scholarly journals First-In-Asian Double-Blind Randomized Trial To Assess The Efficacy And Safety Of Insulin Sensitizer In Nonalcoholic Steatohepatitis Patients

2021 ◽  
Author(s):  
Jee-Fu Huang ◽  
Chia-Yen Dai ◽  
Chung-Feng Huang ◽  
Pei-Chien Tsai ◽  
Ming-Lun Yeh ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Liver Steatosis ◽  
Liver Fat ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Insulin Sensitizer ◽  
Intention To Treat ◽  
End Of Treatment ◽  
Significant Difference ◽  
Treat Analysis

Abstract Background: The efficacy and safety of insulin sensitizer in Asians with non-alcoholic steatohepatitis (NASH) remain elusive. Aims: The double-blind, randomized, placebo-controlled trial was conducted aiming to investigate the efficacy and safety of pioglitazone in NASH patients. Methods: A total of 90 NASH patients (66 males, age= 44.1 ± 12.7 years) were prospectively randomized into oral pioglitazone 30 mg/day (Arm A) or placebo (Arm B) for 24 weeks. The primary endpoint was the efficacy of pioglitazone in reducing inflammation and liver fat at end-of-treatment (EOT). NASH resolution/improvement without fibrosis worsening were also evaluated.Results: At EOT, there was a significantly decline of alanine aminotransferase (86.9 ± 34.3 to 45.7 ± 35.8 IU/L, P=0.003) level in Arm A patients. In intention-to-treat analysis among 66 patients who completed paired biopsies, The NAFLD activity score (NAS) of 30 Arm A patients significantly decreased from 4.27 ± 1.14 at baseline to 2.53 ± 1.63 at EOT (P< 0.0001), whereas there was no significant change in patients of Arm B (3.94 ± 1.41 vs 3.94 ± 1.51, P= 1.0). NASH improvement without worsening of fibrosis was achieved in 46.7% (14/30) patients in Arm A, compared to 11.1% (4/36) patients in Arm B (P= 0.002). Liver fat content reduced (20.2 ± 9.0 to 14.3 ± 6.9%, P<0.0001) on MRI-PDFF in Arm A compared to their counterparts. No significant difference of adverse events occurred between groups. Conclusions: A 24-weeks pioglitazone treatment was well-tolerated and effective in improving liver histology and reducing liver steatosis in Asian NASH patients. (ClinicalTrials.gov number: NCT01068444)

scholarly journals Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Tsuyoshi Miyaoka ◽  
Motohide Furuya ◽  
Jun Horiguchi ◽  
Rei Wake ◽  
Sadayuki Hashioka ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Treatment Resistant ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Intention To Treat ◽  
The Difference ◽  
The Individual

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted.Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS).Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54:−0.23±0.08; placebo:−0.03±0.08,P<0.018), tension (TJ-54:−0.42±0.09; placebo:−0.18±0.09,P<0.045), and poor impulse control (TJ-54:−0.39±0.10; placebo:−0.07±0.10,P<0.037).Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

scholarly journals Levodopa+carbidopa in X-linked Dystonia Parkinsonism (XDP/DYT3/Lubag): A Randomized, Double-blind, Placebo-controlled Trial

2018 ◽  
Vol 52 (6) ◽  
Author(s):  
Roland Dominic G. Jamora ◽  
Rosalia A. Teleg ◽  
Cynthia P. Cordero ◽  
Rodelyn F. Villareal-Jordan ◽  
Lillian V. Lee ◽  
...  
Keyword(s):  
Rating Scale ◽  
Botulinum Toxin A ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Efficacy Analysis ◽  
Intention To Treat ◽  
Oral Medications ◽  
Significant Difference ◽  
Scale Scores

