Effects of AIF on Knee Osteoarthritis Patients: Double-blind, Randomized Placebo-controlled Study

Sung-Hoon Park; Seong-Kyu Kim; Im-Hee Shin; Hyung-Gun Kim; Jung-Yoon Choe

doi:10.4196/kjpp.2009.13.1.33

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Park, Kim, Shin, Kim, and Choe: Effects of AIF on Knee Osteoarthritis Patients: Double-blind, Randomized Placebo-controlled Study

Original Article

Korean J Physiol Pharmacol 2009;13(1):33-37.

Published online: 17 February 2009

DOI: https://doi.org/10.4196/kjpp.2009.13.1.33

Effects of AIF on Knee Osteoarthritis Patients: Double-blind, Randomized Placebo-controlled Study

Sung-Hoon Park¹, Seong-Kyu Kim¹, Im-Hee Shin², Hyung-Gun Kim³, Jung-Yoon Choe¹

¹Department of Internal Medicine, Catholic University of Daegu, Daegu 705-718, Korea

²Department of Medical Statistics, School of Medicine, Catholic University of Daegu, Daegu 705-718, Korea

³Department of Pharmacology, College of Medicine, Dankook University, Cheonan 330-714, Korea

Corresponding to: Jung-Yoon Choe, Department of Internal Medicine, Catholic University of Daegu, School of Medicine, 3056-6, Daemyung 4-dong, Nam-gu, Daegu 705-718, Korea. (Tel) 82-53-650-4577, (Fax) 82-53-629-8248, (E-mail) jychoe@cu.ac.kr

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Anti-inflammatory factor (AIF) is a water soluble extract of three herbs, Panax notoginseng (Burk.) F. H. Chen, Rehmannia glutinosa Libosch and Eleutherococcus senticosus. The present study aimed to investigate the safety and efficacy of herb extracts, AIF, on Korean knee osteoarthritis patients for six weeks. Fifty seven patients with knee osteoarthritis, ranging from 43 to 73 years of age, who fulfilled the “American College of Rheumatology” (ACR) classification of idiopathic osteoarthritis of knee and radiographic criteria were randomly selected and enrolled for the study. After initial screening and resting period, two capsules each of AIF (Each capsule contains; 400 mg) and similar identical placebo were administered twice a day to both groups. Pain intensity at second, fourth, and sixth weeks of study as well as one week after discontinuation of drugs was assessed by using 100 mm visual analogue scale (VAS). Changes in the Korean version of the Western Ontario and McMaster Universities (K-WOMAC) index score were compared at the initiation and completion of the study. VAS assessed by patients were significantly reduced (at visit 2; 54.64±14.72, at visit 4, 37.32±16.58, p<0.001) after AIF administration. Results showed an improvement in the physical function of K-WOMAC scale which was significantly higher (p=0.013) in AIF than placebo group, and decreases of total K-WOMAC score were also significantly higher (p=0.030) in AIF groups than placebo group. No serious adverse effect was observed, and there was no difference in incidence of adverse effect between AIF and placebo groups. In this population of Korean patients with knee osteoarthritis, AIF was found to be safe, tolerable and effective for symptomatic improvement of pain and physical function.

Keywords: Anti-inflammatory factor, Clinical trial, Herbs, Osteoarthritis, K-WOMAC

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Fig. 1.

Schema of patients in the study.

Table 1.

Patient baseline characteristics

Demographics		AIF N=31	Placebo N=26	p value
Age, yr		59.90 (7.54)	58.92 (7.06)	>0.05^∗
Gender, no (%)
Female		28 (90.32)	24 (92.31)	>0.05^†
Male		3 (9.68)	2 (7.69)
Body weight (kg)		58.54 (7.30)	63.70 (9.17)	0.022^∗
Height (cm)		155.68 (6.33)	155.55 (5.42)	>0.05^∗
Previous medical history
Yes		23 (74.19)	17 (65.38)	>0.05^‡
No		8 (25.81)	9 (34.62)
Radiographic exam, no (%)
Right	I	17 (54.84)	16 (61.54)	>0.05^‡
	II	14 (45.16)	10 (38.46)
	III	0 (0.00)	0 (0.00)
	IV	0 (0.00)	0 (0.00)
Left	I	18 (58.06)	14 (53.85)	>0.05^‡
	II	12 (38.71)	12 (46.15)
	III	1 (3.23)	0 (0.00)
	IV	0 (0.00)	0 (0.00)

Values are means (SD).

^∗ t-test,

^† Fisher's exact test,

^‡ Chi-square test.

Table 2.

Summary of adverse events (AEs)

Demographics	AIF N=31	Placebo N=26	χ²	p value
Total AEs	11 (35.5)	9 (34.6)	0.118	0.731
Dyspepsia	6 (19.35)	6 (23.08)
Nasopharyngitis	2 (6.45)
Dysuria	1 (3.23)
AST elevation	1 (3.23)
ALT elevation	1 (3.23)
Insomnia		1 (3.85)
Gingival pain		1 (3.85)
Urticaria		1 (3.85)

Values are number (%) of patients. AST, alanine amino-transferase; ALT, aspartate aminotransferase.

Table 3.

Changes of VAS scores as assessed by patients

	Before administration		After administration		p value^†
	Week −2	Week 0	Week 3	Week 6	p value^†
AIF	N=28	N=28	N=28	N=28
	54.29 (14.32)	54.64 (14.72)	46.96 (16.46)	37.32 (16.58)	<0.01
Placebo	N=24	N=24	N=24	N=24
	52.92 (15.67)	55.21 (15.00)	51.04 (18.41)	42.08 (18.88)	<0.01
p value^∗		0.89		0.34

Values are means (SD).

^∗ two sample t-test,

^† Week 0, Week 6. paired t-test, LOCF.

Table 4.

Changes of K-WOMAC scale scores

		Before administration	After administration	Δ	p value^∗
		Week 0	Week 6	Δ	p value^∗
		N=27	N=27
AIF	Pain	6.22 (3.88)	4.33 (3.03)	1.89 (3.80)	<0.05
	Stiffness	2.96 (3.01)	2.22 (1.85)	0.74 (1.72)	<0.05
	Physical function	24.04 (13.30)	15.26 (13.18)	8.78 (10.84)	<0.05
	Total score	33.22 (17.87)	21.81 (17.33)	11.41 (14.44)	<0.05
		N=24	N=24
Placebo	Pain	5.22 (3.01)	4.22 (3.52)	1.00 (3.71)	0.21
	Stiffness	2.57 (1.81)	2.26 (1.66)	0.31 (1.69)	0.40
	Physical function	20.17 (10.99)	18.09 (12.14)	2.09 (6.67)	0.15
	Total score	27.96 (14.08)	24.57 (16.67)	3.39 (10.16)	0.12
p value^∗				0.41
				0.37
				<0.05
				<0.05

Values are means (SD).

^∗ two sample t-test (AIF – Placebo), † Week 0, Week 6. paired t-test, Δ Week 0- Week 6.

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