• Title/Summary/Keyword: randomized controlled double blind study

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Efficacy of ketamine in the treatment of migraines and other unspecified primary headache disorders compared to placebo and other interventions: a systematic review

  • Chah, Neysan;Jones, Mike;Milord, Steve;Al-Eryani, Kamal;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.5
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    • pp.413-429
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    • 2021
  • Background: Migraine headaches are the second leading cause of disability worldwide and are responsible for significant morbidity, reduction in the quality of life, and loss of productivity on a global scale. The purpose of this systematic review and meta-analysis was to evaluate the efficacy of ketamine on migraines and other primary headache disorders compared to placebo and other active interventions, such as midazolam, metoclopramide/diphenhydramine, and prochlorperazine/diphenhydramine. Methods: An electronic search of databases published up to February 2021, including Medline via PubMed, EMBASE, Web of Science, and Cochrane Library, a hand search of the bibliographies of the included studies, as well as literature and systematic reviews found through the search was conducted to identify randomized controlled trials (RCTs) investigating ketamine in the treatment of migraine/headache disorders compared to the placebo. The authors assessed the risk of bias according to the Cochrane Handbook guidelines. Results: The initial search strategy yielded 398 unduplicated references, which were independently assessed by three review authors. After evaluation, this number was reduced to five RCTs (two unclear risk of bias and three high risk of bias). The total number of patients in all the studies was 193. Due to the high risk of bias, small sample size, heterogeneity of the outcomes reported, and heterogeneity of the comparison groups, the quality of the evidence was very low. One RCT reported that intranasal ketamine was superior to intranasal midazolam in improving the aura attack severity, but not duration, while another reported that intranasal ketamine was not superior to metoclopramide and diphenhydramine in reducing the headache severity. In one trial, subcutaneous ketamine was superior to saline in migraine severity reduction; however, intravenous (I.V.) ketamine was inferior to I.V. prochlorperazine and diphenhydramine in another study. Conclusion: Further double-blind controlled studies are needed to assess the efficacy of ketamine in treating acute and chronic refractory migraines and other primary headaches using intranasal and subcutaneous routes. These studies should include a long-term follow-up and different ketamine dosages in diagnosed patients following international standards for diagnosing headache/migraine.

Effects of Transcranial Direct-Current Stimulation Therapy on Primary Chronic Insomnia: A Proof-of Concept Clinical Trial (일차성 만성불면증 환자에서 경두개 직류전기자극법 치료 효과: 개념 증명 연구)

  • Jun, Jin-Sun;Kim, Tae-Joon;Koo, Sun A;Park, Ji-Sook;Kim, Keun Tae;Yang, Tae-Won;Lim, Jung-Ah;Byun, Jung-Ick;Sunwoo, Jun-Sang;Jung, Ki-Young
    • Journal of Sleep Medicine
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    • v.15 no.2
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    • pp.37-42
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    • 2018
  • Objectives: To assess the effect and safety of transcranial direct-current stimulation (tDCS) in primary chronic insomnia. Methods: A one-month, double-blind, randomized, sham-controlled trial was performed. A total of 7 patients with primary chronic insomnia received tDCS using anodal (n=3), cathodal (n=2), or sham stimulation (n=2). They were followed up at 1 week and 1 month after treatment. The primary outcome measures included improvement in total sleep time (TST), sleep latency (SL), and sleep efficiency (SE) at 1 month follow-up. Results: TST and SE were improved with tDCS at 1 month follow-up in all patients (100%) of the anodal group, one (50%) of the cathodal group, and one (50%) of the sham group. tDCS improved SL at 1 month follow-up in two patients (67%) of the anodal group, one (50%) of the cathodal group, and none (0%) of the sham group. With respect to adverse events, transient itching sensation occurred in one patient of the anodal group. None of the other groups reported adverse events. Conclusions: Our results suggest that tDCS may be effective and safe for treatment of primary chronic insomnia. A larger controlled study needs to be further investigated.

