scholarly journals Reducing VNS stimulation parameters: is it safe?

2022 ◽  
Author(s):  
Tatiana Von Hertwig Fernandes de Oliveira ◽  
Jennyfer Paulla Galdino Chaves ◽  
Thiago Teixeira Silva ◽  
Alexandre Novicki Francisco ◽  
Sérgio Leandro Stebel
Keyword(s):  
Side Effects ◽  
Adjuvant Therapy ◽  
Refractory Epilepsy ◽  
Battery Life ◽  
Safe Procedure ◽  
Standard Protocol ◽  
Double Blind ◽  
Stimulation Parameters ◽  
Low Incidence

Abstract Introduction Vagal nerve stimulation (VNS) is an adjuvant therapy used in the treatment of patients with refractory epilepsy who are not candidates for resective surgery or who have limited results after surgical procedures. Currently, there is enough evidence to support its use in patients with various types of epilepsy. Therefore, the present study was conducted to explore the possibility of optimizing therapy by reducing the consumption of the system's battery. Methods The prospective and double-blind analysis consisted in the evaluation of 6 patients submitted to VNS implantation for 3 months, followed by adjustment of the stimulation settings and continuity of follow-up for another month. The standard protocol was replaced by another with a frequency value of 20 Hz instead of 30 Hz to increase battery life. The safety of this procedure was evaluated through the assessment of two main variables: seizures and side effects. Results The stimulation at 20 Hz showed 68% reduction in the incidence of seizures (p = 0.054) as well as low incidence of side effects. Conclusion The present study suggests that the reduction of the stimulation frequency from 30 to 20 Hz is a safe procedure, and it does not compromise the effectiveness of therapy.

Long-Term Follow-Up of Early Cochlear Implant Device Activation

2021 ◽  
pp. 1-11
Author(s):  
Stefanie Bruschke ◽  
Uwe Baumann ◽  
Timo Stöver
Keyword(s):  
Speech Recognition ◽  
Side Effects ◽  
Cochlear Implant ◽  
Surgical Techniques ◽  
Control Group ◽  
First Year ◽  
Safe Procedure ◽  
Sound Processor

Background: The cochlear implant (CI) is a standard procedure for the treatment of patients with severe to profound hearing loss. In the past, a standard healing period of 3–6 weeks occurred after CI surgery before the sound processor was initially activated. Advancements of surgical techniques and instruments allow an earlier initial activation of the processor within 14 days after surgery. Objective: Evaluation of the early CI device activation after CI surgery within 14 days, comparison to the first activation after 4–6 weeks, and assessment of the feasibility and safety of the early fitting over a 12 month observation period were the objectives of this study. Method: In a prospective study, 127 patients scheduled for CI surgery were divided into early fitting group (EF, n = 67) and control group (CG, n = 60). Individual questionnaires were used to evaluate medical and technical outcomes of the EF. Medical side effects, speech recognition, and follow-up effort were compared with the CG within the first year after CI surgery. Results: The early fitting was feasible in 97% of the EF patients. In the EF, the processor was activated 25 days earlier than in the CG. No major complications were observed in either group. At the follow-up appointments, side effects such as pain and balance problems occurred with comparable frequency in both groups. At initial fitting, the EF showed a significantly higher incidence of medical minor complications (p < 0.05). When developing speech recognition within the first year of CI use, no difference was observed. Furthermore, the follow-up effort within the first year after CI surgery was comparable in both groups. Conclusions: Early fitting of the sound processor is a feasible and safe procedure with comparable follow-up effort. Although more early minor complications were observed in the EF, there were no long-term wound healing problems caused by the early fitting. Regular inspection of the magnet strength is recommended as part of the CI follow-up since postoperative wound swelling must be expected. The early fitting procedure enabled a clear reduction in the waiting time between CI surgery and initial sound processor activation.

scholarly journals Topical Diltiazem Versus Topical Glyceryl Trinitrate In The Management Of Chronic Anal Fissure

