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Introduction: Chronic and inappropriate benzodiazepine (BDZ) prescription and intake represent an important health and social concern worldwide. The aim of our study was to investigate the safety and efficacy of P. incarnata L., herba in reducing BDZ misuse in a real-world population of depressed and anxious patients in a long-term treatment with BDZs. Methods: Over an 18-month period (from July 2021 to December 2022), we previously conducted a retrospective and naturalistic study on euthymic outpatients with a diagnosis of anxiety or depression and chronically taking BDZs. In this study we contacted patients 12 months after their enrollment in the previous study to assess their disease status and their BDZs and P. incarnata intake. Results: Our findings support the effectiveness of a dry extract of P. incarnata L., herba, as an add-on treatment during BDZ tapering in patients with anxiety or depression. We confirmed this effect to be sustained over time, and P. incarnata showed to be easily discontinued with no rebound, withdrawal or psychological dependence effect. The absence of side effects and adverse events confirmed the safety of P. incarnata in a real-world population. Personality disorders confirmed to be a relevant risk factor for maintaining addictive behavior, even when symptoms associated to withdrawal seem to be not particularly relevant. Discussion: We confirmed the possible effectiveness of P. incarnata as an add-on treatment in BDZ reduction. Further studies may be helpful to better investigate the promising properties of P. incarnata in the management of relevant clinical issues, such as anxiety disorders and addiction, that are classically known to benefit from GABAergic treatments. [ABSTRACT FROM AUTHOR]

Background: When considering changing hypnotic pharmacotherapy, lemborexant has attracted attention as a candidate due to its effectiveness and safety profile. However, few studies have investigated switching patterns in clinical practice. Research design and methods: We conducted a retrospective cohort study using a nationwide claims database. Patients prescribed a single hypnotic who either subsequently switched to (switching cohort) or were additionally prescribed (add-on cohort) lemborexant between July 2020 and December 2021 were identified. Proportion of successful switching was defined as remaining on lemborexant alone or without any hypnotic at 6 months after lemborexant initiation. Results: The success proportion was 70.1% in the switching cohort (n = 4,861) and 38.6% in the add-on cohort (n = 9,423). In the add-on cohort, the success proportion was lower in patients with a hypnotic history of ≥180 days (31.4%) and in patients whose prescribed hypnotic was a benzodiazepine or non-benzodiazepine (31.5% and 37.6%, respectively). Conclusion: The proportion of successful switching was higher in patients who switched to lemborexant than in those who added lemborexant as a concomitant treatment. The lower success proportion in the add-on cohort might be related to clinically more severe insomnia, and/or a concomitant prescription of benzodiazepine or non-benzodiazepine, from which discontinuation may be challenging. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusions This study aims to evaluate the add‐on effects of oral Chinese herbal medicine (CHM) for mild cognitive impairment (MCI), when used in addition to donepezil compared to donepezil alone.Randomized controlled trials comparing these treatments across all types of MCI were identified from nine databases and three registers until August 2023. Outcome measures were Mini‐Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and adverse events (AEs). Methodological quality was assessed using Cochrane risk‐of‐bias tool, and evidence certainty was evaluated using the GRADE method.Involving 1611 participants across 20 studies, meta‐analysis results indicate that oral CHM combined with donepezil significantly improved cognitive function in MCI patients compared to donepezil alone, as evidenced by MMSE (1.88 [1.52, 2.24], I2 = 41%, 12 studies, 993 participants) and MoCA (MD: 2.01 [1.57, 2.44], I2 = 52%, 11 studies, 854 participants). Eleven studies reported details of AEs, identifying gastrointestinal symptoms and insomnia as the most common symptoms. No significant difference in AEs frequency was found between the groups (RR: 0.91 [0.59, 1.39], I2 = 4%, 11 studies, 808 participants). All 20 studies were evaluated as having “some concerns” regarding the overall risk of bias. The certainty of evidence for MMSE was “moderate” and “low” for MoCA. From frequently utilized herbs, two classical CHM formulae were identified: Kai xin san and Si wu decoction. The observed treatment effects of commonly used herbs may be exerted through multiple pharmacological mechanisms, including anti‐inflammatory, anti‐oxidative stress, anti‐apoptotic actions, promotion of neuronal survival and modulation of the cholinergic system.The concurrent use of oral CHM and donepezil appears to be more effective than donepezil alone in improving the cognitive function of MCI, without leading to an increase in AEs. While recognizing concerns of overall methodological quality, this combined therapy should be considered as an alternative option for clinical practice. [ABSTRACT FROM AUTHOR]

Introduction: This randomized, placebo-controlled, double-blind, parallel study aimed to evaluate the effect of 3-month supplementation of bovine colostrum (BOV-COL; 8x400 mg per day) on the outcomes of depression treatment in hospitalized patients with substance use disorder (SUD). The hypothesis is that BOV-COL supplementation as an add-on treatment results in favorable alternations in selected blood inflammatory markers or neurotransmitters, leading to better depression treatment outcomes compared with placebo (PLA). Methods: Patients with a Minnesota Multiphasic Personality Inventory-2 score =60 points were enrolled. Twenty-nine participants (n=18 in the BOV-COL group and n=11 in the PLA group) completed the protocol. Results: The mean Beck Depression Inventory-II score was significantly reduced after supplementation in both groups. However, the mean 17-point Hamilton Depression Rating Scale score was decreased in the BOV-COL group, but not in the PLA group. In the BOV-COL group, there was a reduction in interleukin (IL)-1, IL-6, IL-10, the IL-6:IL-10 ratio, IL-17, and tumor necrosis factor alpha (TNF-a), while in the PLA group only IL-6 decreased. Favorable alternations in the total count and differentials of white blood cell subsets were more pronounced in the BOV-COL. There were no changes in neurotransmitter concentrations. Conclusions: BOV-COL supplementation is a promising add-on therapy in patients with depression and SUD. [ABSTRACT FROM AUTHOR]

