• 제목/요약/키워드: double-blind

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Comparison of the Effects of Pilocarpine Solution and Tablet on Salivary Flow Rate

  • Park, Jo-Eun;Song, Chan-Woo;Kim, Ki-Suk;Kim, Mee-Eun
    • Journal of Oral Medicine and Pain
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    • 제40권1호
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    • pp.10-16
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    • 2015
  • Purpose: Pilocarpine has the effects on improvement of salivary flow and subjective symptoms for xerostomic patients. Because of unwanted side effects following its systemic administration, topical pilocarpine has been paid attention as an alternative. This study aimed to investigate effects of pilocarpine solution as mouthwash on salivary flow and adverse effects compared to systemic administration of 5 mg pilocarpine tablet in healthy subjects. Methods: The study was a double blind, placebo-controlled, crossover clinical trial. Five milligrams pilocarpine tablets, 4 mL of 2% pilocarpine solution and placebo solution were given to 12 healthy volunteers (6 males and 6 females) in a predetermined order with wash-out period of at least two days and unstimulated whole saliva was collected before and after administration of each drug. Blood pressure and pulse rate was also measured and subjective effect and potential side effects were evaluated by a self-administrated questionnaire. Results: Systemic (5 mg tablet) and topical (2% solution) use of pilocarpine significantly increased salivary flow rate in healthy subjects compared to placebo (p<0.001). In both the pilocarpine solution and tablet groups, salivary flow rates at 120 minutes after administration remained increased. Subjective effect on salivation was the largest in the pilocarpine tablet group, followed by the pilocarpine solution group (p<0.05). There was no significant difference in blood pressure and pulse rate after administration of all three drugs. Fewer side effects reported in the pilocarpine solution group than in the tablet group. Conclusions: Two percents pilocarpine solution as mouthwash increases salivary flow rate, definitely superior to placebo solution and comparable to pilocarpine tablet, with fewer side effects in healthy subjects. It indicates a possibility of pilocarpine solution as a useful alternative of pilocarpine tablets for the xerostomic patients with systemic diseases.

알레르기 비염의 대체의학적 치료에 관한 최근 논문경향 분석 - Entrez Pubmed 위주 (Systemic review : The study on alternative medicine for allergic rhinitis in Entrez Pubmed)

  • 김자혜;신상호;김미보;고우신;윤화정
    • 한방안이비인후피부과학회지
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    • 제20권1호통권32호
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    • pp.239-249
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    • 2007
  • Background : Allergic rhinitis is the most frequently occuring immunological disorder. It affects men, women and children and represents significant cost in terms of suffering and loss of productivity. Objective & Methods : We referred to the information through Entrex Pubmed from 2004 to 2007 January about alternative medicine for allergic rhinitis, 9 treatises. Results : About 9 treatises, 2 treatises were for the acupuncture treatment, I treatise was for the acupuncture and chinese herbal medicine, 2 treatises were for the single substance(butterbur, soy sauce ingredients), 1 treatise was for the homeopathic preparation, 1 treatise was for the ayur-veda herbal treatment, 1 treatise was for the ultraviolet light phototherapy, 1 treatise was for the systematic review of alternative medicine. Except 2 treatises for the acupuncture treatment, 6 treatises used the double-blind, randomized, placebo-controlled methods. As a result, we found 5 treatises that treat group had more improvement than control group, 3 treatises that treat group had no difference control group on effect significantly. 1 review article exhibited the most of alternative medical literatures were inadequate methodologically and therapeutic efficacy alternative treatment for allergic rhinitis was not supported by currently available evidence. Conclusion : We found that treatises about the alternative medicine for allergic rhinitis were more and more published. We were supposed that many internal treatises were published adequately by methodology to prove Korean medical treatment effects for allergic rhinitis.

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Cancer Prevention with Green Tea and Its Principal Constituent, EGCG: from Early Investigations to Current Focus on Human Cancer Stem Cells

