• 제목/요약/키워드: Placebo

검색결과 976건 처리시간 0.035초

Effects of the Short Foot Exercise With Neuromuscular Electrical Stimulation on Navicular Height in Flexible Flatfoot in Thailand: A Randomized Controlled Trial

  • Namsawang, Juntip;Eungpinichpong, Wichai;Vichiansiri, Ratana;Rattanathongkom, Somchai
    • Journal of Preventive Medicine and Public Health
    • /
    • 제52권4호
    • /
    • pp.250-257
    • /
    • 2019
  • Objectives: Flatfoot, or low medial longitudinal arch, contributes to back and lower extremity injuries and is caused by weak abductor hallucis (AbdH) muscles. The purpose of this study was to investigate the effects of short foot exercise (SFE) alone or with neuromuscular electrical stimulation (NMES) on navicular height, the cross-sectional area (CSA) of the AbdH muscle, and AbdH muscle activity in flexible flatfoot. Methods: Thirty-six otherwise healthy people with flexible flatfoot were randomly assigned to a group that received SFE with placebo NMES treatment (the control group) or a group that received both SFE and NMES treatment (the experimental group). Each group received 4 weeks of treatment (SFE alone or SFE with NMES). Navicular height, the CSA of the AbdH muscle, and AbdH muscle activity were assessed before and after the intervention. Results: No significant differences were found in navicular height or the CSA of the AbdH muscle between the control and experimental groups, while AbdH muscle activity showed a statistically significant difference between the groups ($SFE=73.9{\pm}11.0%$ of maximal voluntary isometric contraction [MVIC]; SFE with $NMES=81.4{\pm}8.3%$ of MVIC; p<0.05). Moreover, the CSA of the AbdH muscle showed a statistically significant increase after treatment in the SFE with NMES group ($pre-treatment=218.6{\pm}53.2mm^2$ ; $post-treatment=256.9{\pm}70.5mm^2$ ; p<0.05). Conclusions: SFE with NMES was more effective than SFE alone in increasing AbdH muscle activity. Therefore, SFE with NMES should be recommended to correct or prevent abnormalities in people with flexible flatfoot by a physiotherapist or medical care team.

Preventive Effects of Fluoride Gel Application on Dental Caries in the Permanent Tooth: A Systematic Review of Randomized Controlled Trials

  • Do, Kyung-Yi;Lee, Eun-Sun
    • 치위생과학회지
    • /
    • 제19권1호
    • /
    • pp.9-22
    • /
    • 2019
  • Background: The purpose of this systematic review was to investigate the effects of topical fluoride gel application on dental caries prevention in the permanent teeth of children and adolescents. Methods: We searched the EMBASE, PubMed, and Cochrane Library databases for randomized controlled trials (RCTs) assessing the effects of self-applied or professionally applied topical fluoride gels in patients <18 years of age; the search was completed on April 1, 2018. All included trials involved an experimental group (fluoride gel application) and a control group (placebo or no treatment). The outcome measures were the D(M)FS and D(M)FT indices, which were compared between the two groups. Review Manager software was used for quantitative synthesis of the final selected articles, and a forest plot was generated via a meta-analysis conducted using a random effects model. Results: The results showed that the D(M)FS and D(M)FT indices were lower in the fluoride application group than in the control group, thus indicating that fluoride gel application was effective in dental caries prevention. We also performed a subgroup analysis to determine whether the effects of fluoride application differed if patients received oral prophylaxis (self or professional) before fluoride gel application. Therefore, the two groups showed slightly larger differences when studies without oral prophylaxis before fluoride gel application were considered; however, the difference was not statistically significant. Conclusion: These findings should be utilized to raise awareness about the caries-prevention effects of topical fluoride application among patients and guardians. Further RCTs should evaluate the effects of fluoride application with or without preceding oral prophylaxis, and appropriate fluoride application guidelines should be developed to maximize the effects of fluoride application in clinical practice.