IntroductionChronic and inappropriate benzodiazepine (BDZ) prescription and intake represent an important health and social concern worldwide. The aim of our study was to investigate the safety and efficacy of P. incarnata L., herba in reducing BDZ misuse in a real-world population of depressed and anxious patients in a long-term treatment with BDZs.MethodsOver an 18-month period (from July 2021 to December 2022), we previously conducted a retrospective and naturalistic study on euthymic outpatients with a diagnosis of anxiety or depression and chronically taking BDZs. In this study we contacted patients 12 months after their enrollment in the previous study to assess their disease status and their BDZs and P. incarnata intake.ResultsOur findings support the effectiveness of a dry extract of P. incarnata L., herba, as an add-on treatment during BDZ tapering in patients with anxiety or depression. We confirmed this effect to be sustained over time, and P. incarnata showed to be easily discontinued with no rebound, withdrawal or psychological dependence effect. The absence of side effects and adverse events confirmed the safety of P. incarnata in a real-world population. Personality disorders confirmed to be a relevant risk factor for maintaining addictive behavior, even when symptoms associated to withdrawal seem to be not particularly relevant.DiscussionWe confirmed the possible effectiveness of P. incarnata as an add-on treatment in BDZ reduction. Further studies may be helpful to better investigate the promising properties of P. incarnata in the management of relevant clinical issues, such as anxiety disorders and addiction, that are classically known to benefit from GABAergic treatments.

Background: Neuropathy is one of the most common long-standing complications of diabetes, affecting over 50% of the diabetic individuals. Managing DPN and its complications involves comprehensive care and a multidisciplinary approach. Besides pharmacological treatments, botanicals and dietary supplements that have also been found to improve symptoms of DPN without affecting glucose control. The possible role of vitamin E in the management of DPN have been postulated in various studies. The present study thus aimed to prospectively assess whether add-on treatment with vitamin E can improve treatment outcomes in diabetic peripheral neuropathy. Methods: The study included newly diagnosed patients with diabetic peripheral neuropathy for a period of initial two months. Patients were randomly allocated to either standard treatment Group (Group A) or the intervention Group (Group B). As a part of intervention, patients received vitamin E 400mg once daily in addition to the standard of care. Efficacy Parameters measured at baseline, 6 months and 12 months included changes in visual analog scoring, mean pain score, brief pain inventory and patient’s global impression of change. Treatment safety, quality of life and treatment adherence was assessed. Data was statistically analysed. Result: The study included a total of 100 patients, 50 patients in each Group. Significantly higher decrease of glycaemic measures was noted for Group B compared to Group A in terms of PPPG and serum creatinine, however, there was comparable change in HbA1c and FPG for both Groups. There was comparable significant reduction in mean VAS scoring at 6 and 12 months for Group B. Considering all the efficacy measures, there was highest reduction for the pain interference in the intervention arm (Group B), in comparison to Group A. (p<0.001). Quality of life measures and mean adherence scoring significantly increased for treatment group B as compared to A at both 6 months and 12 months of study assessments. No major safety concerns were reported during the study period. Conclusion: Our study noted that addition of vitamin E as an added supplementation to the standard of care showed benefits in terms of patient reported reduced pain interference and pain perception, which also significantly improved overall quality of life in these patients. [ABSTRACT FROM AUTHOR]

IntroductionThis randomized, placebo-controlled, double-blind, parallel study aimed to evaluate the effect of 3-month supplementation of bovine colostrum (BOV-COL; 8x400 mg per day) on the outcomes of depression treatment in hospitalized patients with substance use disorder (SUD). The hypothesis is that BOV-COL supplementation as an add-on treatment results in favorable alternations in selected blood inflammatory markers or neurotransmitters, leading to better depression treatment outcomes compared with placebo (PLA).MethodsPatients with a Minnesota Multiphasic Personality Inventory-2 score ≥60 points were enrolled. Twenty-nine participants (n=18 in the BOV-COL group and n=11 in the PLA group) completed the protocol.ResultsThe mean Beck Depression Inventory-II score was significantly reduced after supplementation in both groups. However, the mean 17-point Hamilton Depression Rating Scale score was decreased in the BOV-COL group, but not in the PLA group. In the BOV-COL group, there was a reduction in interleukin (IL)-1, IL-6, IL-10, the IL-6:IL-10 ratio, IL-17, and tumor necrosis factor alpha (TNF-α), while in the PLA group only IL-6 decreased. Favorable alternations in the total count and differentials of white blood cell subsets were more pronounced in the BOV-COL. There were no changes in neurotransmitter concentrations.ConclusionsBOV-COL supplementation is a promising add-on therapy in patients with depression and SUD.

