• 제목/요약/키워드: randomized clinical trial

검색결과 885건 처리시간 0.026초

Evaluation of the Efficacy of Methylprednisolone, Etoricoxib and a Combination of the Two Substances to Attenuate Postoperative Pain and PONV in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective, Randomized, Placebo-controlled Trial

  • Gautam, Sujeet;Agarwal, Amita;Das, Pravin Kumar;Agarwal, Anil;Kumar, Sanjay;Khuba, Sandeep
    • The Korean Journal of Pain
    • /
    • 제27권3호
    • /
    • pp.278-284
    • /
    • 2014
  • Background: Establishment of laparoscopic cholecystectomy as an outpatient procedure has accentuated the clinical importance of reducing early postoperative pain, as well as postoperative nausea and vomiting (PONV). We therefore planned to evaluate the role of a multimodal approach in attenuating these problems. Methods: One hundred and twenty adult patients of ASA physical status I and II and undergoing elective laparoscopic cholecystectomy were included in this prospective, randomized, placebo-controlled study. Patients were divided into four groups of 30 each to receive methylprednisolone 125 mg intravenously or etoricoxib 120 mg orally or a combination of methylprednisolone 125 mg intravenously and etoricoxib 120 mg orally or a placebo 1 hr prior to surgery. Patients were observed for postoperative pain, fentanyl consumption, PONV, fatigue and sedation, and respiratory depression. Results were analyzed by the ANOVA, a Chi square test, the Mann Whitney U test and by Fisher's exact test. P values of less than 0.05 were considered to be significant. Results: Postoperative pain and fentanyl consumption were significantly reduced by methylprednisolone, etoricoxib and their combination when compared with placebo (P<0.05). The methylprednisolone + etoricoxib combination caused a significant reduction in postoperative pain and fentanyl consumption as compared to methylprednisolone or etoricoxib alone (P<0.05); however, there was no significant difference between the methylprednisolone and etoricoxib groups (P>0.05). The methylprednisolone and methylprednisolone + etoricoxib combination significantly reduced the incidence and severity of PONV and fatigue as well as the total number of patients requiring an antiemetic treatment compared to the placebo and etoricoxib (P<0.05). Conclusions: A preoperative single-dose administration of a combination of methylprednisolone and etoricoxib reduces postoperative pain along with fentanyl consumption, PONV, antiemetic requirements and fatigue more effectively than methylprednisolone or etoricoxib alone or a placebo.

두통에 대한 이혈 방혈요법의 유효성 분석: 체계적 문헌고찰 및 메타분석 (Effectiveness of Auricular Blood-letting Therapy for Headaches: A Systematic Review and Meta-Analysis)

  • 이경은;박민령;이지원;황인준;이보람;서종철;권찬영
    • 동의신경정신과학회지
    • /
    • 제34권3호
    • /
    • pp.259-274
    • /
    • 2023
  • Objectives: The purpose of this study was to provide clinical evidence to support the use of auricular blood-letting therapy (ABT) for headaches. Methods: Studies were identified by a comprehensive search of five databases. Randomized controlled trials (RCTs) that investigated the effects of the ABT for headaches were included. Two authors independently extracted the data and assessed the methodological quality of the included studies using Cochrane's risk-of-bias tool. If two or more studies reported the same outcome, a meta-analysis was performed. Meta-analysis results for dichotomous variables are expressed as risk ratios (RRs) and 95% confidence intervals (CIs). Results: A total of eight RCTs were included in this review. The total effective rate (TER) was the most commonly used outcome measurement. Among the eight RCTs, five were included in the metaanalysis. The TER was not statistically significantly different in the ABT group compared to the medication group (two studies, n=55, RR=1.24, 95% CI: 0.78 to 1.96, p=0.36, I2 =86%). However, the TER of the combined ABT and medication group was significantly different compared to the medication alone group (four studies, n=159, RR=1.23, 95% CI: 1.12 to 1.35, p<0.0001, I2 = 0%). Pain and mental health-related outcomes in the combined ABT and medication group were significantly different from the control groups. The methodological quality of the included RCTs was generally low. Conclusions: ABT combined with medication may be effective for treating headaches. However, the number of studies included was small, so the results were insufficient, and statistically significant effects were not confirmed for a single implementation of ABT. Thus, well-designed further studies based on the findings of this study are recommended.