Objective. X-linked dystonia parkinsonism (XDP) is an adult-onset, progressive and debilitating movement disorder described among Filipino males from Panay Island. The available oral medications have been ineffective. While chemodenervation with botulinum toxin A works and deep brain stimulation surgery is promising, these are not affordable for the vast majority of patients. Thus, we decided to look into the efficacy, safety and tolerability of levodopa+carbidopa (levodopa) versus placebo among patients with XDP. Methods. This was a double blind, randomized, placebo-controlled clinical trial. Patients were randomized to receive levodopa or placebo for 6 months. The dose was increased gradually until 1000 mg levodopa/day is reached or until side effects appear. Results. A total of 86 out of 94 randomized patients (91.5%) were included in the intention-to-treat cohort for the primary efficacy analysis. Nineteen patients (9 in levodopa, 10 in placebo) dropped out or were lost to follow up. There was no significant difference in the baseline and last visit Burke Fahn Marsden Dystonia Rating Scale and the part III of the Unified Parkinson’s Disease Rating Scale scores between levodopa and placebo. The most common adverse events in the levodopa group were increased movements, pain and nausea/ vomiting. Conclusion. While levodopa is safe and well-tolerated, it does not have any effect in alleviating the dystonia or parkinsonism in XDP

scholarly journals 117. Adjunctive Daptomycin in the Treatment of staphylococcus Aureus Bacteremia

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S187-S187
Author(s):  
Matthew P Cheng ◽  
Alexander Lawandi ◽  
Guillaume Butler-Laporte ◽  
Samuel De L’Etoile-Morel ◽  
Katryn Paquette ◽  
...  
Keyword(s):  
Staphylococcus Aureus ◽  
Median Duration ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Absolute Difference ◽  
Double Blind ◽  
Intention To Treat ◽  
Care Treatment ◽  
Standard Of Care Treatment ◽  
Treat Analysis

Abstract Background Bloodstream infections (BSI) caused by methicillin-susceptible Staphylococcus aureus (MSSA) are associated with significant morbidity and mortality. The objective of our study was to determine whether daptomycin given in combination with an anti-staphylococcal beta-lactam improved outcomes in MSSA BSI. Methods A randomized, double blind, placebo-controlled trial was performed at two academic hospitals in Montreal, Canada. Patients ≥ 18 years of age with MSSA BSI receiving either cefazolin or cloxacillin monotherapy were considered for inclusion. In addition to the standard of care treatment, participants received a 5-day course of adjunctive daptomycin or placebo. The primary outcome was the duration of MSSA BSI in days. Results Of 318 participants screened, 115 were enrolled and 104 were included in the intention to treat analysis (median age 67 years; 34.5% female). The median duration of bacteremia was 2.04 days among patients who received daptomycin versus 1.65 days in those who received placebo (absolute difference 0.39 days, p=0.40). A modified intention to treat analysis involving participants who remained bacteremic at the time of enrollment found a median duration of bacteremia of 3.06 days among patients who received daptomycin versus 3.0 days in those who received placebo (absolute difference 0.06 days, p=0.77). Ninety-day mortality in the daptomycin arm was 18.9% vs. 17.7% in the placebo arm (p=1.0). There were no significant differences in the proportion of patients who developed renal failure, hepatotoxicity, or rhabdomyolysis between groups. Conclusion Among patients with MSSA BSI, the administration of adjunctive daptomycin therapy to standard of care treatment did not shorten the duration of bacteremia. Disclosures All Authors: No reported disclosures

scholarly journals Controlled Trial of 3-Day Quinine-Clindamycin Treatment versus 7-Day Quinine Treatment for Adult Travelers with Uncomplicated Falciparum Malaria Imported from the Tropics

2001 ◽  
Vol 45 (3) ◽  
pp. 932-935 ◽  
Author(s):  
Phillippe Parola ◽  
Stephane Ranque ◽  
Sekene Badiaga ◽  
Mohamadou Niang ◽  
Olivier Blin ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Controlled Trial ◽  
Cure Rate ◽  
Short Term ◽  
Double Blind ◽  
Intention To Treat ◽  
The Tropics ◽  
Severe Adverse Reactions ◽  
Cessation Of Treatment ◽  
Treat Analysis