Background and objectives: Acute encephalitis syndrome is a health burden to a populous country like India. It is characterized by a sudden onset of fever, altered sensorium with or without seizures, irritability, abnormal behavior, or unconsciousness. This study aims to augment further evidence on the effects of add-on homeopathic treatment in reducing mortality and morbidity in children. Methods: This comparative retrospective study included children hospitalized with acute encephalitis syndrome between July 2016 to December 2016. We compared the parameters of children for whom decisions on the Glasgow Outcome scale and Liverpool outcome score aided by add-on homeopathy against those of children from the same year when the add-on homeopathy was not used. All the children were on conventional supportive care and treatment tailored to each child. We also counted the days until the resumption of oral feeding and the length of hospital stay. Results: Ordinal regression analysis on analyses on 622 children (IH + IMP= 329; IMP only=293) was done. Odds of a shift towards increased recovery were superior in the homeopathy-added group than in the IMP group without adjustment (crude OR 2·30, 95% CI 1·66 to 3·20; p=0·0001) and with adjustment (adjusted OR 3.38, 95% CI 2·38 to 4.81; p=0·0001). There was 14.8% less mortality and 17.4% more recovery in the add-on homeopathy group compared to IMP alone. Individualized homeopathic remedies commonly used were Belladonna (n =238), Stramonium (n =17), Opium (n = 14), Sulphur (n=11), and Hyoscyamus niger (n = 7). Conclusion: This retrospective cohort study advocates for add-on homoeopathy in children suffering acute encephalitis which can produce notable improvements in terms of mortality and morbidity. Further studies in different settings are warranted. [ABSTRACT FROM AUTHOR]

Copyright of Practical Pharmacy & Clinical Remedies is the property of Editorial Department of Practical Pharmacy & Clinical Remedies and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

With the increasing offer of fertility treatment by a largely privatised sector, which has involved the proliferation of treatment add‐ons lacking evidence of effectiveness, In‐Vitro Fertilisation (IVF) patients are expected to make informed choices on what to include in their treatment. Drawing on interviews with 51 individuals undergoing fertility treatment, this article explores patients' approaches to medical evidence interpretation and its role in their decisions to include add‐ons. While most IVF patients share understandings of what counts as medical evidence, our findings show how their approaches also differ. Our analysis focuses on how patients negotiate the notion of medical evidence and its relation to other forms of experience or knowledge. We present four different approaches to evidence in IVF: (1) delegating evaluations of evidence to experts; (2) critically assessing available evidence; (3) acknowledging the process of making evidence; and (4) contextualising evidence in their lived experience of infertility. We suggest that patients' choice to include add‐ons is not due to a lack of information on or understanding of evidence, but rather should be interpreted as part of the complexity of patients' experiences of infertility. [ABSTRACT FROM AUTHOR]

Physiotherapy is mentioned as an adjunctive treatment to improve the symptoms of cervical dystonia in terms of pain, function and quality of life. However, botulinum neurotoxin injection remains the treatment of choice. This systematic review emphasizes physical therapy and evaluates it by including six studies. The methodology is based on a previous systematic review on this topic to provide better comparability and actuality. For this purpose, two databases were searched using the previously published keywords. This time, only randomised controlled trials were evaluated to increase the power. In conclusion, additional physical therapy and active home exercise programs appear to be useful. Further research should focus on the dose–response principle to emphasize physical therapy treatment modalities. [ABSTRACT FROM AUTHOR]

Objective To evaluate the effectiveness of Δ9-tetrahydrocannabinol (dronabinol [DRO]) as an add-on treatment in patients with refractory chronic pain (CP). Methods An exploratory retrospective analysis of 12-week data provided by the German Pain e-Registry on adult patients with treatment refractory CP who received DRO. Results Between March 10, 2017, and June 30, 2019, the German Pain e-Registry collected information on 89,095 patients with pain, of whom 1,145 patients (1.3%) received DRO (53.8% female, mean ± standard deviation age: 56.9 ± 10.6 years), and 70.0% documented use for the entire 12-week evaluation period. The average DRO daily dose was 15.8 ± 7.5 mg, typically in three divided doses (average DRO dose of 5.3 ± 2.1 mg). Average 24-hour pain intensity decreased from 46.3 ± 16.1 to 26.8 ± 18.7 mm on a visual analog scale (absolute visual analog scale difference: –19.5 ± 17.3; P  < 0.001). Among patients who completed follow-up, an improvement from baseline of at least 50% was documented for pain (46.5%), activities of daily living (39%), quality of life (31.4%), and sleep (35.3%). A total of 536 patients (46.8%) reported at least one of 1,617 drug-related adverse events, none of which were serious, and 248 patients (21.7%) stopped treatment. Over the 12-week period, 59.0% of patients reported a reduction of other pain treatments, and 7.8% reported a complete cessation of any other pharmacological pain treatments. Conclusion Add-on treatment with DRO in patients with refractory CP was well tolerated and associated with a significant improvement. [ABSTRACT FROM AUTHOR]

Background: There is consistent evidence that community and clinical samples of individuals with an alcohol use disorder (AUD) have attentional biases toward alcohol cues. The alcohol attentional control training program (AACTP) has shown promise for retraining these biases and decreasing alcohol consumption in community samples of excessive drinkers. However, there is a lack of evidence regarding the effectiveness of ACTP in clinical AUD samples. The main aim of the present study is to investigate whether primary pharmacological and psychological, evidence-based alcohol treatment can be enhanced by the addition of a gamified AACTP smartphone application for patients with an AUD.Design and Methods: The study will be implemented as a randomized controlled trial. A total of 317 consecutively enrolled patients with AUD will be recruited from alcohol outpatient clinics in Denmark. Patients will be randomized to one of three groups upon initiation of primary alcohol treatment: Group A: a gamified AACTP smartphone application + treatment as usual (TAU); Group B: a gamified AACTP sham-control application + TAU; or Group C: only TAU. Treatment outcomes will be assessed at baseline, post-treatment, and at 3- and 6-month follow-ups. Repeated measures MANOVA will be used to compare the trajectories of the groups over time on alcohol attentional bias, alcohol craving, and drinking reductions. It is hypothesized that Group A will achieve better treatment outcomes than either Group B or Group C.Perspectives: Because attentional bias for alcohol cues is proportional to the amount of alcohol consumed, and these biases are not addressed within current evidence-based treatment programs, this study is expected to provide new evidence regarding the effectiveness of the gamified AACTP in a clinical population. Furthermore, due to promising results found using AACTP in community samples of excessive drinkers, there is a high probability that the AACTP treatment in this study will also be effective, thereby allowing AACTP to be readily implemented in clinical settings. Finally, we expect that this study will increase the effectiveness of evidence-based AUD treatment and introduce a new, low-cost gamified treatment targeting patients with an AUD. Overall, this study is likely to have an impact at the scientific, clinical, and societal levels.Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT05102942?term=NCT05102942&draw=2&rank=1, identifier: NCT05102942.

