• Korean Journal of Exercise Nutrition
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• v.25 no.1
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• pp.7-15
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• 2021

[Purpose] Sodium bicarbonate shows ergogenic potential in physical exercise and sports activities, although there is no strong evidence which performance markers show the greatest benefit from this supplement. This study evaluated the effects of sodium bicarbonate supplementation on time trial performance and time to exhaustion in athletes and sports practitioners. [Methods] A systematic review was conducted using three databases, including 17 clinical trials. Among these clinical trials, 11 were considered eligible for the meta-analysis according to the criteria for the assessment of methodological quality using the PEDro Scale. Time to exhaustion was assessed in six studies, while time trial performance was evaluated in five studies. [Results] A significant beneficial effect of supplementation on time to exhaustion was found in a random effects model (1.48; 95% confidence interval [CI], 0.49 to 2.48). There was no significant effect of supplementation on time trial performance in a fixed effects model (slope = -0.75; 95% CI, -2.04 to 0.55) relative to a placebo group. [Conclusion] Sodium bicarbonate has the potential to improve sports performance in general, especially in terms of time to exhaustion.

• Herbal Formula Science
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• v.28 no.2
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• pp.199-209
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• 2020

Objectives : The purpose of this systematic review is to confirm whether Gwibitang is beneficial in chronic fatigue syndrome (CFS). Methods : Clinical trials were searched from databases including Pubmed, Embase, Central Cochrane, CNKI, Wanfang, CQVIP, CiNii, OASIS, Koreamed, and NDSL. The eligible study design was limited into randomized controlled trial, quasi-randomized controlled trial and controlled clinical trial. The outcomes included general effectiveness as nominal scale, and fatigue severity, insomnia severity and quality of life as interval or ratio scale. The meta-analysis and assessment of risk of bias was performed based on the data extracted from the selected trials. Results : The results of eight randomized controlled trials (n=596) were included in the meta-analysis. The results of the synthesis showed Gwibitang is beneficial substantially for relieving and managing the general symptoms, and its heterogeneity was not in important level (RR 0.26 [95% CI 0.17, 0.39], Z=6.47, P<0.00001, I²=0%). Gwibitang was beneficial for alleviating fatigue (SMD -0.78 [95% CI -1.27, -0.30], Z=3.17, P=0.002), but its certainty was low. In case of insomnia, too few trials had been found and their risk of bias was substantial, so no conclusions had been brought to. Conclusions : We found an evidence that Gwibitang could be beneficial for managing and alleviating main symptoms in CFS patients.

• Journal of Korean Medicine Rehabilitation
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• v.27 no.2
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• pp.39-54
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• 2017

Objectives This study aimed to search the Chinese literature on acupotomy for lumbar disc herniation and to analyze their methodologies. Methods Using 4 Chinese databases (CBM [www.sinomed.ac.cn], CNKI [www.cnki.net], WANFANG [www.wanfangdata.com], and WEIPU [www.cqvip.com]), we searched for clinical trials conducted in China over the past 10 years on acupotomy for lumbar disc herniation. The search terms used were "(腰椎椎間板脫出症 or 椎間板脫出症 or 椎間板脫出) and (针刀or 针刀松解术)" and we selected only meta-analyses that were published before December 2016. From among these meta-analyses, we excluded duplicates and selected the remaining 36 randomized controlled trials (RCTs) for our final analysis. Results The largest numbers of acupotomy papers were published in 2008 and 2013 (8 papers each). The average number of subjects was 120; the most common treatment method used for the control group was standard acupuncture (in 11 papers), and the most common concurrent treatment in the treatment group was massage (in 10 papers). The most common site of needle insertion was between the spinous processes, or at less than 0.5 cm on either side of the spinous processes (in 24 papers). The most common site of adhesion lysis was at the transverse process (in 24 papers). Two studies were blinded, and the mean Jadad score was 1.17. Conclusions A large number of RCTs on the use of acupotomy for lumbar disc herniation are conducted every year in China, and the procedure has been shown to be very effective, with few adverse effects. However, the average quality of the studies was not very high. Based on our study, we expect several high-quality clinical trials on acupotomy to be conducted in Korea in the future.

