• Korean Journal of Psychosomatic Medicine
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• v.5 no.2
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• pp.195-204
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• 1997

Objectives : The behavioral and physiological effects following low doses and high doses of melatonin have not been fully explored. In this study the authors investigated the nature and extent of the hypnotic effects, oral temperature, blood pressure effects, performance effects and subjective feelings following the acute administration of low pharmacological oral doses of melatonin at mid-day. Methods : Thirty-five healthy young medical students were randomly assigned to receive 6mg of oral melatonin(N=11), 12mg of oral melatonin(N=12) or a placebo(N=12) in a double-blind, placebo controlled trial. Measures of the behavioral and physiological effects used in the study were Stanford Sleepiness Scale, Digit Symbol Substitution Test, Trail test and visual analogue scale for subjective feelings. Oral temperature and blood pressure were measured. The subjects were studied between 10:00 and 16:00 hours. Data were analyzed by using repeated-measures analyses of variance(ANOVA). Results: Melatonin produced statistically significant effects on oral temperature, but there were no significant effects on time and the $dose{\times}time$ interaction. There was a significant difference on oral temperature between the 12mg oral melatonin group and the placebo group at 12:00 and 16:00 hours, but no significant difference between the 12mg and the 6mg oral melatonin groups. Melatonin produced a dose-related increase in subjective sleepiness and had significant effects on time, the $dose{\times}time$ interaction. There was a significant difference on subjective sleepiness among the placebo, 6mg, 12mg oral melatonin groups at 13:00-16:00 hours. Melatonin did not produce statistically significant dose-related effects on subjective fatigue but produced significant effects on time and the $dose{\times}time$ interaction. There was a significant difference on subjective fatigue between the 12mg, the 6mg oral melatonin groups and the placebo group at 13:00 hour. Conclusions : These data indicated that acute administration of melatonin at mid-day increased subjective sleepiness and fatigue but decreased oral temperatures. These effects were shown especially in 12mg oral melatonin group.

• Nutrition Research and Practice
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• v.5 no.1
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• pp.28-33
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• 2011

Limited information from human studies indicates that dietary quercetin supplementation influences blood lipid profiles, glycemic response, and inflammatory status, collectively termed cardiometabolic risks. We tested the hypothesis that quercetin-rich supplementation, derived from onion peel extract, improves cardiometabolic risk components in healthy male smokers in a randomized, double blinded, placebo-controlled parallel design. Randomly assigned subjects were instructed to take either the placebo (n=43) or 100 mg quercetin capsules each day (n=49) for 10 weeks. Anthropometric parameters and blood pressure were measured, and blood lipids, glucose, interleukin-6, and soluble vascular cell adhesion molecule-1 (sVCAM-1) were determined at baseline and after 10 weeks of quercetin supplementation. Quercetin-rich supplementation significantly reduced serum concentrations of total cholesterol (P<0.05) and LDL-cholesterol (P<0.01), whereas these effects were not shown in the placebo group. Furthermore, significant increases were observed in serum concentrations of HDL-cholesterol both in the placebo (P<0.005) and quercetin-rich supplementation group (P<0.001); however, changes in HDL-cholesterol were significantly greater in subjects receiving quercetin-rich supplementation than the placebo. Both systolic (P<0.05) and diastolic blood pressure (P<0.01) decreased significantly in the quercetin-rich supplementation group. Glucose concentrations decreased significantly after 10 weeks of quercetin-rich supplementation (P<0.05). In contrast, no effects of quercetin-rich supplementation were observed for the inflammatory markers-IL-6 and sVCAM-1. Daily quercetin-rich supplementation from onion peel extract improved blood lipid profiles, glucose, and blood pressure, suggesting a beneficial role for quercetin as a preventive measure against cardiovascular risk.

• The Korean Journal of Physiology and Pharmacology
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• v.13 no.1
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• pp.33-37
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• 2009

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.

• Safety and Health at Work
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• v.6 no.3
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• pp.256-262
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• 2015

