Can the combined treatment of solifenacin and imipramine has a role in desmopressin refractory monosymptomatic nocturnal enuresis? A prospective double-blind randomized placebo-controlled study

2021 ◽  
pp. 039156032199358
Author(s):  
Mohamed Samir ◽  
Mahmoud A Mahmoud ◽  
Hossam Elawady
Keyword(s):  
Placebo Group ◽  
Treatment Group ◽  
Side Effects ◽  
Relapse Rate ◽  
Nocturnal Enuresis ◽  
Combined Treatment ◽  
Controlled Study ◽  
Common Disease ◽  
End Point ◽  
Monosymptomatic Nocturnal Enuresis

Background: Nocturnal enuresis is a common disease of childhood. It can be classified into monosymptomatic nocturnal enuresis (MNE) or nonmonosymptomatic nocturnal enuresis (NMNE). Imipramine is a tricyclic antidepressant used to treat enuresis with initial success rates are high as 50% but some studies record a high relapse rate and it has a cardiotoxic effect when overdosed. Anticholinergics may be effective in the treatment of children with bladder storage dysfunction, including daytime incontinence. However, anticholinergics monotherapy is not effective in treating MNE. In our study, we used a low dose (25 mg) of imipramine in order to avoid its potential side effects and combined it with the synergistic anticholinergic action of solifenacin. Our objective was to evaluate the efficacy and safety of the combination of solifenacin and imipramine compared with placebo in the treatment of desmopressin refractory MNE. Methods: One hundred children aged 6 years or more with primary MNE unresponsive to desmopressin treatment were included. The children were randomly divided into two equal groups. Group A received imipramine 25 mg and solifenacin 5–10 mg oral tablets and group B received placebo once 1 h before bedtime for 3 months. The primary end point was to investigate the efficacy of the combined treatment of solifenacin and imipramine and the secondary end point was the safety of the drugs. Results: Our study showed that the mean post treatment wet nights per month was significantly lesser in the treatment group than placebo group ( p < 0.001) and cure rate was significantly higher in treatment group than placebo group ( p < 0.001). The relapse rate was statistically significantly lower in treatment group than placebo group ( p = 0.032). No significant side effects related to the drugs were reported. Conclusion: The combination treatment of solifenacin and imipramine is a useful and safe treatment for nocturnal enuresis after failure of everything else.

Changes in Microcirculation in Venous Ulcers with Essaven Gel

Angiology ◽  
2001 ◽  
Vol 52 (3_suppl) ◽  
pp. S23-S27 ◽  
Author(s):  
L. Incandela ◽  
G. Belcaro ◽  
M.R. Cesarone ◽  
M.T. De Sanctis ◽  
M. Griffin
Keyword(s):  
Placebo Group ◽  
Treatment Group ◽  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Local Treatment ◽  
Venous Hypertension ◽  
Controlled Study ◽  
Single Application ◽  
Venous Ulcers

Microcirculatory changes in chronic venous insufficiency (CVI) due to venous hypertension produce venous hypertensive microangiopathy (VHM) and lead to ulceration. VHM is charac terized by enlarged, convoluted capillaries; increase in flux, permeability, and edema; and altered microlymphatics. PO2 is decreased and CO2 increased. Capillary exchanges are altered and nutritional alterations in association with microtrauma may cause venous ulcers. The aim of this pilot, cross-over, randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG) (single acute application) in 10 subjects with VHM and venous ulcers. The study was structured over 3 days: day 1 was used for the control evalua tion for all patients. One group was randomized for the sequence placebo (day 2) and EG the following day; the second group with the sequence EG (day 2) and placebo (day 3). Indepen dently from the sequence, measurements of flux and PO2 in standard conditions showed positive changes (significant decrease of the abnormally increased flux, PO2 increase) in the EG treatment group. Changes in the placebo group were limited and associated with skin manip ulation. In conclusion, EG acutely improves microcirculation in limbs with VHM and ulceration even with a single application.

