• 제목/요약/키워드: randomized controlled double blind study

검색결과 209건 처리시간 0.026초

Dose- and Time-Related Effects of Pilocarpine Mouthwash on Salivation

  • Song, Je-Il;Park, Jo-Eun;Kim, Hye-Kyoung;Kim, Mee-Eun;Kim, Ki-Suk
    • Journal of Oral Medicine and Pain
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    • 제42권3호
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    • pp.72-80
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    • 2017
  • Purpose: Pilocarpine as a salivation stimulant in pill form has mostly been used to relieve oral dryness for xerostomic patients but its use may often be limited due to variable side effects from systemic absorption. Therefore, the purpose of this study was to investigate the effects of pilocarpine mouthwash on salivation according to the variable concentration and duration for healthy volunteers. Related adverse effects and subjective assessment on its effects on salivation were also examined. Methods: This study was performed as placebo-controlled, double-blind, randomized clinical trial. Thirty healthy volunteers (male=23, mean age=22.2 years) were randomly allocated to 6 groups with the different concentration of pilocarpine mouthwash (placebo, 0.1%, 0.5%, 1.0%, 1.5%, and 2.0%). The whole experiment consisted of 3 sessions according to the duration of mouthwash, i.e., 1, 3, and 5 minutes with the mean wash-out period ${\geq}2$ days between the sessions. Unstimulated whole saliva was collected before and after gargling with a mouthwash. Results: Salivation of the higher concentration groups ${\geq}1%$ significantly increased than those of lower concentration group. The application period of mouthwash did not cause any changes of salivary flow rate at the higher concentrations ${\geq}1.0%$. The lower concentrations of 0.5% and 0.1% had no effects on salivation even after 5-minute mouthwash. There was no significant difference between blood pressure and pulse rate before and after use of mouthwash. Conclusions: From the results of the current study, pilocarpine mouthwash with at least 1.0% concentration more than a minute might be clinically effective in salivation without any serious side effects. Dose of mouthwash rather than duration seems to be a critical factor to salivation.

Comparison of intrathecal versus intra-articular dexmedetomidine as an adjuvant to bupivacaine on postoperative pain following knee arthroscopy: a randomized clinical trial

  • Ismail, Eman A.;Sayed, Jehan A.;Bakri, Mohamed H.;Mahfouz, Reda Z.
    • The Korean Journal of Pain
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    • 제30권2호
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    • pp.134-141
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    • 2017
  • Background: Postoperative pain is a common, distressing symptom following arthroscopic knee surgery. The aim of this study was to compare the potential analgesic effect of dexmedetomidine after intrathecal versus intra-articular administration following arthroscopic knee surgery. Methods: Ninety patients undergoing unilateral elective arthroscopic knee surgery were randomly assigned into three groups in a double-blind placebo controlled study. The intrathecal dexmedetomidine group (IT) received an intrathecal block with intrathecal dexmedetomidine, the intra-articular group (IA) received an intrathecal block and intra-articular dexmedetomidine, and the control group received an intrathecal block and intra-articular saline. The primary outcome of our study was postoperative pain as assessed by the visual analogue scale of pain (VAS). Secondary outcomes included the effect of dexmedetomidine on total postoperative analgesic use and time to the first analgesic request, hemodynamics, sedation, postoperative nausea and vomiting, patient satisfaction, and postoperative C-reactive protein (CRP) levels. Results: Dexmedetomidine administration decreased pain scores for 4 h in both the intrathecal and intra-articular groups, compared to only 2 h in the control patient group. Furthermore, there was a significant reduction in pain scores for 6 h in the intra-articular group. The time to the first postoperative analgesia request was longer in the intra-articular group compared to the intrathecal and control groups. The total meperidine requirement was significantly lower in the intra-articular and intrathecal groups than in the control group. Conclusions: Both intrathecal and intra-articular dexmedetomidine enhanced postoperative analgesia after arthroscopic knee surgery. Less total meperidine was required with intra-articular administration to extend postoperative analgesia to 6 h with hemodynamic stability.

Immuno-enhancement effects of Korean Red Ginseng in healthy adults: a randomized, double-blind, placebo-controlled trial