JMS SKIMS ◽  
2014 ◽  
Vol 17 (2) ◽  
pp. 55-58
Author(s):  
Shams Ul Bari ◽  
Ajaz Ahmad Malik ◽  
Khurshid Alam Wani ◽  
Ajaz A Rather
Keyword(s):  
Side Effects ◽  
Anal Fissure ◽  
Chronic Anal Fissure ◽  
P Value ◽  
Double Blind ◽  
Surgical Methods ◽  
Significant Difference ◽  
Topical Glyceryl Trinitrate ◽  
One Year

Background: Chemical sphincterotomy is a novel way for treating patients of chronic anal fissure which avoids the risk of fecal incontinence associated with traditional surgical methods. Aims and objectives: The aim of this study was to compare the results of topical Diltiazem with topical Glyceril trinitrate in the management of chronic anal fissure. Methods: 71 patients in the age group of 15 - 61 years with chronic anal fissure were included in this prospective, randomized, double-blind trial over a period of two years with further follow up for one year. The patients were randomly allocated to either Diltiazem gel 2% (37 patients) or Glyceril trinitrate ointment 0.2% (34 patients) and were asked to use the treatment twice daily for 8 weeks. Each patient was reviewed every two weeks. Symptoms, healing, side effects and recurrence were compared using SPSS version 10 employing X2 test. A p-value below 0.05 was considered statistically significant. Results: Patients who received topical diltiazem (DTZ) showed statistically significant difference than those who were prescribed topical glyceril trinitrate in terms of symptoms, wound healing, side effects ( headaches) and recurrence (p=0.03 and 0.003 respectively). Healing occurred in 34 of 37 (92%) patients treated with Diltiazem after 6 weeks and 27 of 34 (80%) patients treated with Glyceril trinitrate after 8 weeks, which shows a significant difference in favour of Diltiazem (P < 0.001). The rest of the patients did not heal and underwent sphincterotomy (SILS). Headache occurred in all of the patients treated with Glyceril trinitrate but none of the patients treated with Diltiazem. Conclusion: Diltiazem gel was found to be better than Glyceril trinitrate ointment due to significantly higher healing rate and fewer side-effects. JMS 2014;17(2):55-58

DBS of the PSA and the VIM in essential tremor

Neurology ◽  
2018 ◽  
Vol 91 (6) ◽  
pp. e543-e550 ◽  
Author(s):  
Michael T. Barbe ◽  
Paul Reker ◽  
Stefanie Hamacher ◽  
Jeremy Franklin ◽  
Daria Kraus ◽  
...  
Keyword(s):  
Side Effects ◽  
Essential Tremor ◽  
Clinical Benefit ◽  
Double Blind ◽  
Crossover Phase ◽  
Ventral Intermediate Nucleus ◽  
Frequency Of Stimulation

ObjectiveTo evaluate deep brain stimulation (DBS) of the posterior subthalamic area (PSA) in essential tremor (ET) and compare it to the ventral intermediate nucleus of the thalamus (VIM) in terms of stimulation efficacy, efficiency, and side effects.MethodsDBS leads were implanted such that contacts were placed in the VIM, on the intercommissural line, and in the PSA. Thirteen patients with ET entered a randomized, double-blind crossover phase and completed a 1-year follow-up.ResultsPSA-DBS significantly reduced tremor severity and improved quality of life. There were no relevant differences in quality and frequency of stimulation side effects between VIM and PSA, with a tendency toward greater tremor improvement with PSA stimulation. Clinical benefit was achieved at significantly lower stimulation amplitudes in the PSA. The majority of patients remained with PSA-DBS after 1 year.ConclusionIn accordance with previous retrospective investigations, our prospective data suggest that PSA-DBS is at least equally effective as but possibly more efficient than VIM-DBS.Classification of evidenceThis study provides Class I evidence that for patients with essential tremor, PSA-DBS is not significantly different from VIM-DBS in suppressing tremor, but clinical benefit from PSA-DBS is attained at lower stimulation amplitudes.

