A Systematic Review and Meta-Analysis of Ayurvedic Herbal Preparations for Hypercholesterolemia.

Background and Objectives: Cardiovascular disease (CVD) is the leading cause of death globally and hypercholesterolemia is one of the major risk factors associated with CVD. Due to a growing body of research on side effects and long-term impacts of conventional CVD treatments, focus is shifting towards exploring alternative treatment approaches such as Ayurveda. However, because of a lack of strong scientific evidence, the safety and efficacy profiles of such interventions have not been well established. The current study aims to conduct a systematic review and meta-analyses to explore the strength of evidence on efficacy and safety of Ayurvedic herbs for hypercholesterolemia. Methods: Literature searches were conducted using databases including Medline, Cochrane Database, AMED, Embase, AYUSH research portal, and many others. All randomized controlled trials on individuals with hypercholesterolemia using Ayurvedic herbs (alone or in combination) with an exposure period of ≥ 3 weeks were included, with primary outcomes being total cholesterol levels, adverse events, and other cardiovascular events. The search strategy was determined with the help of the Cochrane Metabolic and Endocrine Disorders Group. Two researchers assessed the risk of each study individually and discrepancies were resolved by consensus or consultation with a third researcher. Meta-analysis was conducted using the inverse variance method and results are presented as forest plots and data summary tables using Revman v5.3. Results: A systematic review of 32 studies with 1386 participants found randomized controlled trials of three Ayurvedic herbs, Allium sativum (garlic), Commiphora mukul (guggulu), and Nigella sativa (black cumin) on hypercholesterolemia that met inclusion criteria. The average duration of intervention was 12 weeks. Meta-analysis of the trials showed that guggulu reduced total cholesterol and low-density lipoprotein levels by 16.78 mg/dL (95% C.I. 13.96 to 2.61; p-value = 0.02) and 18.78 mg/dL (95% C.I. 34.07 to 3.48; p = 0.02), respectively. Garlic reduced LDL-C by 10.37 mg/dL (95% C.I. -17.58 to -3.16; p-value = 0.005). Black cumin lowered total cholesterol by 9.28 mg/dL (95% C.I. -17.36, to -1.19, p-value = 0.02). Reported adverse side effects were minimal. Conclusion: There is moderate to high level of evidence from randomized controlled trials that the Ayurvedic herbs guggulu, garlic, and black cumin are moderately effective for reducing hypercholesterolemia. In addition, minimal evidence was found for any side effects associated with these herbs, positioning them as safe adjuvants to conventional treatments.

Real-world treatment patterns and adverse events in metastatic renal cell carcinoma from a large US claims database.

BACKGROUND: Vascular endothelial growth factor (VEGF), tyrosine kinase (TK) and mechanistic target of rapamycin kinase (mTOR) inhibitors are common first-line (1 L) treatments for metastatic renal cell carcinoma (mRCC). Despite treatment availability, the 5-year survival rate in patients diagnosed at the metastatic stage is only ≈ 10%. To gain contemporary insights into RCC treatment trends that may inform clinical, scientific and payer considerations, treatment patterns and adverse events (AEs) associated with 1 L therapy were examined in a retrospective, longitudinal, population-based, observational study of patients with mRCC. METHODS: US administrative claims data (Truven Health MarketScan Commercial Databases) were used to assess trends in 1 L treatment initiation in mRCC (2006-2015) and characterize patterns of individual 1 L treatments, baseline characteristics, comorbidities and treatment-related AEs from 2011 through 2015. Outcomes were evaluated by drug class and route of administration. RESULTS: Ten-year trend analysis (n = 4270) showed that TK/VEGF-directed therapy rapidly became more common than mTOR-directed therapy, and oral treatments were favored over intravenous (IV) treatments. Overall, 1992 eligible patients initiated 1 L treatment for mRCC from 2011 through 2015: 1752 (88%) received TK/VEGF-directed agents and 233 (12%) received mTOR-directed agents; 1674 (84%) received oral treatments, and 318 (16%) received IV treatments. The most common 1 L treatment was sunitinib (n = 849), followed by pazopanib (n = 631), temsirolimus (n = 157) and bevacizumab (n = 154). Patient characteristics and comorbidities, including age, diabetes and congestive heart failure, were independent predictors of 1 L mRCC treatment choice. The three most common potentially 1 L treatment-related AEs were nausea/vomiting (128.2 per 100 patient-years [PY]), hypertension (69 per 100 PY) and renal insufficiency (44.6 per 100 PY). A wide variety of agents were used as second-line (2 L) therapy. Substantial latency of onset was observed for several potentially treatment-related toxicities in patients treated with TK/VEGF- or mTOR-directed agents. CONCLUSIONS: In the US, 1 L TK/VEGF inhibitor uptake in recent years appears largely in line with national approvals and guidelines, with varied 2 L agent use. Although retrospective evaluation of claims data cannot assess underlying causality, insights from these real-world RCC treatment and AE patterns will be useful in informing medical and payer decisions.

