Search Results (20)

Background: Feeding and Eating Disorders (FEDs) are severe mental health conditions often emerging during childhood or adolescence, with rising prevalence. They are frequently associated with psychiatric and organic comorbidities, including anxiety symptoms and insomnia. Phytotherapy, particularly Passiflora incarnata L. Herba, has been suggested as a potential treatment option for anxiety and insomnia in youth. Methods: this is an observational and retrospective study that includes patients assessed in a third-level Italian Regional Centre for Feeding and Eating Disorders in Children and Adolescents between 1 January 2020 and 31 December 2023. Eligible patients had a confirmed diagnosis of a FED, along with either an anxiety or a sleep disorder. During follow-up, the clinical efficacy of Passiflora incarnata L. Herba was assessed using the Clinical Global Impression–Improvement scale (CGI-I). Comparative analyses were conducted by stratifying the sample based on the target symptoms (sleep disorders/insomnia and anxiety), FED subtype, and whether polytherapy was used. Results: this study includes 94 patients, with most diagnosed with anorexia nervosa (71.3%). Passiflora incarnata L. Herba was administered at a dosage of 200 mg (1–2 tablets for day). It was often combined with selective serotonin reuptake inhibitors (SSRIs) (56.5%), atypical antipsychotics (27.7%), or benzodiazepines (7.4%). Treatment was initiated for anxiety symptoms (75.5%) or insomnia (28.7%). No side effects were reported. Among patients with specific outcome data, 53.3% reported improvements in anxiety symptoms, and 45.4% reported improvements in insomnia. Conclusions: this is the first study to evaluate the use of Passiflora incarnata L. Herba for anxiety and insomnia in children and adolescents with FEDs. Our findings suggest that Passiflora incarnata L. Herba may serve as a well-tolerated adjunctive treatment, showing symptomatic improvement in up to 53% of the patients with data on treatment outcomes. Notably, 53.3% and 45.4% of participants, with specific outcome data, reported reduced anxiety and insomnia symptoms, respectively. Given its excellent safety profile and preliminary efficacy, Passiflora incarnata L. Herba may represent a promising alternative for patients with mild symptoms or for caregivers hesitant about conventional pharmacotherapy. Full article

Background and Objectives: Most genetic studies have focused on catecholamine system genes to identify etiology in attention-deficit/hyperactivity disorder (ADHD), and there is growing evidence that the interaction of several genes may synergistically or antagonistically affect disease outcomes. We investigated the interaction between the alpha-2 adrenergic receptor (ADRA2A) and its transporter (SLC6A2) to determine the etiology and treatment outcomes for ADHD. Materials and Methods: Children with ADHD (age 8.3 ± 2.0 y, 72 boys and 11 girls) were assessed using the Kiddie Schedule for Affective Disorders-Present and Lifetime (K-SASD-PL), ADHD rating scale-IV (ARS), Clinical Global Impressions-Improvement (CGI-I), and Clinical Global Impressions-Severity (CGI-S) scales. Neuropsychological assessments were performed using a continuous performance test (CPT). Methylphenidate was titrated based on the CGI-I and CGI-S scales for 8 weeks. We assessed two polymorphisms, ADRA2A rs553668 and SLC6A2 rs998424, for their association with disease outcomes. Results: The ADRA2A polymorphism had a significant effect on visual/auditory commission errors in the CPT. The CC genotype for ADRA2A combined with the GG genotype for SLC6A2 showed more commission errors than the other combinations of genotypes. Treatment outcome assessment using the CGI-S showed that the SLC6A2 GG genotype had more favorable treatment outcome (p < 0.05) and significant gene × dose interaction on ARS score across 8 weeks (p < 0.01). Conclusions: Our findings provide preliminary evidence for the effect of ADR2A and SLC6A2 gene–gene interactions on the attention system and treatment response in children with ADHD. Although these findings require future replication, our study contributes to the understanding of the genetic basis of ADHD. Full article