Comparison of the efficacy of moclobemide and fluvoxamine in elderly patients with a severe depressive episode

1993 ◽  
Vol 8 (6) ◽  
pp. 319-324 ◽  
Author(s):  
JP Bocksberger ◽  
JP Gachoud ◽  
J Richard ◽  
Ρ Dick
Keyword(s):  
Side Effects ◽  
Elderly Patients ◽  
Psychomotor Retardation ◽  
Antidepressant Effect ◽  
Reversible Inhibitor ◽  
Double Blind Study ◽  
Double Blind ◽  
New Class ◽  
Low Incidence ◽  
To Receive

SummaryIn a double-blind study carried out on elderly patients (older than 65 years) the efficacy and tolerability of the new antidepressant moclobemide was compared. Moclobemide belongs to a new class of substances called RIMA (Reversible inhibitor of the monoamine oxidase type A). Fluvoxamine, a selective reuptake-inhibitor of 5-HT, belongs to a class of antidepressants known for their better tolerability compared to tricyclic especially with elderly patients. Forty elderly patients (mean age 75 years) with major depression (according to DSM III) were randomized to receive either moclobemide (300 mg) or fluvoxamine (100 mg) twice daily. Dosages were increased when necessary on day 8, to a maximum of 450 mg moclobemide or 200 mg fluvoxamine and in most cases were maintained at these levels for the remainder of the study period (four weeks). Moclobemide was more effective than fluvoxamine showing a marked antidepressant effect and an earlier effect on psychomotor retardation. The two drugs were well tolerated showing a low incidence of side effects.

scholarly journals Effects of Piracetam as an Adjuvant Therapy on Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Vol 15 (2) ◽  
Author(s):  
Kaveh Alavi ◽  
Elham Shirazi ◽  
Maryam Akbari ◽  
Zahra Shahrivar ◽  
Fatemeh-Sadat Noori ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Placebo Group ◽  
Side Effects ◽  
Adjuvant Therapy ◽  
Attention Deficit ◽  
Controlled Study ◽  
Double Blind ◽  
Children With Adhd ◽  
Double Blind Placebo ◽  
Hyperactivity Disorder

Background: Stimulants are highly effective in controlling symptoms of Attention-deficit/hyperactivity disorder (ADHD), but 30% of individuals with ADHD do not respond to them or cannot tolerate their side effects; thus, alternative treatment approaches need to be considered. Objectives: To evaluate the effect and safety of piracetam as an adjuvant therapy plus methylphenidate (MPH) in children with ADHD. Methods: Thirty-six children with ADHD (6-16 years old), admitted to three academic outpatient child psychiatric clinics in the second half of 2015, were randomly assigned to the “methylphenidate plus piracetam group” and the “methylphenidate plus placebo” group, in a double-blind, placebo-controlled study, for 6 weeks. The “Conner’s Parents’ Rating Scale-Revised (CPRS-R), Children Symptom Inventory-4 (CSI-4), Clinical Global Impression-Improvement scale (CGI-I), and Children’ Global Assessment Scale (CGAS) were completed at baseline and at the ends of the third and the sixth week, and the New York State Psychiatric Institute side effect forms were completed weekly, as outcome measures. Results: The level of improvement in CPRS-R, CSI-4, and CGI-I scales were significantly higher in the “methylphenidate plus piracetam” group compared with the “methylphenidate plus placebo” group. Side effects were not remarkable in any group. Conclusions: Piracetam as a short-term adjuvant treatment to methylphenidate can have considerable therapeutic effect and safety profile in children with ADHD and deserves further exploration to assess its potentialities in ADHD treatment.

Improvement in Outlet Obstructive Constipation Symptoms After Vaginal Stent Treatment for Rectocele

2020 ◽  
pp. 155335062097561
Author(s):  
Yitong Yin ◽  
Zhijun Xia ◽  
Meng Luan ◽  
Meiying Qin
Keyword(s):  
Side Effects ◽  
Obstructed Defecation ◽  
Safe Procedure ◽  
Rectal Balloon ◽  
Obstructed Defecation Syndrome ◽  
Incomplete Evacuation ◽  
Stent Treatment ◽  
Balloon Expulsion ◽  
Rectal Pressure

