Development of a cost of illness inventory questionnaire for children with autism spectrum disorder in South Asia.

BACKGROUND: The economic burden of autism is substantial and includes a range of costs, including healthcare, education, productivity losses, informal care and respite care, among others. In India, approximately, 2 million children aged 2-9 years have autism. Given the likely substantial burden of illness and the need to identify effective and cost-effective interventions, this research aimed to produce a comprehensive cost of illness inventory (COII) suitable for children with autism in South Asia (India) to support future research. METHODS: A structured and iterative design process was followed to create the COII, including literature reviews, interviews with caregivers, pilot testing and translation. Across the development of the COII, thirty-two families were involved in the design and piloting of the tool. The COII was forward translated (from English to Hindi) and back translated. Each stage of the process of development of the COII resulted in the further refinement of the tool. RESULTS: Domains covered in the final COII include education, childcare, relocation, healthcare contacts (outpatient, inpatient, medical emergencies, investigations and medication), religious retreats and rituals, specialist equipment, workshops and training, special diet, support and care, certification, occupational adjustments and government rebates/schemes. Administration and completion of the COII determined it to be feasible to complete in 35 minutes by qualified and trained researchers. The final COII is hosted by REDCap Cloud and is a bilingual instrument (Hindi and English). CONCLUSIONS: The COII was developed using experiences gathered from an iterative process in a metropolitan area within the context of one low- and middle-income country (LMIC) setting, India. Compared to COII tools used for children with autism in high-income country settings, additional domains were required, such as complimentary medication (e.g. religious retreats and homeopathy). The COII will allow future research to quantify the cost of illness of autism in India from a broad perspective and will support relevant economic evaluations. Understanding the process of developing the questionnaire will help researchers working in LMICs needing to adapt the current COII or developing similar questionnaires.

[The effectiveness comparison of various conservative treatment options of nasopharyngeal inflammation in children]. / Sravnenie effektivnosti razlichnykh variantov konservativnogo lecheniya vospaleniya glotochnoi mindaliny u detei.

The problem of hyperplasia/inflammation of the structures of the Pirogov-Waldeyer lymphoid-pharyngeal ring and related complications is one of the most frequently discussed in pediatric practice, in particular in matters of methods and expediency of conservative treatment. The article describes the effectiveness of various regiment of conservative treatment of pediatric patients with inflammation of the pharyngeal tonsil (adenoiditis) based on the results of an open comparative observational study. OBJECTIVE: To compare the effectiveness of various schemes of conservative therapy of adenoiditis in children. MATERIAL AND METHODS: 154 patients were divided into three groups: group I - standard therapy; group II - standard therapy + a specially developed homeopathic protocol; group III - a specially developed homeopathic protocol. At each of the visits (day 0th, 7th, 30th, and 90th), ENT-organs endoscopy and a 10-point visual assessment of symptoms were performed by analog score. The effectiveness of treatment (day 7th, 30th, and 90th) was evaluated by both doctors and patients. RESULTS: Analysis of the results showed that the symptoms of adenoiditis were stopped most quickly (day 7th) in patients of group I, but more pronounced and prolonged positive dynamics was noted in comparison groups II and III (only in these groups parents/legal representatives of patients rated the effectiveness as recovery in 25% and 35%, respectively). CONCLUSION: Conservative treatment of adenoiditis: has a positive effect (the severity and duration depends on the therapy regimen); avoids adenotomy, especially in patients who have taken homeopathic medications as a part of combined therapy. The use of a standardized homeopathic protocol is possible, both in combination with the use of other medications, and as monotherapy. Against the background of taking homeopathic medications, undesirable side effects may occur, which the parents of patients should be informed about in advance.

Use of complementary and alternative medicine treatments by mothers of children with developmental disabilities: a cross sectional study.

This study aims to determine the rates of complementary and alternative medicine methods used by mothers of children with developmental disabilities, reasons for using methods, and comparison of methods according to diagnosis groups. The cohort in this cross-sectional and correlational study consisted of the mothers of 390 students with developmental disabilities; 77.2% of the mothers reported using at least one complementary and alternative medicine treatment. The highest level of use was found in the groups of mothers of children with cerebral palsy (100%) and autism spectrum disorder (88.5%). The most commonly used treatments were biological therapies consisting of special diets and multivitamins, manipulative and body-based methods including massage and exercise, and mind-body interventions such as prayer, wearing amulets, and seeking help from a Muslim preacher (hodja). However, mothers never used alternative medicine treatments such as homeopathy, acupuncture, or Ayurveda, nor did they use energy-based healing techniques such as reiki, tai chi, yoga, kinesiology, or neurofeedback exercises. Health care professionals, especially nurses as health care team members, should be knowledgeable and careful about the benefits, side effects, administration methods, and contraindications of complementary and alternative medicine treatments.