  • Fujiki, Hirota;Watanabe, Tatsuro;Sueoka, Eisaburo;Rawangkan, Anchalee;Suganuma, Masami
    • Molecules and Cells
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    • 제41권2호
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    • pp.73-82
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    • 2018
  • Cancer preventive activities of green tea and its main constituent, (-)-epigallocatechin gallate (EGCG) have been extensively studied by scientists all over the world. Since 1983, we have studied the cancer chemopreventive effects of EGCG as well as green tea extract and underlying molecular mechanisms. The first part of this review summarizes groundbreaking topics with EGCG and green tea extract: 1) Delayed cancer onset as revealed by a 10-year prospective cohort study, 2) Prevention of colorectal adenoma recurrence by a double-blind randomized clinical phase II trial, 3) Inhibition of metastasis of B16 melanoma cells to the lungs of mice, 4) Increase in the average value of Young's moduli, i.e., cell stiffness, for human lung cancer cell lines and inhibition of cell motility and 5) Synergistic enhancement of anticancer activity against human cancer cell lines with the combination of EGCG and anticancer compounds. In the second part, we became interested in cancer stem cells (CSCs). 1) Cancer stem cells in mouse skin carcinogenesis by way of introduction, after which we discuss two subjects from our review on human CSCs reported by other investigators gathered from a search of PubMed, 2) Expression of stemness markers of human CSCs compared with their parental cells, and 3) EGCG decreases or increases the expression of mRNA and protein in human CSCs. On this point, EGCG inhibited self-renewal and expression of pluripotency-maintaining transcription factors in human CSCs. Human CSCs are thus a target for cancer prevention and treatment with EGCG and green tea catechins.

락침(落枕) 환자에 대한 Sweet Bee Venom과 Bee Venom의 치료효과 및 Allergy 반응 비교 연구 (Comparison of Treatment Effects and Allergic responses to stiff neck between Sweet Bee Venom and Bee Venom Pharmacopuncture (A pilot study, Double blind, Randomized Controlled Clinical Trail))

  • 이경희;윤현민;고우신;송춘호;장경전;안창범;김철홍
    • 대한약침학회지
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    • 제11권4호
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    • pp.39-48
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    • 2008
  • Objective The purpose of this study is to investigate the difference of treatment effects and allergic responses to stiff neck between Bee Venom Pharmacopuncture and Sweet Bee Venom Pharmacopuncture. Methods Forty one patients who felt stiff neck were randomly divided into two groups, a Bee Venom Pharmacopuncture group(group I) and a Sweet Bee Venom Pharmacopuncture group(group II). Evaluations of the treatment effects were made before and after a treatment using Visual Analog Scale(VAS), Neck Disability Index(NDI), Clinical Evaluation Grade(CEG). The comparison of allergic responses was measured with VAS. The obtained data were analyzed and compared with SPSS. Results The group I and group II showed significant improvement(p<0.05) according to the VAS, NDI, CEG. And the differences between the two groups were insignificant according to VAS, NDI, CEG. But allergic responses such as localized edema, localized itching were significantly lower in group II than group I. Conclusions It seems that there are no big different treatment effects between the two groups. Sweet Bee Venom Pharmacopuncture appears to be more effective measurement against allergic reactions than the Bee Venom Pharmacopuncture. Further studies are needed for the comparison of Bee Venom Pharmacopuncture and Sweet Bee Venom Pharmacopuncture.

Effect of a 5% naproxen patch on reducing pain caused by separators prior to fixed orthodontic treatment

  • Eslamian, Ladan;Rad, Nazila Akbarian;Nobar, Behnam Rahbani;Mortazavi, Seyed Alireza
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제18권3호
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    • pp.151-159
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    • 2018
  • Background: The pain involved in orthodontic treatments may involve inflammatory processes. This study evaluated the effect of using a naproxen patch for pain reduction in the separating stage of fixed orthodontic treatment. Methods: In this double-blind, randomized, controlled clinical trial of 35 orthodontic patients (age: 14-19 years) who had pain during separator placement, each patient randomly placed naproxen and placebo patches in the first permanent molar region, in opposite quadrants of the same jaw. Patches were replaced every 8 hours until 3 days after separator placement. Patients recorded their pain perception at 2, 6, and 24 hours, and on days 2 (6 PM), 3 (10 AM and 6 PM), and 7 (10 AM and 6 PM), using a visual analog scale. Mean pain scores were compared for the two patches, and effects of sex and age thereon determined. Results: Data from 29 patients (21 girls, eight boys) were analyzed. Mean pain values decreased over time for both patches (P < 0.001). Recorded pain did not differ significantly between the sexes (P = 0.059) or between those aged <16 and those ${\geq}16years$ (P = 0.106). Mean pain recorded with naproxen patches was statistically significantly less than that with placebo patches at all time points (P = 0.004). Conclusion: The naproxen patch was more efficient than the placebo patch for reducing pain at all time points. The highest pain score was recorded at 6 hours, and the least pain was recorded at the $7^{th}$ day after separator placement.