ABSTRACT We conducted a randomized, double-blind, placebo-controlled trial to compare a 3-day quinine-clindamycin regimen (group QC) with a 7-day quinine regimen (group Q) for the treatment of uncomplicatedPlasmodium falciparum malaria in travelers returning from the tropics. A total of 55 and 53 patients in groups Q and QC were analyzed, respectively. Adverse effects were similar in both groups, although two patients in group Q had severe adverse reactions, leading to the cessation of treatment. The 28-day cure rate for the evaluated patients (per-protocol analysis) was 100% for group QC, whereas it was 96.3% for group Q (P = 0.5). The 28-day cure rate in the intention-to-treat analysis was 96.2% for group QC, whereas it was 94.6% for group Q (P = 1). There were no significant differences between the two regimens with regard to parasite and fever clearance times. Our study shows that the 3-day quinine-clindamycin regimen is well tolerated and compares favorably with a 7-day quinine treatment. This short-term regimen had previously been evaluated only in areas of endemicity. According to our results, the 3-day quinine-clindamycin regimen may be an alternative for the treatment of imported uncomplicated P. falciparum malaria in travelers returning from the tropics.

scholarly journals Therapeutic Effectiveness of Galphimia glauca in Young People with Social Anxiety Disorder: A Pilot Study

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Ofelia Romero-Cerecero ◽  
Ana Laura Islas-Garduño ◽  
Alejandro Zamilpa ◽  
Ma. Dolores Pérez-García ◽  
Jaime Tortoriello
Keyword(s):  
Anxiety Disorder ◽  
Social Anxiety ◽  
Social Anxiety Disorder ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
A Value ◽  
Double Blind Clinical Trial ◽  
End Of Treatment ◽  
Significant Difference

Social anxiety is one of the most common disorders found in the population attending the first level of health care. Galphimia glauca has been used for many years in Mexican traditional medicine to treat “nervous disorders”. A standardized extract of this species has been evaluated in clinical studies that have proven its efficacy and safety in patients with generalized anxiety disorder. In this work, a double-blind clinical trial was carried out, using sertraline as a control. Patients from both sexes (18 to 35 years old) with moderate or severe social anxiety were included. Experimental group was treated daily (orally), for 10 weeks, with an extract from G. glauca containing 0.374 mg/dose of Galphimine-B (G-B, active compound). Patients in the control group were given sertraline (50 mg) in the same conditions. All patients were evaluated every two weeks. Another assessment was done one month after the end of the administration period. A total of 34 patients was included, 17 in each group. Women were predominant, and the mean age was 25 ± 4.7 years. In patients who received the G. glauca standardized extract, a significant reduction in anxiety was observed, with a value (in the Brief Social Phobia Scale) of 41.1±10.3 points at the start and 11.2±5.6 points at the end of treatment, while patients treated with sertraline had a value of 37.7±7.3 points at the beginning and 11.1±5.2 points at the end. No significant difference was observed between the treated groups. In a similar way, the health scale showed a gradual and continuous improvement in each of the five evaluations. In conclusion, the 10-week oral administration of G. glauca standardized extract showed efficacy and safety in patients with social anxiety disorder, without showing a significant difference from patients treated with sertraline.

scholarly journals Effects and Safety of Gyejibongnyeong-Hwan on Dysmenorrhea Caused by Blood Stagnation: A Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Jeong-Su Park ◽  
Sunju Park ◽  
Chun-Hoo Cheon ◽  
Seong-Cheon Jo ◽  
Han Baek Cho ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Control Group ◽  
Menstrual Pain ◽  
Double Blind ◽  
Menstrual Cycles ◽  
Intention To Treat ◽  
Investigational Drugs ◽  
Significant Difference ◽  
Vas Scores