Efficacy of intraosseous saline injection for pain management during surgical removal of impacted mandibular third molars: a randomized double-blinded clinical trial

  • Jawahar Babu. S;Naveen Kumar Jayakumar;Pearlcid Siroraj
    • Journal of Dental Anesthesia and Pain Medicine
    • /
    • 제23권3호
    • /
    • pp.163-171
    • /
    • 2023
  • Background: Surgical extraction of impacted mandibular third molars is the most common procedure performed by oral surgeons. The procedure cannot be performed effectively without achieving profound anesthesia. During this procedure, patients may feel pain during surgical bone removal (at the cancellous level) or during splitting and luxation of the tooth, despite administration of routine nerve blocks. Administration of intraosseous (IO) lignocaine injections during third molar surgeries to provide effective anesthesia for pain alleviation has been documented. However, whether the anesthetic effect of lignocaine is the only reason for pain alleviation when administered intraosseously remains unclear. This conundrum motivated us to assess the efficacy of IO normal saline versus lignocaine injections during surgical removal of impacted mandibular third molars. The aim of this study was to assess the efficacy of IO normal saline as a viable alternative or adjunct to lignocaine for alleviation of intraoperative pain during surgical removal of impacted mandibular third molars. Methods: This randomized, double-blind, interventional study included 160 patients who underwent surgical extraction of impacted mandibular third molars and experienced pain during surgical removal of the buccal bone or sectioning and luxation of the tooth. The participants were divided into two groups: the study group, which included patients who would receive IO saline injections, and the control group, which included patients who would receive IO lignocaine injections. Patients were asked to complete a visual analog pain scale (VAPS) at baseline and after receiving the IO injections. Results: Of the 160 patients included in this study, 80 received IO lignocaine (control group), whereas 80 received IO saline (study group) following randomization. The baseline VAPS score of the patients and controls was 5.71 ± 1.33 and 5.68 ± 1.21, respectively. The difference between the baseline VAPS scores of the two groups was not statistically significant (P > 0.05). The difference between the numbers of patients who experienced pain relief following administration of IO lignocaine (n=74) versus saline (n=69) was not statistically significant (P > 0.05). The difference between VAPS scores measured after IO injection in both groups was not statistically significant (P >0.05) (1.05 ± 1.20 for the control group vs. 1.72 ± 1.56 for the study group) Conclusion: The study demonstrates that IO injection of normal saline is as effective as lignocaine in alleviating pain during surgical removal of impacted mandibular third molars and can be used as an effective adjunct to conventional lignocaine injection.

Effects of GV1001 on Language Dysfunction in Patients With Moderate-to-Severe Alzheimer's Disease: Post Hoc Analysis of Severe Impairment Battery Subscales

  • Hyuk Sung Kwon;Seong-Ho Koh;Seong Hye Choi;Jee Hyang Jeong;Hae Ri Na;Chan Nyoung Lee;YoungSoon Yang;Ae Young Lee;Jae-Hong Lee;Kyung Won Park;Hyun Jeong Han;Byeong C. Kim;Jinse Park;Jee-Young Lee;Kyu-Yong Lee;Sangjae Kim
    • 대한치매학회지
    • /
    • 제22권3호
    • /
    • pp.100-108
    • /
    • 2023
  • Background and Purpose: The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer's disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-to-severe AD. Methods: We performed a post hoc analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB-social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name-were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events. Results: In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. Conclusions: Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.