Background/Objectives: Tendinopathy is the preferred term to describe various tendon pathologies, including paratendinitis, tendinitis, and tendinosis, in the absence of histopathological evidence in biopsy specimens. The management of tendinopathies is challenging; rest, physiotherapy (such as eccentric training), injections, shock waves, orthotics, medical therapy, and surgery are the main therapeutic options offered to the patient. The conservative treatment of tendinopathies is still difficult, but several options have been proposed, including the use of anti-inflammatory molecules. In this retrospective study, we aimed to assess the efficacy of a conservative approach in improving pain and functional improvement in hip bursitis (HB) and biceps tendinitis (BT) patients. Methods: A series of data concerning the application of Polynucleotides High Purification Technology (PN HPT^TM) in 47 patients with BT and HB was analyzed. All patients received three bi-weekly injections of PN HPT^TM (T0–T2). Follow-up visits were performed at T3 (8 weeks from T2) and T4 (24 weeks from T2). Both the visual analog scale (VAS) for pain assessment and functional impairment (FI) scores were processed in the form of anonymized series for clinical improvement evaluations. Results: Statistically significant differences (p < 0.001) in pain reduction (−85%) and functional improvement (+86%) were found at the end of treatment. The levels of patient satisfaction (PS) and Clinical Global Improvement—Impression (CGI-I) were equal to 93% and 98%, respectively. According to the analyses, other patient data (e.g., gender, age, and BMI) did not appear to influence the positive treatment outcomes. Conclusions: The application of High Purification Technology (PN HPT^TM) was shown to improve both pain and functional deterioration in patients with tendonitis in a similar manner to other conservative treatments. These retrospective analyses may open up new avenues for the implementation of conservative approaches in patients with tendinitis. Full article

The prevalence of N. medianus compression neuropathies remains high in clinical practice. The objective was to evaluate modalities of conservative treatments for carpal tunnel syndrome (CTS) focusing on the role of acetylcholinesterase inhibitors. This observational study involved 51 adult outpatients diagnosed with CTS. Patients were observed during routine clinical protocols and we compared two groups of 25 and 26 individuals, with the first group receiving basic therapy for CTS and 20 mg of ipidacrine (Neiromidin^®) two or three times a day per os, while the second group received only basic therapy. The condition of all patients was assessed twice, with at least a one-month interval. The parameters evaluated included the Boston Carpal Tunnel Questionnaire (BCTQ); the Disabilities of the Arm, Shoulder, and Hand scale (DASH); and pain intensity on the Numeric Rating Scale (NRS). The mean reduction in DASH score was 12.3 (SD 7.7) in Group 1 and 7.1 (SD 6.3) in Group 2 (p < 0.01). Also, other scores showed statistically significant differences between the two groups: −2.3 vs. −1.0 for NRS, −0.89 vs. −0.44 for SSS, and −0.68 vs. −0.31 for FSS, respectively (p < 0.01). Moreover, these findings correlated positively with the global improvement (CGI-I) between the groups. The addition of ipidacrine to basic therapy led to improved recovery in patients with CTSs of varying severity. Full article