Objective. This study was a multicenter, randomized, double-blind, and controlled trial with two parallel arms: the GJBNH group and the placebo group. This trial recruited 100 women aging 18 to 35 years with primary dysmenorrhea caused by blood stagnation. The investigational drugs, GJBNH or placebo, were administered for two menstrual periods (8 weeks) to the participants three times per day. The participants were followed up for two menstrual cycles after the administration.Results. The results were analyzed by the intention-to-treat (ITT) dataset and the per-protocol (PP) dataset. In the ITT dataset, the change of the average menstrual pain VAS score in the GJBNH group was statistically significantly lower than that in the control group. Significant difference was not observed in the SF-MPQ score change between the GJBNH group and the placebo group. No significant difference was observed in the PP analyses. In the follow-up phase, the VAS scores of the average menstrual pain and the maximum menstrual pain continually decreased in the placebo group, but they increased in the GJBNH group.Conclusion. GJBNH treatment for eight weeks improved the pain of the dysmenorrhea caused by blood stagnation, but it should be successively administered for more than two menstrual cycles.Trial Registration. This trial is registered with Current Controlled Trials no.ISRCTN30426947.

scholarly journals Apatinib Mesylate in the treatment of advanced progressed lung adenocarcinoma patients with EGFR-TKI resistance —A Multicenter Randomized Trial

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Ping Fang ◽  
Liqin Zhang ◽  
Xianru Zhang ◽  
Jiawen Yu ◽  
Jun Sun ◽  
...  
Keyword(s):  
Lung Adenocarcinoma ◽  
Kinase Inhibitors ◽  
Controlled Trial ◽  
Objective Response ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Significant Difference ◽  
Tki Resistance ◽  
Egfr Tki

Abstract Few pieces of evidence have been published on the use of Apatinib Mesylate (AM) against EGFR-TKI resistance in lung adenocarcinoma (LA) patients. Here, we investigate the clinical efficacy and safety of AM in the treatment of advanced progressed epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) resistant LA patients. We conducted a double-blind, randomized controlled trial in 68 patients admitted to 18 hospitals of Anhui province in China. The efficacy and safety of AM treatment were evaluated in terms of progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR), as well as related adverse events (AE). A literature knowledge database analysis and a pathway model reconstruction were performed to decipher the relevant mechanism may be involved. Our results showed that, compared to the control group, AM presented improved efficacy in PFS (P = 0.033), ORR (P < 0.001), and DCR (P < 0.001). No significant difference was observed between case and control group in terms of AE, and no drug-related death occurred. Pathway analysis supports that Apatinib can be repurposed for the treatment of LA. Our results suggested that AM could be a potential option for advanced progressed LA patients to combat EGFR-TKI resistance.

scholarly journals Efficacy and Safety of Sahastara Remedy Extract Capsule in Primary Knee Osteoarthritis: A Randomized Double-Blinded Active-Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Narin Kakatum ◽  
Piya Pinsornsak ◽  
Puritat Kanokkangsadal ◽  
Buncha Ooraikul ◽  
Arunporn Itharat
Keyword(s):  
Blood Pressure ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Essential Medicine ◽  
Ethanolic Extract ◽  
Blood Chemistry ◽  
Osteoarthritis Of The Knee ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Significant Difference

Sahastara (SHT) remedy is a Thai traditional medicine described in the Thai National List of Essential Medicine (NLEM) for the relief of muscle pain. The purpose of this study was to investigate the efficacy and safety of SHT remedy extract capsule for treating primary OA. A phase 2, double-blind, randomized, and controlled trial study was used to determine the clinical efficacy and safety of SHT in comparison with diclofenac for the treatment of knee OA. The outcome of reduce pain was measured from VAS, 100 meter time walk, and the WOMAC score of day 14 and day 28 which should reduce significantly when compared with day 0 and should be equal with or better than diclofenac. Blood pressure and blood chemistry values at day 14 and day 28 did not change when compared with day 0. The results found that SHT remedy ethanolic extract capsule can reduce all OA knee scores at day 14 and day 28 significantly when compared with day 0 and also no significant difference with diclofenac ( P > 0.05 ). The SHT also showed safety values on blood pressure and blood chemistry. The SHT was observed that it had no serious side effect. The results of this study are the first report of using the SHT ethanolic extract capsule in the treatment of primary osteoarthritis of the knee. It can be recommended as an anti-inflammatory herbal drug for reducing pain in knee osteoarthritis patients.

