Zhang, Li
(School of Pharmacy, Shanghai University of Traditional Chinese Medicine)
,
Chen, Xiaoyun
(Department of Rheumatology, LongHua Hospital Shanghai University of Traditional Chinese Medicine)
,
Cheng, Yanqi
(Prevention and Health Care Department of Traditional Chinese Medicine, Department of Rheumatology, LongHua Hospital Shanghai University of Traditional Chinese Medicine)
,
Chen, Qilong
(Research Center for TCM Complexity System, Shanghai University of Traditional Chinese Medicine)
,
Tan, Hongsheng
(School of Pharmacy, Shanghai University of Traditional Chinese Medicine)
,
Son, Dongwook
(Korea Ginseng Corporation)
,
Chang, Dongpill
(Korea Ginseng Corporation)
,
Bian, Zhaoxiang
(Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University)
,
Fang, Hong
(Prevention and Health Care Department of Traditional Chinese Medicine, Department of Rheumatology, LongHua Hospital Shanghai University of Traditional Chinese Medicine)
,
Xu, Hongxi
(School of Pharmacy, Shanghai University of Traditional Chinese Medicine)
Background: Korean Red Ginseng (KRG) is widely used for strengthening the immune system and fighting fatigue, especially in people with deficiency syndrome. However, there is concern that the long-term application or a high dose of KRG can cause "fireness" (上火 in Chinese) because of it...
Background: Korean Red Ginseng (KRG) is widely used for strengthening the immune system and fighting fatigue, especially in people with deficiency syndrome. However, there is concern that the long-term application or a high dose of KRG can cause "fireness" (上火 in Chinese) because of its "dryness" (燥性 in Chinese). The aim of this study was to assess the safety and efficacy of a 4-week treatment with KRG in participants with deficiency syndrome. Methods: This was a 4-week, randomized, double-blind, placebo-controlled clinical trial. A total of 180 Chinese participants were randomly allocated to three groups: placebo control group, participants were given a placebo, 3.6 g/d; KRG 1.8 g and 3.6 g groups. The primary outcomes were the changes in fireness and safety evaluation (adverse events, laboratory tests, and electrocardiogram). The secondary outcomes were the efficacy of KRG on fatigue, which include the following: traditional Chinese medicine (TCM) symptom scale and fatigue self-assessment scale. Results: Of the 180 patients, 174 completed the full study. After 4 weeks of KRG treatment, the Fire-heat symptoms score including Excess fire-heat score and Deficient fire-heat score showed no significant change as compared with placebo treatment, and no clinically significant changes in any safety parameter were observed. Based on the TCM syndrome score and fatigue self-assessment score, TCM symptoms and fatigue were greatly improved after treatment with KRG, which showed a dose- and time-dependent effect. The total effective rate was also significantly increased in the KRG groups. Conclusion: Our study revealed that KRG has a potent antifatigue effect without significant adverse effects in people with deficiency syndrome. Although a larger sample size and longer treatment may be required for a more definite conclusion, this clinical trial is the first to disprove the common conception of "fireness" related to KRG.
Background: Korean Red Ginseng (KRG) is widely used for strengthening the immune system and fighting fatigue, especially in people with deficiency syndrome. However, there is concern that the long-term application or a high dose of KRG can cause "fireness" (上火 in Chinese) because of its "dryness" (燥性 in Chinese). The aim of this study was to assess the safety and efficacy of a 4-week treatment with KRG in participants with deficiency syndrome. Methods: This was a 4-week, randomized, double-blind, placebo-controlled clinical trial. A total of 180 Chinese participants were randomly allocated to three groups: placebo control group, participants were given a placebo, 3.6 g/d; KRG 1.8 g and 3.6 g groups. The primary outcomes were the changes in fireness and safety evaluation (adverse events, laboratory tests, and electrocardiogram). The secondary outcomes were the efficacy of KRG on fatigue, which include the following: traditional Chinese medicine (TCM) symptom scale and fatigue self-assessment scale. Results: Of the 180 patients, 174 completed the full study. After 4 weeks of KRG treatment, the Fire-heat symptoms score including Excess fire-heat score and Deficient fire-heat score showed no significant change as compared with placebo treatment, and no clinically significant changes in any safety parameter were observed. Based on the TCM syndrome score and fatigue self-assessment score, TCM symptoms and fatigue were greatly improved after treatment with KRG, which showed a dose- and time-dependent effect. The total effective rate was also significantly increased in the KRG groups. Conclusion: Our study revealed that KRG has a potent antifatigue effect without significant adverse effects in people with deficiency syndrome. Although a larger sample size and longer treatment may be required for a more definite conclusion, this clinical trial is the first to disprove the common conception of "fireness" related to KRG.
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문제 정의
This study assesses the safety and efficacy of KRG treatment in participants with deficiency syndrome. First, we examined the fire-heat symptom score as our primary outcome.
제안 방법
The aim of the present study was to evaluate the safety, particularly in the side effect of “fireness,” and the antifatigue effect of KRG on patients with deficiency syndrome.
Based on the study of fatigue assessment in both China and overseas countries, Wang and Xue [28] developed the fatigue self-assessment scale with consideration of the background of Chinese culture. The scale consists of 23 items and is used to assess the type and severity of fatigue (including three subscales of measuring physical fatigue, mental fatigue, and the consequences of fatigue). Each scale is directly transformed into a 0-4 scale based on the severity of fatigue (0 = no fatigue).
Based on the Guideline of Clinical Research of TCM New Drugs [30], the TCM syndrome questionnaire was used in our study. The questionnaire consists of 10 items categorized as major and secondary symptoms, and each symptom is directly transformed into a 0-3 scale based on the severity of disease. The instrument yields a summed total score ranging between 0 and 30 (0 = no fatigue).
