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

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Effects of Korean Red Ginseng on Dry Mouth: A Randomized, Double-Blind, Placebo-Controlled Trial

  • Park, Jae-Woo;Lee, Beom-Joon;Bu, Young-Min;Yeo, In-Kwon;Kim, Jin-Sung;Ryu, Bong-Ha
    • Journal of Ginseng Research
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    • v.34 no.3
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    • pp.183-191
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    • 2010
  • Dry mouth is easily neglected if not associated with oral diseases. Consequently, xerostomatic patients often use unconventional therapies. In traditional Korean medicine, Korean red ginseng (KRG) has long been used to relieve dry mouth. However, no clinical trials have investigated whether KRG actually has an effect on dry mouth. This study was performed to evaluate the efficacy of KRG for dry mouth. We enrolled 100 volunteers with no obvious oral or salivary gland diseases and divided them into KRG and placebo groups. Each group was divided into six subgroups according to age and gender. The subjects received 6 g/day of KRG or placebo for 8 weeks. The dry mouth visual analog scale (VAS), salivary flow rate, and a dry mouth-related symptom questionnaire were evaluated at baseline and at 4 and 8 weeks. KRG treatment did not show any significant differences for any of the variables. However, KRG improved the dry mouth VAS at 4 weeks and dry mouthrelated symptoms at 8 weeks in women, but not in men. Subgroup analyses revealed that KRG markedly improved the dry mouth VAS in women of menopausal age (40 to 59 years) at 4 and 8 weeks. KRG may have beneficial effects for dry mouth in women, especially those of menopausal age, but not in men. Further investigation in post- and perimenopausal women is required to elaborate on these findings.

Effects of 37℃ Carbon Dioxide Pneumoperitoneum on Core Body Temperature, Systolic Blood Pressure, Heart Rate and Acid-Base Balance: A Randomized Double-blind Controlled Trial (복강경 수술에서 기복제 이산화탄소의 37℃ 가온이 수술 중 체온, 수축기압 및 심박동수와 산염기 균형에 미치는 영향)

  • Park, Jin il;Yoon, Haesang
    • Journal of Korean Biological Nursing Science
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    • v.19 no.2
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    • pp.76-85
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    • 2017
  • Purpose: The purpose of this study was to compare the effects of $21^{\circ}C\;CO_2$ and $37^{\circ}C\;CO_2$ pneumoperitoneum on body temperature, blood pressure, heart rate, and acid-base balance. Methods: Data were collected at a 1300-bed university hospital in Incheon, from February through September 2012. A total of 74 patients who underwent laparoscopic colectomy under general anesthesia with desflurane were randomly allocated to either a control group or an experimental group. The control group received $21^{\circ}C\;CO_2$ pneumoperitoneum; the experimental group received $37^{\circ}C\;CO_2$ pneumoperitoneum. The pneumoperitoneum of the two groups was under abdominal pressure 15 mmHg. Body temperature, systolic blood pressure, heart rate and acid-base balance were assessed at 30 minutes and 90 minutes after pneumoperitoneum, and again at 30 minutes after arriving at the Post Anesthesia Care Unit. Results: Body temperature in the $37^{\circ}C\;CO_2$ pneumoperitoneum group was significantly higher (F= 9.43, p< .001) compared to the $21^{\circ}C\;CO_2$ group. However, there were no statistically significant differences in systolic blood pressure (p= .895), heart rate (p= .340), pH (p= .231), PaCO2 (p= .490) and HCO3- (p= .768) between the two groups. Conclusion: Pneumoperitoneum of $37^{\circ}C\;CO_2$ is effective for the increase of body temperature compared to pneumoperitonium of $21^{\circ}C\;CO_2$, and it does not result in a decrease of blood pressure, heart rate or acid-base imbalance.

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

  • Kim, Ja-Hye;Shin, Sang-Ho;Kim, Mi-Bo;Ko, Woo-Shin;Yoon, Hwa-Jung
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.20 no.1 s.32
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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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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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    • v.18 no.3
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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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    • v.33 no.1
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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.

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

  • Yoo, Su-Jeong;Ko, Sung-Kwon;Kim, Hyeong-Jun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.30 no.4
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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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    • v.22 no.6
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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.