Objective. The objective is to determine the possible improvement in outlet obstructive constipation symptoms after vaginal stent treatment for rectocele. Methods. Female patients with rectocele (n = 156) accompanied with outlet obstructive constipation were selected in this study. Longo’s obstructed defecation syndrome (ODS) questionnaire, rectoanal pressures, and rectal balloon expulsion (BET) were evaluated at baseline, 1 month follow-up, and 6 months follow-up. Moreover, the side effects and the potential reasons for giving up treatment were also detected. Results. Vaginal stent significantly decreased the straining intensity, shortened the straining extensity time, decreased the use of laxatives, and alleviated the symptoms of incomplete evacuation ( P < .05). The vaginal stent also increased the rectal pressure and shortened the balloon expulsion time ( P < .05). Conclusions. As an effective, feasible, and safe procedure, the vaginal stent can be recommended as a treatment of choice for rectocele combined with outlet obstructive constipation.

Ergot derivatives in the prophylaxis of migraine: a multicentric study with a timed-release dihydroergotamine formulation

Cephalalgia ◽  
1983 ◽  
Vol 3 (1_suppl) ◽  
pp. 151-155 ◽  
Author(s):  
N. Martucci ◽  
V. Manna ◽  
P. Mattesi ◽  
G. Troiani ◽  
G. C. Manzoni ◽  
...  
Keyword(s):  
Side Effects ◽  
Sono State ◽  
Double Blind Study ◽  
Prophylactic Effect ◽  
Therapeutic Activity ◽  
Weight Changes ◽  
Double Blind ◽  
Multicentric Study ◽  
Recurrent Headache ◽  
Low Incidence

In this multicentric random double-blind study versus placebo, the therapeutic activity of timed-release dihydroergotamine preparation 10 mg/per os/day has been tested in 90 patients affected by common migraine. The drug presented a prophylactic effect on recurrent headache, mainly on night and awakening migraine. A low incidence of side-effects with no weight changes or other effects on physiologic events was registered. Les résultas obtenus dans cette étude contrôlée, en double aveugle, sur une serie de 90 malades porteurs de ‘migraine commune’, montre que la dihydroergotamine retard est active. Cette substance sembre réellment prévenir les crises du réveil et de la nuit. La tolérance clinique a été exellente. In questo studio multicentrico in doppio cieco randomizzato versus placebo è stata valutata l'attività terapeutica di una diidroergotamina a liberazione programmata (10 mg/per os/die) in 90 pazienti affetti da emicranie comune. Il farmaco ha dimostrato di possedere un effetto sulle cefalee ricorrenti e soprattutto sulla emicrania notturna e del risveglio. Sono state registrate una bassa incidenza di effetti collaterali e nessuna variazione del peso corporeo e di altri parametri fisiologici.

scholarly journals Efficacy of acamprosate in the treatment of alcohol-dependent outpatients

2003 ◽  
Vol 25 (3) ◽  
pp. 156-159 ◽  
Author(s):  
Danilo Antonio Baltieri ◽  
Arthur Guerra de Andrade
Keyword(s):  
Side Effects ◽  
Alcohol Dependence ◽  
Placebo Treatment ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Continuous Abstinence ◽  
Icd 10 ◽  
Alcohol Dependent

OBJECTIVE: To evaluate the efficacy and security of acamprosate in the treatment of 75 men, aged 18 to 59 years, with diagnosis of alcohol dependence according to the ICD-10. METHODS: Double-blind, placebo-controlled study, 24-week long. After a one-week detoxification period, patients were randomly divided in two groups: the first group received acamprosate (six tablets of 333 mg/d for 12 weeks) and the second group received placebo (six tablets for 12 weeks). After the first 12 weeks, patients continued the follow-up for further 12 weeks without medication. RESULTS: Patients who were receiving acamprosate showed significantly higher continuous abstinence time within the 24 weeks of treatment compared with patients who were assigned to placebo treatment (p=.017). Twenty-five percent of patients who were receiving acamprosate and 20% of the placebo-treated patients dropped out. Few side-effects were reported in both groups. CONCLUSION: Acamprosate proved to be safe and effective in treating alcohol-dependent patients and to maintain the abstinence during 24 weeks.