Caregiver Burdens and Preventive Dental Care for Children with Autism Spectrum Disorder, Developmental Disability and/or Mental Health Conditions: National Survey of CSHCN, 2009-2010.

Objective The purpose of this study is to examine the burdens of caregivers on perception of the need and receipt of preventive dental care for a subset of children with special health care needs-children with Autism Spectrum disorder, developmental disability and/or mental health conditions (CASD/DD/MHC). Methods The authors used the 2009-2010 National Survey of CSHCN. The survey included questions addressing preventive dental care and caregivers' financial, employment, and time-related burdens. The associations of these burdens on perceptions and receipt of preventive dental care use were analyzed with bivariate Chi square analyses and multinomial logistic regressions for CASD/DD/MHC (N = 16,323). Results Overall, 16.3 % of CASD/DD/MHC had an unmet preventive dental care need. There were 40.0 % of caregivers who reported financial burden, 20.3 % who reported employment burden, and 10.8 % who reported time burden. A higher percentage of caregivers with financial burden, employment burden, and time-related burden reported that their CASD/DD/MHC did not receive needed preventive dental care (14.1, 16.5, 17.7 % respectively) compared to caregivers without financial, employment, or time burdens (9.0, 9.6 %, 11.0 % respectively). Caregivers with financial burden (adjusted multinomial odds ratio, 1.38 [95 % CI 1.02, 1.86] and employment burden (adjusted multinomial odds ratio, 1.45 [95 % CI 1.02, 2.06] were more likely to report that their child did not receive preventive dental care despite perceived need compared to caregivers without financial or employment burdens. Conclusions for practice Unmet needs for preventive dental care were associated with employment and financial burdens of the caregivers of CASD/DD/MHC.

Child's autism severity: effect on West Virginia caregiver satisfaction with school services.

Survey data was collected from 301 primary caregivers of children with autism registered at West Virginia Autism Training Center (WV ATC), to examine the impact of child's autism severity on caregiver satisfaction with school services. Satisfaction with six school services was measured via a 3-point Likert scale: speech-language therapy, occupational therapy, social skills training, physical therapy, behavioral interventions, and assistance in improving study skills. Ordinal logistic regressions showed that caregivers of children with high autism severity were less likely to be satisfied with school services, as compared to caregivers of children with low autism severity (OR's from 0.45 to 0.39). No significant differences existed in caregiver satisfaction with services between high and low autism severity groups, after addition of caregiver burden to the model. Findings suggest that child's autism severity is a significant predictor of caregiver satisfaction with school services, and should be considered during development of child's Individualized Education Program(IEP) and evaluation of caregiver satisfaction with the IEP.

A scoping review on 'Maharishi Amrit Kalash', an ayurveda formulation for cancer prevention and management.

