UNDENATURED COLLAGEN TYPE II FOR THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE

To test the hypothesis that undenatured type II collagen (UC-II) relieves pain, quality of life, and joint function in women aged from 60 to 80 years with knee osteoarthritis.

Methods:

53 patients in the UC-II treatment group (for 90 days) and 52 in the control group (without UC-II) were evaluated at 1, 30, and 90 days regarding health-related quality of life, pain, and function with questionnaires, anthropometric data, alignment, range of motion, and radiographic analysis.

Results:

Quality of life increased significantly in the Physical domain in the treatment vs control group. Also, there was a difference between the first and the last evaluation on the pain visual analog scale (−3.8 ± 1.8 versus −1.3 ± 2.0) and on the WOMAC score (−9.5 ± 11.9 versus −1.3 ± 11.1). No variation in the temporal evolution of the Mental domain was found.

Conclusion:

Pain, joint stiffness, and quality of life (Physical domain) improved with the inclusion of UC-II for 90 days to the therapeutic toolbox for knee osteoarthritis in individuals aged 60 to 80 years. Level of evidence II, Comparative Prospective Study.

Keywords:
Osteoarthritis; Collagen Type II; Quality of Life; Pain; Drug Therapy

	Total (n = 105)	Control (n = 52)	UC2 (n = 53)	P-value
Sex				0.944
Female	69 (65.7)	34 (65.4)	35 (66.0)
Male	36 (34.3)	18 (34.6)	18 (34.0)
Age
Mean ± Standard Deviation	68.6 ± 5.6	68.6 ± 6.0	68.7 ± 5.3	0.954
Affected side				0.285
Right	58 (55.2)	26 (50.0)	32 (60.4)
Left	47 (44.8)	26 (50.0)	21 (39.6)
LL Alignment				0.965
Valgus	18 (17.1)	9 (17.3)	9 (17.0)
Varus	87 (82.9)	43 (82.7)	44 (83.0)
Kellgren-Lawrence				0.750
2	42 (40.0)	20 (38.5)	22 (41.5)
3	63 (60.0)	32 (61.5)	31 (58.5)
Comorbidities
Hypertension	33 (31.4)	16 (30.8)	17 (32.1)	0.885
Diabetes	6 (5.7)	2 (3.8)	4 (7.5)	0.678
Dyslipidemia	8 (7.6)	5 (9.6)	3 (5.7)	0.488
Hypothyroidism	4 (3.8)	1 (1.9)	3 (5.7)	0.618
BMI
Mean ± Standard Deviation	27.9 ± 2.0	27.9 ± 1.5	27.9 ± 2.4	0.995

Outcomes	Baseline	30 days	90 days	P-value	Difference 90 days - baseline
VAS
Control	7.3 ± 0.7	6.2 ± 1.2	6.0 ± 1.8	< 0.001	-1.3 ± 2.0
UC-II	7.1 ± 0.9	5.1 ± 1.3	3.4 ± 1.6	< 0.001	-3.8 ± 1.8
p-value¹	0.268	< 0.001	< 0.001		< 0.001
SF-12 Physical
Control	31.5 ± 6.3	34.2 ± 7.8	33.0 ± 8.2	0.046	1.5 ± 7.2
UC-II	29.5 ± 7.1	36.5 ± 9.6	45.6 ± 8.0	< 0.001	16.0 ± 7.9
p-value¹	0.145	0.180	< 0.001		< 0.001
SF-12 Mental
Control	50.3 ± 10.0	50.7 ± 9.8	50.1 ± 11.0	*0.801	-0.2 ± 7.4
UC-II	44.8 ± 11.2	45.1 ± 10.3	44.8 ± 10.8	**0.003	0.0 ± 13.4
p-value¹	-	-	-		0.924
WOMAC
Control	58.6 ± 14.3	56.7 ± 13.5	57.3 ± 16.5	0.370	-1.3 ± 11.1
UC-II	54.0 ± 16.6	50.8 ± 14.6	44.6 ± 12.0	< 0.001	-9.5 ± 11.9
p-value¹	0.140	0.034	< 0.001		< 0.001
WOMAC - Pain
Control	11.9 ± 3.6	10.9 ± 4.0	11.0 ± 4.7	-	-1.0 ± 3.8
UC-II	12.0 ± 4.2	9.5 ± 4.0	5.4 ± 3.5	-	-6.6 ± 4.8
p-value¹	0.901	0.073	< 0.001		< 0.001
WOMAC - Stiffness
Control	3.6 ± 1.2	3.6 ± 1.3	3.7 ± 1.3	-	0.1 ± 1.1
UC-II	3.7 ± 1.4	3.5 ± 1.6	3.2 ± 1.3	-	-0.5 ± 0.9
p-value¹	0.685	0.661	0.034		0.001
WOMAC - Function
Control	40.7 ± 10.4	39.7 ± 9.6	40.3 ± 11.2	-	-0.4 ± 7.6
UC-II	37.3 ± 11.6	35.2 ± 11.5	34.2 ± 9.8	-	-3.0 ± 6.2
p-value¹	0.114	0.029	0.004		0.056