Physiotherapy is mentioned as an adjunctive treatment to improve the symptoms of cervical dystonia in terms of pain, function and quality of life. However, botulinum neurotoxin injection remains the treatment of choice. This systematic review emphasizes physical therapy and evaluates it by including six studies. The methodology is based on a previous systematic review on this topic to provide better comparability and actuality. For this purpose, two databases were searched using the previously published keywords. This time, only randomised controlled trials were evaluated to increase the power. In conclusion, additional physical therapy and active home exercise programs appear to be useful. Further research should focus on the dose–response principle to emphasize physical therapy treatment modalities.

Asthma is a heterogeneous disease characterized by airway inflammation resulting from complex interactions between multiple hosts as well as environmental factors. As a chronic respiratory condition, asthma exerts a significant impact on patients and the healthcare system. Per the Global Initiative for Asthma (GINA), inhaled corticosteroids (ICS) with/without long-acting beta2-agonists (LABAs) should be used as the preferred controllers for the management of asthma. Despite a range of therapeutic options, many patients with asthma remain uncontrolled, resulting in an increased risk of hospitalization and emergency room visits and a worsened quality of life. Tiotropium (Spiriva®, Boehringer Ingelheim Pharmaceuticals, Inc; 1.25 µg, two puffs, once daily), delivered via the Respimat® inhaler (Boehringer Ingelheim Pharmaceuticals, Inc.), was the first long-acting muscarinic antagonist to be approved as an add-on maintenance treatment option for patients with asthma aged ≥6 years at GINA steps 4 and 5. By binding to the muscarinic receptors M1 and M3 in the bronchial airways, tiotropium antagonizes the action of acetylcholine, leading to smooth muscle relaxation and reduced mucus secretion. The efficacy and safety of tiotropium add-on to ICS±LABA maintenance treatment have been evaluated in randomized controlled trials (RCTs) involving patients with a range of asthma severities (mild, moderate, and severe) and across age groups (children, adolescents, and adults). Add-on tiotropium was found to be well tolerated and efficacious in all RCTs. Moreover, the findings from real-world studies complement results from RCTs, showing beneficial effects of tiotropium in reducing exacerbations, hospitalization, emergency room visits, and asthma worsening. In this review article, we discuss the pathophysiology of asthma and the role of tiotropium in the management of asthma from the perspective of a primary care physician. [ABSTRACT FROM AUTHOR]

Copyright of Revue Francaise d'Allergologie is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Michael A Ueberall,1 Ute Essner,2 Gerhard HH Mueller-Schwefe31Institute of Neurological Sciences, 90411 Nuernberg, Germany; 2O.Meany Consultancy, 22339 Hamburg, Germany; 3Interdisciplinary Centre for Pain and Palliative Care Medicine, 73033 Goeppingen, GermanyObjective: To evaluate effectiveness, tolerability and safety of an oromucosal spray containing Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD), as add-on treatment in patients with severe chronic pain (SCP).Methods: Exploratory analysis of anonymized 12-week routine/open-label data provided by the German Pain e-Registry (GPR) on adult SCP patients treated with THC:CBD oromucosal spray in 2017.Results: Among those 30.228 cases documented in the GPR in 2017, 800 (2.6%; 57% female, mean ± SD age: 46.3±9.7 years) received a treatment with THC:CBD. All patients fulfilled the legislative preconditions for a treatment with cannabis as medicine as defined by the German Act Amending Narcotics and Other Regulations. THC:CBD-treatment was followed by an aggregated nine-factor symptom relief (ASR-9) improvement at end of week 12 vs baseline of 39.0±26.5% (95%-CI: 36.9–41.1, median: 42, range −41 to 85). A full ASR-9 response (ie, a 50%-improvement in all 9 factors) was found for 123 patients (15.4%), while 488 patients (56.0%) presented with an ≥50% improvement in at least 5 of 9 ASR factors. With a 54.9±17.2% (median: 56%, range: −6 to 85) improvement was significantly superior in the neuropathic pain subgroup (n=497, 62.1%) vs those with mixed (n=249, 31.1%; ASR-9: 18.2±12.0, median: 19, range: −12 to 42%) or nociceptive pain (n=54, 6.8%; ASR-9: −11.9±10.5, median: −11, range: −41% to 12%; p

Introduction Impairment of conventional perception is one of the key dysfunction in patients with schizophrenia even in absence of psychotic symptoms. Objectives Possibility of improvement of conventional perception by add-on treatment with ipidacrine in patients with schizophrenia in long-term remission. Methods 26 (13 females) patients, mean age 40.4 (SD 11.7) with episodic schizophrenia in remission more than one year, receiving stable antipsychotic therapy were included into the open label study. As add-on treatment ipidacrine was administered once per day in dosage 20 mg for two months. Positive and Negative Symptoms Scale (PANSS) was used to assess clinical symptoms and projective psychological method (Rorschach Test) was used to assess conventional perception. Results The study showed that ipidacrine in a low dosage, added to standard antipsychotic treatment, was effective in relation to negative symptoms (PANSS negative subscale score before 22,4 (SD4,7) and after beginning of the study 19,7 (4,5), p=0, 001). Of all the indicators of the Rorschach test, there was significant improvement in the index X+%, which is responsible for the degree of conventionality in reality recognition. The decrease in conventionality was associated with both high individualism and perceptual disorders. The value of of X+ % did not reach the standard one (70%) to the end of the study, but the improvement showed the switching from severe (52,4 (SD 12,2) to moderate (60,6 (SD10,4) impairment level (p=0,039). Conclusions Ipidacrine in a low dosage as add-on treatment has positive effect on conventional perception of stable patients with schizophrenia even in short-term trial.

