• Journal of Dental Anesthesia and Pain Medicine
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• v.23 no.3
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• pp.163-171
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• 2023

Background: Surgical extraction of impacted mandibular third molars is the most common procedure performed by oral surgeons. The procedure cannot be performed effectively without achieving profound anesthesia. During this procedure, patients may feel pain during surgical bone removal (at the cancellous level) or during splitting and luxation of the tooth, despite administration of routine nerve blocks. Administration of intraosseous (IO) lignocaine injections during third molar surgeries to provide effective anesthesia for pain alleviation has been documented. However, whether the anesthetic effect of lignocaine is the only reason for pain alleviation when administered intraosseously remains unclear. This conundrum motivated us to assess the efficacy of IO normal saline versus lignocaine injections during surgical removal of impacted mandibular third molars. The aim of this study was to assess the efficacy of IO normal saline as a viable alternative or adjunct to lignocaine for alleviation of intraoperative pain during surgical removal of impacted mandibular third molars. Methods: This randomized, double-blind, interventional study included 160 patients who underwent surgical extraction of impacted mandibular third molars and experienced pain during surgical removal of the buccal bone or sectioning and luxation of the tooth. The participants were divided into two groups: the study group, which included patients who would receive IO saline injections, and the control group, which included patients who would receive IO lignocaine injections. Patients were asked to complete a visual analog pain scale (VAPS) at baseline and after receiving the IO injections. Results: Of the 160 patients included in this study, 80 received IO lignocaine (control group), whereas 80 received IO saline (study group) following randomization. The baseline VAPS score of the patients and controls was 5.71 ± 1.33 and 5.68 ± 1.21, respectively. The difference between the baseline VAPS scores of the two groups was not statistically significant (P > 0.05). The difference between the numbers of patients who experienced pain relief following administration of IO lignocaine (n=74) versus saline (n=69) was not statistically significant (P > 0.05). The difference between VAPS scores measured after IO injection in both groups was not statistically significant (P >0.05) (1.05 ± 1.20 for the control group vs. 1.72 ± 1.56 for the study group) Conclusion: The study demonstrates that IO injection of normal saline is as effective as lignocaine in alleviating pain during surgical removal of impacted mandibular third molars and can be used as an effective adjunct to conventional lignocaine injection.

• Journal of Korean Medicine for Obesity Research
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• v.24 no.1
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• pp.87-93
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• 2024

Objectives: Obesity is a globally prevalent public health issue. Hence, there is a need for the development of safer and more effective anti-obesity drugs. Lythrum salicaria, a traditional medicinal herb used for centuries, has been reported to improve lipid metabolism and fat accumulation. It also has a low toxicity profile. Therefore, its potential as a functional ingredient in health functional foods needs to be evaluated. Methods: In this randomized, double-blind, placebo-controlled clinical trial, 90 participants will be randomly assigned to either the experimental or control group. Each subject will orally receive L. salicaria extract (1,350 mg/day) (500 mg L. salicaria+850 mg lactose as vehicle) or lactose (1,350 mg/day) as a hard capsule formula for 84 days (12 weeks). The primary outcome will be body fat mass (kg), which will be assessed using dual-energy x-ray absorptiometry (DXA) (performed only at visits 2 and 4). Secondary outcomes include body mass index, body weight, waist-to-hip ratio, body fat percentage (%) measured using DXA, lean body mass (kg) measured using DXA (assessed only at visits 2 and 4), lipids (total cholesterol, triglyceride, high-density lipoprotein cholesterol, and calculated low-density lipoprotein cholesterol), free fatty acid, high sensitivity C-reactive protein, adiponectin, and leptin. Conclusions: This protocol will be implemented after approval of Institutional Review Board of Pusan National University Korean Medicine Hospital (approval number: PNUKHIRB-2022-08-002) and registration with the Korean National Clinical Research Information Service (CRIS) (CRIS-KCT0008060). The results of this trial will provide potential of L. salicaria as a new anti-obesity functional food with fat-reducing effects and low toxicity.