  • Hyun, Sun Hee;Ahn, Ha-Young;Kim, Hyeong-Jun;Kim, Sung Won;So, Seung-Ho;In, Gyo;Park, Chae-Kyu;Han, Chang-Kyun
    • Journal of Ginseng Research
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    • 제45권1호
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    • pp.191-198
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    • 2021
  • Background: Most clinical studies of immune responses activated by Korean Red Ginseng (KRG) have been conducted exclusively in patients. However, there is still a lack of clinical research on immune-boosting benefits of KRG for healthy persons. This study aims to confirm how KRG boosts the immune system of healthy subjects. Methods: A total of 100 healthy adult subjects were randomly divided into two groups that took either a 2 g KRG tablet or a placebo per day for 8 weeks. The primary efficacy evaluation variables included changes in T cells, B cells, and white blood cells (WBCs) before and after eight weeks of KRG ingestion. Cytokines (TNF-α, INF-γ, IL-2 and IL-4), WBC differential count, and incidence of colds were measured in the secondary efficacy evaluation variables. Safety evaluation variables were used to identify changes in laboratory test results that incorporated adverse reactions, vital signs, hematological tests, blood chemistry tests, and urinalysis. Results: Compared to the placebo group, the KRG intake group showed a significant increase in the number of T cells (CD3) and its subtypes (CD4 and CD8), B cells, and the WBC count before and after eight weeks of the intake. There were no clinically significant adverse reactions or other notable results in the safety evaluation factors observed. Conclusion: This study has proven through its eight-week intake test and subsequent analysis that KRG boosts the immune system through an increase in T cells, B cells, and WBCs, and that it is safe according to the study's safety evaluation.

Comparison of ultrasonography guided serratus anterior plane block and thoracic paravertebral block in video-assisted thoracoscopic surgery: a prospective randomized double-blind study

  • Baytar, Merve Sena;Yilmaz, Canan;Karasu, Derya;Baytar, Cagdas
    • The Korean Journal of Pain
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    • 제34권2호
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    • pp.234-240
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    • 2021
  • Background: Various truncal block techniques with ultrasonography (USG) are becoming widespread to reduce postoperative pain and opioid requirements in video-assisted thoracoscopic surgery (VATS). The primary aim of our study was to determine whether the USG-guided serratus anterior plane block (SAPB) is as effective as the thoracic paravertebral block (TPVB) in VATS. Our secondary aim was to evaluate patient and surgeon satisfaction, block application time, first analgesic time, and length of hospital stay. Methods: Patients in Group SAPB received 0.4 mL/kg bupivacaine with a USG-guided SAPB, and patients in Group TPVB received 0.4 mL/kg bupivacaine with a USG-guided TPVB. We recorded the pain scores, the timing of the first analgesic requirement, the amount of tramadol consumption, and postoperative complications for 24 hours. We also recorded the block application time and length of hospital stay. Results: A total of 62 patients, with 31 in each group (Group SAPB and Group TPVB) completed the study. Between the two groups, there were no significant differences in rest and dynamic pain visual analog scale scores at 0, 1, 6, 12, and 24 hours after surgery. The total consumption of tramadol was significantly lower in the TPVB group (P = 0.026). The block application time was significantly shorter in Group SAPB (P < 0.001). Conclusions: An SAPB that is applied safely and rapidly as a part of multimodal analgesia in patients who undergo VATS is not inferior to the TPVB and can be an alternative to it.

Effect of Marham-i-Raal on Episiotomy Wound Healing: A Single-Arm pre-and post-treatment study

  • Sultana, Arshiya;Joonus, Aynul Fazmiya Mohamed;Rahman, Khaleequr
    • 셀메드
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    • 제11권4호
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    • pp.17.1-17.4
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    • 2021
  • Episiotomy is the commonest obstetrics intervention in the world to reduce severe perineal injuries. Its prevalence is 43% to 100% in primiparous women in Asia. Further, worldwide approximately 10-95% of pregnant women undergo episiotomy incision during birth. Delay in wound healing probably increases the risk of wound infection, changes the muscular structure, and ultimately causes muscle tone loss. So, wound care is of specific significance to postnatal maternal outcomes. Hence, this case study aimed to evaluate the effect of Marham-i-Raal in episiotomy wound healing and pain relief. The study was conducted in eleven postpartum primi or multipara pregnant women aged between group 19 and 35 years with term gestational age, singleton pregnancy in a cephalic presentation who had a normal vaginal delivery with mediolateral episiotomy, without a perineal tear, and perineal hematoma. Externally, application of Marham-i-Raal 2g on episiotomy incisional wound, twice a day for 10 days was advised. Wound healing of episiotomy and pain intensity was assessed with REEDA ["redness, oedema, ecchymosis, discharge and approximation of the edges"] scoring and VAS scoring for pain intensity respectively. At one hour (baseline), the REEDA mean score of eleven patients was 3.90±1.04 whereas on day 7-10 it was 0.18±0.40 with statistically significant difference (p<0.001). The VAS mean score at one hour was 6.90±1.22 whereas on day 7-10 it was 0.72±0.78 with a statistically significant difference (p<0.001). Marham-i-Raal would be effective in episiotomy wound healing and reducing pain intensity. Further, randomized double-blind controlled trials in large sample size are recommended.