Objective: Our aim was to explore the feasibility, and efficacy of a Dialectical Behavior Therapy Skill Training Group (DBT‐ST) as an add‐on treatment for adult attention‐deficit/hyperactivity disorder (ADHD) in Latin America. Method: Adults with ADHD (n = 31) with stable medication treatment for ADHD and residual symptoms (ASRS > 20) were randomly assigned to DBT‐ST (n = 16) or treatment as usual (TaU; n = 15) for 12 weeks. Feasibility was accessed by attendance and completion rates at 12 weeks. Efficacy outcomes were measured with the ASRS, and performed at 0, 6, 12, and 16 weeks. Results: The DBT‐ST protocol had 81.25% completion rate, with a mean attendance of 87.25% of the sessions. No significant interactions between group and time were detected for outcome measures. Discussion: The DBT‐ST was feasible as add‐on treatment for adult patients with ADHD in Latin America. Replicating previous findings, DBT‐ST has shown no significantly higher improvement in ADHD symptoms in comparison with TaU. Registered at the Clinical Trials database (NCT03326427). [ABSTRACT FROM AUTHOR]

In this meta-analysis, we aimed to estimate and compare the efficacy of add-on treatment of antidepressants with esketamine nasal spray and second-generation antipsychotics in patients with nonpsychotic major depressive disorder and inadequate response to antidepressants. Searching for acute-phase, double-blind, placebo-controlled, randomized trials, we found 22 second-generation antipsychotic (n = 8363) and 3 intranasal esketamine (n = 641) studies. Mean change in the Montgomery Åsberg Depression Rating Scale total score served as outcome. We determined a higher mean difference (vs placebo) for the pooled esketamine nasal spray trials (mean difference = 4.09, 95% confidence interval: 2.01 to 6.17) than for the pooled second-generation antipsychotic augmentation trials (mean difference  = 2.05, 95% confidence interval: 1.51 to 2.59). Thus, the effect size for intranasal esketamine was nearly twice as high as those for the second-generation antipsychotics. This indicates high efficacy of add-on esketamine nasal spray in treatment-resistant major depressive disorder compared with other well-established, evidence-based pharmacological options such as augmentation with second-generation antipsychotics. [ABSTRACT FROM AUTHOR]

Case: A 69‐year‐old male presented with a two‐year history of memory decline. Results of his cognitive function tests suggested cognitive impairment and brain magnetic resonance imaging showed cortical atrophy, predominantly in the temporal lobes. Based on these findings, he was diagnosed with Alzheimer's disease. Outcome: Although treatment with donepezil was commenced, the patient's cognitive function deteriorated in the year after initiation. However, his cognitive impairment improved in the year after add‐on administration of kamikihito, a traditional Japanese herbal medicine, with donepezil monotherapy. Conclusion: Combination therapy with donepezil and kamikihito seems to be beneficial and worth considering for patients who are secondarily non‐responsive to donepezil monotherapy. [ABSTRACT FROM AUTHOR]

Twenty to forty percent of patients remain intractable to first line antiepileptic medicines. Clobazam is used as an add-on medicine in treatment of intractable epilepsies. This study evaluated the effectiveness of clobazam as add-on drug in intractable epilepsy patients receiving either valproic acid or carbamazepine. This study is an open label, data based clinical study which was undertaken in a neurology outpatient department of a tertiary care centre. In this study, clobazam was added to epileptic patients who were receiving either valproic acid (VPA) or carbamazepine (CBZ) at maximum clinically tolerated dose. The effectiveness of clobazam was measured by percentages of reduction of seizure frequency from base line (0%, 0-49.9%, 50-99.9%, 100%) and the responder rate (50% or greater reduction of seizure frequency from base line). Fisher’s test and Chi-square test were used for data analysis. Out of total 83 patients (62 male, 21 female, age range 14-60 years, mean age 24.5), 50 and 33 were receiving carbamazepine and sodium valproate respectively. All complex partial seizure (CPS) and 42.3% of generalized tonic clonic seizure(GTCS) patients became seizure free. The responder rate for GTCS cases were 67.3%. The percentages of seizure free patients in VPA and CBZ group were 39.4% and 38% respectively. Seizure frequency reduction and responder rate were found to be significant (p < 0.05) between group.

