• 제목/요약/키워드: double blind method

검색결과 87건 처리시간 0.031초

The Effects of Combination of Functional Beverage(Garcinia Cambogia, L-Carnitine, and Soy Peptide) and Exercise on the Improvement of Body Fat

  • Kim, Kyung-Soo;Jung, Ju-Hae;Song, Chan-Hee;Sung, Bong-Ju
    • Biomolecules & Therapeutics
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    • 제11권2호
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    • pp.99-108
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    • 2003
  • Background: There is abundance of studies on the decrease in body fat through limited calorie intake or exercise; however, studies focusing simultaneously on functional foods and exercise are rare. This study was aimed to identify the effects of combination of a functional beverage and exercise on body composition and biochemical metabolic profiles. Method: Eighty-one healthy volunteers (69 females aged 19 to 50 years and 12 males aged 19 to 55 years), who maintained their body weight stable with 23 or higher in BMI (kg/$m^2$) and 25% or higher body fat for the last three months, were recruited in the study through written advertisement. All the subjects gave their informed consent, and the study was conducted in accordance with the Declaration of Helsinki. The study design was a randomized double-blind placebo-controlled parallel group design. All participants were given 12-week programed-exercise, which was performed 3 times a week. One bottle (100 ml) of test (Garcinia cambogia 300 mg, L-carnitine 20 mg, Soy peptide 1,000 mg) or placebo solution was given daily 30 min before each session of programed-exercise. BMI (body mass index), %fat, local fat amount (visceral and mid-thigh), waist circumference, skin fold thickness and some biochemical metabolic parameters like glucose, insulin and free fatty acids, etc in the blood were measured and compared before and after 12-week intervention within groups as well as between groups according to the protocol Results: Twenty six volunteers were dropped out and fifty five volunteers completed the study. At the end of 4, 8, and 12 weeks, approximately 1.98%, 3.00% and 3.50% losses of initial body weight were observed, respectively, in the test group (P<0.01), and 0.29, % ,0.74%, 1.60%, respectively, in the placebo group (P>0.05). BMI changed by 2.40%, 3.41% and 4.46%, respectively, in the test group, and 0.38%, 0.95% and 1.75%, respectively, in the placebo group, at each period of time. The reductions of body weight and BMI were significantly higher in the test group than in the placebo group at each period of time (P<0.05). Conclusions: It is thought that the combination of functional beverage, which contains mostly garcinia cambogia, L-carnitine, and soy peptide, and exercise have synergy effects on reducing body fat.

(-)-Hydroxycitrate를 이용한 비만 여성의 체중 조절 프로그램 실시 및 효과 평가에 관한 연구(I) (The Effect of (-)-Hydroxycitrate on Weight Control Program in Obese Women -I : Effect on Anthropometric Parameters-)

  • 문수재
    • Journal of Nutrition and Health
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    • 제30권2호
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    • pp.155-169
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    • 1997
  • This study investigated the effect of weight control by using the commercial appetite suppressant ((-)-hydroxycitric acid(HCA) formula) and nutrition education on 72 obese women over a period of 8 weeks. During the study it conducted nutritional education for women to control their weight, thus analyzed their changes in anthropometric variables. All obese women were randomized in a double-blind method to consume either HCA(HCA group : experimental group) or placebo(placebo group : control group). Two groups were also divided randomly into 2 groups combined with commercial formula diet in 1 meal a day(HD group and PD group : HCA + gormula diet and placebo + formula diet) or not(HO group and conducted with 4 groups(HD, HO, PD, and PO group). All subjects were assigned to consume 800-1500kcal/d balanced diet which is 500kcal less than their usual energy requirement. To evaluate the effect of the weight control program, weight, percent of body fat, waist and hip circumferences, and 5 skinfold thickness were measured up to 5 times in all obese women. The mean weight of the subjects at the onset of the study was 76.5$\pm$10.6kg. The mean body mass index(BMI) wa 30.1$\pm$3.8 and it was in the upper 5 percentile of mean BMI of Korean women. At the end of the program, mean weight loss was 3.5kg after 2 weeks(p<0.001), and 5.8kg after 4 weeks(p<0.001). The waist, hip ratio(WHR) and skinfold thickness measurements of biceps, triceps, subscapular, suprailiac and abdominum showed significant reduction over the entire study period(p<0.05). These outcome were evaluated by effect of nutritional education and counselling. The reduction of % of body fat was significantly different among the 4 groups. Women who administrated HCA demonstrated more change in weight, BMI than the placebo group. There was also significant reduction in body composition (% of body fat, WHR, and skinfold thickness) than the other groups. The HD group which was administrated HCA combined with formula diet was more decreased than other groups. It showed that this program using commercial HCA and formula diet induced not only a change in weight but also a change in body composition. The outcome of this study suggests that HCA has a more effctive change on weight control which is carried out with nutritional education and counselling.