Background: Heart attack is the most common cause of line-of-duty death in the fire service. Daily aspirin therapy is a preventative measure used to reduce the morbidity of heart attacks but may decrease the ability to dissipate heat by reducing skin blood flow. Methods: In this double-blind, placebo-controlled, crossover study, firefighters were randomized to receive 14 days of therapy (81-mg aspirin or placebo) before performing treadmill exercise in thermal-protective clothing in a hot room [$38.8{\pm}2.1^{\circ}C$, $24.9{\pm}9.1%$ relative humidity (RH)]. Three weeks without therapy was provided before crossing to the other arm. Firefighters completed a baseline skin blood-flow assessment via laser Doppler flowmetry; skin was heated to $44^{\circ}C$ to achieve maximal cutaneous vasodilation. Skin blood flow was measured before and after exercise in a hot room, and at 0 minutes, 10 minutes, 20 minutes, and 30 minutes of recovery under temperature conditions ($25.3{\pm}1.2^{\circ}C$, $40.3{\pm}13.7%\;RH$). Platelet clotting time was assessed before drug administration, and before and after exercise. Results: Fifteen firefighters completed the study. Aspirin increased clotting time before and after exercise compared with placebo (p = 0.003). There were no differences in absolute skin blood flow between groups (p = 0.35). Following exercise, cutaneous vascular conductance (CVC) was $85{\pm}42%$ of maximum in the aspirin and $76{\pm}37%$ in the placebo groups. The percentage of maximal CVC did not differ by treatment before or after recovery. Neither maximal core body temperature nor heart rate responses to exercise differed between trials. Conclusion: There were no differences in skin blood flow during uncompensable heat stress following exercise after aspirin or placebo therapy.

• Journal of Periodontal and Implant Science
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• v.27 no.4
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• pp.701-722
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• 1997

It was reported that low dose doxycycline(LDD) regimen could inhibit pathologically elevated collagenase activity in the gingival crevicular fluid of petients with adult periodontitis without producing typical antibiotic side effects. The purpose of this study was to evaluate the effects of LDD regimen(20mg) administered during non-surgical therapy on clinical index and gingival crevicular fluid enzyme activity in diabetics who are at high risk for periodontal disease. Forty-nine subjects having at least two sites with probing pocket depths greater than 4mm were selected. In this double-blind, placebo-controlled study, the patients were administered 20 mg doxycycline capsule or placebo capsule b.i.d. for 2 weeks. Clinical parameters of dental plaque, gingival inflammation, probing pocket depth and probing attachment level were assessed at week 0, 2, 4, and 8. Gingival crevicular fluid samples were collected at the same time to evaluate the activities of collagenase and elastase. Clinical parameters and elastase activity were significantly reduced in all groups compared to the baseline value after treatment. Significantly greater reduction in pocket depth and gain in attachment level was shown in the LDD-administered group compared to placebo group in both adult periodontitis and diabetic patients. Total collagenase activity was also reduced significantly in all groups after treatment, but the greater reduction was seen in the LDD-administered diabetics group compared to relevant placebo group(at 4, 8week). Significantly greater reduction in active collagenase activity was also seen in the LDD-administered group compared to placebo group in diabetic patients(at 2, 4, 8week). These results indicated that use of low dose doxycycline could be aueseful adjunct to instrumentation therapy in the management of diabetic patient with periodontitis as well as adult periodontitis patient.

• Journal of Dental Anesthesia and Pain Medicine
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• v.20 no.6
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• pp.337-356
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• 2020

This systematic review focused on the efficacy of topical products in reducing temporomandibular joint disorder (TMD)-associated pain, in comparison to placebo or control interventions. The EMBASE, Web of Science, Cochrane Library, and MEDLINE via PubMed databases were searched for randomized controlled trials (RCTs) using topical interventions in adults diagnosed with TMD. The pain intensity was the primary outcome, and other clinical findings were the secondary outcomes. The risk of bias was evaluated according to the Cochrane's handbook. The search up to February 7, 2020 identified a total of 496 unduplicated references. Nine RCTs with 355 adult patients diagnosed with TMD were included. The meta-analysis did not show a significant reduction in baseline pain intensity in the nonsteroidal anti-inflammatory drug (NSAIDs) group, when compared to the placebo group (P = 0.288). One study demonstrated a statistically significant pain score decrease for Theraflex-TMJ compared to placebo after 10 d of treatment (P = 0.003) and follow-up, 5 d after the last application (P = 0.027). Ping On reduced pain at 4 weeks of application (P < 0.001) but not after 7 d of application (P = 0.136). In one study, cannabidiol (CBD) significantly improved the pain intensity compared to placebo (P < 0.001). However, no differences were found with capsaicin in the two studies (P = 0.465). Evidence was of low quality because the studies were considered as having an unclear or a high risk of bias and a small number of studies were analyzed. The evidence is not sufficient to support the use of topical NSAIDs and capsaicin, and limited evidence was found for Threraflex-TMJ, bee venom, Ping On, and CBD, with only one study reporting for each. Additional studies are recommended to validate these results.

