scholarly journals Homeopathic potencies of Opium in alcohol dependence: exploratory open-label study

2021 ◽  
Vol 11 (38) ◽  
pp. 19-24
Author(s):  
Ubiratan Cardinalli Adler ◽  
Ana Elisa Madureira Padula ◽  
Amarilys de Toledo Cesar ◽  
Maristela Schiabel Adler ◽  
José Carlos Fernandes Galduróz
Keyword(s):  
Alcohol Dependence ◽  
Medical Specialty ◽  
Open Label ◽  
Serious Adverse Events ◽  
Open Label Study ◽  
Intention To Treat ◽  
Randomized Controlled Studies ◽  
Treatment Measures ◽  
Pre Treatment ◽  
Treat Analysis

Background: The conventional pharmacological options for the treatment of alcoholism are limited, which led to the search for solutions in alternative or complementary medicine (CAM). Homeopathy is a CAM modality recognized as medical specialty in Brazil. According to the clinical experience of the early homeopaths, Opium was used to treat patients with alcohol dependence. Aim: to perform a preliminary assessment of the effectiveness and tolerability of fifty-millesimal potencies of Opium in the treatment of alcohol-dependent patients. Methods: exploratory, prospective, open-label trial, with pre-treatment measures as control. Confidence intervals were used to estimate the magnitude of the clinical differences. Results: a total of 14 patients were included, from which 12 were evaluated (intention to treat analysis - ITT). There was a significant reduction in the average daily alcohol consumption (-29.37 units of alcohol/day; 95% CI=10.63; 48.11) and in the severity of alcohol dependence, measured by the mean score of the Short Alcohol Dependence Data questionnaire (-10.17; 95% CI= 4.12; 16.22). No serious adverse events were reported. Randomized controlled studies with larger samples are needed.

Transcutaneous auricular vagus nerve stimulation for the treatment of irritable bowel syndrome: a pilot, open-label study

2020 ◽  
Vol 3 (1) ◽  
pp. 5-12
Author(s):  
François Mion ◽  
Sonia Pellissier ◽  
Aurélien Garros ◽  
Henri Damon ◽  
Sabine Roman ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Vagus Nerve ◽  
Open Label ◽  
Open Label Study ◽  
Biological Variables ◽  
Randomized Controlled Studies ◽  
Transit Times ◽  
Blood Cytokines ◽  
Irritable Bowel ◽  
Left Vagus

Aim: Irritable bowel syndrome (IBS) is a frequent disease, associating chronic abdominal pain and abnormal bowel habits. The sympatho-vagal balance may be altered in IBS. We tested the effect of transcutaneous auricular stimulation of the left vagus nerve (taVNS) on symptoms and physiological and biological variables. Patients & methods: Twelve IBS women agreed to apply taVNS for 6 months. Evaluation was based on feasibility, symptoms, psychological questionnaires, fecal caprotectin, blood cytokines and bowel transit times. Results: Nine patients completed the trial: there was a significant improvement of symptoms at 3 and 6 months although none of the measured variables were modified by taVNS. Conclusion: The results suggest taVNS is feasible and may improve IBS symptoms. Randomized controlled studies are needed to confirm these preliminary results. ClinicalTrials.gov : NCT02420158.

scholarly journals Antioxidant effects of immunomodulators in patients with recurrent pyelonephritis

2018 ◽  
pp. 18-28
Author(s):  
M. Kolesnyk ◽  
L. Korol ◽  
N. Stepanova ◽  
V. Driianska ◽  
L. Migal ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Antibiotic Therapy ◽  
Transforming Growth Factor ◽  
Colorimetric Method ◽  
Serum Levels ◽  
Stress Index ◽  
Open Label ◽  
Open Label Study ◽  
Before And After ◽  
Pre Treatment

