Hematologic and Serological Investigation of Effect on Gyeongokgo in Healthy Individuals : a Randomized, Subject-assessor-blind, Placebo-controlled, Single-center Pilot Study원문보기
Sunwoo, Yun-Young
(Iksudang Clinic of Oriental Medicine)
,
Kim, Hye Jung
(Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital)
,
Kim, Ja Young
(Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital)
,
Yang, Na Rae
(Magoknaru Clinic of Oriental Medicine)
,
Lee, Jin Hyun
(Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital)
,
Park, Tae Yong
(Institute for Integrative Medicine, Catholic Kwandong University International St. Mary's Hospital)
There are no published data on Gyeongokgo (GOK) safety or efficacy despite being commonly use. The Gyeongokgo (GOK) is commonly used in traditional Korean medicine to promote a health qi and blood, but their objective data was not sufficient in clinical field. To investigate the safety and efficacy ...
There are no published data on Gyeongokgo (GOK) safety or efficacy despite being commonly use. The Gyeongokgo (GOK) is commonly used in traditional Korean medicine to promote a health qi and blood, but their objective data was not sufficient in clinical field. To investigate the safety and efficacy of GOK with hematologic and serologic testing and the change of the quality of life in healthy individuals. Randomized, subject-assessor-blind, placebo-controlled, single-center pilot study Participants and Interventions 29 healthy volunteer subjects were randomly placed into the GOK group (n = 20) or placebo control group (n = 9) and instructed to take one treatment packet (GOK or placebo) twice daily for 4 weeks. Subjects were assessed using the Fatigue Severity Scale (FSS) and Short Form 36 Health Survey (SF-36) and underwent hematologic and serologic tests and body composition analysis. The FSS total score (p = 0.093) and SF-36 general health index (p = 0.002) were improved following treatment in the GOK group. Post-treatment thyroid-stimulating hormone levels were increased in the GOK group compared with pre-treatment levels (p = 0.0042). C-reactive protein levels decreased (p = 0.0256) in the GOK group compared with that the placebo group. In time-series tests, GOK did not affect post-prandial serum triglycerides, glucose, insulin, or C-peptide levels. Notably, elevations in serum fasting triglycerides at 2- (p = 0.0333) and 4-hours (p = 0.0414) post-prandial were lower than those in the placebo group. GOK reduced fatigue levels and did not significantly affect laboratory test results performed to measure safety, serum glucose, and lipid profiles. Post-meal triglyceride levels were effectively reduced with treatment.
There are no published data on Gyeongokgo (GOK) safety or efficacy despite being commonly use. The Gyeongokgo (GOK) is commonly used in traditional Korean medicine to promote a health qi and blood, but their objective data was not sufficient in clinical field. To investigate the safety and efficacy of GOK with hematologic and serologic testing and the change of the quality of life in healthy individuals. Randomized, subject-assessor-blind, placebo-controlled, single-center pilot study Participants and Interventions 29 healthy volunteer subjects were randomly placed into the GOK group (n = 20) or placebo control group (n = 9) and instructed to take one treatment packet (GOK or placebo) twice daily for 4 weeks. Subjects were assessed using the Fatigue Severity Scale (FSS) and Short Form 36 Health Survey (SF-36) and underwent hematologic and serologic tests and body composition analysis. The FSS total score (p = 0.093) and SF-36 general health index (p = 0.002) were improved following treatment in the GOK group. Post-treatment thyroid-stimulating hormone levels were increased in the GOK group compared with pre-treatment levels (p = 0.0042). C-reactive protein levels decreased (p = 0.0256) in the GOK group compared with that the placebo group. In time-series tests, GOK did not affect post-prandial serum triglycerides, glucose, insulin, or C-peptide levels. Notably, elevations in serum fasting triglycerides at 2- (p = 0.0333) and 4-hours (p = 0.0414) post-prandial were lower than those in the placebo group. GOK reduced fatigue levels and did not significantly affect laboratory test results performed to measure safety, serum glucose, and lipid profiles. Post-meal triglyceride levels were effectively reduced with treatment.
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제안 방법
Adverse events during the trial were assessed through safety assessments and laboratory tests. All adverse reactions that occurred throughout the intervention and follow-up periods were evaluated as World Health Organization Adverse Reaction Terminology, and classified in 1-5 grades according to the Common Terminology Criteria for adverse Events (version 4.
Subsequently, the subjects were asked to complete a daily medication diary to assess compliance, use of other medicines, and alcohol consumption. At the end of the 4-week treatment, the subjects were again gathered, provided with identical meals, and subjected to the same questionnaire and tests as at the first visit.
Considering that elevated CRP can be used as an important indicator of obesity15), GOK might exert an effect on vascular health, which is in turn related to obesity and lipid metabolism. Furthermore, CRP can be used as an indicator of fatigue16), and the results of our study are consistent with a report describing a correlation between decreasing CRP and indicators of actual QOL17-19). Also, our GOK group exhibited a significant increase in TSH.
The probability of random allocation to the GOK group was set at 2:1 to encourage participation. Later, the subjects were gathered at a pre-designated location; provided with identical meals; and subjected to a questionnaire, hematologic tests, urinalysis, and body composition analysis. Subsequently, the subjects were asked to complete a daily medication diary to assess compliance, use of other medicines, and alcohol consumption.
Plasma cytokine levels including tumor necrosis factor (TNF)-α, interleukin (IL)-1β, IL-6, interferon (IFN)-r, IL-2, and IL-10 were determined using a Milliplex MAP Human Cytokine/Chemokine Magnetic Bead Panel (Millipore Corp., Billerica, MA, USA) following the manufacturer’s kit-specific protocols.