A plant-based multivitamin, multimineral, and phytonutrient supplementation enhances the DNA repair response to metabolic challenges

  • Yeo, Eunji;Hong, Jina;Kang, Seunghee;Lee, Wonyoung;Kwon, Oran;Park, Eunmi
    • Journal of Nutrition and Health
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    • 제55권4호
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    • pp.450-461
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    • 2022
  • Purpose: DNA damage and repair responses are induced by metabolic diseases and environmental stress. The balance of DNA repair response and the antioxidant system play a role in modulating the entire body's health. This study uses a high-fat and high-calorie (HFC) drink to examine the new roles of a plant-based multivitamin/mineral supplement with phytonutrients (PMP) for regulating the antioxidant system and cellular DNA repair signaling in the body resulting from metabolic stress. Methods: In a double-blind, randomized, parallel-arm, and placebo-controlled trial, healthy adults received a capsule containing either a PMP supplement (n = 12) or a placebo control (n = 12) for 8 weeks. Fasting blood samples were collected at 0, 1, and 3 hours after consuming a HFC drink (900 kcal). The blood samples were analyzed for the following oxidative stress makers: areas under the curve reactive oxygen species (ROS) levels, plasma malondialdehyde (MDA), erythrocytes MDA, urinary MDA, oxidized low-density lipoprotein, and the glutathione:oxidized glutathione ratio at the time points. We further examined the related protein levels of DNA repair signaling (pCHK1 (Serine 345), p-P53 (Serine 15), and 𝛄H2AX expression) in the plasma of subjects to evaluate the time-dependent effects of a HFC drink. Results: In a previous study, we showed that PMP supplementation for eight weeks reduces the ROS and endogenous DNA damage in human blood plasma. Results of the current study further show that PMP supplementation is significantly correlated with antioxidant defense. Compared to the placebo samples, the blood plasma obtained after PMP supplementation showed enhanced DNA damage response genes such as pCHK1(Serine 345) (a transducer of DNA response) and 𝛄H2AX (a hallmark of DNA damage) during the 8 weeks trial on metabolic challenges. Conclusion: Our results indicate that PMP supplementation for 8 weeks enhances the antioxidant system against oxidative stress and prevents DNA damage signaling in humans.

펄스자기장이 위팔 두갈래근의 지연성 근육통에 미치는 영향 (The Influences of Pulsed Electromagnetic Field Treatment Following Experimentally Induced Delayed-Onset Muscle Soreness in Biceps Brachii)

  • 강선영;박주희;전혜선;이현숙
    • 한국전문물리치료학회지
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    • 제20권2호
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    • pp.11-19
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    • 2013
  • Delayed onset muscle soreness (DOMS) is a painful condition that arises from exercise-induced muscle damage after unaccustomed physical activities. Various therapeutic interventions have been applied to reduce the intensity and duration of DOMS-related symptoms. Recently, pulsed electromagnetic field (PEMF) intervention has been introduced as an alternative noninvasive treatment for DOMS. This randomized, double-blind, placebo-controlled experiment was conducted to examine the effects of PEMF therapy on DOMS in elbow flexors at 24, 48, and 72 hours after the experimental DOMS induction. Thirty healthy volunteers ($23{\pm}2.4$ yrs, $175{\pm}5.7$ cm, and $74{\pm}7.8$ kg) participated in this study. Each was randomly assigned to a PEMF or placebo group. On the first day, DOMS was induced in the elbow flexors by repeated isokinetic motions at low ($60^{\circ}/s$) and fast ($120^{\circ}/s$) speeds in all subjects. Thereafter, the PEMF group received 15-min daily treatment with a PEMF device. The placebo group received sham treatment of the same duration. Overall, PEMF application was more effective than the sham treatment in reducing the physiological symptoms associated with the DOMS including perceived soreness, median frequency, and electromechanical delay of the surface electromyography. In addition, median frequency and isokinetic peak torque of the PEMF group recovered to the pre-DOMS induction level earlier than the placebo group. In conclusion, this study suggests that PEMF can be applied as a new recovery strategy in reducing DOMS symptoms. Further experiments are required to examine the effect of the PEMF treatment on different types of exercise conditions and to determine the optimal treatment dosage and duration in a real clinical setting.