The Review on the Prostate Disease-related Studies with Acupuncture Therapy in PubMed (PubMed 검색(檢索)을 이용한 전립선(前立腺) 질환(疾患)의 침치료(鍼治療)관련 연구(硏究)에 대한 고찰(考察))

  • Song, Ho-Sueb
    • Journal of Pharmacopuncture
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    • v.7 no.2
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    • pp.65-73
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    • 2004
  • Objective : This study was to review on the prostate disease-related studies with Acupuncture therapy in renowned medical internet site of PubMed, and to make master plan of the study, especially, on Bee Venom Acupuncture(BVA) of Prostate disease and then to devise the idealistic therapeutic ways of it. Method : We made the internet search with the key words of bee venom(bee venom therapy, apitoxin, apitherapy, bee sting, bee sting therapy), acupuncture, prostate, prostatitis, prostrate cancer in Pubmed, from June 1st to July 1st,2004. Results : 1.25 papers were found in 19 publised jounals. of which two named'Urology'and Prostate' had three papars, two called 'JUrology' and 'Cancer Immunol Immunother' had two papers, and the others had a paper respectively. 2. In the classification by papers' types, Review papers were 8 and Original were 17 where there were 5 clinical trials, 11 experimental studies and 1 epidemiologic paper. Of 5 clinical trials, 2 belonged to Randomized Control Study, and of 11 experimental studies, 4 belonged to in vitro and 7 belonged to in vivo with in viro studies, and 1 epidemeologic belonged to meta-analysis. 3. In the classification by prostate diseases, 4 were about prostatitis, 3 were about prostate related symptoms, 16 were about prostate cancer, and two were about the others. 4. In the classification by applied treatment methods, 5 were related with Acupuncture, 10 were related with BVA(Bee Venom, Bee), and 10 were related with the others. Of 5 related with Acupuncture, 3 used general acupuncture, 1 used electrical acupuncture, and 1 used general acupuncture and electrical acupuncture at the same time. 5. In 2 RCTs of Clinical trials, Control group was set up to the group using different compatible treatment method or using meridians not related with treating prostate disease. Single or double blind methods couldn't be found. 6. In the clinical trials, IPSS, NIH, CPSI or subjective global assessment were used as the Index of Evaluation. 7. The Leg Greater Yang Bladder Meridian(B), The Leg Lesser Um Kidney Meridian(K) and Conception Vessel Meridian(CV) were used as major meridians, and B10(Taejo, Dazhu), B23(Shinsu, Shenshu), B28(Panggwangsu, Pangguangshu), B35(Hoeyang, Huiyang), B39(Wiyang, Weiyang), B40(Wijung, Weizhong), B54(chilbyon, Zhibian), K1(Yongchon, Yongquan), K10(Umgok, Yingu), CV3(Chungguk, Zhongji), CV4(Kwanwon, Guanyuan),S6(Hyopko, Jiache) were used as acupoints. Electrical acupuncture(EA) was considered to be more important and CV3(Chungguk, Zhongji), CV4(Kwanwon, Guanyuan) were mainly selected as EA applied acupoints. 8. It is mostly said that Acupuncture appeared to be a safe, effective, and durable treatment alternative in improving symptoms of patients with prostate diseases, refractory to conventional medicine. A larger controlled study was required to confirm these encouraging initial results. Conclusion : Papers about BVA of Prostate cancer or Prostatitis were not found, and low permeability of Prostate is concerned, BVA with the anti-inflammatory and anti-cancer effect can be adopted as a new alternatives of Prostate disease treatment, so it is thought that Study of how to make access to prostate, animal experiment including in vivo and in vitro and more clinical trials with using acupoints on related meridian should be followed.

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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    • v.11 no.2
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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.