The Efficacy and Tolerability of Combined Antidepressant Treatment in Different Depressive Subgroups

1993 ◽  
Vol 162 (3) ◽  
pp. 363-368 ◽  
Author(s):  
Sinead O'brien ◽  
Patrick McKeon ◽  
Myra O'regan
Keyword(s):  
Treatment Group ◽  
Side Effects ◽  
Major Depression ◽  
Orthostatic Hypotension ◽  
Antidepressant Treatment ◽  
Combined Treatment ◽  
Endogenous Depression ◽  
Double Blind Study ◽  
Double Blind ◽  
Global Improvement

Eighty patients admitted to hospital with major depression were randomly allocated to six weeks of treatment with tranylcypromine, amitriptyline, or tranylcypromine and amitriptyline in combination, in a double-blind study. Scores on the HRSD improved significantly in all three groups, but there were no differences between the three groups. Patients on tranylcypromine and amitriptyline combined improved more according to their self-ratings after six weeks, and response was earlier as measured by a clinical global improvement scale. Those with endogenous depression improved more than those with neurotic depression, irrespective of treatment group. Combined treatment was less well tolerated than single treatments and gave rise to more side-effects, although there was no serious toxicity. Orthostatic hypotension was observed more frequently in patients on combined treatment. This group also experienced a significant increase in weight and prolongation of the P-R interval on ECG.

Ondansetron Is Effective to Treat Spinal or Epidural Morphine-induced Pruritus 

1999 ◽  
Vol 90 (2) ◽  
pp. 432-436 ◽  
Author(s):  
Alain Borgeat ◽  
Hans-Ruedi Stirnemann
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Visual Analog Scale ◽  
Case Reports ◽  
Controlled Study ◽  
Epidural Administration ◽  
Analog Scale ◽  
Double Blind ◽  
Hemoglobin Oxygen Saturation ◽  
Group A

Background Spinally and epidurally administered morphine is frequently associated with pruritus. Isolated case reports indicate that ondansetron may be effective in this context. This study aims to investigate the effectiveness of ondansetron to treat this side effect. Methods In a prospective, randomized, double-blind, placebo-controlled study, 100 patients with pruritus (&gt; 4 on a visual analog scale, on which 0 represents no pruritus and 10 represents worst pruritus imaginable) after spinal or epidural administration of morphine, received either 8 mg ondansetron intravenously (ondansetron group) in 100 ml NaCl 0.9% or vehicle (placebo group). A decrease of more than 4 points on the visual analog scale 60 min after treatment was considered a success. Changes in levels of pain and sedation, hemodynamic values, and other side effects were checked regularly. The presence or absence of pruritus was assessed for the last time 24 h later. Results The two groups were similar for demographic characteristics, the route of administration of morphine, and severity of pruritus at the beginning of the study. The ondansetron group showed a success rate of 70% versus 30% for the placebo group (P &gt; 0.05). Among the successfully treated patients, three (9%) in the ondansetron group and six (40%) in the placebo group reported the recurrence of pruritus (P &lt; 0.05). Among the successfully treated patients, none complained of residual pruritus 24 h later. No changes in pain or sedation levels were noted. Hemodynamic values remained stable, hemoglobin oxygen saturation did not decrease, and no other side effects were observed. Conclusion The administration of 8 mg ondansetron intravenously is an effective treatment for spinally or epidurally administered morphine-induced pruritus. In this clinical condition the treatment is safe and well tolerated.

A Controlled Study of Trancopal in the Treatment of Sleep Disturbances Due to Anxiety

1978 ◽  
Vol 6 (2) ◽  
pp. 115-120 ◽  
Author(s):  
J M T Warnock
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Sleep Disturbances ◽  
Controlled Study ◽  
Night Time ◽  
Double Blind ◽  
Matching Placebo ◽  
Daily Record ◽  
Single Night

Sixty-eight patients presenting with sleep disturbances due to mild neurotic anxiety were treated for two weeks with a single night-time dose of 400 mg Trancopal or matching placebo under double-blind conditions. Patients kept a daily record of the quality of their sleep and the observer carried out a weekly rating of anxiety using a modified Hamilton scale. By Day 7 patients receiving Trancopal had a significantly better rating for sleep and mean Hamilton scores for day-time anxiety than the placebo group. Side-effects were minimal. It was concluded that for patients with sleep disturbances due to neurotic anxiety Trancopal is a well tolerated and effective alternative to the hypnotics.

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.

scholarly journals Analgesic efficacy of nefopam for cancer pain: a randomized controlled study

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 378
Author(s):  
Koravee Pasutharnchat ◽  
Wichita Wichachai ◽  
Rungrawan Buachai
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Cancer Pain ◽  
Breakthrough Pain ◽  
Analgesic Efficacy ◽  
Pain Reduction ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Significant Pain

