In this study, we investigated the therapeutic effects of a novel formulation of low-dose calcium and vitamin $D_3$ blended with Rehmannia glutinosa Libosch and Eleutherococcus senticosus Max (RE+), in postmenopausal women. The controls were given either a placebo or high dose calcium and...
In this study, we investigated the therapeutic effects of a novel formulation of low-dose calcium and vitamin $D_3$ blended with Rehmannia glutinosa Libosch and Eleutherococcus senticosus Max (RE+), in postmenopausal women. The controls were given either a placebo or high dose calcium and vitamin $D_3$ (Ca + D). Bone mineral density (BMD) in the L2-3 lumber spines and femur regions was assessed, and serum osteocalcin, bone-specific alkaline phosphatase (BALP), and cross-linked N-telopeptide of type I collagen (NTx) were used as markers of osteoblast and osteoclast activity. Furthermore, all variables were measured before and after 6 and 12 months of treatment. The osteocalcin level was higher in the RE+ group, and BALP was almost the same in all groups. Serum NTx was significantly decreased in the RE+ group after 12 months (p<0.05). The NTx in the Ca + D and placebo groups showed no significant change. The decrease of femur BMD was further demonstrated in the placebo group, but significantly increased in the RE+ group after 6 and 12 months of treatment (p<0.05). There were significant differences in the percent changes of femur BMD between the placebo and RE+ groups (p<0.01) and Ca+D and RE+ groups (p<0.05). The decrease of spine BMD in the placebo group was inhibited both in the Ca + D and RE+ groups, however, there was significant difference only between the placebo and RE+ groups (p<0.05). These findings suggest that continuous oral therapy of the RE+ formulation reduces rapidly decreasing bone mineral density in postmenopausal women more effectively than high doses of calcium and vitamin $D_3$ alone by inhibiting osteoclastic activity. Therefore, it seems that the RE+ has its own antiosteoporotic effects. We suggest larger clinical studies to determine the most efficacious dosage and benefits of this novel treatment.
In this study, we investigated the therapeutic effects of a novel formulation of low-dose calcium and vitamin $D_3$ blended with Rehmannia glutinosa Libosch and Eleutherococcus senticosus Max (RE+), in postmenopausal women. The controls were given either a placebo or high dose calcium and vitamin $D_3$ (Ca + D). Bone mineral density (BMD) in the L2-3 lumber spines and femur regions was assessed, and serum osteocalcin, bone-specific alkaline phosphatase (BALP), and cross-linked N-telopeptide of type I collagen (NTx) were used as markers of osteoblast and osteoclast activity. Furthermore, all variables were measured before and after 6 and 12 months of treatment. The osteocalcin level was higher in the RE+ group, and BALP was almost the same in all groups. Serum NTx was significantly decreased in the RE+ group after 12 months (p<0.05). The NTx in the Ca + D and placebo groups showed no significant change. The decrease of femur BMD was further demonstrated in the placebo group, but significantly increased in the RE+ group after 6 and 12 months of treatment (p<0.05). There were significant differences in the percent changes of femur BMD between the placebo and RE+ groups (p<0.01) and Ca+D and RE+ groups (p<0.05). The decrease of spine BMD in the placebo group was inhibited both in the Ca + D and RE+ groups, however, there was significant difference only between the placebo and RE+ groups (p<0.05). These findings suggest that continuous oral therapy of the RE+ formulation reduces rapidly decreasing bone mineral density in postmenopausal women more effectively than high doses of calcium and vitamin $D_3$ alone by inhibiting osteoclastic activity. Therefore, it seems that the RE+ has its own antiosteoporotic effects. We suggest larger clinical studies to determine the most efficacious dosage and benefits of this novel treatment.
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대상 데이터
After being imported by the Poongsan Pharmaceutical Company, alcohol was added and processed in steam. Eleutherococcus senticosus (Araliaceae), widely distributed by China (East-North province), was obtained in the fall and also imported by the Poongsan Pharmaceutical Company. The marker substance, 5-HMF (5-(Hydroxymethyl)-2-furaldehyde}, was used for RGX, and Eleutheroside E {(— )-Syringaresinol-4-4'-O- /9-D-Diglucoside} was used for ES.
Potential subjects were screened initially by interview to ensure that they were postmenopausal women who were free of chronic diseases, such as known cardiovascular disease, diabetes mellitus, or malignant tumors and previous pathological fractures, and who had a body mass index (BMI; in kg/m2) between 20 and 30. Sixty-seven women were initially recruited, and 41 women were finally enrolled. We randomly assigned the participants to one of three groups.
The 41 participants were randomly assigned to one of three groups: RE + , Ca + D, and placebo, resulting in 14, 14, and 13 volunteers, respectively. The BMD and biochemical markers were assessed at the beginning (TO), and at 6 (T6) and 12 months (T12) after administration of the supplements.