Vaccination Litigation: The Need for Rethinking Compensation for Victims of Vaccination Injury.

Opposition to vaccination has a lengthy history dating back to shortly after the discoveries by Jenner in relation to smallpox. In recent years though governments have sought to counter the concerns of anti-vaccinationists in a variety of ways, including legislatively in Australia, in an effort to protect against childhood diseases and to maintain herd immunity. However, cases continue to make their way through the courts where parents oppose the vaccination of their children, often inspired by the views of both registered and unregistered health practitioners, including homeopaths and chiropractors. This article catalogues recent decisions by the courts in Australia, New Zealand, the United Kingdom and Canada, most of which are in favour of vaccination and have dismissed the arguments of those opposed to vaccination as unscientific. It argues that Australia should give serious consideration to emulating the model existing in multiple countries, including the United States, and should create a no-fault vaccination injury compensation scheme.

Use of complementary and alternative medicine by pediatric oncology patients during palliative care.

PURPOSE: Although the popularity of complementary and alternative medicine (CAM) has risen in the last decade, information about its use by pediatric patients in palliative care is still scarce. The purpose of the study was to assess the frequency and types of CAM administered by parents with children suffering from cancer during the palliative phase. METHODS: All parents who lost their child due to cancer in the federal state North Rhine Westfalia/Germany were eligible for the study. The first group of eligible parents was contacted in 1999-2000 and a second group of parents in 2005-2006. Upon agreement, parents were asked to complete a semi-structured questionnaire about the frequency of CAM use and the specific treatments that had been used. The types of CAM were categorized according to the National Center for Complementary and Alternative Medicine (NCCAM). RESULTS: A total of 96 parents participated in the study (48 in each cohort). Forty-three percent of all parents in both groups reported CAM use. The results show an increase of CAM use from 38 % in the first group to 49 % in the second cohort of pediatric patients during palliative care. The most common types of CAM used in both groups were homeopathy and treatment with mistletoe preparations. CONCLUSIONS: The study provides information about usage of CAM in children suffering from cancer during the palliative phase of the disease. Further research is required to investigate benefits, potential adverse effects, and the potential efficacy of CAM in this population.

Psychosocial development of full term singletons, born after preimplantation genetic diagnosis (PGD) at preschool age and family functioning: a prospective case-controlled study and multi-informant approach.