BACKGROUND: Cancer is one of the leading causes of morbidity and mortality. Current treatments include chemotherapy, radiotherapy, etc., are known to be associated with several side effects. Hence, complementary and alternative medicine is growing in acceptance around the world, particularly Ayurvedic formulations. MAK is one of the most scientifically acclaimed formulations with potential anti-neoplastic and chemoprotective properties. OBJECTIVE: To study literature available on the anti-neoplastic and chemoprotective effects of MAK. MATERIAL AND METHODS: A systematic literature review was conducted using multiple web-based sources: Google Scholar (185), PubMed (33), DHARA (49), AYUSH research portal (2), EBSCO (66), and CTRI (1) for all studies published before February 2021 using keywords: Maharishi Amrit Kalash, Amrit Kalash, Amrit, MAK-4, MAK-5, MAK-7, and others. A manual search was conducted on the reference list of all included articles to identify additional studies. Studies with cancer and/or chemotoxicity outcomes were selected manually. Evidence from both preclinical and clinical level studies have been included in the current review. RESULTS: Out of total 79 studies on applications of MAK, 13 studies were found to state its anti-neoplastic and chemoprotective effects. The studies showed role of MAK in initiation of neoplastic transformation of cancer cells (1), carcinogenesis inhibition (4), metastases inhibition/reduction (1), cancer growth inhibition (4), induction of morphological and biochemical differentiation of cancer cells (3), and reduction in chemotoxicity (4). In studies with controlled clinical trial design (3), MAK use among patients with cancer showed a significant reduction in anorexia, vomiting, and other side effects associated with chemotherapy. A general improvement in quality-of-life scores (Karnofsky Performance Status) and well-being was also observed among patients using MAK. CONCLUSION: Evidence from pre-clinical studies show promising results for use of MAK as an anti-cancer and a chemoprotective agent. More clinical studies are needed to assess the impact of MAK use for tumour regression among patients with cancer. Current scoping review provides sufficient evidence on MAK to be considered for further exploration for its anti-cancer/chemoprotective effects in bigger randomized clinical trials.

A reanalysis of a randomized trial on meditation for migraine headaches: Distraction is not enough but meditation takes time.

OBJECTIVE: Migraine headaches affect about approximately 15% of the population and some notable efforts have been made to develop meditation interventions to address pain and mood among this population. However, key active ingredients and the necessary duration of meditation interventions to produce an effect are still unknown. The purpose of this study is to assess key meditation ingredients that positively impact mood and headache factors across different meditation techniques and to establish an initial time or" dose" needed to reach proactive treatment efficacy. METHOD: In this longitudinal study, three active management forms of meditation were compared to a cognitive distraction meditation to assess the effects on migraine headaches and emotions over a 30 day period when practiced 20 min per day. RESULTS: The active group showed significant decreases in anger (p = .005) and migraine pain (p = .002) over time. Further analysis showed that the bulk of the change for the active management group occurred in the final 10 days, after 20 days of practice of the technique (p < .05). CONCLUSION: This suggests that cognitively active forms of meditation are more effective in reducing migraine headache pain and negative mood than distraction techniques. However, individuals engaging in these strategies need to consistently practice these techniques for approximately 20 days to proactively reduce migraine headache pain and negative mood.

Physician-pharmacist collaboration on chronic non-cancer pain management during the opioid crisis: A qualitative interview study.

BACKGROUND: Management of chronic non-cancer pain is complex, requiring clinicians to balance pain management with the risk of opioid abuse. The role of ambulatory care pharmacists in chronic pain management is well-established, but little research has explored the feasibility of building collaboration on chronic pain and opioid management between physicians and community pharmacists. OBJECTIVE: To explore physician and pharmacist perspectives on the opioid crisis and the possibility of physician and community pharmacist collaborations to manage chronic non-cancer pain in the context of the opioid crisis. METHODS: Semi-structured interviews were performed with a snowball convenience sample 15 physicians and 25 pharmacists in North Carolina between November 2016 and April 2017. Transcribed data were analyzed using applied thematic analysis, and resulting codes were organized into themes and domains which emerged from analysis. RESULTS: Both physicians and pharmacists described current care deficiencies and steps needed to mitigate opioid abuse and diversion. Physicians discussed the need for additional supports and resources for chronic pain management and regarded positively the role of the community pharmacist in chronic pain management and mitigating opioid abuse. Pharmacists identified cost as the major barrier to implementing new services, and expressed willingness to participate in new chronic pain and opioid interventions. CONCLUSION: Within the study sample, strong interest exists for collaboration between physicians and community pharmacists. This highlights a potential opportunity to expand care for patients with chronic non-cancer pain.