Introduction: Fluvoxamine is used in children and adolescents (‘youths’) for treating obsessive compulsive disorder (OCD) but also off-label for depressive and anxiety disorders. This study aimed to investigate the relationship between fluvoxamine dose and serum concentrations, independent correlates of fluvoxamine concentrations, and a preliminary therapeutic reference range (TRR) for youths with OCD and treatment response. Methods: Multicenter naturalistic data of a therapeutic drug monitoring service, as well as prospective data of the ‘TDM Vigil study’ (EudraCT 2013-004881-33), were analyzed. Patient and treatment characteristics were assessed by standardized measures, including Clinical Global Impressions—Severity (CGI-S) and —Change (CGI-I), with CGI-I of much or very much improved defining treatment response and adverse drug reactions using the Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale. Multivariable regression analysis was used to evaluate the influence of sex, age, body weight, body mass index (BMI), and fluvoxamine dose on fluvoxamine serum concentrations. Results: The study included 70 youths (age = 6.7–19.6 years, OCD = 78%, mean fluvoxamine dose = 140.4 (range = 25–300) mg/d). A weak positive correlation between daily dose and steady-state trough serum concentrations was found (r_s = 0.34, p = 0.004), with dose variation explaining 16.2% of serum concentration variability. Multivariable correlates explaining 25.3% of the variance of fluvoxamine concentrations included higher fluvoxamine dose and lower BMI. Considering responders with OCD, the estimated TRR for youths was 55–371 ng/mL, exceeding the TRR for adults with depression of 60–230 ng/mL. Discussion: These preliminary data contribute to the definition of a TRR in youth with OCD treated with fluvoxamine and identify higher BMI as a moderator of lower fluvoxamine concentrations. Full article

Background: SPN-812 has been approved for attention-deficit/hyperactivity disorder (ADHD) treatment in children and adolescents. Objective: We aimed to analyze the efficacy and safety of different doses of SPN-812 for ADHD pediatric patients of different ages, verify its clinical efficacy, and evaluate its safety. Methods: Up until 30 August 2023, randomized controlled trials (RCTs) were searched in EMBASE, MEDLINE, the Cochrane Library, and clinicaltrials.gov to evaluate different doses of SPN-812 and a placebo. Results: We pooled 1619 patients from five RCTs with a duration of 6–8 weeks. Patients (6–17 years old) in SPN-812 (100, 200, and 400 mg/d) groups were superior to the control group in all efficacy outcomes with lower attention-deficit/hyperactivity disorder rating scale-5 (ADHD-RS-5), Conners 3-parent short form composite T score (Conners 3-PS), Weiss functional impairment rating scale-parent (WFIRS-P), and increased clinical global impression-improvement (CGI-I) score (both p < 0.05). At the same time, only SPN-812 300 mg/d did not show a significantly high risk of the adverse events (AEs) such as somnolence and decreased appetite (p = 0.09). There was no significant difference between placebo and SPN-812 groups (100, 200, and 400 mg/d) in serious adverse events (SAEs) such as syncope. The subgroup analyses showed that, both in children and adolescents subgroups, SPN-812 showed better efficacy than the placebo. The two age subgroups showed a significantly higher risk of AEs and an insignificant risk of SAEs than the placebo. Conclusion: At present, SPN-812 (100, 200, and 400 mg/d) is superior to the corresponding control in efficacy measures. However, the safety problem cannot be ignored. Full article

Global developmental delay (GDD) is a complex disorder that requires multimodal treatment involving different developmental skills. The objective of this single-blind, randomized, controlled pilot study is to evaluate the feasibility and effectiveness of conventional rehabilitation programs integrated with the BTs-Nirvana virtual reality system. Patients with GDD aged 12 to 66 months were enrolled and treated for a 48-session cycle. Patients were randomized into two groups, (1) conventional treatment and (2) conventional treatment supplemented with the use of BTs-Nirvana, in a 1:1 ratio. Before and after treatments, areas of global development were tested with the Griffiths-III Mental Developmental Scale and the clinical indicator of global improvement were measured with the Clinical Global Impressions-Improvement (CGI-I). Feasibility was confirmed by the high retention rate. The experimental group presented a significantly improvement in General Quotient (GQ) after treatment (GQ, p = 0.02), and the effect of the two treatments was significantly different in both the GQ (t =2.44; p = 0.02) and the Foundations of Learning subscale (t =3.66; p < 0.01). The overall improvement was also confirmed by the CGI-I (p = 0.03). According to these preliminary data, virtual reality can be considered a useful complementary tool to boost the effectiveness of conventional therapy in children with GDD. Full article