• Korean Journal of Biological Psychiatry
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• v.3 no.2
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• pp.277-287
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• 1996

Objective : It has been proposed that cognition and related aspects of mental functioning are decreased in depression as well as in alcoholism. The objective of the study was to compare behavioral side effects of paroxetine and amitriptyline in depressed patients accompanied by alcoholism. The focused comparisons were drug effects concerning psychomotor performance, cognitive function, sleep and daytime sleepiness during the first 2 weeks of treatment. Methods : After an alcohol detoxification period(3 weeks) and a washout period(1 week), a total of 20 male inpatients with alcohol use disorder (DSM-IV), who also had a major depressive episode(DSM-IV), were treated double-blind with paroxetine 20mg/day(n=10) or amitriptyline 25mg/day(n=10) for 2 weeks. All patients were required to have a scare of at least 18 respectively on bath the Hamilton Rating Scale far Depression(HAM-D) and Beck Depression Inventory(BDI) at pre-drug baseline. Patients randomized to paroxetine received active medication in the morning and placebo in the evening whereas those randomized to amitriptyline received active medication in the evening and placebo in the morning. All patients performed the various tasks in a test battery at baseline and at days 3, 7 and 14. The test battery included : critical flicker fusion threshold for sensory information processing capacity : choice reaction time for gross psychomotor performance : tracking accuracy and latency of response to peripheral stimulus as a measure of line sensorimotor co-ordination and divided attention : digit symbol substitution as a measure of sustained attention and concentration. To rate perceived sleep and daytime sleepiness, 10cm line Visual analogue scales were employed at baseline and at days 3, 7 and 14. The subjective rating scales were adapted far this study from Leeds sleep Evaluation Questionnaire and Epworth Sleepiness Scale. In addition a comprehensive side effect assessment, using the UKU side effect rating scale, was carried out at baseline and at days 7 and 14. The efficacy of treatment was evaluated using HAM-D, BDI and clinical global impression far severity and improvement at days 7 and 14. Results : The pattern of results indicated thai paroxetine improved performance an mast of the lest variables and also improved sleep with no effect on daytime sleepiness aver the study period. In contrast, amitriptyline produced disruption of performance on same tests and improved sleep with increased daytime sleepiness in particular at day 3. On the UKU side effect rating scale, mare side effects were registered an amitriptyline. The therapeutic efficacy was observed in favor of paroxetine early in day 7. Conclusion : These results demonstrated thai paroxetine in much better than amitriptyline for the treatment of depressed patients accompained by alcoholism at least in terms of behavioral safety and tolerability, furthermore the results may assist in explaining the therapeutic outcome of paroxetine. For example, and earlier onset of antidepressant action of paroxetine may be caused by early improved cognitive function or by contributing to good compliance with treatment.

• Journal of Nutrition and Health
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• v.42 no.5
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• pp.442-452
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• 2009

Smoking has been known to exacerbate the initiation and propagation of oxidative stresses. Efforts have been made to reduce the smoking-induced oxidative stresses using commercial dietary supplements. Propolis is the resinous substance collected by bees from the leaf buds and bark of trees, especially poplar and conifer trees. In this trial, we examined whether a daily supplementation of 800 mg propolis can protect endogenous lymphocytic DNA damage and modulate antioxidative enzyme activities and the level of antioxidant vitamin in smokers using a placebo-controlled, doubleblinded cross-over trial. After two weeks of running-in period, 29 smokers (mean age 34.38 ${\pm}$ 1.73) received 6 tablets/day of either propolis or placebo pills for 4 weeks. After 2 weeks of washout period the subjects switched they pills for cross-over study. The degree of DNA damage (assessed by tail DNA, tail length and tail moment) was not significantly changed with propolis intake or placebo intake. Similarly, total antioxidant status (TAS) remained at the same level regardless of the treatment. Erythrocyte catalase, glutathione peroxidase (GSH-Px), superoxide dismutase (SOD), plasma vitamin C and tocopherol level did not differ before and after propolis treatment, and did not differ between treatments. Putting all these results together, we would suggest that it is still too early to claim that propolis possess antioxidative activities.