Comorbidity prevalence, healthcare utilization, and expenditures of Medicaid enrolled adults with autism spectrum disorders.

A retrospective data analysis using 2000-2008 three state Medicaid Analytic eXtract was conducted to examine the prevalence and association of comorbidities (psychiatric and non-psychiatric) with healthcare utilization and expenditures of fee-for-service enrolled adults (22-64 years) with and without autism spectrum disorders (International Classification of Diseases, Ninth Revision-clinical modification code: 299.xx). Autism spectrum disorder cases were 1:3 matched to no autism spectrum disorder controls by age, gender, and race using propensity scores. Study outcomes were all-cause healthcare utilization (outpatient office visits, inpatient hospitalizations, emergency room, and prescription drug use) and associated healthcare expenditures. Bivariate analyses (chi-square tests and t-tests), multinomial logistic regressions (healthcare utilization), and generalized linear models with gamma distribution (expenditures) were used. Adults with autism spectrum disorders (n = 1772) had significantly higher rates of psychiatric comorbidity (81%), epilepsy (22%), infections (22%), skin disorders (21%), and hearing impairments (18%). Adults with autism spectrum disorders had higher mean annual outpatient office visits (32ASD vs 8noASD) and prescription drug use claims (51ASD vs 24noASD) as well as higher mean annual outpatient office visits (US$4375ASD vs US$824noASD), emergency room (US$15,929ASD vs US$2598noASD), prescription drug use (US$6067ASD vs US$3144noASD), and total expenditures (US$13,700ASD vs US$8560noASD). The presence of a psychiatric and a non-psychiatric comorbidity among adults with autism spectrum disorders increased the annual total expenditures by US$4952 and US$5084, respectively.

Emergency Department Use Among Adults with Autism Spectrum Disorders (ASD).

A cross-sectional analyses using Nationwide Emergency Department Sample (2006-2011) was conducted to examine the trends, type of ED visits, and mean total ED charges for adults aged 22-64 years with and without ASD (matched 1:3). Around 0.4% ED visits (n = 25,527) were associated with any ASD and rates of such visits more than doubled from 2006 to 2011 (2549-6087 per 100,000 admissions). Adults with ASD visited ED for: primary psychiatric disorder (15%ASD vs. 4.2%noASD), primary non-psychiatric disorder (16%ASD vs. 14%noASD), and any injury (24%ASD vs. 28%noASD). Mean total ED charges for adults with ASD were 2.3 times higher than for adults without ASD. Findings emphasize the need to examine the extent of frequent ED use in this population.

Prescription Drug Use and Polypharmacy Among Medicaid-Enrolled Adults with Autism: A Retrospective Cross-Sectional Analysis.