Dexmedetomidine during suprazygomatic maxillary nerve block for pediatric cleft palate repair, randomized double-blind controlled study

  • Mostafa, Mohamed F.;Aal, Fatma A. Abdel;Ali, Ibrahim Hassan;Ibrahim, Ahmed K.;Herdan, Ragaa
    • The Korean Journal of Pain
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    • 제33권1호
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    • pp.81-89
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    • 2020
  • Background: For children with cleft palates, surgeries at a young age are necessary to reduce feeding or phonation difficulties and reduce complications, especially respiratory tract infections and frequent sinusitis. We hypothesized that dexmedetomidine might prolong the postoperative analgesic duration when added to bupivacaine during nerve blocks. Methods: Eighty patients of 1-5 years old were arbitrarily assigned to two equal groups (forty patients each) to receive bilateral suprazygomatic maxillary nerve blocks. Group A received bilateral 0.2 mL/kg bupivacaine (0.125%; maximum volume 4 mL/side). Group B received bilateral 0.2 mL/kg bupivacaine (0.125%) + 0.5 ㎍/kg dexmedetomidine (maximum volume 4 mL/side). Results: The modified children's hospital of Eastern Ontario pain scale score was significantly lower in group B children after 8 hours of follow-up postoperatively (P < 0.001). Mean values of heart rate and blood pressure were significantly different between the groups, with lower mean values in group B (P < 0.001). Median time to the first analgesic demand in group A children was 10 hours (range 8-12 hr), and no patients needed analgesia in group B. The sedation score assessment was higher in children given dexmedetomidine (P = 0.03) during the first postoperative 30 minutes. Better parent satisfaction scores (5-point Likert scale) were recorded in group B and without serious adverse effects. Conclusions: Addition of dexmedetomidine 0.5 ㎍/kg to bupivacaine 0.125% has accentuated the analgesic efficacy of bilateral suprazygomatic maxillary nerve block in children undergoing primary cleft palate repair with less postoperative supplemental analgesia or untoward effects.

High Molecular Weight Poly-Gamma-Glutamic Acid Regulates Lipid Metabolism in Rats Fed a High-Fat Diet and Humans

  • Park, Ji-Ho;Choi, Jae-Chul;Sung, Moon-Hee;Kang, Jae-Heon;Chang, Moon-Jeong
    • Journal of Microbiology and Biotechnology
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    • 제21권7호
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    • pp.766-775
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    • 2011
  • We investigated the effect of high molecular weight polygamma- glutamic acid (hm ${\gamma}$-PGA) on adiposity and lipid metabolism of rats in the presence of an obesity-inducing diet. Thirty-two Sprague-Dawley rats were fed either a normal-fat (11.4% kcal fat, NFC) or high-fat (51% kcal fat, HFC) diet. After 5 weeks, half of each diet-fed group was treated with hm ${\gamma}$-PGA (NFP or HFP) for 4 weeks. The HFC group had significantly higher body weight, visceral fat mass, fasting serum levels of total cholesterol, LDL cholesterol, and leptin, and lower serum HDL cholesterol level compared with those of the NFC group (p < 0.05). Treatment with hm ${\gamma}$-PGA decreased body weight gain and perirenal fat mass (p<0.05), fasting serum total cholesterol, and mRNA expression of glucose-6- phosphate dehydrogenase (G6PD), regardless of dietary fat contents (p < 0.01). However, hm ${\gamma}$-PGA increased serum HDL cholesterol in the HFC group (p < 0.05). In vitro, 3-hydroxy-3-methylglutaryl coenzyme-A (HMGCoA) reductase activity was suppressed by the addition of hm ${\gamma}$-PGA. In agreement with observations in animal study, the supplementation of hm ${\gamma}$-PGA (150 mg/day) to 20 female subjects in an 8-week double-blind, placebocontrolled study resulted in a tendency to decrease total cholesterol and LDL cholesterol concentrations. We thus conclude that dietary supplementation of hm ${\gamma}$-PGA may act as a hypocholestrolemic agent, secondary to its inhibitor effect on HMG-CoA reductase, and decrease abdominal adiposity by decreasing hepatic lipogenesis. The present study is an important first step in establishing the effect of hm ${\gamma}$-PGA on cholesterol levels in rats and humans.

Comparing the effect of a desensitizing material and a self-etch adhesive on dentin sensitivity after periodontal surgery: a randomized clinical trial