• The Journal of the Korean Society for Microbiology
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• v.21 no.4
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• pp.503-513
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• 1986

Previous studies have developed the technique of topical application of tetracycline(TC) into the periodontal pockets and examined the change of clinical parameters and subgingival microbial morphotypes. The purpose of this study was to longitudinally examine the clinical and microbiological effects of topically applied TC in a double-blind and split-mouth design. Thirteen patients with moderate periodontitis, who were treated with or without TC application and scaling treatment, were examined. TC gel(3%) was used to apply into the selected periodontal pockets twice a week for 2 weeks. During the experiment, clinical parameters and subgingival microbial morphotypes were examined, and for isolation of black-pigmented Bacteroides(BPB) and streptococci, an anaerobic sample culturing was done at week 0, 2, and 7. In clinical observation the TC-scaled group exhibited a significant decrease of Gingival Inflammatory Index, Plaque Index, Sulcus Bleeding Index, pocket depth, and gingival crevicular fluid when compared to the TC-unsealed, placebo-scaled, and placebo-unsealed groups. The result of microbial morphotype observation showed a significant increase of coccal form and a decrease of spirochetes in the TC-scaled, TC-unscaled, and placebo-scaled groups. The culture study of streptococci revealed that TC with scaling treatment resulted in a significant increase of S. sanguis I at week 2, but its proportion had returned to the base line level. The anaerobic culture study showed that BPB was significantly reduced in the TC-scaled and TC-unsealed groups at week 7. Among BPB species, B. intermedius declined significantly with time treatment(week 2 and 7) in the TC-scaled and TC-unsealed groups. These results suggest that the settled pathogenic microflora can be succeeded by nonpathogenic microflora in periodontal pockets after TC treatment.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.5 no.1
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• pp.83-92
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• 1994

Paroxetine is a potent and selective serotoin re-uptake inhibitor. It is well known as an effective and safe antidepressant and increasingly used for neurotic or non-psychotic depression with anxiety symptoms. The present study assessed antidepressant and antianxiety efficacy and tolerability of paroxetine against placebo in child-adolescent and adult depressive neurosis patients. 232 subjects aged 8-55 years and meeting DSM-III-R criteria for depressive neurosis or dysthymia were divided into 8 subgroups according to their sex and age(8-11 yeard old, 12-17 years old, 18-35 years old and 36-55 years old subgroup in each male and female group). In each subgroup, the randomly assigned half of the patients were treated with paroxetine(10-30mg/day) and the others with placebo for the first 2 weeks in double blind fashion. After 1 week of drug-washout period, paroxetine and placebo groups were crossed over. The depression and anxiety symptoms were assessed with Hamilton Depression Scale(HDS) and Hamilton Anxiety Scale(HAS) at baseline and every 1 week during the trial periods. The levels of reduction in HDS and HAS scores from baseline after 2-week trial were compared between paroxetine- and placebo- treated periods by paired t-test. In all the 8 subgroups, statistically significant differences between paroxetine and placebo were found on the antidepressant efficacy after 2-week treatment. The antidepressant efficacy of paroxetine compared to placebo was most prominent in child and adolescent female groups. On anxiety symptoms, paroxetine was also significantly more effective than placebo. The antianxiety efficacy of paroxetine compared to placebo was most prominent in male and female child groups and young adult female group aged 18-35 years. As for the adverse effects of paroxetine, 3 out of 232 subjects reported mild indigestion and abdominal pain. however, in all the 3 cases, the symptoms improved without reduction of dosage or discontinuation of the drug. In conclusion, paroxetine showed significantly higher antidepressant and antianxiety efficacy compared to placebo in child-adolescent and adult depressive neurosis patients after 2-week treatment. Further trials of paroxetine in depressive neurosis are warranted to elucidate the long-term antidepressant and antianxiety efficacy of paroxetine.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.5 no.2
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• pp.174-180
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• 2002