Background: Nefopam is a non-opioid, non-steroidal, central acting drug used effectively for postoperative pain. The efficacy of nefopam for cancer pain remains unclear. We aimed to evaluate the analgesic efficacy of nefopam for cancer pain in a randomized controlled trial. Methods: Patients with moderate to severe cancer pain (n=40) were randomly divided into two groups. The nefopam group (n=20) received three 20 mg doses of nefopam every 8 hours. The placebo group (n=20) received normal saline. Intravenous patient-controlled analgesia with morphine was given for breakthrough pain for 48 hours. The primary outcome was significant pain reduction. Secondary outcomes were morphine consumption over 48 hours and incidence of side effects. Results: The nefopam group showed pain reduction at 12 hours (65% of patients), 24 hours (80%), 36 hours (85%), and 48 hours (65%). The placebo group showed pain reduction at 12 hours (70%), 24 hours (75%), 36 hours (80%), and 48 hours (60%). However, there were no statistically significant differences between the groups (p>0.05). The median dosage of morphine consumption in 48 hours was lower in the nefopam group (25.5 mg) compared with the placebo group (37 mg), but this was not statistically significant (p=0.499). There were no statistically significant differences in blood pressure and heart rate between the groups. Side effects in both groups were comparable. Conclusions: At dosage of 60 mg in 24 hours, nefopam did not provide significant pain reduction in moderate to severe cancer pain patients. However, there was a trend of reduced opioid consumption. Further studies with larger sample sizes, longer duration, or higher doses of nefopam are warranted. Registration: Thai Clinical Trail Registry (TCTR) ID TCTR20181016001; registered on 12 October 2018.

scholarly journals The efficacy of a homoeopathic complex (Nux moschata D6, Phosphoricum acidum D30, Helleborus niger D6, Opium D30) in management of excessive daytime sleepiness

2018 ◽  
Author(s):  
◽  
Nondumiso Shabangu
Keyword(s):  
Placebo Group ◽  
Treatment Group ◽  
Excessive Daytime Sleepiness ◽  
Daytime Sleepiness ◽  
Epworth Sleepiness Scale ◽  
Statistical Significance ◽  
Controlled Study ◽  
Exact Tests ◽  
Double Blind ◽  
Stanford Sleepiness Scale

Background : Excessive daytime sleepiness (EDS) is the inclination or compulsion to fall asleep whilst intending to stay awake; it is believed to negatively affect occupational and social functioning and may be a predisposition towards accidents (Hayley et al. 2014), low productivity and interpersonal problems (Fong et al. 2005). Excessive daytime sleepiness is one of the most common sleep-related symptoms and it affects an estimated 20% of the population (Pagel .2009). The causes of EDS are numerous and include intrinsic sleep disorders (e.g. narcolepsy, obstructive apnoea/ hypopnea syndrome, idiopathic hypersomnia), and extrinsic disorders (Banerjee et al. 2004). Sleep deprivation is probably the most common cause of excessive daytime sleepiness. This clinic trial intended to evaluate the effectiveness of a homoeopathic complex (Nux moschata D6, Phosphoricum acidum D30, Helliborus niger D6, Opium D30) in the management of EDS in terms of the Epworth Sleepiness Scale (Johns, 1991) and Stanford Sleepiness Scale (Hoddes et al. 1973). And this randomised, double-blind placebo controlled study also aimed to provide a safe and effective alternative therapy for EDS. Aim of the study : The objective of this study was to determine the efficacy of a homoeopathic complex (Nux moschata D6, Phosphoricum acidum D30, Helliborus niger D6, Opium D30) and placebo in the management of EDS in terms of the Epworth Sleepiness Scale (ESS) and the Stanford Sleepiness Scale (SSS). Materials and Methodology : A sample group of 35 participants was selected voluntarily to conduct the study on basis of the inclusion and exclusion criteria. The participants were than randomly divided into two groups; a treatment group consisting of 23 participants and a placebo group consisting of 12 participants. Each participant had to attend three consultations in total with the researcher over a period of four weeks at the Durban University of Technology (DUT) Homoeopathic Day Clinic. At the first consultation a comprehensive case history (appendix F) was taken and physical examination (appendix E) was performed by the researcher but no medication was handed at that point. At each consultation the participants with the help of the researcher completed the Epworth Sleepiness Scale (ESS), and the seven days’ baseline Stanford Sleepiness Scale (SSS) was handed to the participants at the first and second consultation which the participants completed without the help of the researcher throughout the trial till their last consultation. Results : Results from the two measuring tools were statistically analysed with SPSS version 24.0. the participant’s level of sleepiness improved in both the treatment group and the placebo group. Intra-group analyses of ESS means revealed that both groups improved significantly over time, intergroup ANOVA analysis however revealed no significant differences between the groups. Section analyses however using the Fisher’s Exact Tests did reveal statistically significant differences within certain variables at some points of the study. Intra-group analyses of SSS data revealed no statistically significant change in SSS scores over the three weeks in both the Homoeopathic Complex and the Placebo Groups, as well as the Inter-group Fischer’s Exact tests revealed no statistically significant differences between the groups. Conclusion : Barring a few exceptions described in Chapter 4 & 5 it can be concluded from the results of the study that statistically the Homoeopathic complex (Nux moschata D6, Phosphoricum acidum D30, Helliborus niger D6, Opium D30) was not superior to placebo in the treatment of EDS. The data shows that both the Homoeopathic Complex and the placebo interventions had a positive effect on EDS and were effective in improving the level of excessive daytime Sleepiness. Irrespective of the general lack of statistical significance between groups a closer analysis of the intragroup and inter-group data does reveal a trend suggesting clinical significance in support of the effectiveness of the homoeopathic complex in the treatment of EDS however this needs to be further explored and confirmed in subsequent studies.