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산삼 약침이 정상인의 심박변이도(HRV)에 미치는 영향 (The Effects of distilled Wild Ginseng Herbal Acupuncture on the Heart Rate Variability(HRV))

  • 노정두;김락형;송범용;육태한
    • 대한약침학회지
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    • 제11권1호
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    • pp.55-69
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    • 2008
  • Objective : We investigated the effects of distilled Wild Ginseng Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Wild Ginseng Herbal Acupuncture on the balance of the autonomic nervous system. Method : We investigated the effects of distilled Wild Ginseng Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Wild Ginseng Herbal Acupuncture on the balance of the autonomic nervous system. 1 healthy volunteers consisted of 31 subjects in experiment(distilled Wild Ginseng Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 31 subjects in experiment group were injected distilled Wild Ginseng Herbal Acupuncture at $GB_{21}$(Kyonjong) and 30 subjects in control group were injected Normal Saline at $GB_{21}$(Kyonjong). except of 2 subjects(in control group) who can't be measured and 11 subjects(7 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 24 subject in experiment group and 24 subject in control group are studied. We measured HRV by PolyG-I on 7 times : before and after injection per 5 minutes during 30 minutes. The SPSS 10.0 for windows was used to analyze the data and the paired t-test(in group) and Student t-test(between two groups) were used to verify the result. Result : 1. After distilled Wild Ginseng Herbal Acupuncture injection, Mean HRV is significantly low only for first 5 minute, SDNN is significantly high after 5 minute, Complexity is significantly low after 5 minute, HRV index is significantly high after 10 minute and pNN50 is significantly low after 5 minute. 2. SDNN of distilled Wild Ginseng Herbal Acupuncture Group significantly increased from 20minute to 25minute, and pNN50 of distilled Wild Ginseng Herbal Acupuncture Group significantly decreased from 10minute to 15minute and 20 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Wild Ginseng Herbal Acupuncture injection, Ln(TP), Ln(VLF) and Ln(LF) are significantly high after 5 minute, normalized LF is significantly high after 5 minute and normalized HF is significantly low after 5 minute. 4. Ln(TP) and Ln(VLF) of distilled Wild Ginseng Herbal Acupuncture Group significantly increased from 20minute to 25 minute compared with those of Normal Saline group. Conclusion : The results suggest that distilled Wild Ginseng Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system and sympathetic nervous system compared to Normal Saline within normal range.

아토피 피부염 외용제에 관련된 국내 임상 및 실험 논문 고찰 (Review of Clinical and Experimental Studies on External Application Treatment for Atopic Dermatitis in the Korean Literature)

  • 민들레;박은정;강경하
    • 대한한방소아과학회지
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    • 제27권1호
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    • pp.36-49
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    • 2013
  • Objectives The goal of this review is to investigate clinical and experimental studies on external application treatment for atopic dermatitis in Korean literature and to propose for the better method of clinical studies in order to seek more effective treatment. Methods Electronic researches were performed with KTKP, OASIS, National Assembly Library, Korean Medicine Database, KISS, DBpia, and KISTI. Results and Conclusions In Twenty six studies, the numbers of clinical and experimental studies are respectively 10 (38.46%) and 16 (61.54%). The numbers of studies that used herbal complex were 20 (76.92%), and out of that, 6 studies had used a single herbal medicine (23.08%). The external application with oriental medicine for the atopic dermatitis used with Phellodendri Cortex (7), Sophorae Radix (6), Scutellariae Radix (6), Lonicerae Flos (5), Coptidis Rhizoma (5) and so on. Among the clinical studies, the 5 studies were double-blind and randomized-controlled study (50%). The numbers of studies that used Hanifin and Rajka Diagnostic Criteria (1980) were 6 (60%), and that used the Diagnostic Criteria in Korean Atopic Dermatitis (2005) were 4 (40%). Among the clinical studies, categories to evaluate of atopic dermatitis are respectively SCORAD Index (80%), Total IgE (80%), Eosinophil count (70%) and so on. All of the clinical studies (100%) showed a statistically significant decline in atopic dermatitis according to the SCORAD Index, Modified SCORAD Index, the Clinic index score. Among the experimental studies, the numbers of studies that used NC/Nga mice were 9 (56.25%), and out of that 5 studies used BALB/c mice (31.25%). Most of the studies (68.75%) used DNCB as allergy inducing materials. The scales for evaluation of atopic dermatitis were Clinical skin severity score, Histopathologic examination, Immunohematologic examination, safety test and so on. In 12 cases (75%) of experimental studies, the IgE level of experimental group showed a statistically significant decline after using external application. In 8 study cases (50%), Clinical skin severity score of experimental group showed a statistically significant decline after using external application.

