scholarly journals An Open-label Randomized Control Trial Comparing Clonidine and Buprenorphine for Medically-Assisted Opium Withdrawal of Adolescents

2020 ◽  
Vol 9 (4) ◽  
Author(s):  
Mahboubeh Firouzkouhi Moghadam ◽  
Nour-Mohammad Bakhshani ◽  
Alireza Noroozi ◽  
Farnaz Sharifi Mood ◽  
Shahab Lotfinia
Keyword(s):  
Opioid Dependence ◽  
Controlled Trial ◽  
Good Alternative ◽  
Withdrawal Symptoms ◽  
Opiate Withdrawal ◽  
Opioid Use ◽  
Open Label ◽  
Treatment Demand ◽  
Withdrawal Treatment ◽  
Significant Difference

Background: There is an increasing trend in treatment demand for opioid dependence among adolescents in Iran. However, evidence regarding effective treatment in this population is very limited. Objectives: This study aimed to compare the efficacy of clonidine and buprenorphine for inpatient medically-assisted withdrawal of adolescents with opioid dependence aged 12 and 16 years. Materials and Methods: The study is an open-label, randomized controlled trial with convenience sampling. In total, 36 adolescents took part in this study who were randomly assigned to buprenorphine or clonidine groups. The Clinical Opiate Withdrawal Scale was used to monitor the withdrawal severity on days one, two, three, seven, and 14. Results: The findings showed both treatments were effective. However, withdrawal symptoms in the buprenorphine group showed a greater reduction in the first seven days of withdrawal treatment. There was no significant difference in the length of hospitalization between the two groups. Patients with a longer duration of opioid use showed higher levels of withdrawal symptoms in the buprenorphine group on days one and three. Conclusions: Buprenorphine treatment was found to be more effective than clonidine in controlling opioid withdrawal during the initial days of treatment. However, it lost its superiority towards the end of the follow-up. It seems that clonidine could be a good alternative to buprenorphine in the medically-assisted withdrawal of adolescents with opioid dependence.

scholarly journals Efficacy and safety of a centrally acting analgesic flupirtine in primary knee osteoarthritis in comparison to tramadol: a randomized controlled trial

2018 ◽  
Vol 7 (3) ◽  
pp. 381
Author(s):  
Tanmoy Kanti Goswami ◽  
Pradip Kumar Ghoshal ◽  
Avijit Hazra ◽  
Asish Biswas
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Effects ◽  
Controlled Trial ◽  
Opioid Analgesics ◽  
Womac Score ◽  
Open Label ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Considerable Morbidity

Background: Osteoarthritis (OA) is a chronic, degenerative joint disorder responsible for considerable morbidity, particularly in old age. Flupirtine, a new centrally acting analgesic, is devoid of the adverse effects of NSAIDs and opioid analgesics. In this study author compared the effectiveness and safety of flupirtine with tramadol in knee OA.Methods: An open label, randomized, controlled trial was done with patients of primary knee OA of both sexes, age >50 years. Patients were recruited from Rheumatology OPD of SSKM Hospital. A minimum WOMAC score of 35 was essential for recruitment. Patients with serious comorbidities were excluded. They were treated orally with either flupirtine (100mg thrice daily) or tramadol (50mg thrice daily) for 12 weeks.Results: Ninety patients were recruited and data of 42 on flupirtine and 41 on tramadol were analysed. There was significant improvement in pain, stiffness and physical function compared to baseline in both the groups. However, there was no significant difference between groups at 4, 8 and 12 weeks. Responder rate (50% reduction in pain score from baseline) was 66.67% with flupirtine and 48.78% with tramadol (p = 0.122). Flupirtine caused 4 adverse events compared to 16 with tramadol. However, both the drugs were well-tolerated.Conclusions: The effectiveness of flupirtine in knee OA is comparable to tramadol, while causing minimal adverse effects. Long-term benefits need to be explored.

scholarly journals Effect of acupuncture for methadone maintenance treatment patients: study protocol of a randomized clinical trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Hao Wen ◽  
Shichao Xu ◽  
Jingchun Zeng ◽  
Shuqi Ge ◽  
Yuan Liao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adjunctive Therapy ◽  
Opioid Dependence ◽  
Methadone Maintenance ◽  
Controlled Trial ◽  
Urine Test ◽  
Efficacy And Safety ◽  
Opioid Use ◽  
Randomized Controlled ◽  
Sf 36