The purpose of our work was to investigate the effect of immunomodulatory medicines on the intensity of oxidative stress (OS), the cytokines level and the activity of renospecific enzymes in patients with recurrent pyelonephritis (rPN). Methods. A prospective, randomized, open-label study involved of 100 women aged 33.4 ± 8.8 year old. According to the sensitivity of the detected pathogens all patients received antibacterial therapy for two weeks. Along with the main course of antibiotic therapy, 25 patients were assigned Sodium nucleinate at a dose of 0.25 g 4 times per day during 14 days, 18 patients were prescribed Galavit intramuscularly 2 ml per dayfor 10 days, and 27patients were prescribed Proteflazid according to the manufacturer’s instructions. The comparison group consisted of 30 women with rPN who received antibiotic therapy exclusively.Women were screened before and after the treatment. The content of malondialdehyde (MDA), ceruloplasmin (CP), transferrin (TF) and sulfhydryl groups (SH-groups) were determined in the blood by colorimetric method. Oxidative stress index (OSI) was calculated. The concentration of interleukins (IL) -1f, -4, -8, -10, -17, tumor necrosis factor a (TNF-a), transforming growth factor f (TGF-f), monocytic chemoactive protein-1 (MCP-1) and interferon y (IFN-y) were analyzed in the blood of the women using an ELISA. To evaluate the functional state of the renal parenchyma the activity of tubular lysosome enzymes a total f-N-acetylhexosaminidase and f-galactosidase were determined in urine. Results. The use of Sodium nucleinate decreased of the OS activity by reducing MDA level (p <0.001) and increasing the concentration of CP (p < 0.03). The serum levels ofIL-4 (p = 0.007), lL-17 (p = 0.04), TGF-f (p = 0.02) and MCP-1 (p = 0.03) were decrease. The use of Galavit contributed to a statistically significant decrease in the concentration of TNF-a (p <0.001), IL-8(p <0.001), IFN-y (p = 0.001) and TGF-f (p <0.001). The administration of Proteflazid resulted in a decrease in the concentrations of IL-8 and IFN-y, with a decrease in OSI (p =0.04) compared to pre-treatment. All applied immunomodulators partially reduced the activity of renospecific enzymes markers of kidney damage. Conclusions. The use of immunomodulators in the complex therapy of patients with rPN contributes to the partial normalization of functional activity of immune system by the decreasing ofthe production ofcytokines as its mediators and the reducing ofthe OS intensity.

Rituximab in diffuse cutaneous systemic sclerosis: an open-label clinical and histopathological study

2008 ◽  
Vol 69 (01) ◽  
pp. 193-197 ◽  
Author(s):  
V Smith ◽  
J T Van Praet ◽  
B Vandooren ◽  
B Van der Cruyssen ◽  
J-M Naeyaert ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Short Form ◽  
Health Assessment ◽  
Histopathological Study ◽  
Open Label ◽  
Serious Adverse Events ◽  
Open Label Study ◽  
Skin Sclerosis ◽  
Potential Efficacy ◽  
Diffuse Cutaneous Systemic Sclerosis

Objectives:The safety and potential efficacy of rituximab was examined in diffuse cutaneous systemic sclerosis (dc-SSc).Methods:A 24 week open-label study in which eight patients with dc-SSc received an infusion of 1000 mg rituximab administered at baseline and day 15, together with 100 mg methylprednisolone at each infusion. Assessment included CD19+ peripheral blood lymphocyte number, skin sclerosis score, indices of internal organ functioning, the health assessment questionnaire disability index, the 36-item Short Form health survey and histopathological evaluation of the skin.Results:Ritixumab induced effective B-cell depletion in all patients (<5 CD19+ cells/μl blood). There was a significant change in skin score at week 24 (p<0.001). Also, significant improvements were measured in the dermal hyalinised collagen content (p = 0.014) and dermal myofibroblast numbers (p = 0.011). Two serious adverse events occurred, which were thought to be unrelated to the rituximab treatment.Conclusions:Rituximab appears to be well tolerated and may have potential efficacy for skin disease in dc-SSc.This study is registered with ClinicalTrials.gov, number NCT00379431.

Open-label Study with Nalmefene as Needed Use in Alcohol-Dependent Patients with Evidence of Elevated Liver Stiffness and/or Hepatic Steatosis

2019 ◽  
Author(s):  
Sebastian Mueller ◽  
Mathias Luderer ◽  
Doris Zhang ◽  
Didier Meulien ◽  
Björn Steiniger Brach ◽  
...  
Keyword(s):  
Alcohol Consumption ◽  
Alcohol Dependence ◽  
Hepatic Steatosis ◽  
Transient Elastography ◽  
Heavy Drinking ◽  
Liver Stiffness ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Liver Parameters