감기 임상연구의 최신 동향 및 평가도구에 관한 연구 (Study of Instruments for Assessment and Clinical Research Trends in Common Cold)

  • 양수영;변준섭;황지호;안정조;홍권의;강위창;이용구;박양춘
    • 대한한의학회지
    • /
    • 제29권2호
    • /
    • pp.165-181
    • /
    • 2008
  • Objectives: This study was conducted to help clinical studies for treating the common cold with Oriental medicine. We inspected tendencies of clinical studies of the common cold in western medicine and analyzed the assessing instruments for it by scrutinizing PubMed publications for the last five years. Materials and Methods: We inspected 32 theses and scrutinized their objectives, periods, participants, materials and methods, the instrument of assessment for the studies, and validity, reliability, criteria and symptom score for questionnaires, results and JADAD score. Results: 1. The median for total period of study was 7 months, the median for days of treatment was 7.5, and most studies were carried out during the winter/spring period, because of the enhanced risk of cold infections. 2. The studies focused on unorthodox medicines or new drug products, such as antipyretic analgesics (e.g. paracetamol), decongestant and bronchodilator (e.g. ephedrine), echinacea, antioxidants (e.g. zinc), probiotic bacteria and so on. 3. All theses except one had subjectscomposed of cold patients who were infected naturally. The median number of subjects for final analysis was 187. 4. 27 studies used survey as the instrument of assessment. Among these, only one thesis was verified for validity. 5. The mean of JADAD score was 4.41, suggesting most of theses of worth. 7 studies were assessed as ineffective. Conclusion: Recent studies of the common cold are focused on unorthodox medicines or new drug products, and it is necessary to provide an objective instrument for assessing common cold treatments.

  • PDF

소아 거식증 (Infantile Anorexia)의 한의학(韓醫學)적 치료에 관한 고찰 - 중의학(中醫學) 저널을 중심으로 - (A Literature Study on Treatment of Infantile Anorexia Based on Chinese Medical Journals)

  • 김희연;성우용;김기봉
    • 대한한방소아과학회지
    • /
    • 제27권4호
    • /
    • pp.87-98
    • /
    • 2013
  • Objectives The purpose of this study is to find a literature study of infantile anorexia clinical cases with Traditional Chinese Medicine (TCM) to utilize with Korean medicine treatment methods. Methods 5 TCM journals with the highest impact factors were searched and selected among the journals listed in www.cnki.net. The search keywords were, "Children's Anorexia", "Infantile Apositia", "Infantile Anorexia", "Anorexia Nervosa", and "child of anorexia". he search was limited to the publication date from 2000 to 2012. Results Total 20 studies were selected: Acupuncture (5), Herbal medicine (9), Complex Treatment (3), External Application (2) and Moxibustion (1). Among the Acupuncture related studies, 1 study tested the effect of Sifeng (EX-UE10, 四縫), 3 studies tested the effect of Sifeng (EX-UE10, 四縫) and other acupoints treatment together, and 1 study tested the effect of combination of other acupoints. In all these studies, the study groups showed better therapeutic effects compared to the control groups. The Herbal medicine related studies showed the improvement in appetite and weight as a result of Herbal Medicines treatment. Among the Complex Treatment related studies, 2 studies tested the effect of Acupuncture and Chiropractic co-treatment, 1 study tested the effect of Moxibustion and Herbal medicine co-treatment. In all these studies, symptoms of Infantile anorexia showed significantly improved. Other papers related to External Application and Moxibustion treatment were reported improving in appetite and had other the clinical effects as well. Conclusions Clinical studies testing the effect of TCM for the treatment of Infantile Anorexia have been conducted in small scales, and all the studies showed a certain level of symptom improvement of the patients in the study groups. These results implicate that the methods in Korean medicine can be highly potential treatment options for the treatment of Infantile Anorexia. Accurate and well-controlled studies in large scale would be required to prove the effect of Korean medicine for the treatment of patients with Infantile Anorexia.