• Journal of Oriental Neuropsychiatry
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• v.28 no.3
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• pp.217-230
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• 2017

Objectives: This study was conducted to review studies on somatization disorder in traditional Chinese medicine. Methods: We reviewed studies in the China National Knowledge Infrastructure (CNKI) to 2017. Keywords were 軀體化障碍, Somatization disorder, somatic symptom disorder. We included Randomized Controlled Trial (RCT), and excluded non-Randomized Controlled Trial (nRCT), non-related somatization disorder or traditional Chinese medicine, non-clinical trials, dissertations for degrees. Jadad scale and Cochrane Library's Risk of Bias (RoB) were used for assessment of the quality of studies. Results: Twelve studies were selected. The Chinese Classification of Mental Disorders-3 (CCMD-3) was most frequently used as diagnostic criteria for somatization disorder. As for outcome measurement, Hamilton Rating Scale for Depression (HAMD) was used most commonly. Meta-analysis of 10 studies revealed effective rate of Chinese Herbal Medicine groups (CHM) was significantly higher than Western Medicine groups (WM) (RR: 1.14, 95% CI: 1.02 to 1.27, p=0.02, $I^2=40%$). There was no significant difference in effective rate of CHM+WM and WM (RR: 1.12, 95% CI: 0.84 to 1.49, p=0.46, $I^2=83%$). And also, effective rate of Acupuncture group (Acu) revealed no significant difference compared to that of WM (RR: 1.17, 95% CI: 0.95 to 1.44, p=0.13, $I^2=84%$). For HAMD, there was significant difference in CHM vs, WM group and Acu vs. WM group. Quality of selected 12 RCTs was low. Conclusions: Therapies practiced in traditional Chinese medicine may be effective options for somatization disorder. treatment. For further clinical studies in Korean medicine, this study could be groundwork for development of diagnosis and treatment on somatization disorder.

• Journal of Acupuncture Research
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• v.28 no.3
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• pp.55-71
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• 2011

Objectives : The purposes of this preliminary study was to examine the feasibility of recruiting women into a clinical trial designed to examine the effects of acupuncture in treating urinary incontinence (UI) in premenopausal women with delivery history and the feasibility of performing the study procedures. We also tried to determine if there was preliminary evidence to suggest that acupuncture may be effective in reducing UI and improving disease-specific quality of life. Methods : This study was a pragmatic randomized clinical trial. Subjects between the ages of 20 and 49 years were randomly assigned to a treatment(n=11) or control group(n=11) and analyzed. Both groups were supposed to do Kegel exercise at home during 4 weeks and acupuncture was applied to the treatment group twice a week(8 sessions) additionally. Subjects performed 1 hour pad test and completed a 3-day urination diary, international consultation on incontinence modular questionnaire(ICIQ), and incontinence - quality of life(I-QOL) at base line and 5 weeks. Results : Both group showed improvement in 1 hour pad test and the reducing amount of UI was significantly larger in treatment group(p=0.0182). The significant improvements in ICIQ and I-QOL were also observed in treatment group and sustained until the follow-up measurement at 16 weeks. Any adverse reaction related to acupuncture did not happen. Conclusions : It was feasible to recruit subjects and perform the study procedures. The positive results of this study support the requirement for additional research investigating the efficacy of acupuncture in the treatment of UI in women.

• Journal of Pharmaceutical Investigation
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• v.35 no.6
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• pp.437-443
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• 2005

A rapid, selective and sensitive reversed-phase HPLC method for the determination of a major metabolite of terfenadine, fexofenadine, in human serum was developed, validated, and applied to the pharmacokinetic study of terfenadine. Fexofenadine and internal standard, haloperidol were extracted from human serum by liquid-liquid extraction with acetonitrile and analyzed on a $Symmetry^{TM}$ C8 column with the mobile phase of 1% triethylamine phosphate (pH 3.7)-acetonitrile (67:33, v/v, adjusted to pH 5.6 with triethylamine). Detection wavelength of 230 nm for excitation, 280 nm for emission and flow rate of 1.0 mL/min were fixed for the study. The assay robustness for the changes of mobile phase pH, organic solvent content, and flow rate was confirmed by $3^{3}$ factorial design using a fixed fexofenadine concentration (50 ng/mL) with respect to its peak area and retention time. In addition, the ruggedness of this method was investigated at three different laboratories using same quality control (QC) samples. This method showed linear response over the concentration range of 10-500 ng/mL with correlation coefficients greater than 0.999. The lower limit of quantification using 0.5 mL of serum was 10 ng/mL, which was sensitive enough for the pharmacokinetic studies of terfenadine. The overall accuracy of the quality control samples ranged from 95.70 to 114.58% for fexofenadine with overall precision (% C.V.) being 3.53-14.39%. The relative mean recovery of fexofenadine for human serum was 90.17%. Stability studies (freeze-thaw, short-term, extracted serum sample and stock solution) showed that fexofenadine was stable during storage, or during the assay procedure in human serum. However, the storage at $-70^{\circ}C$ for 4 weeks showed that fexofenadine was not stable. The peak area and retention time of fexofenadine were not significantly affected by the changes of mobile phase pH, organic solvent content, and flow rate under the conditions studied. This method showed good ruggedness (within 15% C.V.) and was successfully used for the analysis of fexofenadine in human serum samples for the pharmacokinetic studies of orally administered Tafedine tablet (60 mg as terfenadine) at three different laboratories, demonstrating the suitability of the method.