• Journal of Dental Anesthesia and Pain Medicine
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• v.21 no.6
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• pp.479-506
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• 2021

Background: Chronic neuropathic pain (NP) presents therapeutic challenges. Interest in the use of cannabis-based medications has outpaced the knowledge of its efficacy and safety in treating NP. The objective of this review was to evaluate the effectiveness of cannabis-based medications in individuals with chronic NP. Methods: Randomized placebo-controlled trials using tetrahydrocannabinol (THC), cannabidiol (CBD), cannabidivarin (CBDV), or synthetic cannabinoids for NP treatment were included. The MEDLINE, Cochrane Library, EMBASE, and Web of Science databases were examined. The primary outcome was the NP intensity. The risk of bias analysis was based on the Cochrane handbook. Results: The search of databases up to 2/1/2021 yielded 379 records with 17 RCTs included (861 patients with NP). Meta-analysis showed that there was a significant reduction in pain intensity for THC/CBD by -6.624 units (P < .001), THC by -8.681 units (P < .001), and dronabinol by -6.0 units (P = .008) compared to placebo on a 0-100 scale. CBD, CBDV, and CT-3 showed no significant differences. Patients taking THC/CBD were 1.756 times more likely to achieve a 30% reduction in pain (P = .008) and 1.422 times more likely to achieve a 50% reduction (P = .37) than placebo. Patients receiving THC had a 21% higher improvement in pain intensity (P = .005) and were 1.855 times more likely to achieve a 30% reduction in pain than placebo (P < .001). Conclusion: Although THC and THC/CBD interventions provided a significant improvement in pain intensity and were more likely to provide a 30% reduction in pain, the evidence was of moderate-to-low quality. Further research is needed for CBD, dronabinol, CT-3, and CBDV.

• Journal of The Korean Society of Integrative Medicine
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• v.11 no.3
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• pp.127-135
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• 2023

Purpose : This study was performed to evaluate the effects of magnetic therapy (MT) on pain threshold, blood flow, and balance in patients with knee osteoarthritis. Methods : A single-blind, randomized controlled trial (RCT) was conducted with 30 patient with knee osteoarthritis. They were randomly allocated 2 groups; magnetic therapy group (MTG; n=15) and placebo magnetic therapy group (PG; n=15). The MTG group received 30 minutes magnetic therapy and 20 minute conservative physical therapy (Hotpack, ICT), magnetic therapy was conducted in magnetic therapy device (OM-100, NUGA, Korea). In the placebo magnetic group received 30 minutes placebo magnetic therapy and 20 minute conservative physical therapy. Each group performed 50 minutes a day 3 times a week for 8 weeks. The primary outcome pressure pain threshold test, blood flow, balance ability were measured by a pressure threshold meter (Commander algometer, JTECH medical, USA), laser dofler image (Moor LDI2-IR, Moor instruments, USA), balance measurement system (BioRescue, Marseille, France). The measurement were performed before and after the 8 weeks intervention period. Results : Both groups demonstrated significant improvement of outcome in pain threshold, blood flow, and balance ability during intervention period. magnetic therapy group revealed significant differences in pain threshold, blood flow, and balance as compared to the placebo magnetic therapy group groups (p<.05). Our results showed that magnetic therapy was more effective than placebo therapy on pain threshold, blood flow, and balance in patients with knee osteoarthritis. Conclusion : Our findings indicate that magnetic therapy can improve pain threshold, blood flow, and Balance, highlight the benefits of magnetic therapy. This study will be able to be used as an intervention data for recovering pain threshold, blood flow, and balance in patients with knee osteoarthritis.

• The Journal of Korean Obstetrics and Gynecology
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• v.22 no.3
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• pp.223-235
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• 2009

Purpose: To evaluate thermal effect and medication compliance of red ginseng extract. Methods: Randomized, double-blind, placebo-controlled, cross-over clinical study was performed. Twenty four healthy, married women aged 30-45 years with FSFI score below 25 were randomly divided into two groups; red ginseng group(N=12) and placebo group(N=12). During the first 6-week period (Study1), each group was dosed with red ginseng or placebo twice a day. Before starting the second 6-week period(Study2), a crossover design was chosen with a 2-week break(Washout period). Interchanging two groups after Washout period, red ginseng and placebo were dosed to each group. The efficacy of thermal effect was measured with subjective warm sensation scale and lower abdomen temperature by Digital Infrared Thermographic imaging(DITI) before and after each 6-week period. A medication compliance was assessed after each 6-week period and the correlation medication compliance between Sasang Constitution and subjective warm sensation was analyzed. Results: Overall 23 participants completed the study. In subjective warm sensation scale, after taking placebo, all participants exhibited an improving trend, but there was no significant difference. In lower abdomen temperature by DITI, statistically significant objective thermal effect of red ginseng was also not shown. A medication compliance was higher in Yin constitution(Taeumin, Soeumin), and showed an upward trend with decreasing subjective warm sensation. But no statistically significant difference was exhibited. Conclusion: Statistically significant thermal effect of red ginseng was not shown in this study. We anticipate if a long-term clinical trial is practiced, significant thermal effect of red ginseng will be shown.

• Nutrition Research and Practice
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• v.10 no.3
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• pp.364-364
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• 2016