), renal, and cardiovascular effects, 7 which makes them less than ideal to use in the long term for patients with chronic pain.…”