Abstract Aims This open-label study in patients with alcohol dependence and evidence of elevated liver stiffness and/or hepatic steatosis was designed to explore the efficacy of nalmefene (18 mg) in reducing alcohol consumption and its subsequent effects on a variety of clinically relevant liver parameters. Methods Adult patients with a diagnosis of alcohol dependence and evidence of elevated liver stiffness and/or hepatic steatosis (liver stiffness >6 kPa or controlled attenuation parameter (CAP) >215 dB/m as measured by transient elastography) were recruited at two study sites in Germany. During the 12-week treatment period, patients were instructed to take nalmefene each day they perceived a risk of drinking alcohol. Results All 45 enrolled patients took at least one dose of nalmefene and 39 completed the study. After 12 weeks of study treatment with nalmefene patients showed a reduction in alcohol consumption of −13.5 days/month heavy drinking days and −45.8 g/day total alcohol consumption. Most liver parameters showed modest changes at Week 12; there was a 13% decrease in liver stiffness and 10% reduction in CAP values. Results indicated non-significant negative associations between alcohol consumption and liver stiffness and/or CAP over this 12-week study. Nalmefene was generally well tolerated, and most adverse events were mild or moderate, the most frequent being dizziness. Conclusions Patients treated with nalmefene for 12 weeks had reductions in alcohol consumption by ~50% relative to baseline and showed trends to improvement in liver stiffness and CAP.

scholarly journals Fourteen-Day Sequential Therapy Containing Rabeprazole Versus 10 And 14-Day Concomitant Therapy in The First Line Treatment of Helicobacter Pylori Infection: A Randomized, Open-Label Clinical Trial

2021 ◽  
Author(s):  
Hassan Seddik ◽  
Hanae Boutallaka ◽  
Sanaa Berrag ◽  
Samir Mrabti ◽  
Khaoula Loubaris ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Adverse Effects ◽  
Eradication Rate ◽  
Cost Effective ◽  
Sequential Therapy ◽  
Open Label ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
13C Urea Breath Test ◽  
Treat Analysis

Abstract Aims:To compare an optimized sequential therapy to 10 and 14-day non-Bismuth quadruple therapies currently recommended, in terms of efficacy, incidence of adverse effects and cost.Patients and methods:This open-label prospective study randomized patients with confirmed Helicobacter pylori (H.Pylori) infection to 3 groups (1:1:1): The first group received quadruple therapy of twice-daily (bid) Omeprazole 20mg, Amoxicillin 1g, Clarithromycin 500mg and Metronidazole 500mg for 10days (QT-10), the second group received a 14 day quadruple therapy following the same regimen (QT-14), and the third received an optimized sequential therapy consisting on a bid Rabeprazole 20 mg plus amoxicillin 1g for 7 days, followed by bid Rabeprazole 20 mg, clarithromycin 500 mg and metronidazole 500mg for the next 7 days (OST-14). Adverse events (AEs) were recorded throughout the study, and the H.Pylori eradication rate was determined 4 to 6 weeks after treatment using the 13C urea breath test.Results:In intention to treat analysis, eradication rate was 85,5%, 91,8% and 95,4% respectively in QT-10, QT-14 and OST-14 groups (p=0,03). In the per protocol analysis, the eradication rate was significantly higher in the OST- 14 group compared to the QT-14 and QT-10 groups (98,1%, 94,4% and 89,5% respectively, p=0,02).The overall incidence of AEs was significantly lower in the OST-14 group (p=0,01). Furthermore, the OST-14 was the most cost-effective among the three groups.Conclusion:14-day optimized sequential therapy is a safe and effective alternative that allows a higher eradication rate compared to 10 and 14-days quadruple therapies while causing less adverse effects and allowing a gain in term of cost.

scholarly journals Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache

Cephalalgia ◽  
2015 ◽  
Vol 36 (6) ◽  
pp. 503-509 ◽  
Author(s):  
Daniel Fossum Bratbak ◽  
Ståle Nordgård ◽  
Lars Jacob Stovner ◽  
Mattias Linde ◽  
Mari Folvik ◽  
...  
Keyword(s):  
Pilot Study ◽  
Cluster Headache ◽  
Chronic Cluster Headache ◽  
Post Treatment ◽  
Attack Frequency ◽  
Open Label ◽  
Intention To Treat ◽  
Efficacy Outcome ◽  
Treat Analysis