, Tokyo, Japan). Routine urinalysis was performed on a US-3100Rplus analyzer (Eiken Chemical Co. Ltd., Tokyo, Japan) in chronological order, and urine sediments were subjected to automated morphologic examination using a laser-based fluorescent flow cytometer, UF-1000i (Sysmex Co., Hyogo, Japan). For cytokine analysis, plasma samples were collected using EDTA, centrifuged, and stored at -80℃.
. Study subject QOL was assessed based on FSS and SF-36 scores before and after the study period. Both questionnaires can be viewed in the Appendix.
Ten different items were evaluated, consisting of the eight individual items: PF (physical functioning), RP (role limitations – physical), BP (bodily pain), GH (general health), VT (vitality), SF (social functioning), RE (role limits – emotional), and MH (mental health), in addition to the physical component summary (PCS = PF + RP + BP + GH) and mental component summary (MCS = VT + SF+ RE + MH).
The SF-36 was administered to assess QOL, and both intra- and inter-group analyses were performed. Ten different items were evaluated, consisting of the eight individual items: PF (physical functioning), RP (role limitations – physical), BP (bodily pain), GH (general health), VT (vitality), SF (social functioning), RE (role limits – emotional), and MH (mental health), in addition to the physical component summary (PCS = PF + RP + BP + GH) and mental component summary (MCS = VT + SF+ RE + MH).
, impaired fasting glucose, impaired glucose tolerance, or diabetes);5) steroid or hormonal drug use less than 1 month before the start of the study;6) pregnancy or breastfeeding; and7) any abnormal findings that might possibly have impacted the study results. The researchers first confirmed any matters that contravened the clinical trial conditions via a phone call or visit to each subject. Following this, a total of 32 subjects (16 male and 16 female) underwent screening including hematologic tests, urinalysis, electrocardiography, and a chest x-ray.
This study was a 4-week-long, single-center, subject-assessor-blind, placebo-controlled, parallel, randomized clinical trial. Before starting the study, approval was granted by the Catholic Kwandong University International St.
대상 데이터
Five participants (four in the GOK group and one in the control group) exhibited levels of AST, ALT, GGT, or total bilirubin that were above the standard range after the treatment period. We found that these participants had above average alcohol intake during the study.
The researchers first confirmed any matters that contravened the clinical trial conditions via a phone call or visit to each subject. Following this, a total of 32 subjects (16 male and 16 female) underwent screening including hematologic tests, urinalysis, electrocardiography, and a chest x-ray. The 29 subjects who passed the screening were randomly allocated by the random number table to a GOK treatment group of 20 subjects (9 males and 11 females), or a placebo control group of 9 subjects (4 males and 5 females).
Of the 32 subjects originally enrolled in this study, 3 were excluded due to abnormal hematologic findings during screening, and the remaining 29 subjects were included in the final analysis. There were no significant differences in general characteristics between the two groups(Table 1).
This study was also registered as KCT0002652 in Clinical Research inform action Service(CRIS). Subjects were physically and mentally healthy males and females aged 20 to 40 who had seen one of the clinical trial flyers posted in the hospital between March and April 2015 and had willfully consented to participate(Fig. 1). The following exclusion criteria were applied:1) underlying diseases including hypertension, hepatitis, or tuberculosis;2) a history of endocrinologic or hormone disorders;3) a history of hepato-pancreato-biliary or renal disorders;4) a history of impaired blood glucose regulation (i.
Following this, a total of 32 subjects (16 male and 16 female) underwent screening including hematologic tests, urinalysis, electrocardiography, and a chest x-ray. The 29 subjects who passed the screening were randomly allocated by the random number table to a GOK treatment group of 20 subjects (9 males and 11 females), or a placebo control group of 9 subjects (4 males and 5 females). The probability of random allocation to the GOK group was set at 2:1 to encourage participation.
데이터처리
Statistical analyses were performed by a statistician who was blinded to the subjects’ status. We used a paired t-test or Wilcoxon signed-rank test for changes within the groups and an independent two-sample t-test or Mann-Whitney U test (Wilcoxon rank sum test) for inter-group differences following treatment. All statistical analyses were performed using SAS v9.
이론/모형
Adverse events during the trial were assessed through safety assessments and laboratory tests. All adverse reactions that occurred throughout the intervention and follow-up periods were evaluated as World Health Organization Adverse Reaction Terminology, and classified in 1-5 grades according to the Common Terminology Criteria for adverse Events (version 4.03).
성능/효과
There are two likely explanations for this. First, the degree of perceived change was not great because the subjects in both groups were healthy adults with normal insulin tolerance before treatment. Second, the saccharide and black rice in the placebo are nutritious ingredients commonly used in traditional Korean medicine to nourish the body.
Hematologic and serologic test results and QOL questionnaires revealed that in healthy 20- to 40-year-old adults, a 4-week GOK regimen did not cause any hepatotoxicity or nephrotoxicity; had a beneficial effect on some items of perceived QOL; and was associated with elevated TSH, reduced CRP, and reduced fasting TG levels.
The FSS questionnaire results showed no significant difference in scores between the GOK and control groups following the treatment period. However, after the treatment period, the GOK group did show a statistically significant decrease in overall score, as well as for the following specific items:1) “I lose motivation when I am fatigued,” 2) “I become tired when I exercise,”3) “I become tired easily,” 4) “I engage in less physical activity because of fatigue,” and 5) “I often experience problems due to fatigue”(Table 2).
후속연구
Finally, traditional Korean medicine prescriptions should be made according to the patient’s medical symptoms, a practice that was not incorporated into the study design and might have reduced the precision of the results. Future studies should include further investigation into CRP and TSH levels and identify objective indices that can be applied to explain the clinical effects of GOK and investigate its mechanism(s) of action.
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