BACKGROUND: A lack of gold standard treatment for autism spectrum disorders (ASD), no clear ASD management guidelines, and lack of evidence-based pharmacological interventions other than aripiprazole and risperidone elevate the risk of off-label prescribing and adverse effects among individuals with ASD, more so among adults. OBJECTIVE: The aim of this study was to identify and compare the types of prescription drug use, rates of polypharmacy, and characteristics associated with polypharmacy among adults with and without ASD in a retrospective cross-sectional analysis of a three-state Medicaid Analytic eXtract database (2000-2008). METHODS: Adults aged 22-64 years with ASD (ICD9-CM code: 299.xx) were propensity score-matched to 'no ASD' controls by age, sex, and race. General polypharmacy (≥6 unique classes of prescription drugs in a year) and psychotropic polypharmacy (≥3 unique prescription drug classes of psychotropic medications within a 90-day period) were the main study outcomes. Chi-square tests for rates, t tests for mean number of claims, and multivariate logistic regressions for likelihood of prescription drug use and polypharmacy were run. RESULTS: Annually, almost 75% of adults with ASD had >20 prescription drug claims compared with 33% of adults without ASD. Around 85% of adults with ASD used at least one psychotropic drug class compared with 42% of adults without ASD. Highly common psychotropics were antipsychotics (66%ASD vs 20%noASD), anticonvulsants (59%ASD vs 20%noASD), and anxiolytics/hypnotics/sedatives (21%ASD vs 11%noASD). Other than psychotropics, many adults with ASD used medical prescription drugs such as antimicrobials (47%), dermatologic agents (48%), respiratory agents (38%), gastrointestinal agents (31%), alternative medications (25%), antiparkinsonian agents (22.6%), antihyperlipidemics/statins (7.3%), and immunologics (2.0%). Rates of general (48%ASD vs 32%noASD) and psychotropic polypharmacy (19%ASD vs 6%noASD) were significantly higher in the ASD group. CONCLUSION: Prescription drug use and polypharmacy rates among adults with ASD are substantially higher than those in an age-, sex-, and race-matched cohort of adults without ASD. Adults with ASD frequently use therapeutic treatments other than psychotropics. Healthcare providers, who usually report low confidence in treating patients with ASD, should play an active role in constant monitoring of prescription drug use patterns and patient response to interventions. Prescribers and caregivers are encouraged to make decisions after weighing the benefits and risks associated with a pharmacological treatment. Further investigations into the common use of any alternative treatments that can affect a patient's response to core treatments should also be conducted.

Access to services, quality of care, and family impact for children with autism, other developmental disabilities, and other mental health conditions.

This cross-sectional study examined perceived access to services, quality of care, and family impact reported by caregivers of children aged 3-17 years with autism spectrum disorders, as compared to caregivers of children with other developmental disabilities and other mental health conditions. The 2009-2010 National Survey of Children with Special Health Care Needs was utilized to examine the association between child's special needs condition and three outcomes (N = 18,136): access to services (difficulty using services, difficulty getting referrals, lack of source of care, and inadequate insurance coverage), quality of care (lack of care coordination, lack of shared decision making, and no routine screening), and family impact (financial, employment, and time-related burden). Multivariate logistic regressions were performed to compare caregivers of children with autism spectrum disorders to caregivers of children with developmental disabilities (cerebral palsy, Down syndrome, developmental delay, or intellectual disability), mental health conditions (attention deficit hyperactivity disorder, anxiety, behavioral/conduct problems, or depression), or both developmental disabilities and mental health conditions. Caregivers of children with autism spectrum disorders were significantly more likely to report difficulty using services, lack of source of care, inadequate insurance coverage, lack of shared decision making and care coordination, and adverse family impact as compared to caregivers of children with developmental disabilities, mental health conditions, or both.

Perception of cancer recurrence risk: more information is better.

OBJECTIVE: Breast cancer is the most common cancer among women worldwide. Given the advances in extending survival, the number of recently diagnosed breast cancer patients and longer-term breast cancer survivors is growing. The goals of this study were to better understand (1) perceptions of provider cancer recurrence risk communication, (2) perceived risk of breast cancer recurrence in cancer patients and survivors, and (3) accuracy of perceived risk. METHODS: A survey was conducted on women with a prior breast cancer (n=141). RESULTS: Approximately 40% of women perceived that providers had not talked about their breast cancer recurrence risk; although only 1 person reported not wanting a physician to talk to her about her risk. Women were largely inaccurate in their assessments of risk. Greater worry, living in a rural area, and longer time since diagnosis were associated with greater inaccuracy. Women tended to think about distal recurrence of cancer as often of local recurrence. CONCLUSIONS: Perceived risk of breast cancer recurrence was inaccurate, and patients desired more communication about recurrence risk. PRACTICE IMPLICATIONS: Consistent with findings from other studies, greater efforts are needed to improve the communication of cancer recurrence risk to patients. Attention should be paid to those from rural areas and to distal cancer recurrence in women with a previous history of breast cancer.