Pharmacological Treatment of Major Depressive Episodes with Mixed Features: A Systematic Review

  • Shim, In Hee;Bahk, Won-Myong;Woo, Young Sup;Yoon, Bo-Hyun
    • Clinical Psychopharmacology and Neuroscience
    • /
    • 제16권4호
    • /
    • pp.376-382
    • /
    • 2018
  • We reviewed clinical studies investigating the pharmacological treatment of major depressive episodes (MDEs) with mixed features diagnosed according to the dimensional criteria (more than two or three [hypo]manic symptoms+principle depressive symptoms). We systematically reviewed published randomized controlled trials on the pharmacological treatment of MDEs with mixed features associated with mood disorders, including major depressive disorder (MDD) and bipolar disorder (BD). We searched the PubMed, Cochrane Library, and ClinicalTrials.gov databases through December 2017 with the following key word combinations linked with the word OR: (a) mixed or mixed state, mixed features, DMX, mixed depression; (b) depressive, major depressive, MDE, MDD, bipolar, bipolar depression; and (c) antidepressant, antipsychotic, mood stabilizer, anticonvulsant, treatment, medication, algorithm, guideline, pharmacological. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We found few randomized trials on pharmacological treatments for MDEs with mixed features. Of the 36 articles assessed for eligibility, 11 investigated MDEs with mixed features in mood disorders: six assessed the efficacy of antipsychotic drugs (lurasidone and ziprasidone) in the acute phase of MDD with mixed features, although four of these were post hoc analyses based on large randomized controlled trials. Four studies compared antipsychotic drugs (olanzapine, lurasidone, and ziprasidone) with placebo, and one study assessed the efficacy of combination therapy (olanzapine+fluoxetine) in the acute phase of BD with mixed features. Pharmacological treatments for MDEs with mixed features have focused on antipsychotics, although evidence of their efficacy is lacking. Additional well-designed clinical trials are needed.

Bright Light Therapy in the Morning or at Mid-Day in the Treatment of Non-Seasonal Bipolar Depressive Episodes (LuBi): Study Protocol for a Dose Research Phase I / II Trial

  • Geoffroy, Pierre Alexis;El Abbassi, El Mountacer Billah;Maruani, Julia;Etain, Bruno;Lejoyeux, Michel;Amad, Ali;Courtet, Philippe;Dubertret, Caroline;Gorwood, Philip;Vaiva, Guillaume;Bellivier, Frank;Chevret, Sylvie
    • Psychiatry investigation
    • /
    • 제15권12호
    • /
    • pp.1188-1202
    • /
    • 2018
  • Objective This study protocol aims to determine, using a rigorous approach in patients with bipolar disorder (BD) and non-seasonal major depressive episode (MDE), the characteristics of bright light therapy (BLT) administration (duration, escalation, morning and mid-day exposures) depending on the tolerance (hypomanic symptoms). Methods Patients with BD I or II and treated by a mood stabilizer are eligible. After 1 week of placebo, patients are randomized between either morning or mid-day exposure for 10 weeks of active BLT with glasses using a dose escalation at 7.5, 10, 15, 30 and 45 minutes/day. A further follow-up visit is planned 6 months after inclusion. Patients will be included by cohorts of 3, with at least 3 days of delay between them, and 1 week between cohorts. If none meet a dose limiting toxicity (DLT; i.e hypomanic symptoms), the initiation dose of the next cohort will be increased. If one patient meet a DLT, an additionnal cohort will start at the same dose. If 2 or 3 patients meet a DLT, from the same cohort or from two cohorts at the same dose initiation, the maximum tolerated dose is defined. This dose escalation will also take into account DLTs observed during the intra-subject escalation on previous cohorts, with a "Target Ceiling Dose" defined if 2 DLTs occured at a dose. Discussion Using an innovative and more ergonomic device in the form of glasses, this study aims to better codify the use of BLT in BD to ensure a good initiation and tolerance.

Evaluation of efficacy of Valsalva maneuver for attenuating propofol injection pain: a prospective, randomized, single blind, placebo controlled study