Sibel Cakir,1 Zeynep Senkal2 1Department of Psychiatry, Mood Disorders, Geriatric Psychiatry Unit, Istanbul Medical School, Istanbul University, 2Department of Psychiatry, Marmara University, Istanbul, Turkey Background: Second-generation antipsychotics (SGAs) have been used in the augmentation of treatment-resistant depression. However, little is known about their effectiveness, tolerability, and adverse events in the treatment of late-life depression, which were the aim of this study.Methods: The retrospective data of patients aged >65 years who had a major depressive episode with inadequate response to antidepressant treatment and had adjuvant SGA treatment were analyzed. The outcome measures were the number of the patients who continued to use SGAs in the fourth and twelfth weeks, adverse events, and changes in symptoms of depression. Results: Thirty-five patients were screened: 21 (60%) had quetiapine, twelve (34.28%) had aripiprazole, and two (5.71%) had olanzapine adjuvant treatment. The mean age was 72.17±5.02 years, and 65.7% of the patients were women. The mean daily dose was 85.71±47.80 mg for quetiapine, 3.33±1.23 mg for aripiprazole, and 3.75±1.76 mg for olanzapine. The Geriatric Depression Scale scores of all patients were significantly decreased in the fourth week and were significant in the aripiprazole group (P=0.02). Of the 35 patients, 23 (65.7%) patients discontinued the study within 12 weeks. The frequency of adverse events was similar in all SGAs, and the most common were sedation, dizziness, constipation, and orthostatic hypotension with quetiapine, and akathisia and headache because of aripiprazole. Conclusion: This study indicates that dropout ratio of patients with SGAs is high, and a subgroup of patients with late-life depression may benefit from SGAs. Effectiveness is significant in aripiprazole, and adverse events of SGAs were not serious but common in elderly patients. Keywords: treatment resistance, aripiprazole, quetiapine, olanzapine, elderly

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Schizophrenia is a serious mental illness characterized by incoherent or illogical thoughts, bizarre behavior and speech, and delusions or hallucinations, such as hearing voices. Person suffering from the disorder may be seriously impaired. Also, family members may be seriously affected. However, through proper treatment many individuals suffering from schizophrenia can recover. Anti-psychotic drugs play a crucial role in schizophrenia treatment. However, anti-psychotics may treat the positive symptoms of schizophrenia and do little to improve the lost ability of the patient due to negative symptoms. Second-generation anti-psychotics are slightly more effective than first-generation anti-psychotics in treating positive symptoms of symptoms, but their efficacy against negative symptoms has not been borne out. Many patients continue to suffer from persistent symptoms and relapses, particularly when they fail to adhere to prescribed medication. This underlines the need for multi modal care that include psychosocial and physical therapies such as yoga, adjunct to anti-psychotic medication to help alleviate symptoms and improve patient's quality of life. Yoga as an additional treatment along with anti-psychotics can be use, as it has proved to deal with both the positive and negative symptoms of schizophrenia. Unlike anti-psychotic drugs, yoga has no side effects. This paper evaluates research on efficacy of yoga as an add-on treatment of schizophrenia. Review shows that yoga is useful in treating negative symptoms of schizophrenia in stabilized patients though more research is required to understand yoga's effect on schizophrenia. [ABSTRACT FROM AUTHOR]

Treatment of vitiligo is challenging and requires a multidisciplinary approach. Fractional carbon dioxide (CO2) laser as an add-on to conventional treatment has been reported to be effective, but there is no consensus on its use. A systematic review was performed by searching major databases for relevant publications to February 2017. Six studies with 85 participants were included. For those with refractory vitiligo, the addition of fractional CO2 laser to routine treatment modalities was superior to conventional treatment alone in terms of > 50% re-pigmentation (risk ratio (RR) 4.90, 95% confidence interval (95% CI), 1.15-20.93; p = 0.03), physician improvement score (mean difference (MD) 0.81, 95% CI 0.33-1.29; p < 0.001), < 25% re-pigmentation (RR 0.64, 95% CI 0.49-0.85; p=0.002) and patient satisfaction (MD 1.61, 95% CI 0.73-2.49; p < 0.001). Side-effects were minor. These results provide evidence supporting that fractional CO2 laser is a valuable treatment modality for patients with vitiligo, especially for those with refractory vitiligo. [ABSTRACT FROM AUTHOR]

Currently available data indicate superior therapeutic effects of combination treatment for Alzheimer dementia with memantine and acetylcholine esterase inhibitors in certain clinical contexts. Out of five randomized, placebo-controlled, double-blind trials two showed superior therapeutic effects in comparison to monotherapy with acetylcholinesterase inhibitors regarding various domains. Recently published meta-analyses and cost-benefit analyses also showed positive results. Recently published German guidelines for dementia treatment also take these new data into account and recommend combination treatment in patients with severe dementia on stable donepezil medication. This article gives an overview of current evidence for combination therapy. [ABSTRACT FROM AUTHOR]

Chantal Mathieu, Evy DegrandeDepartment of Endocrinology, Katholieke Universiteit Leuven, Leuven, BelgiumAbstract: Vildagliptin is a new oral antidiabetic agent that enhances pancreatic islet cell responsiveness to glucose. An extensive clinical program involving approximately 22,000 patients and 7000 patient-years of exposure to vildagliptin has shown that the agent is well tolerated and efficacious in improving glycemic control in patients with type 2 diabetes mellitus (T2DM). Monotherapy trials have shown that significant HbA1c lowering is accompanied by body weight-neutral and lipid-neutral effects, low risk of edema, and low risk of hypoglycemia. These characteristics make vildagliptin a favorable partner for combination therapy. Studies of vildagliptin as an add-on to metformin have shown significant improvements in glycemic control (comparable to that of thiazolidinedione add-on), with the combination being well tolerated and associated with low risks for hypoglycemia and adverse effects on weight or lipid levels. Good tolerability and clinically relevant improvements in glycemic control have also been observed with vildagliptin as an add-on treatment to sulfonylurea, thiazolidinedione, or insulin treatment or in initial combination treatment with pioglitazone. Improved β-cell function and glycemic control have been shown with vildagliptin in subjects with impaired glucose tolerance and in T2DM patients with mild hyperglycemia, with some evidence in the latter suggesting the potential for modifying disease course.Keywords: diabetes, vildagliptin, incretin, metformin, add-on treatment, hypoglycemia