Background: Acne vulgaris remains the leading dermatological condition. The efficacy of laser treatment has been supported by many clinical studies, but studies investigating its multidimensional action are lacking. Aim: To comprehensively investigate the efficacy of 1450-nm diode laser treatment in patients with inflammatory acne and provide objective and subjective data for doctors in clinical practice. Methods: This retrospective study included patients with inflammatory acne lesions who underwent three courses of 1450-nm diode laser treatment between October 2019 and August 2020. Facial surface analysis was performed via objective computer assessments using the Canfield VISIA imaging system. Post-treatment subjective assessments were retrieved and analyzed using the clinical global impression–improvement index (CGI-I) and patient global impression of improvement scales (PGI-I). Results: The final analysis included 20 patients. The changes in the porphyrin VISIA system scores demonstrated significant improvement, with median scores being 35.83, 48.83, and 54.83, respectively. The changes in the red area VISIA scores also showed improvement, with the median scores being 48, 50.33, and 58.83, respectively. The average CGI-I scale scores were 2.2 ± 1.01, 1.70 ± 0.80, and 1.50 ± 0.76, respectively (p = 0.001), and the average PGI-I scale scores were 3.10 ± 0.85, 3.10 ± 0.97, and 3.05 ± 0.95, respectively (p = 0.727), with no significant changes observed in sebum production. Conclusions: The present study is the first to provide objective and subjective evidence proving that the 1450-nm diode laser can reduce inflammatory acne lesions. Full article

The aim of our study was to evaluate the effectiveness of lurasidone augmentation of clozapine in treatment-resistant schizophrenia (SZ) in a retrospective chart review. From the medical records of 916 SZ patients, we identified 16 individuals treated with a combination of clozapine and lurasidone. The detailed clinical data are described separately for each patient. We compared the Clinical Global Impression—Severity (CGI-S) scores between three points of observation: before the treatment and one month and two months after its initiation. CGI Improvement (CGI-I) scores were used to evaluate the treatment response between the first and last points of observation. The vast majority of patients (14/16, 87.5%) responded to lurasidone augmentation of clozapine (CGI-I scores 1 or 2). Therapeutic effects were observable after 3–12 weeks of treatment (median 6 (4–6)). A reduction in CGI-S scores was observed after the first month of observation. There was an observable reduction in positive, depressive and anxiety symptoms, as well as an improvement in psychosocial functioning. Two patients discontinued treatment due to side effects. Our study suggests that lurasidone augmentation of clozapine may lead to improvements in a broad range of SZ symptom dimensions. Full article

The potential benefits of Lactobacillus gasseri LA806 in IBS were previously identified in a comprehensive preclinical research program. The purpose of this multicenter study was to explore in real-life conditions changes in IBS symptoms and quality of life in patients receiving a 4-week supplementation with L. gasseri LA806. Altogether 119 patients meeting Rome IV criteria for IBS were included, of whom 118 received the supplement. The majority of patients (71.8% (95% CI 63.6−79.9%)) manifested a ≥30% decrease in abdominal pain at 4 weeks, the mean abdominal pain score diminishing by 54.2% (from 5.3 ± 2.2 to 2.2 ± 2.4, p < 0.0001). A statistically significant decrease in abdominal pain was seen as early as the first week. A decrease of ≥30% in both abdominal pain score and global IBS symptom score was attained in 61.5% of patients (95% CI 51.7−71.2%). The mean IBS-SSS score fell by 152 ± 112 points (p = 0.001), with symptoms being attenuated in 85% of patients (CGI-I). Supplementation led to a 10-fold decrease in the number of patients reporting severe IBS symptoms. The concomitant intake of antidiarrheals, antispasmodics and analgesics decreased and quality of life scores significantly improved. These preliminary results warrant confirmation by a randomized, placebo-controlled study that this study will allow a better design. Full article