There was no seasonal difference in the time of the patients entering the study. The remaining 180 participants were assigned to a placebo group (n = 30) or a KRG group based on each dose (1.8 or 3.6 g of KRG, n = 30 for each group) using a computer-generated randomization schedule. General characteristics of the participants are shown in Table 1.
No moderate or serious adverse events were reported during the 4-week study period. The evaluation was also expanded to include laboratory tests and the electrocardiogram. The results of these tests were also in the normal range, so our results indicated that treatment with KRG for 4 weeks showed no significant adverse effects in people with deficiency syndrome.
This study assesses the safety and efficacy of KRG treatment in participants with deficiency syndrome. First, we examined the fire-heat symptom score as our primary outcome. We found that KRG treatment was not associated with an increase in the fire-heat symptom score for people with deficiency syndrome.
Thus, it is reasonable for us to choose people with deficiency syndrome as our study participants. The second important limitation of our study is that we did not consider a follow-up period; all of our measurements were conducted during the 4 weeks of KRG treatment. However, our main objective is to evaluate the safety of KRG in patients with deficiency syndrome, rather than its effectiveness, and our results demonstrate a similar fire symptom score during KRG treatment and placebo treatment.
대상 데이터
Our study was well designed according to the CONSORT 2017 statement [23]. The participants were recruited at the LongHua Hospital Shanghai University of Traditional Chinese Medicine (Shanghai, China) from March 2017 to December 2017.
Among the 202 participants screened, 22 participants were excluded because of laboratory test results consistent with the exclusion criteria. There was no seasonal difference in the time of the patients entering the study.
Among the 180 participants, a total of 6 participants dropped out. Four participants dropped out of the placebo group (1 due to the recurrence of eczema, 1 due to low compliance of dietary restrictions, and 2 due to withdrawal of consent); 2 participants dropped out of the KRG 3.
데이터처리
Differences in mean change from baseline between the treatment groups were examined using a mixed-effects model. A paired t test was used to determine the significance of change from baseline within each treatment group. All p values shown are two-tailed.
The within-treatment difference was analyzed by the paired t test; *** P < 0.001 compared before and after treatment with 1.8 g KRG.
성능/효과
As for the difference in the changes among the three groups, our results (Table 2) showed that the reduction of total fire-heat score was −0.11 ± 0.09 and −0.11 ± 0.09 after the treatment of 1.8 g and 3.6 g KRG, respectively, which showed no significant reduction as compared with the placebo group (mean of changed value −0.09 ± 0.10).
The reduction in KRG on the TCM symptom score also showed a time-dependent effect; after the treatment with 3.6 g KRG for 1 week, the reduction in the total TCM symptom scale was −0.1 ± 0.07, which was then increased to −0.44 ± 0.21 after 4 weeks of treatment (Table 4).
The reduction in the total TCM symptom score was increased from −0.37 ± 0.14 with KRG 1.8 g to −0.44 ± 0.21 with KRG 3.6 g after 4 weeks of treatment.
After the 4-week treatment, the improvement was better in the KRG 1.8 g (0.33 ± 0.24) and KRG 3.6 g (0.33 ± 0.23) groups than in the placebo group (0.53 ± 0.34), and the differences were statistically significant (Fig. 5).
Our results indicated that the scores decreased significantly after the administration of 3.6 g KRG (−0.1 ± 0.07) for 1 week as compared with those of the placebo group (−0.01 ± 0.03), whereas administration of 1.8 g KRG showed a significant reduction after 2 weeks of treatment.
6 g group (1 due to allergic reaction to peanuts and 1 due to drug treatment for common cold). Thus, a total of 174 participants completed the 4-week treatment without major protocol violations and had a compliance rate of more than 90%.
17 for DFS, respectively. For the difference in within-group treatment, the results showed that the total fire-heat score as well as EFS and DFS was gradually decreased in all three groups (Fig. 3). After treatment with both placebo and KRG for 4 weeks, the total fire-heat score showed a statistically significant difference as compared with initial scores within the same groups.
3). After treatment with both placebo and KRG for 4 weeks, the total fire-heat score showed a statistically significant difference as compared with initial scores within the same groups. As for the difference in the changes among the three groups, our results (Table 2) showed that the reduction of total fire-heat score was −0.
The evaluation was also expanded to include laboratory tests and the electrocardiogram. The results of these tests were also in the normal range, so our results indicated that treatment with KRG for 4 weeks showed no significant adverse effects in people with deficiency syndrome.
The curative effect of KRG was also evaluated based on total integral symptom scores. From our results, we found that the total effective rate was greatly increased after the treatment with KRG, which was 30.4%, 75%, and 84.5% in the placebo, KRG 1.8 g, and KRG 3.6 g groups, respectively (Table 5). In the placebo group, 39 participants showed no alleviation of fatigue symptoms, which was decreased to 15 and 9 for KRG 1.
1) Curative effect rate: syndrome score decreased by ≥ 95%.
Our study showed that there was no safety concern with the consumption of KRG. In conclusion, the results of our study suggest that KRG has the potential to improve fatigue-related symptoms in people with deficiency syndrome. We believe this will be an important research study that supports the future development of clinical trials involving KRG treatment.
후속연구
Therefore, we suggest that the follow-up period will not significantly affect our results or conclusions. However, it is clear that a research design with a follow-up period will be required for further evaluation of the safety of KRG.
We believe this will be an important research study that supports the future development of clinical trials involving KRG treatment. For more comprehensive evaluation of its safety and efficacy in the Chinese population, further study of KRG on Chinese people with a larger sample size and longer treatment is required.
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