scholarly journals Double-Blind Cross-Over Placebo Controlled Study of Flunarizine in Patients With Therapy Resistant Epilepsy

1989 ◽  
Vol 16 (2) ◽  
pp. 187-190 ◽  
Author(s):  
E. Starreveld ◽  
F. de Beukelaar ◽  
A.F. Wilson ◽  
D.R. McLean ◽  
Helen P. Findlay
Keyword(s):  
Placebo Group ◽  
Depressive Symptoms ◽  
Side Effects ◽  
Seizure Frequency ◽  
Controlled Study ◽  
Double Blind ◽  
Adverse Side Effects ◽  
Generalized Seizures ◽  
Daily Dose ◽  
The Mean

ABSTRACT:Twenty-five patients with long-standing therapy resistant epilepsy were studied in an eight-month double- blind cross-over add-on trial with a daily dose of 15 mg flunarizine. In five patients the seizure frequency decreased 50% or more. The mean seizure frequency reduction in the patients on flunarizine was 35%. Particularly the control of secondary generalized seizures improved. Flunarizine did not significantly alter the plasma levels of the regular anticonvulsant drugs. Minimal adverse side effects were reported equally in the flunarizine and the placebo group. In three patients depressive symptoms improved and two patients became free of postictal headaches. Flunarizine appears to be a safe adjuvant anticonvulsant.

scholarly journals Efficacy of sildenafil on ischaemic digital ulcer healing in systemic sclerosis: the placebo-controlled SEDUCE study

2015 ◽  
Vol 75 (6) ◽  
pp. 1009-1015 ◽  
Author(s):  
Eric Hachulla ◽  
Pierre-Yves Hatron ◽  
Patrick Carpentier ◽  
Christian Agard ◽  
Emmanuel Chatelus ◽  
...  
Keyword(s):  
Placebo Group ◽  
Systemic Sclerosis ◽  
Healing Rate ◽  
Controlled Study ◽  
Digital Ulcer ◽  
Cox Models ◽  
Intention To Treat ◽  
End Point ◽  
Phosphodiesterase Type 5 Inhibitor ◽  
Phosphodiesterase Type

ObjectiveTo assess the effect of sildenafil, a phosphodiesterase type 5 inhibitor, on digital ulcer (DU) healing in systemic sclerosis (SSc).MethodsRandomised, placebo-controlled study in patients with SSc to assess the effect of sildenafil 20 mg or placebo, three times daily for 12 weeks, on ischaemic DU healing. The primary end point was the time to healing for each DU. Time to healing was compared between groups using Cox models for clustered data (two-sided tests, p=0.05).ResultsIntention-to-treat analysis involved 83 patients with a total of 192 DUs (89 in the sildenafil group and 103 in the placebo group). The HR for DU healing was 1.33 (0.88 to 2.00) (p=0.18) and 1.27 (0.85 to 1.89) (p=0.25) when adjusted for the number of DUs at entry, in favour of sildenafil. In the per protocol population, the HRs were 1.49 (0.98 to 2.28) (p=0.06) and 1.43 (0.93 to 2.19) p=0.10. The mean number of DUs per patient was lower in the sildenafil group compared with the placebo group at week (W) 8 (1.23±1.61 vs 1.79±2.40 p=0.04) and W12 (0.86±1.62 vs 1.51±2.68, p=0.01) resulting from a greater healing rate (p=0.01 at W8 and p=0.03 at W12).ConclusionsThe primary end point was not reached in intention-to-treat, partly because of an unexpectedly high healing rate in the placebo group. We found a significant decrease in the number of DUs in favour of sildenafil compared with placebo at W8 and W12, confirming a sildenafil benefit.Trial registration numberNCT01295736.

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