Visceral fat and body weight are reduced in overweight adults by the supplementation of Doenjang, a fermented soybean paste

  • Cha, Youn-Soo;Yang, Ji-Ae;Back, Hyang-Im;Kim, Soo-Ran;Kim, Min-Gul;Jung, Su-Jin;Song, Won O;Chae, Soo-Wan
    • Nutrition Research and Practice
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    • v.6 no.6
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    • pp.520-526
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    • 2012
  • Various forms of fermented soybean products are well documented for their health benefits. The efficacy of anti-obesogenic effect of Doenjang, one of the most commonly used seasonings in Korean cuisine, has been reported only in animal models; thus, an evaluation of Doenjang needs to be conducted in human studies. We aimed to test the hypothesis that Doenjang supplementation reduces body weight and changes body composition in overweight adults. A total of 51 overweight adults participated in this study. A group of males with BMI ${\geq}23kg/m^2$ and waist to hip ratio (WHR) ${\geq}$ 0.90, and a group of females with BMI ${\geq}23kg/m^2$ and WHR ${\geq}$ 0.85 were randomly assigned to either a Doenjang supplement (9.9 g dry/day) group or a placebo group for a 12-week randomized, double-blind and placebo-controlled study. Anthropometric parameters, abdominal fat distribution by computerized tomography (CT) and blood components were measured before and after the intervention period. After the 12-week study, the Doenjang supplementation group had significant reductions in body weight (kg), body fat mass (kg) and body fat (%) compared to the placebo group, the supplementation of Doenjang resulted in a significant reduction in visceral fat ($cm^2$), although no changes were observed in total and subcutaneous fat are as ($cm^2$), serum lipid profiles and dietary intakes. The present study demonstrated that daily supplementation of 9.9 g dry/day of Doenjang for 12 weeks reduces body weight and visceral fat in overweight adults.

Availability of Diagnosis of Yin-deficiency in Elderly People with Xerostomia and Factors Influencing Subjective Oral Dryness: A Prospective Cross-sectional Study (노인 구강건조증에 대한 음허 진단의 유용성 및 주관적 구강건조감의 영향요인 : 전향적 단면 조사 연구)

  • Kim, Juyeon;Kim, Jinsung;Park, Jaewoo;Ryu, Bongha
    • The Journal of Korean Medicine
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    • v.34 no.3
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    • pp.13-24
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    • 2013
  • Objectives: The aims of this study were to investigate the availability of diagnosis of Yin-deficiency in the elderly with xerostomia and factors influencing subjective oral dryness. Methods: We surveyed 50 patients recruited by the clinical trial, 'Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized, Double-blind, Placebo-controlled, Two-center Trial'. The subjects were assessed on their subjective oral dryness using the Dry Mouth Symptom Questionnaire (DMSQ). Their salivary functions were measured by Unstimulated Salivary Flow Rate (USFR) measurements. In addition, the subjects were evaluated on their Qi-stagnation and Yin-deficiency conditions using the Qi-stagnation questionnaire and Yin-deficiency questionnaire. Results: There were statistically significant correlations between three variables (USFR, DMSQ score and Qi-stagnation score) and Yin-deficiency score. In the multiple regression analysis, the regression model was statistically significant (F = 10.273, p < .001). The factor most strongly influencing the subjective oral dryness was USFR (${\beta}$ = -0.386). Yin-deficiency had the next strongest impact on the subjective oral dryness (${\beta}$ = 0.371). Qi-stagnation affected the subjective oral dryness weakly (${\beta}$ = 0.075). In the simple regression analysis, Yin-deficiency had a statistically significant effect on each of six subscales of DMSQ (p < .01). Among the six subscales, DMSQ-1 ('Oral dryness at night or on awakening') was the most strongly influenced by Yin-deficiency. Conclusions: The results of this study show that the diagnosis of Yin-deficiency in the elderly with xerostomia was available and Yin-deficiency was an important factor influencing the subjective oral dryness. Therefore, the consideration of Yin-deficiency is significant for diagnosis and treatment in the elderly with xerostomia.