Purpose: Ursodeoxycholic acid (UDCA) is known to decrease hepatic injury by promoting the biliary secretion of retained toxic endogenous bile acids in hepatobiliary diseases complicated by total parenteral nutrition (TPN). However, most studies have focused on treatment for complications after TPN. We investigated the preventive role of early administration of UDCA in TPN-induced hepatobiliary complications by a randomized, double-blind, placebo-controlled trial. Methods: Between May 2000 and May 2002, thirteen patients, who were given TPN more than 10 days in the hospital, were assigned randomly to two groups. One was the case group (7 patients) who were given UDCA simultaneously with TPN regimen, and the other, the control group (6 patients) who were given placebo. Their age ranged from 1 day to 13 years. They were affected with diseases impossible for enteral nutrition, such as prematurity, cerebral palsy, chronic diarrhea, anorexia nervosa, pancreatitis, and cyclic vomiting. The duration of TPN ranged from 10 to 70 days. Hematologic parameters including liver function test were measured at regular intervals, and the duration, composition, administration rate, total calorie of TPN were recorded. The serum levels of total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase were compared between groups after cessation of the study. Results: The autoregressive coefficient of the control group was 0.4419 (p=0.0651) in bilirubin, -0.0431 (p=0.7923) in AST, 0.2398 (p=0.2416) in ALT, and 0.2459 (p=0.1922) in alkaline phosphatase by mixed procedure model when the parameters were referred to the case group. Conclusion: The serum level of total bilirubin did not increase in comparison with that of the control group, but statistically insignificant, when both TPN and UDCA were administered simultaneously from the beginning.

• Proceedings of the Korean Society of Food Hygiene and Safety Conference
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• 2004.11a
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• pp.50-58
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• 2004

Valy-Tyrosine (VY) derived from alkaline pretense hydrolyzate of sardine muscles showed the in vitro Angiotensin I converting enzyme (ACE) inhibitory activity and the in vivo antihypertensive effect in SHR. We investigated the antihypertensive effect of the VY on mild hypertensive subjects including subjects with high-normal blood pressure using a randomized double-blind placebo-controlled study. (1) Nineteen subjects (Age 48.9${\pm}$4.3, M/F;18/1) took a 100ml drink either containing 125${\mu}$g of VY or placebo twice daily for 4 weeks. The reductions of the systolic (SBP) and diastolic blood pressure (DBP) were observed in mild hypertensive subjects (n=5) with averages of 17.8${\pm}$2.5 mmHg (p<0.01 vs placebo) and 11.0${\pm}$2.0 mmHg(p<0.05 vs placebo), respectively. Neither SBP nor DBP changed in the subjects of both the placebo group and the high-normal blood pressure group. (2) A randomized double-blind cross-over placebo-controlled study was carried out in 10 mild essential hypertensive subjects (Age 50.6${\pm}$4.6, M/F;10/0). They took a 100ml drink either containing 62.5${\mu}$g of VY or placebo twice daily for 4 weeks alternatively with a 6-week interval. The percent changes in SBP and DBP were -6.9 % and -5.8 % (p<0.05) one week after the VY drink administration, respectively. No adverse effects such as coughing or allergic phenomena could be observed in any of the subjects of drinking VY during the experimental period. These results suggest that the drink containing at least 125${\mu}$g/day of VY may have a significant antihypertensive effect on mild hypertensive subjects without any adverse effects.