The Effect of CYP2D6/3A5 Genotypes on Plasma Concentrations of Haloperidol after Adjunctive Treatment of Aripiprazole

  • Shim, Joo-Cheol;Ahn, Jung-Mi;Jung, Do-Un;Kong, Bo-Geum;Kang, Jae-Wook;Liu, Kwang-Hyeon;Shin, Jae-Gook
    • 생물정신의학
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    • 제18권2호
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    • pp.95-100
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    • 2011
  • Objectives To evaluate the drug interactions between aripiprazole and haloperidol, authors investigated plasma concentrations of those drugs by genotypes. Method Fifty six patients with a confirmed Diagnostic and Statistical Manual of Mental Disorders 4th edition diagnosis of schizophrenia were enrolled in this eight-week, double blind, placebo-controlled study. Twenty-eight patients received adjunctive aripiprazole treatment and twenty-eight patients received placebo while being maintained on haloperidol treatment. Aripiprazole was dosed at 15 mg/day for the first 4 weeks, and then 30 mg for the next 4 weeks. The haloperidol dose remained fixed throughout the study. Plasma concentrations of haloperidol and aripiprazole were measured by high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) at baseline, week 1, 2, 4 and 8. $^*1$, $^*5$, and $^*10$ B alleles of CYP2D6 and $^*1$ and $^*3$ alleles of CYP3A5 were determined. The Student's T-test, Pearson's Chi-square test, Wilcoxon Rank Sum test and Logistic Regression analysis were used for data analysis. All tests were two-tailed and significance was defined as an alpha < 0.05. Results In the frequency of CYP2D6 genotype, $^*1/^*10$ B type was most frequent (36.5%) and $^*1/^*1$ (30.8%), $^*10B/^*10B$ (17.3%) types followed. In the frequency of CYP3A5 genotype, $^*3/^*3$ type was found in 63.5% of subjects, and $^*1/^*3$ type and $^*1/^*1$ were 30.8% and 5.8% respectively. The plasma levels of haloperidol and its metabolites did not demonstrate significant time effects and time-group interactions after adjunctive treatment of aripiprazole. The genotypes of CYP2D6 and 3A5 did not affect the plasma concentration of haloperidol in this trial. No serious adverse event was found after adding aripiprazole to haloperidol. Conclusion No significant drug interaction was found between haloperidol and aripiprazole. Genotypes of CYP2D6 and 3A5 did not affect the concentration of haloperidol after adding aripiprazole.

알쏭이모자반 (Sargassum confusum) 주정추출물이 성인여성 체지방 감소에 미치는 영향 (The effect of Sargassum confusum on reduction of body fat in obese women)