The Effects of distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture on the Heart Rate Variability (녹용 약침과 산조인 약침이 정상인의 심박변이도(HRV)에 미치는 영향)

  • Kim, Hui-Jun;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Pharmacopuncture
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    • v.12 no.3
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    • pp.31-40
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    • 2009
  • Objective : This study was to investigate the effects of distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture on autonomic nervous system with Heart Rate Variability(HRV). Purpose of the trial was to observe what influence distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture have on the autonomic nervous system. Methods : 60 healthy male volunteers were divided into three groups which consist of two experimental groups such as Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture, and a control group. Study design was a randomized, placebo-controlled, double-blind clinical trial. 20 subjects in experimental group were injected distilled Cervi Pantotrichum Cornu Pharmacopuncture at $GB_{21}$(Kyonjong), 20 subjects in other experimental group were injected distilled Zizyphi Spinosi Semen Pharmacopuncture and 20 subjects in control group were injected Normal Saline at $GB_{21}$(Kyonjong). One volunteer of each groups were excluded from analysis because of error during measuring HRV. At the end of the study 57 volunteers completed HRV analysis. HRV was measured by QECG-3:LXC3203(LAXTHA Inc. Korea) at P0, P1, P2, P3, P4, P5 and P6 and its time-course dependent change in each group was analyzed using paired t-test, and the difference of HRV fluctuation among two experimental group and a control was evaluated by one way ANOVA(p<0.05). Results : A. Time Domain Analysis 1. Analysis of Mean HRV, SDNN and Complexity After injection of distilled Cervi Pantotrichum Cornu Pharmacopuncture, Mean HRV was significantly decreased only at 20 minutes after injection. SDNN was significantly increased from 15 minute after injection. Complexity was significantly decreased only at 15 minute after injection. After injection of distilled Zizyphi Spinosi Semen Pharmacopuncture, Complexity was significantly decreased at 10, 15 and 30 minutes after injection. 2. Analysis of HRV index, pNN50 After injection of distilled Cervi Pantotrichum Cornu Pharmacopuncture, pNN50 was significantly decreased at 15, 20 and 25 minutes after injection. Compared with Normal Saline injection, distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture showed significant difference on HRV index and pNN50 at 5 minutes after injection. B. Frequency Domain Analysis 1. Analysis of Ln(TP), Ln(VLF) After injection of distilled Cervi Pantotrichum Cornu Pharmacopuncture, Ln(TP) was significantly increased at 15 and 30 minutes after injection. Ln(VLF) was significantly increased at 10, 15 and 30 minutes after injection. After injection of distilled Zizyphi Spinosi Semen Pharmacopuncture, Ln(VLF) was significantly increased only at 30 minutes after injection. Compared with Normal Saline injection, distilled Cervi Pantotrichum Cornu Pharmacopuncture showed significant difference on Ln(TP) after 5 minutes of injection. Conclusions : Our results suggest that Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture in healthy adult man tend to activate the autonomic nervous system and sympathetic nervous system compared to Normal Saline within normal range.

Effects of Keumsa Sangwhang (Phellinus linteus) Mushroom Extracts on the Natural Killer Cell Activity in Human (금사상황버섯 추출물이 사람의 natural killer 세포 활성에 미치는 영향)

  • Eom, Sang-Yong;Zhang, Yan-Wei;Kim, Nam-Sik;Kang, Jong-Won;Hahn, Youn-Soo;Shin, Kyeong-Seob;Song, Hyung-Gen;Park, Soon-Young;Kim, Jeong-Su;Kim, Heon;Kim, Yong-Dae
    • Korean Journal of Food Science and Technology
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    • v.38 no.5
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    • pp.717-719
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    • 2006
  • A randomized, double blind, placebo-controlled human intervention study involving 62 healthy volunteers was performed to investigate the effects of Keumsa sangwhang (Phellinus linteus) mushroom extracts (KPLE) on natural killer (NK) cell activity in peripheral blood. The volunteers were randomly distributed into two groups, one receiving KPLE (3.3 g/day) and the other a placebo by oral administration for 8 weeks. In this study, the number of NK cells did not increase with KPLE administration, however the cytotoxic activity of NK cells against the Jurkat leukemia cell line increased significantly. This result suggests that administration of KPLE induces cell-mediated immunity by increasing NK cell activity in humans.