Schizophrenia is a heterogeneous psychiatric disorder with a broad spectrum of clinical and biological manifestations. Due to the lack of objective tests, the accurate diagnosis and selection of effective treatments for schizophrenia remains challenging. Numerous technologies have been employed in search of schizophrenia biomarkers. These studies have suggested that neuroinflammatory processes may play a role in schizophrenia pathogenesis, at least in a subgroup of patients. The evidence indicates alterations in both pro- and anti-inflammatory molecules in the central nervous system, which have also been found in peripheral tissues and may correlate with schizophrenia symptoms. In line with these findings, certain immunomodulatory interventions have shown beneficial effects on psychotic symptoms in schizophrenia patients, in particular those with distinct immune signatures. In this review, we evaluate these findings and their potential for more targeted drug interventions and the development of companion diagnostics. Although currently no validated markers exist for schizophrenia patient stratification or the prediction of treatment efficacy, we propose that utilisation of inflammatory markers for diagnostic and theranostic purposes may lead to novel therapeutic approaches and deliver more effective care for schizophrenia patients. [ABSTRACT FROM AUTHOR]

Introduction: Seizure is a dysfunction of the brain. The drugs that are more effective in the treatment of seizures and have the least complications are considered as favorable. In this study, we compared the effect of levetiracetam with valproate sodium as an add-on therapy in controlling seizures in patients with epilepsy. Methodology: In this study, 200 patients aged 14 to 75 years suffering from refractory epilepsy, either partial or generalized types, were included. Half of the patients received valproate sodium and the other half received levetiracetam as the add-on therapy for lamotrigine. For the levetiracetam group, a six-week period was considered for the drug to reach appropriate blood levels and in the next six weeks, the patients were examined for clinical and EEG symptoms, liver enzymes and CBC, and the results were compared with the conditions before treatment. Results: The add-on therapy with valproate and levetiracetam, both decrease the frequency and duration of seizures. The side effects of levetiracetam were found to be conventional complications (such as dizziness, insomnia and somnolence), which are often transient. However, valproate had additional side effects such as hypersensitivity, hair loss, tremor and weight gain. Also, the results of laboratory tests during the study indicated changes in liver enzyme of four cases in the valproate group whereas there were not any notable enzyme changes in levetiracetam group. Conclusion: This study showed that levetiracetam and valproate were both effective in alleviating epilepsy, resistant to monotherapy with lamotrigine, and reduced the frequency and time of seizures and improved the lives of individuals as well. [ABSTRACT FROM AUTHOR]

Children aged 6-11 years with uncontrolled asthma are treated with low-dose inhaled corticosteroid (ICS) with stepwise increase in ICS dosage and/or add-on maintenance treatment, as necessary. The objective of the present study was to evaluate the efficacy and safety of tiotropium add-on treatment in children with severe and mild symptomatic asthma. The present prospective cohort study included 144 children with severe and mild asthma (age, 6-11 years) who received ICS (budesonide) with ≥1 controller treatment combination therapies for ≥1 month and score ≥1.5 based on Asthma Control Questionnaire-Interviewer-Administered. In addition to ICS with ≥1 controller treatment, children received 5 µg once-daily tiotropium (treatment group; n=72) or did not receive tiotropium (control group; n=72). The peak forced expiratory volume in 1-sec change from the baseline 3 h post-administration of tiotropium was significantly improved in the treatment group compared with the control group (384±31 vs. 248±28 ml; P<0.0001). The trough forced expiratory volume in 1-sec (224±28 vs. 140±31 ml; P<0.0001) and forced expiratory flow at 25-75% of forced vital capacity (389±36 vs. 116±27 ml/sec; P<0.0001) showed significant improvement following treatment with tiotropium. Significant differences were noted for trough forced vital capacity (153±29 vs. 139±30 ml/sec; P<0.0001), mean weekly rescue treatment usage (0.29±0.08 vs. 0.36±0.09; P<0.0001), mean weekly peak expiratory flow measurement (4.12±3.56 vs. 7.46±3.29 l/min; P<0.0001) and mean weekly symptom-free time (0.19±0.04 vs. 0.16±0.04 days; P<0.0001) between both cohorts. Children of both groups tolerated any adverse effects. Tiotropium 5 µg administered once/day as an add-on treatment to ICS with ≥1 controller treatments in children (6-11 years of age) with severe and mild symptomatic asthma was found to be efficacious and safe (level of evidence 2; technical efficacy stage 4). [ABSTRACT FROM AUTHOR]

Background: Despite adequate treatment with antipsychotics, a substantial number of patients with schizophrenia demonstrate only suboptimal clinical outcome. To overcome this challenge, various psychopharmacological combination strategies have been used, including antidepressants added to antipsychotics. Methods: To analyze the efficacy of add-on antidepressants for the treatment of negative, positive, cognitive, depressive, and antipsychotic-induced extrapyramidal symptoms in schizophrenia, published randomized controlled trials assessing the efficacy of adjunctive antidepressants in schizophrenia were reviewed using the following parameters: baseline clinical characteristics and number of patients, their on-going antipsychotic treatment, dosage of the add-on antidepressants, duration of the trial, efficacy measures, and outcomes. Results: There were 36 randomized controlled trials reported in 41 journal publications (n = 1582). The antidepressants used were the selective serotonin reuptake inhibitors, duloxetine, imipramine, mianserin, mirtazapine, nefazodone, reboxetin, trazodone, and bupropion. Mirtazapine and mianserin showed somewhat consistent efficacy for negative symptoms and both seemed to enhance neurocognition. Trazodone and nefazodone appeared to improve the antipsychotics-induced extrapyramidal symptoms. Imipramine and duloxetine tended to improve depressive symptoms. No clear evidence supporting selective serotonin reuptake inhibitors' efficacy on any clinical domain of schizophrenia was found. Add-on antidepressants did not worsen psychosis. Conclusions: Despite a substantial number of randomized controlled trials, the overall efficacy of add-on antidepressants in schizophrenia remains uncertain mainly due to methodological issues. Some differences in efficacy on several schizophrenia domains seem, however, to exist and to vary by the antidepressant subgroups--plausibly due to differences in the mechanisms of action. Antidepressants may not worsen the course of psychosis. Better designed, larger, and longer randomized controlled trials are needed. [ABSTRACT FROM AUTHOR]

