Efficacy and safety of herbal medicines for idiopathic Parkinson's disease: a systematic review.

The objective of this study is to assess the efficacy and safety of herbal medicines (HMs), as a monotherapy or adjunct therapy, compared to placebo or conventional approaches in the treatment of idiopathic Parkinson's disease (PD). We conducted a systematic review of randomized controlled trials from both conventional and alternative medicine sources. Outcome measures were overall improvement, quality of life, reduction of levodopa dose, and adverse events. Nine studies were included, each testing a different HM. Six of the trials had limited internal validity due to major flaws in design, including the lack of proper randomization; insufficient blinding; unclear inclusive criteria in terms of diagnostic criteria, baseline staging, and duration of disease; lack of proper sample size calculation; and insufficient data analysis. Imbalances in gender and ethnicity among the patients in the included trials were observed. No major adverse events emerged, and no specific pattern was detected from the trials describing such data. In addition to major methodological defects, heterogeneity in (1) HM tested, (2) control treatment, and (3) outcome measure hindered in-depth data analysis and synthesis. Current evidence is insufficient to evaluate the efficacy and safety of various HMs. Further studies with improved trial design and reporting, with assessment on cost-effectiveness, quality of life, and qualitative data are warranted.     

A meta-analysis of Chinese herbal medicines for vascular dementia

OBJECTIVE: To investigate the efficacy and safety of Chinese herbal medicines in the treatment of patients with vascular dementia. DATA RETRIEVAL: We retrieved publications from Cochrane Library (2004 to July 2011), PubMed (1966 to July 2011), the Chinese Science and Technique Journals Database (1977 to July 2011), the China National Knowledge Infrastructure (1979 to July 2011), Google Scholar (July 2011), and the Chinese Biomedical Database (1977 to July 2011) using the"Chinese medicine OR Chinese herbal medicine" and "vascular dementia OR mild cognition impair OR multi-infarct dementia OR small-vessel dementia OR strategic infarct dementia OR hypoperfusion dementia OR hemorrhagic dementia OR hereditary vascular dementia". SELECTION CRITERIA: Randomized controlled trials comparing Chinese herbal medicines with placebo/western medicine in the treatment of patients with vascular dementia were included. Diagnostic standards included Diagnostic and Statistical Manual of Mental Disorders-IV, and National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l’Enseignement en Neurosciences. Two participants independently conducted literature screening, quality evaluation and data extraction. The quality of each trial was assessed according to the Cochrane Reviewers’ Handbook 5.0. MAIN OUTCOME MEASURES: Effective rate, Mini-Mental State Examination scores, Hasegawa Dementia Scale scores, and incidence of adverse reactions. RESULTS: We identified 1 143 articles discussing the effects of Chinese medicine on vascular dementia. Thirty-one of these were included in the analysis. These studies involved a total of 2 868 participants (1 605 patients took Chinese medicine decoctions (treatment group); 1 263 patients took western medicine or placebo). The results of our meta-analysis revealed that Chinese herbal remedies in the treatment group were more efficacious than the control intervention (relative risk (RR)=1.27; 95% confidence interval (CI): 1.18-1.38, P<0.01). Mini-Mental State Examination scores were higher in patients taking Chinese herbal medicines than in those in the control group (weighted mean difference (WMD)=2.83; 95%CI: 2.55-3.12, P<0.01). Patients in the treatment group showed better disease amelioration than those in the control group (Hasegawa Dementia Scale scores; WMD=2.41, 95%CI: 1.48-3.34, P<0.01). There were also considerably fewer adverse reactions among those in the treatment group compared with those in the control group (RR=0.20, 95%CI: 0.08-0.47, P<0.01). CONCLUSION: Chinese herbal medicine appears to be safer and more effective than control measures in the treatment of vascular dementia. However, the included trials were generally low in quality. More well-designed, high-quality trials are needed to provide better evidence for the assessment of the efficacy and safety of Chinese medicines for vascular dementia.     