Evaluation of the Effectiveness and Safety of Zanthoxylum piperitum Leaf Extract against Mild Degenerative Osteoarthritis of Knee: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial (경증의 퇴행성 슬관절염에 대한 초피나무잎 추출물의 유효성 및 안전성 평가: 무작위 배정, 이중맹검, 위약대조 임상연구)

  • Jeong, Ji-Hong;Lee, Soo-Hwan;Yoon, Hong-Ryoul;Kim, Soon-Joong
    • Journal of Korean Medicine Rehabilitation
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    • v.31 no.4
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    • pp.167-191
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    • 2021
  • Objectives Degenerative osteoarthritis of knee is a disease with an increasing number of patients worldwide and its general treatments have some side effects. Methods 102 subjects were classified into test group 1, test group 2, and control group, and clinical trial products were taken for 12 weeks. The effectiveness was evaluated with changes in visual analogue scale, Korean-Western Ontario and McMaster Universities Osteoarthritis Index, inducible nitric oxide synthase, and cyclooxygenase-2. Results Both test group 1 and test group 2 were effective in reducing the pain of degenerative osteoarthritis of knee, and only test group 2 was effective in improving the ability to perform daily activities. No clinically significant changes were observed for any safety parameter. Conclusions In conclusion, the data of this study indicate that Zanthoxylum piperitum leaf extract has effectiveness and safety against mild degenerative osteoarthritis of knee.

The efficacy of low-level diode laser versus laser acupuncture for the treatment of myofascial pain dysfunction syndrome (MPDS)

  • Khalighi, Hamid Reza;Mortazavi, Hamed;Mojahedi, Seyed Masoud;Azari-Marhabi, Saranaz;Parvaie, Parvin;Anbari, Fahimeh
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.1
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    • pp.19-27
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    • 2022
  • Background: Myofascial pain dysfunction syndrome (MPDS) is the most common type of temporomandibular disorder. This study compared the efficacies of low-level diode laser therapy (LLLT) and laser acupuncture therapy (LAT) in the treatment of MPDS. Methods: This double-blind randomized controlled clinical trial included 24 patients with MPDS who were randomly divided into two equally sized groups. Patients in the LLLT group received 12 sessions of low-level diode laser irradiation applied to the trigger points of the masticatory muscles during 1 month. The same protocol was also used in the LAT group according to the specific trigger points. We measured pain intensity and maximum mouth opening in both groups at baseline, during treatment, and 2 months after treatment completion. Results: The pain intensities decreased from 6.58±1.31 to 0.33±0.65 and from 7.08 ± 1.37 to 0 in the LLLT and LAT groups, respectively. The maximum mouth openings increased from 32.25 ± 8.78 mm to 42.58 ± 4.75 mm and from 33 ± 6.57 mm to 45.67 ± 3.86 mm in the LLLT and LAT groups, respectively. Pain intensity (P = 0.839) and level of maximum mouth opening (P = 0.790) did not differ significantly between the groups. Conclusion: Our results showed similar efficacy between LLLT and LAT in the treatment of MPDS signs and symptoms.

Dental plaque removal efficiency of a smart toothbrush based on augmented reality in children (증강현실 기반 스마트 칫솔의 치면세균막 제거효과 평가)

  • Min-Ji Park;Suk-Bin Jang;Jae-Young Lee
    • Journal of Korean society of Dental Hygiene
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    • v.23 no.1
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    • pp.33-42
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    • 2023
  • Objectives: Based on the strengths of augmented reality (AR), this study aimed to determine the dental plaque removal efficiency of a guided brushing program in children. Methods: This randomized, controlled, double-blind crossover clinical trial evaluated the plaque removal rate after regular brushing versus AR-based guided toothbrushing in 20 children aged 5-12 years. Results: Overall, the dental plaque removal efficiency of AR-based brushing was superior to that of regular brushing (p<0.05). When classified in detail, no significant difference was noted in the plaque removal rate between the two brushing methods in the anterior region (p=0.056), whereas a significant difference in the plaque removal rate was observed in the posterior region (p<0.05). Conclusions: Based on these results, the efficacy of dental plaque removal for brushing using an AR-based smartphone application was confirmed; thus, this can be used for oral health education incorporating ICT technology in the future.