Effectiveness of Clobazam as Add-on Drug in Intractable Epilepsies. This study evaluated the effectiveness of clobazam as add-on drug in intractable epilepsy patients receiving either valproic acid or carbamazepine. This study is an open label, data based clinical study which was undertaken in a neurology outpatient department of a tertiary care centre. In this study, clobazam was added to epileptic patients who were receiving either valproic acid (VPA) or carbamazepine (CBZ) at maximum clinically tolerated dose. The effectiveness of clobazam was measured by percentages of reduction of seizure frequency from base line (0%, 0-49.9%, 50-99.9%, 100%) and the responder rate (50% or greater reduction of seizure frequency from base line). Fisher's test and Chi-square test were used for data analysis. Out of total 83 patients (62 male, 21 female, age range 14-60 years, mean age 24.5), 50 and 33 were receiving carbamazepine and sodium valproate respectively. All complex partial seizure (CPS) and 42.3% of generalized tonic clonic seizure(GTCS) patients became seizure free. The responder rate for GTCS cases were 67.3%. The percentages of seizure free patients in VPA and CBZ group were 39.4% and 38% respectively. Seizure frequency reduction and responder rate were found to be significant (p < 0.05) between group. [ABSTRACT FROM AUTHOR]

Introduction: Memantine, an uncompetitive N-methyl D-aspartate receptor (NMDAR) openchannel blocker holds great promise for its potential clinical effectiveness as add-on therapy to on-going treatment with antipsychotics. Methods: We report here the results of a chart review-based retrospective case series study that examined the effectiveness of off-label use of memantine in patients with schizophrenia when used as adjunctive therapy to standard neuroleptic therapy. Results: 17 of the 26 patients, whose case files were reviewed using a study-specific proforma showed clinical improvement in positive and/or negative psychopathology as well as in cognitive and/or functional domains. The doses of ongoing antipsychotic medications could be reduced in a sizeable number of responders. None of the subjects reported serious adverse events. Discussion: Memantine holds great promise as adjunctive therapy for treatment of schizophrenia. Randomized controlled trials, wherein memantine is administered at adequate doses for an adequate period of time to ongoing antipsychotic treatment are required to confirm its efficacy in alleviating symptoms of schizophrenia. [ABSTRACT FROM AUTHOR]

Antipsychotic polypharmacy remains prevalent; it has probably increased for the treatment of schizophrenia in real-world clinical settings. The current evidence suggests some clinical benefits of antipsychotic polypharmacy, such as better symptom control with clozapine plus another antipsychotic, and a reversal of metabolic side-effects with a concomitant use of aripiprazole. On the other hand, the interpretation of findings in the literature should be made conservatively in light of the paucity of good studies and potentially serious side-effects. Also, although the available data are still limited, two smaller-scale clinical trials provide preliminary evidence that converting antipsychotic polypharmacy to monotherapy could be a valid and reasonable treatment option. Several studies have explored strategies to change physicians’ antipsychotic polypharmacy prescribing behaviours. These have revealed that, while the impact of purely educational interventions may be limited, more aggressive procedures such as directly notifying physicians by letters or phone calls can be more effective in reducing antipsychotic polypharmacy. In conclusion, antipsychotic polypharmacy can work for some clinically difficult conditions; however, it should be the exception rather than the rule and may be avoidable in many patients. More importantly, the paucity of the data clearly emphasizes the need for further investigations on not only advantages and disadvantages of antipsychotic polypharmacy, but also regarding effective interventions in already prescribed polypharmacy regimens. [ABSTRACT FROM PUBLISHER]

Previous comparative reviews of add-on therapies for patients with major depressive disorder (MDD) with an inadequate response to antidepressants have not used meta-analytic techniques to compare different drug classes and have included non-licensed therapies. This meta-analysis reviewed all published peer-reviewed evidence for the efficacy of EU-licensed therapies in patients with MDD and an inadequate response to antidepressant monotherapy. Papers concerning randomized clinical trials (RCTs) were identified using criteria from the Cochrane Handbook for Systematic Reviews of Interventions. Add-on therapies reviewed were antidepressants, quetiapine XR, lithium, and S-adenosyl-l-methionine (SAMe). Seven RCTs that reported response and remission in a way that allowed quantitative analysis were included in this meta-analysis. Comparison of the different drug classes indicated that most interventions had similar efficacy. The likelihood of response was significantly greater with SAMe versus placebo and lithium and with quetiapine XR versus placebo. Most add-on interventions demonstrated comparable efficacy in patients with MDD and an inadequate response to initial antidepressants. However, there is currently a paucity of high-quality data regarding the use of add-on treatments in patients with MDD who are inadequate responders to antidepressants, with quetiapine XR presenting the most comprehensive evidence base to date. [ABSTRACT FROM PUBLISHER]