scholarly journals Randomized, double-blind, three-arm, parallel-group study to compare the efficacy and safety of a single dose of 100 and 200 mg of mifepristone for cervical ripening in term pregnancies

2021 ◽  
Vol 10 (2) ◽  
pp. 428
Author(s):  
Leonardo J. Orozco ◽  
Silvia Guerrero ◽  
Mixel J. Rosales ◽  
Jose S. Ramos
Keyword(s):  
Controlled Trial ◽  
Uterine Fibroids ◽  
Cervical Length ◽  
Mean Value ◽  
Cervical Ripening ◽  
Efficacy And Safety ◽  
Chi Square ◽  
Double Blind ◽  
Significant Difference ◽  
Chi Square Test

Background: Mifepristone is an antiprogestin developed to antagonize the action of progesterone by inhibiting its receptors. It has had a recognized role in the medical termination of early pregnancy, reduction in the volume of uterine fibroids and endometriosis symptoms. A new indication for labor induction and cervical ripening in has been proposed. The objective was to compare the efficacy and safety of mifepristone 100 and 200 mg with placebo for cervical ripening in term pregnancies.Methods: Double-blind, placebo-controlled trial of 90 term pregnancy women randomly assigned to receive orally tablet of 100 mg and 200 mg mifepristone or placebo. Efficacy was assessed by measuring changes in cervical ripening according to Bishop 72 hours after treatment. Statistical analysis was using the t-student test and the chi-square test. The relative risk (RR) was determined with a 95% confidence interval.Results: The bishop score and the number of contractions at 48 hours in the group of 200mg of mifepristone presented a significantly higher mean value in relation to the placebo (p=0.04). At 72 hours, cervical length showed a significant difference (p<0.01) in both mifepristone groups compared to the placebo group. Also, at 72 hours a significant increase in the mean duration of contractions was demonstrated in the 100 mg mifepristone group.Conclusions: There was a significant increase in Bishop's score for the 200 mg mifepristone group probably due to a significant increase in contractions at 24 hours. No differences were observed between groups in adverse events.

scholarly journals Ear Acupressure for Smoking Cessation: A Randomised Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Anthony L. Zhang ◽  
Yuan Ming Di ◽  
Christopher Worsnop ◽  
Brian H. May ◽  
Cliff Da Costa ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Efficacy And Safety ◽  
Intention To Treat ◽  
Exhaled Carbon Monoxide ◽  
Randomised Controlled ◽  
To Receive ◽  
Treat Analysis

This study investigated the efficacy and safety of ear acupressure (EAP) as a stand-alone intervention for smoking cessation and the feasibility of this study design. Adult smokers were randomised to receive EAP specific for smoking cessation (SSEAP) or a nonspecific EAP (NSEAP) intervention which is not typically used for smoking cessation. Participants received 8 weekly treatments and were requested to press the five pellets taped to one ear at least three times daily. Participants were followed up for three months. Primary outcome measures were a 7-day point-prevalence cessation rate confirmed by exhaled carbon monoxide and relief of nicotine withdrawal symptoms (NWS). Intention-to-treat analysis was applied. Forty-three adult smokers were randomly assigned to SSEAP (n=20) or NSEAP (n=23) groups. The dropout rate was high with 19 participants completing the treatments and 12 remaining at followup. One participant from the SSEAP group had confirmed cessation at week 8 and end of followup (5%), but there was no difference between groups for confirmed cessation or NWS. Adverse events were few and minor.

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