  • Hajizadeh, Hila;Nemati-Karimooy, Atefeh;Majidinia, Sara;Moeintaghavi, Amir;Ghavamnasiri, Marjaneh
    • Restorative Dentistry and Endodontics
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    • 제42권3호
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    • pp.168-175
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    • 2017
  • Objectives: This double-blind randomized placebo-controlled clinical trial evaluated the ability of a desensitizing agent and a self-etch adhesive on cervical dentin sensitivity (CDS) after periodontal surgery. Materials and Methods: Ninety hypersensitive teeth of 13 subjects were included in the study. After periodontal surgery, the teeth of each posterior sextant treated with one of the following materials: G1: Clearfil $S^3$ Bond (Kuraray Dental), G2: Gluma Desensitizer (Heraeus Kulzer), and G3: placebo (water). The sensitivity was assessed using evaporative stimuli before treatment (baseline, T0), 1 day after treatment (T1), after 1 week (T2), and 1 month (T3) according to visual analog scale (VAS). Results: Following the treatment, all the 3 groups showed significant reduction of CDS in T1 compared to T0. Reduction of CDS between T1 and T2 was observed only in G1 but there was no significant difference between T2 and T3 in this group. Although we observed a significant difference in T3 compared to T1 and T2 in G2 and G3, comparison of treatment groups in each assessment time showed a significant difference only in T3. According to paired comparison, this was due to the difference between G2 and G3. Conclusions: Dentin sensitivity following periodontal surgery will decrease spontaneously over time, but treating the sensitive teeth with Gluma Desensitizer and Clearfil $S^3$ Bond can have some benefits.

한열변증을 통한 열증 대상자에 산양삼과 재배인삼의 상부 승열 작용에 대한 인체적용시험 (Clinical Trial for the Heat-Rising Action of Ginseng and Cultivated Wild Ginseng to The Subject Diagnosed as Heat Pattern by Cold-Heat Patternization)

  • 유수정;고성권;김형준
    • 대한한방부인과학회지
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    • 제30권4호
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    • pp.45-58
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    • 2017
  • Objectives: The aim of this trial is to investigate the effect of Ginseng and Wild Cultivated Ginseng to Heat pattern subject. Methods: Eighty-nine Subjects were diagnosed as heat pattern by Cold-Heat Patternization and divided into Ginseng group (n=30), Wild Cultivated Ginseng group (n=31) and Placebo group (n=28) in their 1 st visit. In each visit, The researchers measured the subject's facial temperature using the infrared thermometer (Testo 835-T1). After that, The subjects were asked to mark the current score of flushing on the Visual Analogue Scale (VAS) and to complete the Chalder-Fatigue Scale (CFS) in each visit. The subjects took the test drug for one week and returned the remaining drug on the 2nd visit. The trial result was analyzed with one-way ANOVA using SPSS for Windows version 18. Results: 1. Systolic blood pressure was significantly lower in the Ginseng group and Wild Cultivated Ginseng group than in the control group (p=0.021). 2. There was no significant difference in facial temperature between each groups. 3. The current score of flushing showed the greatest decrease in the Ginseng group compared to the other groups but there was no significant difference (p=0.205). 4. The score of Chalder-Fatigue Scale was decreased in all groups but not statistically significant (p=0.180). Conclusions: This study showed that taking Ginseng extract and Wild Cultivated Ginseng extract do not affect to heat-rising reaction to the subjects diagnosed as heat pattern.

Lactobacillus reuteri DSM 17938 Improves Feeding Intolerance in Preterm Infants

  • Kaban, Risma K.;Wardhana, Wardhana;Hegar, Badriul;Rohsiswatmo, Rinawati;Handryastuti, Setyo;Amelia, Novie;Muktiarti, Dina;Indrio, Flavia;Vandenplas, Yvan
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • 제22권6호
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    • pp.545-553
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    • 2019
  • Purpose: Feeding tolerance is extremely important in preterm infants. This study aimed to evaluate whether preterm infants receiving Lactobacillus reuteri DSM 17938 would develop fewer symptoms of feeding intolerance. Secondary outcomes were duration of parenteral nutrition, time to reach full feeding, length of hospital stay, sepsis, necrotizing enterocolitis (NEC), diarrhea, and mortality. Methods: This double-blind randomized controlled trial of L. reuteri DSM 17938 versus placebo included 94 neonates with a gestational age of 28-34 weeks and birth weight of 1,000-1,800 g. Results: Feeding intolerance (vomiting and/or distension) was less common in the probiotic group than in the placebo group (8.5% vs. 25.5%; relative risk, 0.33; 95% confidence interval, 0.12-0.96; p=0.03). No significant intergroup differences were found in proven sepsis, time to reach full feeding, length of hospital stay, or diarrhea. The prevalence of NEC (stages 2 and 3) was 6.4% in the placebo group vs. 0% in the probiotic group (relative risk, 1.07; 95% confidence interval, 0.99-1.15; p=0.24). Mortality rates were 2.1% in the probiotic group and 8.5% in the placebo group, p=0.36). Conclusion: The administration of L. reuteri DSM 17938 to preterm infants was safe and significantly reduced feeding intolerance. No significant differences were found in any other secondary outcomes.