  • 민기성;한 대석;권상오;여경목;김복남;이선영
    • Journal of Nutrition and Health
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    • 제47권1호
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    • pp.23-32
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    • 2014
  • 해조류인 알쏭이 모자반 추출물의 섭취로 인한 체지방 감소 효능을 평가하고자 이중맹검법을 사용하여 BMI 23 이상의 과체중 혹은 비만 성인 여성에게 8주간 알쏭이 모자반 추출물을 섭취하게 한 후 체격지수, 혈액 분석, 식사섭취상황 등을 조사하였다. 최종 대조군은 14명, 실험군은 16명이었으며 1일3회 각 4개의 캡슐을 섭취시켰다. 인체시험 결과 시험전후 비교시 대조군에 비하여 시험군의 체지방률과 체지방량, 허리둘레가 지속적으로 유의하게 감소하였으며 혈청 트리글리세롤과 렙틴농도가 더욱 유의하게 감소하였고 변배설량은 유의하게 증가하여 지방 배설효과를 기대할 수 있었다. 시험기간 동안 7명의 피험자가 심각하지 않은 부작용으로 시험에서 탈락하였으나 건강상 불편함을 호소하는 피험자 수의 두 군간의 차이는 보이지 않았다. 따라서 알쏭이 모자반 추출물은 8주간 섭취 시 심각한 부작용을 유발하지 않으면서 피험자의 허리둘레, 체지방율과 함께 혈청 렘틴 수치를 유의하게 감소시킬 수 있고 배변횟수를 유의하게 증가시켜 특히 복부비만을 해소할 수 있는 비교적 안전한 기능성 소재로 기대되므로 작용기전을 설명할 수 있는 심층 연구가 필요로 된다.

퇴행성 관절염 환자를 대상으로 새로운 진통제 평가를 위한 임상시험자료의 GEE 분석 (Analysis of Repeated Measured VAS in a Clinical Trial for Evaluating a New NSAID with GEE Method)

  • 임회정;김윤이;정영복;성상철;안진환;노권재;김정만;박병주
    • Journal of Preventive Medicine and Public Health
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    • 제37권4호
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    • pp.381-389
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    • 2004
  • Objective : To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. Methods : A randomized, double-blind, active comparator-controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent(or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. Results : While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT:aOR=1.37, 95% CI=(0.8200, 2.26), PP:aOR=1.47, 95% CI=(0.73, 2.95)). The goodness-of-fit statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. Conclusions : Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.

서양산 고추냉이 추출물이 함유된 세치제의 효능에 대한 임상적 실험연구 (A CONTROL OF PLAQUE, GINGIVITIS AND ANTI-CARIES EFFECT OF DENTIFRICE CONTAINING HORSERADISH EXTRACTS)

  • 서현우;박호원;김종수;이시영;신일식
    • 대한소아치과학회지
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    • 제39권1호
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    • pp.26-33
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    • 2012
  • 식물성 자연추출물 중 하나인 고추냉이 추출물을 배합한 세치제의 구강환경 개선 효과를 알아보기위해 총72명을 대상으로 교차실험 및 이중맹검법을 실시하여 치면세균막지수, 치은염지수 및 우식활성도검사 등을 비교 검토한 결과 다음과 같은 결론을 얻었다. 1. 치면세균막지수는 초기값에 비해 대조군은 28%, 고추냉이 추출물 배합세치군은 58%의 억제효과를 나타내었다. 2. 치은염지수는 초기값에 비해 대조군은 26%, 고추냉이 추출물 배합세치군은 40%의 억제효과를 나타내었다. 3. Dentocult-SM을 이용한 우식활성도 평가에서는 초기값에 비해 대조군은 4%, 고추냉이 추출물 배합세치군은 69%의 억제효과를 나타내어 고추냉이 추출물 배합세치군이 대조군에 비해 유의할만한 Streptococcus mutans 억제효과를 나타내었다. 이상의 결과들로 보아 고추냉이 추출물을 배합한 세치제는 치면세균막 억제와 치은염의 감소 그리고 우식활성도 억제에 중요한 역할을 하여 구강환경 개선에 뛰어난 효과를 보이는 것으로 사료된다.

칠제향부환(七製香附丸)이 원발성(原發性) 월경통(月經痛) 환자(患者)의 복부(腹部) 및 수장부(手掌部) 온도(手掌部 溫度)에 미치는 영향(影響) (The effect of Chiljehyangbuhwan on the abdomial & palmar temperature in the primary dysmenorrhea patients)