피부 열전도 온도에 근거를 둔 거짓 뜸 개발 및 평가 연구 (Credibility of a Newly Developed Sham Moxibustion)

  • 장민기;윤은혜;정찬영;변혁;김은정;김경호;김갑성;이승덕
    • Journal of Acupuncture Research
    • /
    • 제27권1호
    • /
    • pp.117-127
    • /
    • 2010
  • Background : To demonstrate the efficacy of moxibustion therapy, randomized controled trials are required. But, clinical trials of moxibustion had limitations due to the absence of a sham moxibustion model for an appropriate placebo. Objectives : To develop a new sham moxibustion model based on the thermal characteristics of commercial indirect moxibustion, especially temperature, and to evaluate whether it could be applied in clinical trials. Methods : By applying heat insulation, we created a sham moxibustion device that was indistinguishable from a real one with the naked eye. It also stimulated heat but had inert remedial value. A clinical trial was performed on subjects to test double blinding. The subjects were randomly assigned into two groups, a treatment group and a sham group. Acupoint Zusanli($ST_{36}$) was used in each group for 3 times. A sham acupuncture credibility questionnaire was modified into a moxibustion credibility questionnaire and was filled out after treatment. Results : No major difference was detected in the subjects' baseline data. Most subjects and practitioners could not distinguish the sham moxibustion device from the real one. But, subjects who had experience of moxibustion therapy more likely to distinguish the sham moxibustion device from the real one than subjects who didn't have experience of moxibustion therapy. The treatment group showed a significant difference in the VAS(Visual Analog Scale) for intensity of sensation during treatment than that of the sham group. Conclusions : The sham moxibustion device in this study is proved sufficient and credible to be applied in investigations of the effect of moxibustion. But it is more appropriate for the people who don't have experience of moxibustion therapy.

본태성 진전에 대한 중의학 연구동향 (A Review on Treatment of Essential Tremor in Traditional Chinese Medicine)

  • 신아리;배영롱;임재유;이승환;김상호;임정화
    • 동의신경정신과학회지
    • /
    • 제28권2호
    • /
    • pp.95-107
    • /
    • 2017
  • Objectives: This study was performed to review studies on Essential Tremor (ET) in Traditional Chinese medicine (TCM). Methods: We reviewed papers in the China National Knowledge Infrastructure (CNKI) from 2007~2016. Search keywords were 原发性震颤, 特发性震颤, essential tremor and idiopathic tremor, and excluded non-clinical studies, non-related to ET or TCM studies, theses for degrees and non-Randomized Controlled Trial (RCT). The quality of the articles was assessed by Jadad scale and the Risk of Bias (RoB). Results: Thirteen studies were selected. 'Criteria for the diagnosis of ET' was most frequently used as diagnostic criteria. 'Tremor rating scale' was primarily used for outcome measurement. Meta-analysis of nine trials revealed the effective rate of acupuncture and Western medicine (WM+Acu) groups was significantly higher compared to the WM group (RR: 1.48, 95 percent CI: 1.20 to 1.82, p=0.0002, $I^2=0$ percent) and tremor rating scale was also significantly decreased in the treatment group (MD: -1.35, 95 percent CI: -2.17 to -0.54, p=0.001, $I^2=0$ percent). Also, effective rates of Electro-acupuncture (EA) and Chinese herbal medicine (CHM) groups were significantly higher than that of the WM group {(RR: 1.53, 95 percent CI: 1.22 to 1.92, p=0.0003, $I^2=0$ percent) in EA vs. WM and (RR: 1.35, 95 percent CI: 1.16 to 1.57, p<0.0001, $I^2=0$ percent) in CHM vs. WM}. However, the quality of selected clinical studies was poor. Conclusions: Treatment of ET in TCM may be more effective and safe than in Western medicine. Therefore, we hope this study will lead to further clinical research on treatment of ET in Korean medicine.

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

  • 김주연;김진성;박재우;류봉하
    • 대한한의학회지
    • /
    • 제34권3호
    • /
    • pp.13-24
    • /
    • 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.

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

  • 김희준;송범용;육태한
    • 대한약침학회지
    • /
    • 제12권3호
    • /
    • pp.31-40
    • /
    • 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.