Efficacy and safety of Curcuma domestica extracts compared with ibuprofen in patients with knee osteoarthritis: a multicenter study

Figures & data

Figure 1 Flow of participants through stages of a randomized trial.

Table 1 Baseline characteristics of 331 participants

Baseline characteristics	Ibuprofen (n=160)	Curcuma domestica extracts (n=171)	P-valuea
Mean age ± SD (years)	60.9±6.9	60.3±6.8	0.452
Sex:female	139 (86.9%)	157 (91.8%)	0.144
Mean BMI ± SD (kg/m^2)	26.6±4.0	26.5±3.7	0.918
Mean duration of pain ± SD (months)	52.0±51.7	51.3±53.4	0.898
Knee pain
Unilateral	92 (57.5%)	93 (54.4%)	0.569
Bilateral	68 (42.5%)	78 (45.6%)
Using walking aids	11 (6.9%)	12 (7.0%)	0.959
Using knee support (one to seven times/week)	64 (40.0%)	60 (35.1%)	0.356
Routinely taking pain medicine (three to seven times/week)	48 (30.0%)	42 (24.6%)	0.266
Exercising knee (one to seven times/week)	122 (76.3%)	127 (74.3%)	0.677
WOMAC total ± SD	5.2±1.7	5.3±1.8	0.611
WOMAC pain ± SD	5.4±1.7	5.3±1.8	0.899
WOMAC stiffness ± SD	5.2±2.6	5.1±2.6	0.847
WOMAC functions ± SD	5.1±1.8	5.3±2.0	0.440
6-minute walk distance ± SD (meters)	304.5±83.8	310.9±84.8	0.489
X-ray gradingb
Grade I	21 (13.2%)	21 (12.3%)	0.543
Grade II	57 (35.8%)	74 (43.3%)
Grade III	54 (34.0%)	48 (28.1%)
Grade IV	27 (17.0%)	28 (16.3%)

Notes:

a Unpaired t-test or chi-square test;

b Kellgren–Lawrence grading: 0= normal radiograph; I= doubtful pathology; II= minimal osteophytes, possible narrowing, cysts, and sclerosis; III= moderate, as in definite osteophytes with moderate joint space narrowing; IV= severe, with large osteophytes and definite joint space narrowing.

Abbreviations: BMI, body mass index; SD, standard deviation; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.

Figure 2 The changes over time of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total, WOMAC pain, WOMAC stiffness, and WOMAC function scores at weeks 0, 2, and 4 of both groups using repeated-measures analysis of variance.

Table 2 Mean, SD, and difference (95% CI) of WOMAC total, WOMAC pain, WOMAC stiffness, and WOMAC function scores and 6-minute walk distance at week 4 adjusted by week 0 in ibuprofen and Curcuma domestica groups

Mean score at week 4 adjusted by week 0 ± SD	Ibuprofen (n=160)	C. domestica extracts (n=171)	Mean differencea (95% CI)	P-value
WOMAC total score	3.23±1.97	3.36±2.04	−0.07 (−0.43, 0.29)	0.010b
WOMAC pain subscale	3.17±1.98	3.25±2.11	−0.09 (−0.47, 0.29)	0.018b
WOMAC stiffness subscale	3.16±2.36	3.28±2.38	−0.15 (−0.59, 0.29)	0.060b
WOMAC function subscale	3.26±2.05	3.41±2.09	0.06 (−0.43, 0.32)	0.010b
6-minute walk (meters)	347.99±86.60	345.43±91.66	7.18 (−7.01, 21.38)	0.320c

Notes:

a Estimated marginal means week 4 adjusted by week 0 of ibuprofen group minus C. domestica extracts group;

b analysis of covariance and unpaired t-test for noninferiority test;

c analysis of covariance for equality.

Abbreviations: CI, confidence interval; SD, standard deviation; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.

Table 3 Adverse events (AEs) occurring during study compared between two groups

Adverse events	Ibuprofen (n=182)	Curcuma domestica extracts (n=185)	P-valuea
Number of patients with AE	65 (35.7%)	55 (29.7%)	0.222
Number of events
Abdominal pain/distension	33 (18.1%)	20 (10.8%)	0.046b
Dyspepsia	29 (15.9%)	21 (11.4%)	0.201
Nausea	15 (8.2%)	9 (4.9%)	0.191
Loose stool	16 (8.8%)	22 (11.9%)	0.330
Melena	2 (1.1%)	–	0.245
Pitting edema	13 (7.1%)	7 (3.8%)	0.156

Notes:

a Chi-square test, Fisher’s exact test;

b statistical significance.

Table 4 Patients’ global assessment and satisfaction at week 4

Variables	Ibuprofen (n=160)	Curcuma domestica extracts (n=171)	P-valuea
Global assessment			0.665
Improved	102 (63.8%)	110 (64.3%)
Indifferent	52 (32.5%)	58 (33.9%)
Deteriorated	6 (3.7%)	3 (1.8%)
Satisfaction index			0.707
Satisfied	153 (95.6%)	166 (97.1%)
Indifferent	7 (4.4%)	4 (2.3%)
Unsatisfied	–	1 (0.6%)

Note:

a Chi-square test for trend.