Time course of adverse events most commonly associated with topiramate for migraine prevention

The efficacy, safety and tolerability of topiramate has been demonstrated in three large multicenter, randomized, double-blind, placebo-controlled trials. To characterize the time course of adverse events (AEs) that led to treatment discontinuation in ≥2% of patients who received topiramate 100 mg/day during three pivotal, multicenter, randomized, double-blind, placebo-controlled, and 26-week trials. The pooled population comprised all randomized patients who reported safety data during the double-blind phase (topiramate 100 mg/day, n  = 386; placebo n  = 372), which consisted of a 4-week titration period and a 22-week maintenance period. Incidence, time to onset, and cumulative mean rate of AEs were assessed. Overall, AEs led to treatment discontinuation in 24.9% of patients receiving topiramate 100 mg/day and 11.0% receiving placebo ( P  < 0.001). AEs leading to discontinuation during the double-blind phase in ≥2% of patients included paresthesia (8.0% discontinued), any cognitive symptoms (7.3% discontinued), fatigue (4.7% discontinued), insomnia (3.4% discontinued), nausea (2.3% discontinued), loss of appetite, anxiety, and dizziness (2.1% discontinued because each AE). Most AEs began during the titration period. Paresthesia, any cognitive symptoms, nausea, and loss of appetite occurred at a higher rate in the topiramate group than in the placebo group ( P  < 0.01). AEs leading to discontinuation of topiramate are probably to occur during dose titration. If a patient has not experienced one of these AEs within the first 6 weeks of initiating topiramate 100 mg/day, these AEs are unlikely to occur.     

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review

Background

Adverse event monitoring in studies of psychotherapy is crucial to clinical decision-making, particularly for weighing of benefits and harms of treatment approaches. In this systematic review, we identified how adverse events are defined, measured, and reported in studies of psychosocial interventions for children with mental disorders.

Method

Medline, PsycINFO, Embase, ProQuest Dissertations and Theses Global, and the Cochrane Library were searched from January 2011–January 2023, and Google Scholar from January 2011–February 2023. English language experimental and quasi-experimental studies that evaluated the efficacy or effectiveness of psychosocial interventions for childhood mental disorders were included. Information on the definition, assessment, and report of adverse events was extracted using a checklist based on Good Clinical Practice guidelines.

Results

In this review, 117 studies were included. Studies most commonly involved treating anxiety disorders or obsessive-compulsive disorder (32/117; 27%); 44% of the experimental interventions tested (52/117) were cognitive behavioral therapies. Adverse events were monitored in 36 studies (36/117; 31%) with a protocol used in 19 of these studies to guide monitoring (19/36; 53%). Twenty-seven different events were monitored across the studies with hospitalization the most frequently monitored (3/36; 8%). Event severity was fully assessed in 6 studies (17%) and partially assessed in 12 studies (33%). Only 4/36 studies (11%) included assessing events for cause.

Conclusions

To date, adverse events have been inconsistently defined, measured and reported in psychosocial intervention studies of childhood mental health disorders. Information on adverse events is an essential knowledge component for understanding the potential impacts and risks of therapeutic interventions.     

Comparison of the risk of adverse events between risperidone and haloperidol in delirium patients

The aim of this study was to determine the risk of adverse events for risperidone and haloperidol in delirium patients. The authors conducted a retrospective study with medical records of 266 Japanese delirium inpatients who were referred to them between July 2001 and May 2005. Information on gender, age, delirium, drug therapy, adverse events, death, and other relevant factors was collected and analyzed for each patient. As a primary antipsychotic drug for the treatment of delirium, risperidone was used in 93 patients; oral haloperidol was used in 95; and intravenous or intramuscular haloperidol was used in 61. The incidence of adverse events was 6.5% for risperidone, 31.4% for oral haloperidol, and 32.8% for haloperidol injection. The incidence of death during delirium was 3.2% for risperidone, 2.1% for oral haloperidol, and 13.1% for haloperidol injection. The incidence of death within 1 year after the onset of delirium was 30.1% for risperidone, 29.5% for oral haloperidol, and 45.9% for haloperidol injection. Between risperidone, oral haloperidol, and intravenous or intramuscular haloperidol the incidence of adverse events was significantly lowest for risperidone, and the incidence of death during delirium was significantly highest for intravenous or intramuscular haloperidol. The use of haloperidol as a first-line drug in delirium patients who can receive the drug orally will not contribute to the establishment of drug therapy for delirium based on risk-benefit assessment of the therapy.     