Abstract Background Opioid dependence is an increasing public health problem all over the world. Patients with opioid dependence have to receive methadone maintenance therapy (MMT) as replacement therapy for years or even for their entire life. Acupuncture as a kind of therapy has been used to treat substance dependence for many years. Jin’s three-needle acupuncture (JTN), a type of acupuncture technique, has been applied to treat various diseases for several decades. However, JTN as an acupuncture technique has not been used to treat patients receiving MMT. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT. Methods/design This study is a parallel-arm, randomized controlled trial that aims to evaluate the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT. A total of 140 eligible participants who range in age from 18 to 60 years and fulfil the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), for opiate dependence will be enrolled into this study. All eligible participants will be randomly assigned to the acupuncture group or routine group in a 1:1 allocation ratio. Participants who are enrolled in the acupuncture group will receive MMT and JTN treatment for 30 min per session. Meanwhile, those who are assigned to the routine arm will receive MMT only. All 18 sessions of JTN treatment will be delivered over 6 weeks (3 per week) and followed by a 4-week follow-up period. The primary outcome measure will be the visual analogue scale (VAS) for drug craving and the daily consumption of methadone (DCOM). Secondary outcome measures will include the urine test for opioid use, the 36-item Short Form Survey (SF-36), the Beck Anxiety Inventory (BAI), the Beck Depression Inventory II (BDI-II) and Pittsburgh sleep quality index (PSQI). VAS, DCOM, BAI, BDI-II and the urine test for opioid use will be evaluated at baseline, the second week, the fourth week, the sixth week and the tenth week. SF-36 and PSQI will be assessed at baseline, the fourth week, the sixth week and the tenth week. Discussion The results of this trial will provide evidence on the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT. Trial registration Chinese Clinical Trial Registry ChiCTR1900026357. Registered on 2 October 2019.

scholarly journals Perioperative rifaximin is not associated with enhanced functional and volumetric recovery after major liver resection

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Jan Bednarsch ◽  
Zoltan Czigany ◽  
Sven H. Loosen ◽  
Lara Heij ◽  
Lorenz Ruckgaber ◽  
...  
Keyword(s):  
Liver Function ◽  
Primary Endpoint ◽  
Major Hepatectomy ◽  
Controlled Trial ◽  
Liver Volume ◽  
Relative Increase ◽  
Control Group ◽  
Open Label ◽  
Significant Difference ◽  
The Impact

AbstractThe objective of this randomized controlled trial (RCT) was to assess the impact of rifaximin on the course of liver function, liver regeneration and volumetric recovery in patients undergoing major hepatectomy. The ARROW trial was an investigator initiated, single-center, open-label, phase 3 RCT with two parallel treatment groups, conducted at our hepatobiliary center from 03/2016 to 07/2020. Patients undergoing major hepatectomy were eligible and randomly assigned 1:1 to receive oral rifaximin (550 mg twice daily for 7–10 or 14–21 days in case of portal vein embolization preoperatively and 7 days postoperatively) versus no intervention. Primary endpoint was the relative increase in postoperative liver function measured by LiMAx from postoperative day (POD) 4 to 7. Secondary endpoint were the course of liver function and liver volume during the study period as well as postoperative morbidity and mortality. Between 2016 and 2020, 45 patients were randomized and 35 patients (16 individuals in the rifaximin and 19 individuals in the control group) were eligible for per-protocol analysis. The study was prematurely terminated following interim analysis, due to the unlikelihood of reaching a significant primary endpoint. The median relative increase in liver function from POD 4 to POD 7 was 27% in the rifaximin group and 41% in the control group (p = 0.399). Further, no significant difference was found in terms of any other endpoints of functional liver- and volume regeneration or perioperative surgical complications following the application of rifaximin versus no intervention. Perioperative application of rifaximin has no effect on functional or volumetric regeneration after major hepatectomy (NCT02555293; EudraCT 2013-004644-28).