We randomly assigned the participants to one of three groups. The women enrolled in the study were between 51 and 71 years old, had been postmenopausal for at least three years, and had osteopenia or osteoporosis having lumbar spine BMDs greater than 1.0 SD, below the young adult mean (T-score < —1.0) (WHO, 1994). Subjects who had conditions affecting bone metabolism, such as kidney, liver, parathyroid, and thyroid disease were excluded from the study.
데이터처리
RE + : formulation of calcium and vitamin D3, blended with Rehmannia glutinosa Libosch and Eleutherococcus senticosus Max. Data art mean of BMD change ±SD, ap<0.05 compared with TO with paired t-test, bp<0.05 compared with placebo group with ANOVA. There were significant differences in the changes between placebo and RE+ groups by repetitive-measured ANOVA (p<0.
Data were presented as mean±SD. Mean differences in each group were avaluated by a student's t-test for paired samples. Percenlage changes in BMD and biochemical markers were calculated [(post-treatment-baseline values)/ baseline valuesX 100] for each group.
The BMD of the lumbar spine gradually declined in the placebo group, but it increased in the RE+ and Ca + D groups. The change in the RE+ at T6 was significant with TO by the paired t-test (p < 0.05) and compared with the placebo group by ANOVA (p<0.05). The BMD of the femur declined in the placebo group; the BMD increased in the RE + and Ca + D groups, however, a significant treatment effect was found in T6 and T12, only in the RE + group with TO by the paired t-test (p<0.
Percenlage changes in BMD and biochemical markers were calculated [(post-treatment-baseline values)/ baseline valuesX 100] for each group. To determine whether the changes over the course of treatment were significantly different from the baseline in each group, paired t-tests were performed. The repetitive-measured analysis of variance (ANOVA) was used to detect differences in the changes recordec.
RE + : formulation of calcium and vitamin D3, blended with Rehmannia glutinosa Libosch and Eleutherococcus senticosus Max. Data art mean of BMD change ±SD, ap<0.05 compared with TO with paired t-test, bp<0.05 compared with placebo group with ANOVA. There were significant differences in the changes between placebo and RE+ groups by repetitive-measured ANOVA (p<0.
이론/모형
All three markers were measured at the baseline and 6 and 12 months after treatment by using the competitive enzyme-linked inimunosorbant assay (ELISA). Baseline serum calcium, phosphate, creatinine, and total alkaline phosphatase levels were also determined by routine methods employing an autoanalyzer (Shimadzu CL-7200, Shimadzu Co.
성능/효과
The percentage change of osteocalcin was slightly higher, but not significantly, in the RE+ group than in the placebo and Ca + D groups at six and 12 months, compared to the respective baseline values. Although the mean serum NTx concentration declined slightly, but insignificantly at 6 months, the decreased value in the RE+ group was significantly sustained for 12 months (p<0.05).
In conclusion, in the present study, the continuous oral therapy of the herbs, RGX and ES, was proved to be highly effective in controlling rapid reduction of bone turnover in postmenopausal women, and it showed fewer adverse effects than the administration of high dose calcium and vitamin D3 supplementation alone. Because the number of participants in this study was limited, long-term evaluation with larger numbers of participants is highly recommended, in order to more precisely determine the effects of this formulation in preventing and treating osteoporosis
05). The BMD of the femur declined in the placebo group; the BMD increased in the RE + and Ca + D groups, however, a significant treatment effect was found in T6 and T12, only in the RE + group with TO by the paired t-test (p<0.05) and compared with the placebo group by ANOVA (p<0.05). There were significant differences in the RE+ group, compared by repetitive-measured ANOVA with the placebo and Ca + D groups (p<0.
However, it should further elucidated the decrease of lumbar BMD at T12 than T6 in the RE+ group. The F-BMD (total rignt femur including neck, Wards, trochanter and shaft) was significantly increased after 6 and 12 months in the RE + group compared with 0 month, placebo and Ca + D groups, whereas it was only slightly increased in the Ca + D group (Fig. 2B). When the Ca + D group was compared with 1he placebo group, our results were not consistent with the findings of Dawson-Hughes et al (1997); their study showed a significant benefit in BMD of the hip, spine, and total tody.
The concentrations of serum BALP were almost constant in all three groups, but the concentration of serum osteocalcin increased in the RE+ group at 6 and 12 months, whereas it was almost constant in the placebo and Ca + D groups (Table 3). The percentage change of osteocalcin was slightly higher, but not significantly, in the RE+ group than in the placebo and Ca + D groups at six and 12 months, compared to the respective baseline values. Although the mean serum NTx concentration declined slightly, but insignificantly at 6 months, the decreased value in the RE+ group was significantly sustained for 12 months (p<0.
05). There were significant differences in the RE+ group, compared by repetitive-measured ANOVA with the placebo and Ca + D groups (p<0.01; p<0.05).
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