Neuropsychiatric adverse events of bupropion treatment: a brief update

The clinical use of bupropion as an aid for smoking cessation has raised some concern in clinicians and public opinion. Clinical and post-marketing surveillance studies indicate a favourable side effect profile, but spontaneous reports of suspected adverse reactions to medical authorities indicate adverse neuropsychiatric events to be more frequent than previously thought. Except for the risk of seizures, adverse neuropsychiatric events have not been examined systematically. Insomnia has been reported quite frequently. In the placebo-controlled trials, depression scores were unaffected by bupropion treatment. Suspected adverse events reported to medical authorities in the UK or Germany indicate depression to be the most common psychiatric disorder associated with bupropion treatment. Switch to mania or hypomania is very rare, as are psychosis or organic mental disorders. Suicide attempts associated with bupropion use have been reported as possible adverse events. This topic warrants further attention.     

S-adenosylmethionine levels in psychiatric and neurological disorders: a review

Introduction - S-adenosylmethionine (SAMe) is an important methyl donor in over 35 methylation reactions involving DNA, proteins, phosphalipids and catechol- and indole- amines. Material and Methods - This article reviews the studies that have examined brain and blood levels of SAMe in several psychological, neurological and metabolic disorders. Results - Although studies have found no consistent changes in whole blood SAMe levels in psychiatric patients, other investigators have found low cerebrospinal fluid (CSF) SAMe levels in patients with neurological disorders such as Alzheimer's dementia, subacute combined degeneration of the spinal cord (SACD), and HIV-related neuropathies, as well as in patients with metabolic disorders such as 5, 10-CH2-H4 folate reductase deficiency. Conclusion - Intravenous or oral administration of SAMe thus represents a possible treatment for these neurological and metabolic disorders.     

Neurological Manifestations of COVID-19: A systematic review and current update

The novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was first identified in December of 2019 in the city of Wuhan, China. Since the outbreak, various reports detail its symptoms and outcomes, primarily focusing on respiratory complications. However, reports are emerging of the virus’ effects systemically, including that of the nervous system. A review of all current published literature was conducted, and we report that headache and anosmia were common neurological manifestations of SARS-CoV-2. Less common symptoms include seizure, stroke and isolated cases of Guillain-Barre syndrome. Further research is now warranted to precisely determine the relationship between those patients developing neurological sequelae, their clinical state and any subsequent morbidity and mortality.     

Bronchial asthma and mental disorders -- a systematic review of empirical studies

Bronchial asthma occurs independently from gender and in all age groups belonging to the frequent diseases with a high demand for treatment. A part of those affected suffer from comorbid mental burden and disorders. The review analyses studies investigating the prevalence of mental burden and disorders in patients with bronchial asthma. The database MEDLINE was searched for studies published from 1980 to 2002. Patients with bronchial asthma frequently show mood and anxiety disorders, with prevalence rates up to 41 % and 52 %. There is no significant correlation between the severity of asthma and the existence of a mental burden or disorder. However, persons with difficult-to-treat asthma (brittle asthma) show more mental burden than patients with controllable symptoms. Compliant patients show a lower prevalence rate of depressive burden than noncompliant patients. The reviewed studies are very heterogeneous with respect to their methodology and the investigated samples limiting the interpretation of their results significantly. In the future more well-designed epidemiological studies have to be performed to achieve valid and representative conclusions about the prevalence rates of mental burden and disorders in patients with bronchial asthma.