  • Kumar, Sanjay;Khuba, Sandeep;Agarwal, Anil;Gautam, Sujeet;Yadav, Madhulika;Dixit, Aanchal
    • Korean Journal of Anesthesiology
    • /
    • 제71권6호
    • /
    • pp.453-458
    • /
    • 2018
  • Background: Pain on injection is a limitation with propofol use. The effect of the Valsalva maneuver on pain during propofol injection has not been studied. This maneuver reduces pain through the sinoaortic baroreceptor reflex arc and by distraction. We aimed to assess the efficacy of the Valsalva maneuver in reducing pain during propofol injection. Methods: Eighty American Society of Anesthesiologists class I adult patients undergoing general anesthesia were enrolled and divided into two groups of 40 each. Group I (Valsalva) patients blew into a sphygmomanometer tube raising the mercury column up to 30 mmHg for 20 seconds, while Group II (Control) patients did not. Anesthesia was induced with 1% propofol immediately afterwards. Pain was assessed on a 10-point visual analog scale (VAS), where 0 represented no pain, and 10, the worst imaginable pain, and a 4-point withdrawal response score, where 0 represented no pain, and 3, the worst imaginable pain. Scores were presented as median (interquartile range). Results: We analyzed the data of 70 patients. The incidence of pain was significantly lower in the Valsalva than in the control group (53% vs. 78%, P = 0.029). The withdrawal response score was significantly lower in the Valsalva group (1.00 [0.00-1.00] vs. 2.00 [2.00-3.00], P < 0.001). The VAS score was significantly lower in the Valsalva group (1.00 [0.00-4.00] vs. 7.00 [6.25-8.00], P < 0.001). Conclusions: A prior Valsalva maneuver is effective in attenuating injection pain due to propofol; it is advantageous in being a non-pharmacological, safe, easy, and time-effective technique.

경증의 퇴행성 슬관절염에 대한 초피나무잎 추출물의 유효성 및 안전성 평가: 무작위 배정, 이중맹검, 위약대조 임상연구 (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)

  • 정지홍;이수환;윤홍렬;김순중
    • 한방재활의학과학회지
    • /
    • 제31권4호
    • /
    • pp.167-191
    • /
    • 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.

항암화학요법 유발 말초신경병증에 대한 한약의 치료 효과: 체계적 문헌고찰 및 메타 분석 (The Therapeutic Efficacy of Herbal Medicine for Chemotherapy-Induced Peripheral Neuropathy: A Systematic Review and Meta-Analysis)

  • 김은혜;윤지현;이지영;윤성우
    • 대한암한의학회지
    • /
    • 제25권2호
    • /
    • pp.23-36
    • /
    • 2020
  • Objective: This study was aimed to report the therapeutic effects of herbal medicine on chemotherapy-induced peripheral neuropathy (CIPN). Methods: The prior studies were searched from the databases included PubMed, Cochrane Library, EMBASE, CNKi, CiNii, KISS, NDSL, KMBASE, and OASIS until September 2020. The main search keywords were chemotherapy, peripheral neuropathy, and herbal medicine, and only randomized controlled trials that analyzed the therapeutic efficacy of herbal medicine were included. The Cochrane's Risk of Bias was used for assessment of the risk of bias and the Review Manager 5.3 program was used for meta-analysis. Meta-analyses were grouped by the administration routes of herbal medicines (oral administration or topical use). Results: Nine studies with a total of 563 participants were included. Compared with usual care, the effective rate was higher in oral administrated herbal medicine (RR 1.67, 95% CI 1.25 to 2.23; p<0.001, I2=31%). In addition, topical herbal medicine showed an significantly higher effective rate than placebo (RR 2.20, 95% CI 1.52 to 3.18; p<0.001, I2=0%) and usual care (RR 2.24, 95% CI 1.74 to 2.89; p<0.001, I2=66%). There was no severe adverse effect in all participants. Conclusions: Herbal medicine appears to improve neuropathy caused by chemotherapy in cancer patients more than conventional therapy of CIPN. However, as there is heterogeneity between the included studies and a lack of blinding, further well-designed researches are more needed.

Vitamin D Effect on Ultrasonography and Laboratory Indices and Biochemical Indicators in the Blood: an Interventional Study on 12 to 18-Year-Old Children with Fatty Liver