Acute Blocking of Naloxone-Precipitated Opiate Withdrawal Symptoms by Methohexitone

1990 ◽  
Vol 157 (5) ◽  
pp. 748-752 ◽  
Author(s):  
N. Loimer ◽  
R. Schmid ◽  
K. Lenz ◽  
O. Presslich ◽  
J. Grünberger
Keyword(s):  
Bolus Injection ◽  
Controlled Trial ◽  
Drop Out ◽  
Withdrawal Symptoms ◽  
Opiate Withdrawal ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Withdrawal Therapy ◽  
Drop Out Rates ◽  
Withdrawal Signs

In a double-blind placebo-controlled trial of 18 patients, methohexitone blocked objective signs of opiate withdrawal caused by a bolus injection of naloxone. Furthermore, in continuing the naloxone therapy for 48 hours, no withdrawal signs appeared. Levels of withdrawal distress returned to normal levels within six days. This approach can be regarded as an effective and well tolerated withdrawal therapy with low drop-out rates.

scholarly journals A randomised controlled trial to evaluate a medication monitoring system for TB treatment

2022 ◽  
Vol 26 (1) ◽  
pp. 44-49
Author(s):  
J. Acosta ◽  
P. Flores ◽  
M. Alarcón ◽  
M. Grande-Ortiz ◽  
L. Moreno-Exebio ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Treatment Success ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Second Phase ◽  
Open Label ◽  
Pulmonary Tb ◽  
Tb Treatment ◽  
Significant Difference

BACKGROUND: Adherence to TB treatment and therefore treatment success could be improved using digital adherence technology.OBJECTIVE: To evaluate the effectiveness of a medication event reminder monitor system (MERM) on treatment success and treatment adherence in patients with drug-susceptible pulmonary TB in Perú.METHODS: This was an experimental, randomised, open-label, controlled study conducted among patients in the second phase of TB treatment. The intervention group received their medications through MERM with the support of a treatment monitor, whereas the control group used the usual strategy. Participants were followed until they completed the 54 doses of the second phase of treatment.RESULTS: The study included 53 patients in each group; four in the intervention group withdrew from the study. Treatment success was significantly more frequent in the MERM group (RR 1.15, 95% CI 1.02–1.30; P = 0.0322). There was no significant difference in the adherence outcomes; however, the percentage of patients who missed at least one dose and patients with more than 10% of total doses missed were lower in the intervention group.CONCLUSION: The use of MERM in the second phase of treatment showed a significant improvement in the treatment success rate in patients with drug-susceptible pulmonary TB.

scholarly journals Efficacy of hepatoprotector jamu formula (combination of Curcuma longa, Curcuma xanthorrhiza, and Taraxacum officinale) compared to Fructus schizandrae extract in mild liver injury: a randomized controlled trial

2021 ◽  
Vol 913 (1) ◽  
pp. 012089
Author(s):  
D Ardiyanto ◽  
Z Zulkarnain ◽  
P R W Astana ◽  
A Triyono ◽  
F Novianto ◽  
...  
Keyword(s):  
Liver Injury ◽  
Curcuma Longa ◽  
Controlled Trial ◽  
Taraxacum Officinale ◽  
Open Label ◽  
Serum Glutamic Oxaloacetic Transaminase ◽  
Impaired Liver Function ◽  
Traditional Medicines ◽  
Significant Difference ◽  
Curcuma Xanthorrhiza

Abstract The prevalence of impaired liver function in developing countries is increasing. Indonesia has several traditional medicines that can be used as alternative treatments for liver dysfunction. The aim of this study was to determine the efficacy of hepatoprotector jamu formula (combination of Curcuma longa, Curcuma xanthorrhiza, and Taraxacum officinale) compared to Fructus schizandrae fruit extract for treating mild liver injury. This study was a RCT using parallel open label design which involved 60 subjects for 42 days of intervention. The parameters used to evaluate efficacy were Serum Glutamic Pyruvic Transaminase (SGPT) and Serum Glutamic Oxaloacetic Transaminase (SGOT). There was a significant difference of average SGPT levels on day 21 and day 42 compared to day 0 in both hepatoprotector jamu group and Fructus Schizandrae extract group (p < 0.001). Compared to the baseline, there were a significant difference of average SGOT levels on the follow up days in hepatoprotector jamu group (p=0.023 on day 21; p=0.003 on day 42) as well as Fructus Schizandrae extract group (p=0.028 on day 21; p=0.042 on day 42. The efficacy of hepatoprotector jamu formula was comparable to Fructus schizandrae extract in improving mild liver injury.