Aim: The aim of this study was to evaluate the efficacy of ultrasound guidance (US) in the treatment of cervical dystonia (CD) with botulinum neurotoxin type A (BoNT-A) injections in comparison to anatomical landmarks (AL). To date, US is routinely used in many centers, but others deny its usefulness. Materials and Methods: Thirty-five patients (12 males, 23 females) with a clinical diagnosis of CD were included in the study. Intramuscular administration of BoNT-A was performed using either US guidance, or with AL, in two separate therapeutic sessions. The efficacy of BoNT-A administration was assessed with the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), Tsui modified scale, Craniocervical Dystonia Questionnaire (CDQ-24) and Clinical Global Impression—Improvement scale (CGI-I). Additionally, patients at therapeutic sessions were digitally recorded and evaluated by two blinded and independent raters. Results: A significant decrease in total TWSTRS, severity subscale TWSTRS, Tsui score, and CDQ-24 was found in both the AL and US group; however, in the TWSTRS disability and pain subscales, a significant decrease was found only in the US group. Moreover, US guided treatment also resulted in a greater decrease in TWSTRS, Tsui score and CDQ-24 compared to anatomical landmarks use only. Conclusions: US guidance might be helpful in improving the results of BoNT-A injections in cervical dystonia, reducing associated pain and disability; however, more studies are needed to evaluate its clinical efficacy. Full article

Background: There are a number of medications prescribed to address comorbid challenging behaviors in children with autism spectrum disorder (ASD), including risperidone and aripiprazole. This retrospective case series reports the use of these drugs in children aged 2 to 13 years. Methodology: A total of 82 children (mean age, 5 years; 79% male) with ASD treated at the Kids Neuro Clinic and Rehab Center in Dubai between January 2020 and September 2021 were included in this retrospective case series. All patients had comorbid challenging behaviors that were resistant to standard supportive therapies alone and warranted pharmacological intervention. The Childhood Autism Rating Scale—2nd Edition Standard form (CARS2-ST) and the Clinical Global Impression (CGI)—Severity (CGI-S) and CGI—Improvement (CGI-I) scales were used to assess the severity of ASD at baseline and to monitor response to treatment with risperidone or aripiprazole. Results: Besides the expected improvement in comorbid challenging behaviors, 79/82 patients (96%) attained a CGI-I score of 2 or 1 following treatment, and 35/82 patients (43%) achieved both a CGI-I score of 1 and minimal-to-no symptoms as per the CARS2-ST test, with complete resolution of their ASD signs and symptoms. The differences in the overall mean CARS2-ST and CGI-S scores pre- and post-treatment were statistically significant (Z = −7.86, p < 0.0001 for both), with pre- and post-treatment mean values of 42 and 23 for CARS2-ST, respectively, and 6 and 2 for CGI-S, respectively. The main side effects were asymptomatic elevated prolactin (n = 12) and excessive weight gain (n = 2). Conclusions: ASD core symptoms and comorbid behaviors in young children improved following chronic treatment with antipsychotic medications, either with or without medications for attention deficit hyperactivity disorder, when combined with standard supportive therapies. Double-blind, placebo-controlled clinical trials are needed to verify these findings. Full article

Background: Depression is a common psychiatric comorbidity in individuals with Down syndrome (DS), particularly adults, with an estimated lifetime prevalence of at least 10%. The current literature on the treatment of depression in adults with DS is limited to case series published more than two decades ago, prior to the widespread use of modern antidepressant medications such as selective serotonin reuptake inhibitors (SSRIs). The purpose of this retrospective chart review study was to examine the effectiveness, tolerability, and safety of SSRIs for depression in adults with DS. Methods: Medical records of 11 adults with DS and depression were reviewed. Assignment of scores for severity (S) of symptoms of depression and improvement (I) of symptoms with treatment with an SSRI was made retrospectively using the Clinical Global Impression Scale (CGI). Demographic and clinical characteristics of the study population, SSRI name, dose, and duration of treatment; and adverse effects were also recorded. Results: All 11 patients (7 male, 4 female; mean age = 27.2 years, range 18–46 years) completed a 12-week treatment course with an SSRI. The median duration of time after initiation of the SSRI covered by record review was 2.1 years, with a range of 24 weeks to 6.7 years. Nine of the 11 patients (82%; 95% CI 52%, 95%) were judged responders to SSRIs based on a rating of “much improved” or “very much improved” on the CGI-I after 12 weeks of treatment (median time of follow-up was 14.4 weeks, with a range of 12.0–33.0 weeks). Adverse effects occurred in four patients (36%). The most common adverse effects were daytime sedation and anger. Conclusions: In this preliminary retrospective study, the majority of patients responded to a 12-week course of SSRI treatment and some tolerated long-term use. Controlled studies are needed to further assess the efficacy, tolerability, and safety of SSRIs for the treatment of depression in adults with DS. Full article