Objective The main object of this pilot study was to investigate the safety of administering onabotulinumtoxinA (BTA) towards the sphenopalatine ganglion (SPG) in intractable chronic cluster headache. Efficacy data were also collected to provide indication on whether future placebo-controlled studies should be performed. Method In a prospective, open-label, uncontrolled study, we performed a single injection of 25 IU ( n = 5) or 50 IU BTA ( n = 5) towards the SPG in 10 patients with intractable chronic cluster headache with a follow-up of 24 weeks. The primary outcome was adverse events (AEs) and the main efficacy outcome was attack frequency in weeks 3 and 4 post-treatment. Results A total of 11 AEs were registered. There was one severe adverse event (SAE): posterior epistaxis. The number of cluster headache attacks (main efficacy outcome) was statistically significantly reduced in the intention-to-treat analysis from 18 ± 12 per week in baseline to 11 ± 14 ( p = 0.038) in weeks 3 and 4, and five out of 10 patients had at least 50% reduction of attack frequency compared to baseline. The cluster attack frequency was significantly reduced for five out of six months post-treatment. Conclusion Randomised, placebo-controlled studies are warranted to establish the potential of this possible novel treatment of cluster headache.

scholarly journals Oral neuromuscular training in patients with dysphagia after stroke: a prospective, randomized, open-label study with blinded evaluators

BMC Neurology ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Patricia Hägglund ◽  
Mary Hägg ◽  
Eva Levring Jäghagen ◽  
Bengt Larsson ◽  
Per Wester
Keyword(s):  
Neuromuscular Training ◽  
Open Label ◽  
Swallowing Function ◽  
Open Label Study ◽  
Label Study ◽  
Intention To Treat ◽  
End Of Treatment ◽  
Swallowing Dysfunction ◽  
Lip Force

Abstract Background Oral and pharyngeal swallowing dysfunction are common complications in acute stroke patients. This primary aim of this study was to determine whether oral neuromuscular training improves swallowing function in participants with swallowing dysfunction after stroke. A secondary aim was to assess how well results of the timed water-swallow test (TWST) correspond with swallowing dysfunction diagnosed by videofluoroscopy (VFS). Methods This was an intention-to-treat two-centre prospective randomized open-label study with blinded-evaluators (PROBE) design. At 4 weeks after stroke onset, participants with swallowing dysfunction were randomized to 5 weeks of continued orofacial sensory-vibration stimulation with an electric toothbrush or additional oral neuromuscular training with an oral device (Muppy®). Participants were examined with TWST, a lip-force test, and VFS before (baseline), after 5 weeks’ treatment (the end-of-treatment), and 12 months after treatment (follow-up). The baseline VFS results were compared with the TWST results. The primary endpoint was changes in swallowing rate assessed using TWST, from baseline to the end of training and from baseline to follow-up based on intention-to-treat analyses. The secondary endpoint was the corresponding changes in lip-force between baseline, the end of treatment, and follow-up. Results The participants were randomly assigned as controls (n = 20) or for intervention with oral neuromuscular training (n = 20). After treatment, both groups had improved significantly (intervention, P < 0.001; controls, P = 0.001) in TWST but there was no significant between-group difference in swallowing rate. At the 12-month follow-up, the intervention group had improved further whereas the controls had deteriorated, and there were significant between-group differences in swallowing rate (P = 0.032) and lip force (P = 0.001). A TWST < 10 mL/sec at baseline corresponded to VFS-verified swallowing dysfunction in all assessed participants. Conclusion The 5-week oral neuromuscular training improved swallowing function in participants with post-stroke dysphagia compared with the controls 12 months after intervention, but there was no between-group difference in improvement immediately after treatment. TWST results corresponded with VFS results, making TWST a feasible method for identifying persons with swallowing dysfunction after stroke. Larger randomized controlled trials are required to confirm our preliminary positive long-term results. Trial registration Retrospectively registered at ClinicalTrials.gov: NCT04164420. Registered on 15 November 2019.

scholarly journals Nalmefene, Given as Needed, in the Routine Treatment of Patients with Alcohol Dependence: An Interventional, Open-Label Study in Primary Care

2018 ◽  
Vol 24 (6) ◽  
pp. 293-303 ◽  
Author(s):  
Philippe Castera ◽  
Edmund Stewart ◽  
Josef Großkopf ◽  
Carlos Brotons ◽  
Maiken Brix Schou ◽  
...  
Keyword(s):  
Primary Care ◽  
Alcohol Dependence ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Routine Treatment
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