Phaseolus vulgaris, Garcinia cambogia (HCA)가 함유된 다이어트 식이 조성물의 체지방 개선 및 체중 변화에 미치는 영향 (Effects of a Dietary Supplement Consisting of Phaseolus vulgaris and Garcinia cambogia (RCA) on the Lipid Level and Body Weight)

  • 김유희;유재욱;이유진;김경범;조대헌;황진영
    • 한국식품영양과학회지
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    • 제33권3호
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    • pp.518-522
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    • 2004
  • 이에 본 연구에서는 한국인에 적합한 비만 개선책을 찾고자 지방흡수억제 기능과 과잉의 탄수화물 흡수 억제 기전이 함께 작용하는 방법으로서 강낭콩(white kidney bean, Phaseolus vulgaris)에서 $\alpha$-amylases 활성을 저해하는 탄수화물 흡수 억제하는 추출물과 지방산과 콜레스테롤 합성에 관여하는 효소의 저해제인 HCA(hydroxycitric acid)를 함유하여 지방 합성을 저해, 식욕 억제 효과와 지방의 분해 촉진을 유도하는 가르시니아 캄보지아(Garcinia cambogia), 그리고 배변 활동을 원활하게 하도록 도움을 주는 수용성 식이 섬유(microstalline cellulose) 등을 배합하여 비만 개선용 다이어트 식이 조성물을 제조한 후 임상 실험을 수행한 결과 체중과 체지방 지수에서 유의한 감소효과를 얻을 수 있었다. 이들 결과를 종합하면, 강낭콩 추출물인 파제올라민과 가르시니아 캄보지아 추출물의 지방 합성 저해 효과, 그리고 수용성 식이 섬유 등을 첨가하여 제조한 비만 개선용 다이어트 식이 조성물이 임상실험에서 체중 증가를 효과적으로 억제할 수 있음을 관찰할 수 있었으며, 이는 현대 성인 질병 가운데 하나인 비만을 효과적으로 예방, 치료할 수 있는 다이어트 식이로 유용할 것으로 사료된다.

A comparison of the efficacy of amoxicillin and nasal irrigation in treatment of acute sinusitis in children

  • Khoshdel, Abolfazl;Panahande, Gholam Reza;Noorbakhsh, Mohamad Kazem;Ahmadi, Mohamad Reza Malek;Lotfizadeh, Masoud;Parvin, Neda
    • Clinical and Experimental Pediatrics
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    • 제57권11호
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    • pp.479-483
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    • 2014
  • Purpose: The efficacy of antibiotic therapy for acute sinusitis is controversial. This study aimed to compare the efficacies of amoxicillin with nasal irrigation and nasal irrigation alone for acute sinusitis in children. Methods: This randomized, double-blind, controlled study included 80 children aged 4-15 years with a clinical presentation of acute sinusitis. Patients were randomly assigned to receive either amoxicillin (80 mg/kg/day) in 3 divided doses orally for 14 days with saline nasal irrigation (for 5 days) and 0.25% phenylephrine (for 2 days) or the same treatment without amoxicillin. Clinical improvements in their initial symptoms were assessed on days 3, 14, 21, and 28. Results: On day 3, patients in the amoxicillin with nasal irrigation group showed significant clinical improvement (P=0.001), but there was no significant difference in the degree of improvement between the amoxicillin with nasal irrigation and nasal irrigation alone groups during follow-up (P>0.05). In addition, no significant differences were seen in age, sex, and degree of improvement between groups (P>0.05). Conclusion: High-dose amoxicillin with saline nasal irrigation relieved acute sinusitis symptoms faster and more often than saline nasal irrigation alone. However, antibiotic treatment for acute sinusitis confers only a small therapeutic benefit over nasal irrigation.

중풍 환자의 하지 경직에 대한 자하거 약침의 효과 연구 (The effect of Hominis Placenta Pharmacopuncture on Leg spasticity of stroke patients (A Pilot study, Double blind, Randomized, Controlled Clinical Trial))

  • 노주환;박정아;윤현민;장경전;송춘호;안창범;김철홍
    • 대한약침학회지
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    • 제12권4호
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    • pp.97-110
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    • 2009
  • Objective : The purpose of this study is to determine the effect of Hominis Placenta Pharmacopuncture(HPP) on lower limb spasticity control in stroke patients. Methods : Twenty stroke patients with Leg spasticity were randomly divided into two groups, a Distilled water Pharmacopuncture(group I) and a HPP(group II). The number of Pharmacopuncture was 5 times a week and acupuncture treatment was 3 times a week for 3 weeks. Modified Ashworth Scale(MAS), H-reflex/M-response ratio(H/M ratio), Berg Balance Scale(BBS) and Time Up & Go(TUG) were used for evaluation of spasticity control before experiment, after 1 week, 2 weeks, 3 weeks. Results : Group I showed significant improvement(p$<$.05) in BBS but no significant improvement in MAS, H/M ratio, and TUG. Group II showed significant improvement(p$<$.05) in MAS, BBS, and TUG, but no significant improvement in H/M ratio. The results showed significant difference in TUG, but no significant difference in MAS, H/M ratio and BBS between 2 groups. Conclusion : These results showed that HPP might decrease lower limb spasticity and increase leg motor function in stroke patients. Further studies will be required to examine more cases in the long period for the effect on lower limb in spasticity by HPP.