• Journal of Pharmaceutical Investigation
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• v.36 no.1
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• pp.45-51
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• 2006

A rapid, selective and sensitive reversed-phase HPLC method for the determination of dipyridamole in human serum was developed, validated, and applied to the pharmacokinetic study of dipyridamole. Dipyridamole and internal standard, loxapine, were extracted from human serum by liquid-liquid extraction with diethyl ether and analyzed on a Nova Pak $C_{I8}$ column with the mobile phase of 40 mM ammonium acetate:methanol:acetonitrile (35:35:30)(v/v/v, pH 7.8). Detection wavelength of 280 nm and flow rate of 1.0 mL/min were fixed for the study. The assay robustness for the changes of mobile phase pH, organic solvent content, and flow rate was confirmed by $3^3$ factorial design using a fixed dipyridamole concentration (50 ng/mL) with respect to its peak area and retention time. And also, the ruggedness of this method was investigated at three different laboratories using same quality control (QC) samples. This method showed linear response over the concentration range of 2-2000 ng/mL with correlation coefficients greater than 0.999. The lower limit of quantification using 0.5 mL of serum was 2 ng/mL, which was sensitive enough for pharmacokinetic studies of dipyridamole. The overall accuracy of the quality control samples ranged from 103.94 to 105.86% for dipyridamole with overall precision (% C.V.) being 4.60-11.49%. The relative mean recovery of dipyridamole for human serum was 97.64%. Stability studies showed that dipyridamole was stable during storage, or during the assay procedure in human serum. The peak area and retention time of dipyridamole were not significantly affected by the changes of mobile phase pH, organic solvent content, and flow rate under the conditions studied. This method showed good ruggedness (within 15% C.V.) and was successfully used for the analysis of dipyridamole in human serum samples for the pharmacokinetic studies of orally administered Dimor tablet (75 mg as dipyridamole) at three different laboratories, demonstrating the suitability of the method.

• Journal of Pharmaceutical Investigation
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• v.36 no.1
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• pp.23-29
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• 2006

A rapid, selective and sensitive reversed-phase HPLC method for the determination of promethazine in human serum was developed, validated, and applied to the pharmacokinetic study of promethazine. Promethazine and internal standard, chlorpromazine, were extracted from human serum by liquid-liquid extraction with n-hexane containing 0.8% isopropanol and analyzed on a Capcell Pak CN column with the mobile phase of acetonitrile-0.2 M potassium dihydrogen phosphate (42:58, v/v, adjusted to pH 6.0 with 1 M NaOH). Detection wavelength of 251 nm and flow rate of 0.9 mL/min were fixed for the study. The assay robustness for the changes of mobile phase pH, organic solvent content, and flow rate was confirmed by $3^{3}$ factorial design using a fixed promethazine concentration (10 ng/mL) with respect to its peak area and retention time. In addition, the ruggedness of this method was investigated at three different laboratories using same quality control (QC) samples. This method showed linear response over the concentration range of 1-40 ng/mL with correlation coefficients greater than 0.999. The lower limit of quantification using 1 mL of serum was 1 ng/mL, which was sensitive enough for pharmacokinetic studies. The overall accuracy of the quality control samples ranged from 96.15 to 105.40% for promethazine with overall precision (% C.V.) being 6.70-11.22%. The relative mean recovery of promethazine for human serum was 63.54%. Stability (freeze-thaw and short-term) studies showed that promethazine was stable during storage, or during the assay procedure in human serum. However, the storage at $-80^{\circ}C$ for 4 weeks showed that promethazine was not stable. Extracted serum sample and stock solution were not allowed to stand at ambient temperature for 12 hr prior to injection. The peak area and retention time of promethazine were not significantly affected by the changes of mobile phase pH, organic solvent content, and flow rate under the conditions studied. This method showed good ruggedness (within 15% C.V.) and was successfully used for the analysis of promethazine in human serum samples for the pharmacokinetic studies of orally administered Himazin tablet (25 mg as promethazine hydrochloride) at three different laboratories, demonstrating the suitability of the method.