• Proceedings of the Korean Society of Food Hygiene and Safety Conference
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• 2004.11a
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• pp.59-70
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• 2004

A randomized double-blind placebo-controlled study was conducted on 63 subjects to determine the antihypertensive effect of a vegetable drink in which sardine protein hydrolysates containing a dipeptide, Valyl-Tyrosine (VY), were incorporated. The subjects, consisting of people with mild hypertension, high-normal blood pressure and normal blood pressure, were randomly divided into test (male/female=25.6, average age 50.1${\pm}$10.4 years old) and control groups (26/6, 49.0${\pm}$5.0). Each subjects in the test group was given 195g of the vegetable drink containing 0.5g of sardine peptides (sardine protein hydrolysates) with 0.4 mg of VY (test drink) once a day for 13 weeks in a row, and subjects in the control group were given the same amount of the vegetable drink without sardine peptides (control drink) in the same manner. In the test group, 40 subjects with mild hypertension of high-normal blood pressure (130 mmHg${\leq}$systolic blood pressure (SBP)<160 mmHg and/or 80 mmHg${\leq}$diastolic blood the start of the test to 134.4${\pm}$11.1 mmHg during the first week of the test period, after which similar values were seen throughout the test period (13 weeks). Compared to the control group, the difference in SBP from vaseline was statistically significant in the test group throughout the intake period. DBP also decreased significantly from 88.0${\pm}$7.9 mmHg at baseline to 83.5${\pm}$8.6 mmHg after 13 weeks. In the control group, SBP and DBP were 140.8${\pm}$8.4 mmHg and 90.5${\pm}$6.6 mmHg respectively at the start of the test, and neither decreased during the test period. In subjects with normal blood pressure, neither those in the test group nor those in the control group showed a significant change in SBP and DBP during the test period. An excessive ingestion test was performed on 25 subjects with hypertension, mild hypertension, high-normal blood pressure, and normal blood pressure by giving 585g (3 times the recommended amount of intake) of the test drink for 14 days in a row. As a result, a significant decrease of blood pressure was observed in the hypertension, mild hypertension and high-normal blood pressure groups, but no excessive decline in blood pressure or any side-effects were associated with any subjects during the test period. In the groups with normal blood pressure, the excessive ingestion of the test drink did not affect blood pressure. In these two studies, physical check-ups and biochemical analyses of blood and urine were also conducted in all subjects, and no abnormalities were observed. These results suggest that the test drink containing sardine protein hydrolysates exhibited the antihypertensive effect in only the subjects with mild hypertension or high-normal blood pressure. No adverse effects were observed in either hypertensive of normotensive subjects.

• Tuberculosis and Respiratory Diseases
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• v.58 no.5
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• pp.498-506
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• 2005

Background : This study compared the bronchodilator efficacy and safety of tiotropium inhalation capsules ($18{\mu}g$ once daily) with a ipratropium metered dose inhaler (2 puffs of $20{\mu}g$ q.i.d.) in patients with chronic obstructive pulmonary disease (COPD). Method : After the initial screening assessment and a two-week run-in period, patients received either tiotropium $18{\mu}g$ once daily or ipratropium $40{\mu}g$ four times daily over a period of 4 weeks in a double blind, double dummy, parallel group study. The outcome measures were the lung function, the daily records of the peak expiratory flow rate (PEFR), the patients' questionnaire, and the use of concomitant salbutamol. The forced expiratory volume in one second ($FEV_1$) and the forced vital capacity (FVC) were measured 5 minutes before inhalation, and 0.5, 1, 2 and 3 hours after inhaling the study drug on days 0, 14 and 28. Result : In 16 centers, 134 patients with a mean (SD) age of 66 (7) years and a predicted $FEV_1$ of 42 (12)% were analyzed. The trough $FEV_1$ response was significantly higher in the tiotropium group than in the ipratropium group after a four-week treatment period. The weekly mean morning PEFR of the tiotropium group was consistently higher than that of the ipratropium group during the 4-week treatment period with differences ranging from 12.52 to 13.88 l/min, which were statistically significant. Tiotropium was well tolerated by the COPD patients during the 4-week treatment period and had a similar safety profile to ipratropium. Conclusion : This study shows that tiotropium administrated once daily has a superior bronchodilator effect with a similar safety profile in treating COPD patients compared with ipratropium, inhaled four times daily.