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 s...
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; $54.64{\pm}14.72$, at visit 4, $37.32{\pm}16.58$, 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.
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; $54.64{\pm}14.72$, at visit 4, $37.32{\pm}16.58$, 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.
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제안 방법
In this study, we conducted a clinical trial on AIF for the treatment of osteoarthritis and compared its symptomatic outcomes with those of placebo treated group.
taking and a physical examination. Laboratory tests included; simple radiography of the knee, complete blood cell count, blood chemistry, urinalysis, and a urine pregnancy test (premenopausal women). Simple radiography of the affected knee was also performed.
대상 데이터
advertisements. A total 64 patients (ages ranging from 43 to 73 years) with osteoarthritis of the knee, according to the "American College of Rheumatology" (ACR) classification of idiopathic osteoarthritis of knee with radiographic criteria of grade I and grade Ⅱ, were enrolled (Kellgren and Lawrence, 1957; Altman et al., 1986). All study subjects were required to stop all analgesic medication and physical therapy at least for 1 week prior to commencement of study.
After initial screening and resting period, the 57 participants were randomly assigned to one of two groups: AIF and placebo, respectively. The AIF participants were treated with the formulation which contained 200 mg of AIF, 192 mg of corn starch, 4 mg of HPMC, 4 mg of magnesium stearate in each capsule.
Sixty four patients were recruited, and 57 patients were randomly allocated to either AIF (31 patients) or placebo (26 patients) groups. Seven of the original 64 patients were not enrolled due to screening failure (three patients) or consent withdrawal (four patients) (Fig.
placebo, respectively. The AIF participants were treated with the formulation which contained 200 mg of AIF, 192 mg of corn starch, 4 mg of HPMC, 4 mg of magnesium stearate in each capsule. The placebo participants were treated with the formulation of 392 mg of corn starch, 4 mg of HPMC, 4 mg of magnesium stearate in each capsule.
The AIF participants were treated with the formulation which contained 200 mg of AIF, 192 mg of corn starch, 4 mg of HPMC, 4 mg of magnesium stearate in each capsule. The placebo participants were treated with the formulation of 392 mg of corn starch, 4 mg of HPMC, 4 mg of magnesium stearate in each capsule. The all groups were administered two capsules bid for 6 weeks.
데이터처리
Treatment efficacies were compared using the Chi-square (Z2) test. Inter-group K-WOMAC score changes were compared using the two sample t-test. Discontinued case data were analyzed using LOCF (Last-Observation-Carried-Forward) analysis.
Repeated measures two factor analysis was used to compare temporal differences. Intra-group differences were analyzed using the paired t-test, and the sample t-test was used to analyze inter-group differences. Treatment efficacies were compared using the Chi-square (Z2) test.
Inter-group K-WOMAC score changes were compared using the two sample t-test. Discontinued case data were analyzed using LOCF (Last-Observation-Carried-Forward) analysis.
, Chicago, IL). The analysis was performed on a per-protocol (PP) and intention to treat (ITT) basis. Repeated measures two factor analysis was used to compare temporal differences.
Intra-group differences were analyzed using the paired t-test, and the sample t-test was used to analyze inter-group differences. Treatment efficacies were compared using the Chi-square (Z2) test. Inter-group K-WOMAC score changes were compared using the two sample t-test.
성능/효과
01) (Table 3). Assessments of K-WOMAC scores at weeks 0 and 6 showed significant improvements in pain, stiffness, physical function and total scores in the AIF group only. AIF was found to be significantly more effective for improving physical function and total K-WOMAC scores than the placebo (Table 4).
(data not shown). Decreases in VAS scores were significant in both study groups (p<0.01 between week 0 and week 6), and the rate of response to AIF was 4.76 percentage points higher at 6 weeks than placebo group, however no significant difference was found between the two groups (p=0.89 at week 0, 0.34 at week 6) because of significantly high placebo effect in the placebo group between week 0 and 6 (p<0.01) (Table 3). Assessments of K-WOMAC scores at weeks 0 and 6 showed significant improvements in pain, stiffness, physical function and total scores in the AIF group only.
In conclusion, AIF was shown to be effective at improving pain and knee function in osteoarthritis patients, as assessed by using the VAS and K-WOMAC scale, and was found to have an acceptable safety profile. Therefore, it may be an applicable candidate as supplementary drugs for symptomatic osteoarthritis patients.
, 2006). In the present experiment, there was no significant difference in VAS between groups because of significantly high placebo effect in placebo group between week 0 and 6 (p<0.01), nevertheless, the administration of AIF for 6 weeks improved VAS, since the rate of response to AIF was 4.76 percentage points higher at 6 weeks than placebo group, and significantly improved K-WOMAC scores.
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