scholarly journals Treatment of patients with Schistosomiasis mansoni: a double blind clinical trial comparing praziquantel with oxamniquine

1986 ◽  
Vol 28 (3) ◽  
pp. 174-180 ◽  
Author(s):  
Luiz Caetano da Silva ◽  
José Murilo R. Zeitune ◽  
Lucia Maria F. Rosa-Eid ◽  
Dirce Mary C. Lima ◽  
Rita H. Antonelli ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Statistical Significance ◽  
Double Blind ◽  
Chemical Structures ◽  
Double Blind Clinical Trial ◽  
Negative Findings ◽  
Rectal Biopsies ◽  
Cure Rates

A double-blind clinical trial involving 120 patients with chronic schistosomiasis was carried out to compare the tolerability and efficacy of praziquantel and oxamniquine. The patients were randomly allocated into two groups. One was treated with praziquantel, 55 mg/kg of body weight CBWT), and the other one with oxamniquine, 15mg/kg bwt, administered in a single oral dose. The diagnosis and the parasitological follow-up was based on stool examinations by quantitative Kato-Katz method and on rectal biopsies. Side-effects — mainly dizziness, sleepness, abdominal distress, headache, nausea and diarrhea — were observed in 87% of the cases. Their incidence, intensity and duration were similar for both drugs but abdominal pain was significantly more frequent after praziquantel intake and severe dizziness was more commonly reported after oxamniquine. A significant increase of alanine-aminotransferase and y-glutamyltransferase was found with the latter drug and of total bilirubin with the former one. A total of 48 patients treated with praziquantel and 46 with oxamniquine completed with negative findings the required three post-treatment parasitological controls — three slides of each stool sample on the first, third and sixth month. The achieved cure rates were 79.2% and 84.8%, respectively, a difference without statistical significance. The non-cured cases showed a mean reduction in the number of eggs per gram of feces of 93.5% after praziquantel and of 84.1% after oxamniquine. This diference also was not significant. Five patients retreated with praziquantel were cured but only one out of three treated a second time with oxamniquine. These findings show that both drugs — despite their different chemical structures, pharmacological properties and mechanisms-of-action — induce similar side-effects as well as a comparable therapeutical efficacy, in agreement with the results reported from analogous investigations.

scholarly journals Adjuvant Therapy with Budesonide Post-Kasai Reduces the Need for Liver Transplantation in Biliary Atresia

2021 ◽  
Vol 10 (24) ◽  
pp. 5758
Author(s):  
Joachim F. Kuebler ◽  
Omid Madadi-Sanjani ◽  
Eva D. Pfister ◽  
Ulrich Baumann ◽  
David Fortmann ◽  
...  
Keyword(s):  
Side Effects ◽  
Adjuvant Therapy ◽  
Biliary Atresia ◽  
Experimental Therapy ◽  
Control Group ◽  
Multicenter Observational Study ◽  
Kasai Procedure ◽  
Native Liver ◽  
Survival With Native Liver

Based on the hypothesis that autoimmunological factors coregulate the pathomechanism in biliary atresia (BA), adjuvant therapy with steroids has become routine, although its efficacy has never been proven. In 2010, a study on the advantages of budesonide compared to prednisolone in autoimmune hepatitis gave rise to experimental therapy using budesonide as an adjuvant BA treatment. Ninety-five BA patients prospectively received a budesonide 2 mg/dose rectal foam daily for three months (SG). A case-matched control group (CG: 81) was retrospectively recruited. The outcome measures were survival with native liver (SNL), determined at six months and two years after the Kasai procedure. The follow-up rate was 100%. At six months, SNL was statistically not different but became so after two years (SG: 54%; CG: 32%; p < 0.001). No steroid-related side effects were observed, except for eight patients with finally caught-up growth retardation. This study demonstrates for the first time a significantly longer survival with native liver in patients with BA after adjuvant therapy. However, indication, dosage, and duration of any budesonide application is not given in neonates with BA. Hence, we suggest extending the postoperative use of budesonide in a multicenter observational study with a clearly defined follow-up protocol, particularly in terms of potentially underestimated side effects.

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