	(3 months - baseline)	(1 month - baseline)	(3 months - 1 month)
VAS	-2.4 (-3.2 - -1.7)	-0.9 (-1.5 - -0.4)	-1.5 (-2.3 - -0.7)
VAS	< 0.001	0.002	< 0.001
Control	-1.3 ± 2.0	-1.1 ± 1.4	-0.2 ± 2.3
UC-II	-3.8 ± 1.8	-2.0 ± 1.5	-1.7 ± 1.7
SF-12 Physical	14.5 (11.6 - 17.5)	4.2 (1.6 - 6.9)	10.3 (7 - 13.5)
SF-12 Physical	< 0.001	0.002	< 0.001
Control	1.5 ± 7.2	2.7 ± 6.2	-1.2 ± 8.9
UC-II	16.0 ± 7.9	6.9 ± 7.5	9.1 ± 7.8
SF-12 Mental	0.2 (-4 - 4.4)	0 (-2.3 - 2.4)	0.2 (-3.6 - 4)
SF-12 Mental	0.924	0.981	0.928
Control	-0.2 ± 7.4	0.3 ± 4.6	-0.6 ± 5.8
UC-II	0.0 ± 13.4	0.4 ± 7.2	-0.4 ± 12.6
WOMAC	-8.2 (-12.6 - -3.7)	-1.4 (-4.7 - 1.9)	-6.8 (-10.5 - -3.1)
WOMAC	< 0.001	0.411	< 0.001
Control	-1.3 ± 11.1	-1.9 ± 6.7	0.6 ± 11.4
UC-II	-9.5 ± 11.9	-3.3 ± 10.2	-6.2 ± 7.3
WOMAC Pain	-5.7 (-7.3 - -4)	-1.5 (-2.8 - -0.2)	-4.2 (-5.4 - -2.9)
WOMAC Pain	< 0.001	0.024	< 0.001
Control	-1.0 ± 3.8	-1.0 ± 2.9	0.0 ± 3.3
UC-II	-6.6 ± 4.8	-2.5 ± 3.8	-4.1 ± 3.4
WOMAC Stiffness	-0.6 (-1 - -0.3)	-0.2 (-0.6 - 0.1)	-0.4 (-0.8 - 0)
WOMAC Stiffness	0.001	0.195	0.033
Control	0.1 ± 1.1	0.0 ± 0.8	0.1 ± 0.9
UC-II	-0.5 ± 0.9	-0.2 ± 1.0	-0.3 ± 1.1
WOMAC Function	-2.6 (-5.3 - 0,1)	-1.1 (-3.7 - 1,4)	-1.5 (-4 - 1)
WOMAC Function	0.056	0.381	0.244
Control	-0.4 ± 7.6	-1.0 ± 4.9	0.6 ± 7.2
UC-II	-3.0 ± 6.2	-2.1 ± 7.8	-0.9 ± 5.9

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[1] Correspondence: David Sadigursky. Centro Empresarial Thomé de Souza. Av. Antônio Carlos Magalhães, 3244, sala 616, Salvador, BA, Brazil, 418200000. davidsad@gmail.com