• Journal of Pharmaceutical Investigation
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• v.35 no.4
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• pp.265-271
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• 2005

A rapid, selective and sensitive reversed-phase HPLC method for the determination of etodolac in human serum was developed, validated, and applied to the pharmacokinetic study of etodolac. Etodolac and internal standard, ibuprofen were extracted from human serum by liquid-liquid extraction with hexane/isopropanol (95:5, v/v) and analyzed on a Luna C18(2) column with the mobile phase of 1% aqueous acetic acid-acetonitrile (4:6, v/v). Detection wavelength of 227 nm and flow rate of 1.0 mL/min were fixed for the study. The assay robustness for the changes of mobile phase pH, organic solvent content, and flow rate was confirmed by $3^3$ factorial design using a fixed etodolac concentration $(1\;{\mu}g/mL)$ with respect to its peak area and retention time. And also, the ruggedness of this method was investigated at three different laboratories using same quality control (QC) samples. This method showed linear response over the concentration range of $0.05-40\;{\mu}g/mL$ with correlation coefficients greater than 0.999. The lower limit of quantification using 0.5 mL of serum was 0.05 ${\mu}g/mL$, which was sensitive enough for pharmacokinetic studies. The overall accuracy of the quality control samples ranged from 92.00 to 110.00% for etodolac with overall precision (% C.V.) being 1.08-10.11%. The percent recovery for human serum was in the range of 76.73-115.30%. Stability studies showed that etodolac was stable during storage, or during the assay procedure in human serum. The peak area and retention time of etodolac were not significantly affected by the changes of mobile phase pH, organic solvent content, and flow rate under the conditions studied. This method showed good ruggedness (within 15% C.V.) and was successfully used for the analysis of etodolac in human serum samples for the pharmacokinetic studies of orally administered Lodin XL tablet (400 mg as etodolac) at three different laboratories, demonstrating the suitability of the method.

• Journal of Pharmaceutical Investigation
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• v.35 no.6
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• pp.423-429
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• 2005

A selective and sensitive reversed-phase HPLC method for the determination of fenoprofen in human serum was developed, validated, and applied to the pharmacokinetic study of fenoprofen calcium. Fenoprofen and internal standard, ketoprofen, were extracted from human serum by liquid-liquid extraction with diethyl ether and analyzed on a Luna C18(2) column with the mobile phase of acetonitrile-3 mM potassium dihydrogen phosphate (32:68, v/v, adjusted to pH 6.6 with phosphoric acid). Detection wavelength of 272 nm and flow rate of 0.25 mL/min were fixed for the study. The assay robustness for the changes of mobile phase pH, organic solvent content, and flow rate was confirmed by $3^{3}$ factorial design using a fixed fenoprofen concentration $(2\;{\mu}g/mL)$ with respect to its peak area and retention time. And also, the ruggedness of this method was investigated at three different laboratories using same quality control (QC) samples. This method showed linear response over the concentration range of $0.05-100\;{\mu}g/mL$ with correlation coefficients greater than 0.999. The lower limit of quantification using 1 mL of serum was $0.05\;{\mu}g/mL$, which was sensitive enough for pharmacokinetic studies. The overall accuracy of the quality control samples ranged from 92.27 to 109.20% for fenoprofen with overall precision (% C.V.) being 5.51-11.71 %. The relative mean recovery of fenoprofen for human serum was 81.7%. Stability (freeze-thaw, short and long-term) studies showed that fenoprofen was not stable during storage. But, extracted serum sample and stock solution were allowed to stand at ambient temperature for 12 hr prior to injection without affecting the quantification. The peak area and retention time of fenoprofen were not significantly affected by the changes of mobile phase pH, organic solvent content, and flow rate under the conditions studied. This method showed good ruggedness (within 15% C.V.) and was successfully used for the analysis of fenoprofen in human serum samples for the pharmacokinetic studies of orally administered Fenopron tablet (600 mg as fenoprofen) at three different laboratories, demonstrating the suitability of the method.