A Moxifloxacin-based Regimen for the Treatment of Recurrent, Drug-sensitive Pulmonary Tuberculosis: An Open-label, Randomized, Controlled Trial

2019 ◽  
Vol 70 (1) ◽  
pp. 90-98 ◽  
Author(s):  
Rubeshan Perumal ◽  
Nesri Padayatchi ◽  
Nonhlanhla Yende-Zuma ◽  
Anushka Naidoo ◽  
Dhineshree Govender ◽  
...  
Keyword(s):  
Adverse Events ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Treatment Success ◽  
Control Group ◽  
Open Label ◽  
Serious Adverse Events ◽  
Conversion Rates ◽  
Significant Difference ◽  
Culture Conversion

Abstract Background The substitution of moxifloxacin for ethambutol produced promising results for improved tuberculosis treatment outcomes. Methods We conducted an open-label, randomized trial to test whether a moxifloxacin-containing treatment regimen was superior to the standard regimen for the treatment of recurrent tuberculosis. The primary and secondary outcomes were the sputum culture conversion rate at the end of 8 weeks and the proportion of participants with a favorable outcome, respectively. Results We enrolled 196 participants; 69.9% were male and 70.4% were co-infected with human immunodeficiency virus (HIV). There was no significant difference between the study groups in the proportion of patients achieving culture conversion at the end of 8 weeks (83.0% [moxifloxacin] vs 78.5% [control]; P = .463); however, the median time to culture conversion was significantly shorter (6.0 weeks, interquartile range [IQR] 4.0–8.3) in the moxifloxacin group than the control group (7.9 weeks, IQR 4.0– 11.4; P = .018). A favorable end-of-treatment outcome was reported in 86 participants (87.8%) in the moxifloxacin group and 93 participants (94.9%) in the control group, for an adjusted absolute risk difference of −5.5 (95% confidence interval −13.8 to 2.8; P = .193) percentage points. There were significantly higher proportions of participants with Grade 3 or 4 adverse events (43.9% [43/98] vs 25.5% [25/98]; P = .01) and serious adverse events (27.6% [27/98] vs 12.2% [12/98]; P = .012) in the moxifloxacin group. Conclusions The replacement of ethambutol with moxifloxacin did not significantly improve either culture conversion rates at the end of 8 weeks or treatment success, and was associated with a higher incidence of adverse events. Clinical Trials Registration NCT02114684.

scholarly journals Fusion and Opioid-Sparing With the Use of Ketorolac in Posterior Thoracolumbar Spinal Fusions: A Prospective Double-Blinded Randomized Placebo-Controlled Trial

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Evan J Lytle ◽  
Chad F Claus ◽  
Doris Tong ◽  
Diana Sigler R.Ph ◽  
Dominick Lago ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Perioperative Complications ◽  
Controlled Trial ◽  
Univariate Analysis ◽  
Opioid Use ◽  
Allocation Mechanism ◽  
Opioid Sparing ◽  
Analgesic Regimen ◽  
Significant Difference ◽  
Double Blinded

Abstract INTRODUCTION Use of Ketorolac in spinal fusion is limited due to the risk of pseudarthrosis. Recent literature suggested that such an effect could be type and dose-related. We sought to demonstrate that Ketorolac use was safe with significant opioid-sparing effect and non-inferior fusion rate. METHODS This is a prospective, double-blinded, randomized placebo-controlled trial designed according to the 2013 SPIRIT Guidelines. It is a 2-arm parallel design with a 1:1 randomization. Over a 2- period under 6 surgeons at 2 sites, consecutive patients who underwent elective 1 to 3 level minimally invasive thoracolumbar fusion were screened for inclusion/exclusion. Patients with fusion confounders were excluded. A centralized treatment allocation mechanism and Excel-generated block randomization were used. Patients received a 48-hr scheduled treatment of intravenous Ketorolac (15 mg IV Q6H) or saline. We implemented a standardized analgesia regimen using a standardized order set. The primary outcome was fusion as evaluated XR/CT using the Suk criteria at 6/12 mo by a blinded neuroradiologist. The secondary outcomes were morphine-equivalence (MME) in the first 48 hr postop and during the hospital stay, NSAIDs-specific perioperative complications, VAS, length of stay, and quality-of-life outcomes at 6/12 mo. Univariate analysis was used, P < .05 considered significant. The sample size was estimated to be 600. This is an interim analysis to evaluate the safety and MME reduction. RESULTS A total of 142 patients were analyzed. Patient characteristics and operative data were comparable between the groups except EBL. No significant difference in fusion was found at 6-mo. There was a significant reduction in total/48-hr MME and length of stay (LOS) for the ketorolac group. The only complication was a superficial hematoma in a ketorolac-assigned patient requiring evacuation. CONCLUSION Ketorolac demonstrated safety, a significant reduction in postoperative opioid use and length of stay when used as part of a multi-modal analgesic regimen after thoracolumbar fusion.