Background: The purpose of this article is to update the diagnostic assessment, therapeutic approach, and 12–18 month follow-up of patients added to the Italian Lombardy Attention Deficit Hyperactivity Disorder (ADHD) Register. Methods: Medical records of patients added to the Registry from 2011 to 2021 were analysed. Results: 4091 of 5934 patients met the criteria for a diagnosis of ADHD, and 20.3% of them presented a familiarity with the disorder. A total of 2879 children (70.4%) had at least one comorbidity disorder, in prevalence a learning disorder (39%). Nearly all (95.9%) received at least one psychological prescription, 17.9% of them almost one pharmacological treatment, and 15.6% a combination of both. Values of ≥5 of the Clinical Global Impression—Severity scale (CGI-S) are more commonly presented by patients with a pharmacological prescription than with a psychological treatment (p < 0.0001). A significant improvement was reported in half of the patients followed after 1 year, with Clinical Global Impression—Improvement scale (CGI-I) ≤ 3. In all, 233 of 4091 are 18-year-old patients. Conclusions: A ten-year systematic monitoring of models of care was a fruitful shared and collaborative initiative in order to promote significant improvement in clinical practice, providing effective and continuous quality of care. The unique experience reported here should spread. Full article

Introduction: Response to treatment, according to Clinical Global Impression-Improvement (CGI-I) scale, is an easily interpretable outcome in clinical trials of autism spectrum disorder (ASD). Yet, the CGI-I rating is sometimes reported as a continuous outcome, and converting it to dichotomous would allow meta-analysis to incorporate more evidence. Methods: Clinical trials investigating medications for ASD and presenting both dichotomous and continuous CGI-I data were included. The number of patients with at least much improvement (CGI-I ≤ 2) were imputed from the CGI-I scale, assuming an underlying normal distribution of a latent continuous score using a primary threshold θ = 2.5 instead of θ = 2, which is the original cut-off in the CGI-I scale. The original and imputed values were used to calculate responder rates and odds ratios. The performance of the imputation method was investigated with a concordance correlation coefficient (CCC), linear regression, Bland–Altman plots, and subgroup differences of summary estimates obtained from random-effects meta-analysis. Results: Data from 27 studies, 58 arms, and 1428 participants were used. The imputation method using the primary threshold (θ = 2.5) had good performance for the responder rates (CCC = 0.93 95% confidence intervals [0.86, 0.96]; β of linear regression = 1.04 [0.95, 1.13]; bias and limits of agreements = 4.32% [−8.1%, 16.74%]; no subgroup differences χ² = 1.24, p-value = 0.266) and odds ratios (CCC = 0.91 [0.86, 0.96]; β = 0.96 [0.78, 1.14]; bias = 0.09 [−0.87, 1.04]; χ² = 0.02, p-value = 0.894). The imputation method had poorer performance when the secondary threshold (θ = 2) was used. Discussion: Assuming a normal distribution of the CGI-I scale, the number of responders could be imputed from the mean and standard deviation and used in meta-analysis. Due to the wide limits of agreement of the imputation method, sensitivity analysis excluding studies with imputed values should be performed. Full article