Curcuma longa and Boswellia serrata extract combination for hand osteoarthritis: an open-label pre-post trial.

2022-11-23
Pharmaceutical biology 60(1)
- Yves Henrotin
- Yvan Dierckxsens
- Gaëlle Delisse
- Nathalie Maes
- Adelin Albert

PubMed: 36416059
DOI: 10.1080/13880209.2022.2147550

Study Design

Type: Observational
Sample size: n = 232
Population: 232 patients suffering from hand pain with or without joint deformity
Methods: Open-label, non-controlled, post-observational study. 3-month treatment with food supplement (89 mg C. longa dry extract, 120 mg B. serrata resin, 1.8 µg vitamin D). Pain evaluated on 10-point VAS.
Blinding: Open-label
Duration: 3 months
Funding: Unclear

Context

Osteoarthritis (OA) of the hand is a common painful musculoskeletal disorder with no cure. There is a need for an efficient and safe treatment to relieve OA pain.

Objective

To investigate the effects of a Curcuma longa and Boswellia serrata food supplement in addition to standard care on hand pain.

Materials and methods

This open-label, non-controlled, post-observational study was based on 232 patients suffering from hand pain with or without joint deformity. Patients received a medical prescription for a three-month treatment with a food supplement containing 89 mg of C. longa dry extract, 120 mg of B. serrata resin, and 1.8 µg vitamin D. Pain was evaluated on a 10-point visual analog scale (VAS). The number of painful hand joints, patient satisfaction, nonsteroidal anti-inflammatory drugs intake, and side effects were also recorded.

Results

Baseline pain intensity (regression coefficient ± SE: -0.19 ± 0.01, p < 0.0001) and the number of painful joints (regression coefficient ± SE: -0.022 ± 0.0029, p < 0.0001) decreased significantly throughout the 3 months treatment period. NSAIDs intake and topical drug application were significantly decreased by 64% (p < 0.0001) and 79% (p < 0.0001) after 12 weeks, respectively. Only 3/239 (1.3%) patients reported side effects probably related to the product. 80.3% were satisfied with the treatment and 75.5% wished to continue treatment.

Conclusion

This is the first clinical trial showing that C. longa and B. serrata resin can relieve symptoms in patients with hand osteoarthritis. The study provides useful information for the design of a clinical trial including a broader population.

Research Insights

Vitamin D→Improved Treatment Satisfaction
80.3% were satisfied with the treatment
Effect
Beneficial
Effect size
Small
Dose
1.8 µg
Vitamin D→Improved Willingness to Continue Treatment
75.5% wished to continue treatment
Effect
Beneficial
Effect size
Small
Dose
1.8 µg
Vitamin D→Reduced Hand Pain
Baseline pain intensity (regression coefficient ± SE: -0.19 ± 0.01, p < 0.0001) ... decreased significantly throughout the 3 months treatment period
Effect
Beneficial
Effect size
Small
Dose
1.8 µg
Vitamin D→Reduced Nonsteroidal Anti-Inflammatory Drug Intake
NSAIDs intake ... significantly decreased by 64% (p < 0.0001) after 12 weeks
Effect
Beneficial
Effect size
Large
Dose
1.8 µg
Vitamin D→Reduced Number of Painful Joints
the number of painful joints (regression coefficient ± SE: -0.022 ± 0.0029, p < 0.0001) decreased significantly throughout the 3 months treatment period
Effect
Beneficial
Effect size
Small
Dose
1.8 µg
Vitamin D→Reduced Topical Drug Application
topical drug application ... significantly decreased by 79% (p < 0.0001) after 12 weeks
Effect
Beneficial
Effect size
Large
Dose
1.8 µg

Adverse Events Reported

Vitamin D→Overall tolerability
Only 3/239 (1.3%) patients reported side effects probably related to the product.
Finding
Reported
Magnitude
3/239 (1.3%)