  • Namakin, Kokab;Hosseini, Mahya;Zardast, Mahmoud;Mohammadifard, Mahyar
    • Pediatric Gastroenterology, Hepatology & Nutrition
    • /
    • 제24권2호
    • /
    • pp.187-196
    • /
    • 2021
  • Purpose: The rising prevalence of childhood obesity in the past decades has caused non-alcoholic fatty liver disease (NAFLD) to become the most common cause of pediatric chronic liver disease worldwide. This study was aimed at determining the effect of vitamin D (Vit D) on ultrasonography and laboratory indices of NAFLD and some blood biochemical indicators in children. Methods: In this interventional study liver ultrasonography was performed in 200 children with overweight and obesity. A 108 had fatty liver among which 101 were randomly divided into two groups of study (n=51) and control (n=50). The study group was treated with Vit D, 50000 U once a week whereas the control group received placebo with the same dose and package, both for 12 weeks. At the end of the intervention lab tests and ultrasound study was performed once again to evaluate the response to treatment. Results: It was found out that Vit D supplementation improved the fatty liver grade in the study group. The mean changes in hemoglobin (Hb), uric acid, highdensity lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), insulin, albumin and alanine aminotransferase (ALT) was significantly higher in the study group compared to controls (p<0.05). After the intervention and means adjustment, a significant difference was obtained in HDL-C, insulin, LDL-C and homeostasis model assessment of insulin resistance (HOMA-IR) between the two groups. Conclusion: Vit D supplementation in addition to improving the fatty liver grade in ultrasonography and increasing the blood Vit D level, increases the HDL and Hb level besides decreasing uric acid, LDL, HOMA-IR, insulin and ALT levels.

FES와 과제지향 훈련이 뇌졸중 환자의 복부근 두께와 균형에 미치는 영향 (The Effect of Task Oriented Exercise and Abdominal Muscle Contraction using FES on Abdominal Muscle Thickness and Balance of Stroke Patients)

  • 홍종윤;이효정
    • 정형스포츠물리치료학회지
    • /
    • 제14권2호
    • /
    • pp.117-126
    • /
    • 2018
  • Purpose: The purpose of this study was to evaluate the effect of task-oriented exercise and abdominal muscle contraction using functional electrical stimulation (FES) on abdominal muscle thickness and balance of stroke patients. Methods: Ten stroke patients who met the selection criteria were assigned randomly into two groups of five. One group received FES therapy before task-oriented training (experimental group), while the other group received a FES placebo before task-oriented training (control group). The Mann-Whitney U test was used to compare the groups, and the Wilcoxon Signed-ranks test was used to compare differences between the groups before and after intervention. The Mann-Whitney U test was used to compare the rate changes of each item before and after intervention, between the two groups. Results: In the rectus abdominalis and external oblique muscle thickness tests that used ultrasound, there was a statistically significant difference in the experimental group (p<.05),but no significant difference in the control group (p>.05). There was also a significant difference between the groups (p<.05). In the Balance test that used the Berg Balance Scale (BBS) and timed up and go test (TUG), there was a statistically significant difference in the experimental and control groups (p<.05), but there was no significant difference between the groups (p>.05). Conclusions: FES therapy before task-oriented training increases the thickness of abdominal muscles and improves balance abilities.

Transcranial direct current stimulation for spinal cord injury-associated neuropathic pain

  • Li, Caixia;Jirachaipitak, Sukunya;Wrigley, Paul;Xu, Hua;Euasobhon, Pramote
    • The Korean Journal of Pain
    • /
    • 제34권2호
    • /
    • pp.156-164
    • /
    • 2021
  • Several types of pain occur following spinal cord injury (SCI); however, neuropathic pain (NP) is one of the most intractable. Invasive and non-invasive brain stimulation techniques have been studied in clinical trials to treat chronic NP following SCI. The evidence for invasive stimulation including motor cortex and deep brain stimulation via the use of implanted electrodes to reduce SCI-related NP remains limited, due to the small scale of existing studies. The lower risk of complications associated with non-invasive stimulation, including transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), provide potentially attractive alternative central neuromodulation techniques. Compared to rTMS, tDCS is technically easier to apply, more affordable, available, and potentially feasible for home use. Accordingly, several new studies have investigated the efficacy of tDCS to treat NP after SCI. In this review, articles relating to the mechanisms, clinical efficacy and safety of tDCS on SCI-related NP were searched from inception to December 2019. Six clinical trials, including five randomized placebo-controlled trials and one prospective controlled trial, were included for evidence specific to the efficacy of tDCS for treating SCI-related NP. The mechanisms of action of tDCS are complex and not fully understood. Several factors including stimulation parameters and individual patient characteristics may affect the efficacy of tDCS intervention. Current evidence to support the efficacy of utilizing tDCS for relieving chronic NP after SCI remains limited. Further strong evidence is needed to confirm the efficacy of tDCS intervention for treating SCI-related NP.