Donepezil for cancer-related fatigue: A double-blind, randomized, placebo-controlled study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9003-9003
Author(s):  
E. Bruera ◽  
B. El Osta ◽  
V. Valero ◽  
L. Driver ◽  
J. Palmer ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Controlled Trial ◽  
Subscale Score ◽  
Assessment System ◽  
Phone Call ◽  
Controlled Study ◽  
Fatigue Improvement ◽  
Open Label ◽  
Double Blind ◽  
Significant Difference

9003 Background: Fatigue is the most frequent symptom in advanced cancer. No standard treatment is available. We previously found that open-label donepezil significantly improved fatigue by day 3 and 7 in patients (pts) on opioids for cancer pain (Fisch et al, ASCO 2003). The purpose of this study was to compare donepezil (D) with placebo (P) for fatigue in pts with advanced cancer. Methods: In this randomized, double-blind, placebo-controlled trial, pts with fatigue score = 4 on a 0 to 10 scale (10 = worst fatigue) for > 1 week, hemoglobin = 10g/dl for = 4 weeks, and no major contraindication to D were randomized to receive D 5 mg or P orally every morning for 7 days. All pts were offered open-label D during week 2. Assessment included: research nurse daily phone call for fatigue and toxicity evaluation, Edmonton Symptom Assessment System (ESAS), Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F), Sleeping Pattern Assessment, and overall effectiveness of the treatment. The FACIT-F fatigue subscale score on day 8 was considered the primary endpoint. Results: 103 pts were evaluable for final analysis. Mean difference in scores for symptoms intensity between baseline and day 8 are shown in Table 1 . FACIT-F fatigue subscale score at day 8 decreased a mean of 6 (10.6 SD) in the D arm (p < 0.001) and 7.2 (9.5 SD) in the P arm (p < 0.001). There was no significant difference in fatigue improvement between both arms according to the FACIT-F subscale (p = 0.57) and ESAS fatigue (p = 0.18) scores, and no significant difference in sleep quality score between D and P. On day 15 of the open-label phase, mean fatigue intensity remained significantly improved as compared to baseline on FACIT-F fatigue subscale (p < 0.001) and ESAS fatigue (p < 0.001) scores. No significant toxicities were observed. Conclusions: Both donepezil and placebo resulted in significant fatigue improvement. Donepezil was not significantly superior to placebo after one week. Our pilot findings are probably due to placebo effect. No significant financial relationships to disclose. [Table: see text]

Patient-Controlled Methylphenidate for Cancer Fatigue: A Double-Blind, Randomized, Placebo-Controlled Trial

2006 ◽  
Vol 24 (13) ◽  
pp. 2073-2078 ◽  
Author(s):  
Eduardo Bruera ◽  
Vicente Valero ◽  
Larry Driver ◽  
Loren Shen ◽  
Jie Willey ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Study Drug ◽  
Symptom Assessment ◽  
Assessment System ◽  
Research Nurse ◽  
Symptom Improvement ◽  
Open Label ◽  
Double Blind ◽  
Fatigue Score ◽  
Significant Difference

Purpose To evaluate the effectiveness of patient-controlled methylphenidate as compared with placebo in cancer patients with fatigue, as measured by the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F). Patients and Methods Patients with a fatigue score of at least 4 on a scale of 0 to 10 (0 = no fatigue, 10 = worst possible fatigue) and hemoglobin level of at least 10 g/dL were included. Patients were randomly assigned to receive 5 mg methylphenidate or placebo every 2 hours as needed (maximum of four capsules a day), for 7 days. Patients completed a daily diary including study drug record and fatigue intensity. A research nurse telephoned patients daily to assess toxicity and fatigue level. All patients were offered open-label methylphenidate for 4 weeks. FACIT-F and the Edmonton Symptom Assessment System (ESAS) were assessed at baseline, and days 8, 15, and 36. The FACIT-F fatigue subscore on day 8 was considered the primary end point. Results Of 112 patients randomly assigned, 52 patients in the methylphenidate and 53 in the placebo group were assessable for analysis. Fatigue intensity improved significantly on day 8 in both the methylphenidate and placebo groups. However, there was no significant difference in fatigue improvement by FACIT-F (P = .31) or ESAS (P = .14) between groups. In open-label phase, fatigue intensity maintained low as compared with baseline. No significant toxicities were observed. Conclusion Both methylphenidate and placebo resulted in significant symptom improvement. Methylphenidate was not significantly superior to placebo after 1 week of treatment. Longer study duration is justified. The role of daily telephone calls from a research nurse should be explored as a palliative care intervention.

Sign in / Sign up

Export Citation Format

Share Document