  • 이창훈;조정훈;장준복;이경섭;윤영진
    • 대한한방체열의학회지
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    • 제5권1호
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    • pp.46-58
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    • 2006
  • Purpose: We intended to observe the relations between Chiljehyangbuhwan and abdominal & palmar temperature according to primary dysmenorrhea severity. Methods: We selected the 100 primary dysmenorrhea patients by the screening tests (first screening test-inquiry, second screening test-clinical test. additionally WHR (Waist-to-Hip ratio) by Inbody 2.0). By the fixed blocked randomization and double blind method, Chiljehyangbuhwan or placebo was administered for 1 menstration period. Finally, 69 patients remainded. Before and after administration, we measured 4 points abdominal temperature (Chon-jung (CV17), Chung-wan(CV12), Kwan-won(CV4). Chung-guk(CV3)) by DITI(DOREX Inc., USA). And then we checked the difference of temperature $({\Delta}T)$ between CV17 and CV12/CV17 and CV4/CV17 and CV3/CV12 and CV4/CV12 and CV3. Also, we measured 2 points (palmar region, upper front of forearm) for the difference of palmar temperature $({\Delta}T)$. Then, we checked palmar temperature minus upper front of forearm temperature and took an average of right and left ${\Delta}T.$ After that. we compared ${\Delta}T$ with primary dysmenorrhea severity evaluated by VRS (verbal rating scale) and MVRS (multidimensional verbal rating scale). In dysmenorrhea severity. we standardized scale score and 3-group-severity by score (mild, moderate. severe). Besides, we compared palmar ${\Delta}T$ with abdominal ${\Delta}T$. For statistics, we used ANOVA and Spearman's rho correlations. SPSS 13.0 for windows. Results: In case of MVRS, though Chiljehyangbuhwan was correlated to abdominal ${\Delta}T$(CV12 and CV3/CV12 and CV4). it was not correlated to palmar ${\Delta}T$. In case of VRS, though Chiljehyangbuhwan was not correlated to abdominal ${\Delta}T$. it was correlated to palmar ${\Delta}T$. However. palmar ${\Delta}T$ was not correlated to abdominal ${\Delta}T$. Statistically they showed significant result (p<0.05). Conclusion: The primary dysmenorrhea patients showed that severity by MVRS was connected with abdominal ${\Delta}T$ (CV12 and CV3/CV12 and CV4) and severity by VRS was connected with palmar ${\Delta}T$ after Chiljehyangbuhwan administration. So we can consider Chiljehyangbuhwan partially effects the abdominal & palmar temperature according primary dysmenorrhea severity. However, palmar temperature was not correlated to abdominal temperature. Therefore, we need further study.

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선행적 진통 요법의 효과성에 대한 연구 -발치 전과 후 진통 요법의 효과 비교- (A Study on Efficacy of Preemptive Analgesia - A Comparison on Efficacy of Preoperative and Postoperative Analgesic Administration -)

  • 정영수;김문기;박형식;이의웅;강정완
    • 대한치과마취과학회지
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    • 제3권1호
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    • pp.10-18
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    • 2003
  • Background: Studies on the pain have been dealing with many different ways for last several centuries. Especially, preemptive analgesia is being used as a method to control the postoperative pain. Many studies on its efficacy have been processed in different ways about various drugs, administration methods and times for various operations. And the value of preemptive analgesia are still controversial regarding the results of other clinical studies. The authors performed a clinical study on efficacy of preemptive analgesia using an non-steroidal anti-inflammatory drug (NSAID) for the surgical extraction of impacted third molar teeth and present the more effective pain treatment after oral surgery with literature review. Methods: Using a randomized double blind test design, this study compared the analgesic efficacies of an NSAID, Talniflumate 370 mg. This drug administrated first either 1 hour preoperatively (experimental group) or when the pain developed moderately to severely over 5 scale of verbal rating scales (0-10) to respective 30 patients undergoing the removal of impacted third molars. Pain intensity and the time from the end of surgery were assessed postoperatively whenever the patients demanded additional drug over 5 scale for forty eight hours using same verbal rating scales. Results: The sex distribution, the age of the patients. and the time required for surgery in two groups were similar. The average first time for demanding additional drug after surgery was 163.9 minutes in experimental group and 191.5 minutes in control group. At this time, the average pain intensity was 5.8 in experimental group and 6.1 in control group. And the average second time for demanding additional drug was 365.5 minutes in experimental group and 351.8 minutes in control group. At this time. the average pain intensities were 6.6 in experimental group and 6.2 in control group. No statistically significant difference was found between the average first times and second times, and the average pain intensities at first and second times in two groups. Conclusions: From these results the efficacy of preemptive analgesia used in this study was not appeared. This clinical study indicates that many NSAIDs administrated preoperatively in present practices have weak efficacy of preemptive analgesia for postoperative pain, thus the authors recommend that only postoperative analgesics are adequate without preoperative use of analgesics.

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