Efficacy and safety of vitamin D3 B.O.N intramuscular injection in Korean adults with vitamin D deficiency

  • Choi, Han Seok;Chung, Yoon-Sok;Choi, Yong Jun;Seo, Da Hea;Lim, Sung-Kil
    • Osteoporosis and Sarcopenia
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    • v.2 no.4
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    • pp.228-237
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    • 2016
  • Objective: There has been no prospective study that examined intramuscular injection of high-dose vitamin D in Korean adults. The aim of this study was to assess the efficacy and safety of high-dose vitamin $D_3$ after intramuscular injection in Korean adults with vitamin D deficiency. Method: This study was a 24-week, prospective, multicenter, randomized, double-blind, placebo-controlled trial. A total of 84 subjects ${\geq}19$ and <65 years of age were randomly allocated to either the vitamin $D_3$ or placebo group in a 2:1 ratio. After randomization, a single injection of plain vitamin $D_3$ 200,000 IU or placebo was intramuscularly administered. If serum 25-hydroxyvitamin D (25[OH]D) concentrations were <30 ng/mLon week 12 or thereafter, a repeat injection was administered. Results: After a single intramuscular injection of vitamin $D_3$ to adults with vitamin D deficiency, the proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 12 weeks was 46.4% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). The proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 24 weeks was 73.2% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). Mean change in serum 25(OH)D concentrations at weeks 12 and 24 after vitamin $D_3$ injection was $12.8{\pm}8.1$ and $21.5{\pm}8.1ng/mL$, respectively, in the vitamin $D_3$ group, with no significant changes in the placebo group. Serum parathyroid hormone concentrations showed a significant decrease in the vitamin $D_3$ group but no change in the placebo group. Conclusion: Intramuscular injection of vitamin $D_3$ 200,000 IU was superior to placebo in terms of its impact on serum 25(OH)D concentrations, and is considered to be safe and effective in Korean adults with vitamin D deficiency.

Study on the Anti-stress Effect of Chenwangbosim-Dan Extract∘Fermented Rice Extract (GABA ː gamma-aminobutyric acid 30%) Complex : A double-blind, randomized, placebo-controlled study (천왕보심단(天王補心丹)∘쌀발효추출물(GABAːgamma-aminobutyric acid 30%) 복합물의 항(抗)스트레스에 대한 유효성 연구ː무작위 배정 및 이중맹검)

  • Choyoung, Hong;Seo, Sang Gwon;Seunggon, Na;Hosong, Cho;Mi-Kyung, Lee;Mu Hyun, Jin;Seok-Seon, Roh;Youngsung, Ju
    • The Korea Journal of Herbology
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    • v.38 no.2
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    • pp.1-7
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    • 2023
  • Objectives : From this study, we sight to identify Anti-stress effect of Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex Methods : In order to measure the degree of functional evaluation of tension relief due to stress, it was evaluated whether the psychological indicators VAS(Visual Analog Scale) and POMS(Profile Of Mood State) were improved. Which is generally used for stress measurement and has a high frequency of clinical use. All clinical trial subjects were required to take the drug once a day at 9 ± 30 min in the morning for 2 weeks. Results : After intake, the group that Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had a statistically significant improvement effect compared to before intake due to an improved 30.81% of the VAS scores. The POMS-T score improved 54.13%, the POMS-V score improved 117.5% and the POMS-F score improved 59%, which had a statistically significant effect compared to Placebo group (p<0.001). There is a significant difference between two group, so even considering the placebo effect, the anti stress effect was confirmed in the Chenwangbosim-Dan (Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex intake group. Conclusions : The above results showed that the Chenwangbosim-Dan(Tianwangbuxin-Dan) Extract∘Fermented Rice Extract (GABA : gamma-aminobutyric acid 30%) Complex had an anti-stress effect. Therefore, it is expected to be developed as a safe and comfortable mental care health functional food that can reduce the risk of drug abuse.