STUDY QUESTION: Do full term singletons born after preimplantation genetic diagnosis (PGD) differ in their psychosocial functioning from children born after intracytoplasmic sperm injection (ICSI) and spontaneous conceived controls (SC)? SUMMARY ANSWER: The psychosocial maturation process of 5-6-year-old PGD children is comparable between the three conception groups (PGD, ICSI and SC). WHAT IS ALREADY KNOWN: In general, a lot of research has been published regarding follow-up of children born after artificial reproductive technologies (ART), which mainly is reassuring. But the ART population itself is marked by broad diversity [IVF, ICSI, gamete donation, preimplantation genetic screening (PGS) or PGD] which complicates comparisons. Some literature concerning the socio-emotional development of PGD/PGS children is available and it suggests a normal maturation process. However, the complex reality of PGD families (e.g. safety of the technique and psychological burden of genetic histories) asks for an exclusive PGD sample with matched control groups and a multi-informant approach. STUDY DESIGN, SIZE, DURATION: Between April 2011 and May 2013, the psychosocial wellbeing of preschoolers and their families born after PGD was assessed in a prospective case-controlled, matched follow-up study, with a multi-informant approach. PARTICIPANTS/MATERIALS, SETTING, METHODS: A group of 47 PGD, 50 ICSI and 55 SC 5-6-year-old children participated in a follow-up study performed at the Centre for Medical Genetics of the Universitair Ziekenhuis Brussel (UZ Brussel). Assessments took place in the hospital and in kindergartens. Children performed the Bene-Anthony family relations test (FRT), yielding their perceptions upon family relationships. Parents and teachers completed the child behaviour checklist (CBCL) and Caregiver Teacher Report Form (C-/TRF), respectively. Parental and family functioning were measured by the NEO-FFi, the parenting stress index (PSI), the Greenberger Work-Parenting Investment Questionnaire and the Marlowe-Crowne Social Desirability Scale (MCSDS). Statistical analysis was performed by using analysis of covariance (ANCOVA). MAIN RESULTS AND THE ROLE OF CHANCE: No differences were detected between the psychosocial development of PGD children and the control groups. Parents did not differ in reporting problem behaviour and they were stricter than teachers. Concerning family functioning the ART parents scored comparable with each other. PGD and ICSI mothers were emotionally more stable [NEO-FFi Neuroticism/emotionality: P = 0.013, η(2) = 0.066; 95% confidence interval (CI) 95% (0.003;0.148)]. They experienced less parental stress in general [PSI, Total stress: P = 0.001, η(2) = 0.102, 95% CI (0.02;0.192)] and on different sublevels opposed to their SC counterparts. Yet ART mothers presented higher ratings on the NEO-FFi Conscientiousness [P = 0.011, η(2) = 0.064; 95% CI (0.003;0.144)] indicating a higher feeling of competence and goal directedness. Mediation analysis confirmed: PGD and ICSI mothers who experienced less family stress were emotionally more stable. A power analysis indicated that a sample with 152 children is sufficient to detect a medium size effect with 80% power using ANCOVA. LIMITATIONS, REASONS FOR CAUTION: The current sample comprised only Dutch speaking Caucasians, hence conclusions should be drawn cautiously. Future research should include larger groups, prematures, multiples and children from different cultural backgrounds. WIDER IMPLICATIONS OF THE FINDINGS: This current research is the first to compare PGD preschoolers with matched controls. Concerns about the behavioural effects on the offspring should not inhibit the use of PGD. Furthermore, our findings suggest that on the long run ART procedures might enhance personal resources of women to cope with family stress. These findings are reassuring for women who might feel insecure and anxious during their ART trajectory. STUDY FUNDING/COMPETING INTERESTS: This research project gained funding from the OZR (a grant by the Research group of the Vrije Universiteit Brussel), the FWO (Fonds Wetenschappelijk Onderzoek) and the Wetenschappelijk Fonds Willy Gepts. The UZ Brussel and the Centre of Medical Genetics received funding from pharmaceutical firms for data collection. UZ Brussel and the Centre for Medical Genetics have received many educational grants for organizing the data collection, from IBSA, Ferring, Organon, Shering-Plough, Merck and Merck Belgium. M.B. has received consultancy and speaker's fees from Organon, Serono Symposia and Merck. The other authors have no competing interests. TRIAL REGISTRATION NUMBER: not applicable.

The homeopathic choice for children: a qualitative research on the decision making process of the families.

AIM: To explore the experiences of parents who chose homeopathic treatment for their children, with particular regard to the decision-making process within the family and the availability of conventional and homeopathic healthcare services. METHODS: Semi-structured interview with parents immediately after or before the homeopathic visit at the Homeopathic Clinic of Campo di Marte Hospital of Lucca (Italy) from1st March, 2012 to 18 July 2012. Answers were analyzed by frequency of response and grouped into main areas: 1. Choice of homeopathy. 2. Intra-family dynamics. 3. Behaviour in emergency situations. 4. The relationship with the homeopathic doctor. 5. The role of friends and acquaintances. 6. The 'cut off' of use of homeopathy. RESULTS: Parents who choose homeopathic treatments for their children are strongly influenced by context. The choice of homeopathy is usually made by mothers and is rarely hindered by fathers, grandparents or friends, whose approval is important and encourages parents to use homeopathy for their children, both for prevention and treatment. Easy access to the homeopathic doctor was frequently requested, especially for acute situations. CONCLUSION: This research confirms the importance of context in decision making processes. Other characteristics of families which use homeopathy, such as level of education, personal coping strategies and family context should be investigated.

Cognitive and psychomotor development of 5- to 6-year-old singletons born after PGD: a prospective case-controlled matched study.

STUDY QUESTION: Do preschool preimplantation genetic diagnosis (PGD) children differ in their cognitive and psychomotor development from children born after ICSI and spontaneous conception (SC)? SUMMARY ANSWER: The cognitive development of PGD pre-schoolers was comparable to children born after ICSI and SC but motor development differed between ICSI and SC groups. STUDY DESIGN, SIZE DURATION: The cognitive abilities and motor skills of 5- to 6-year-old singletons born after PGD (n = 47) were assessed in comparison with 49 ICSI and 48 SC children in a prospective, case-controlled, matched follow-up study between April 2011 and May 2013. PARTICIPANTS/MATERIALS, SETTING, METHODS: PGD singletons, ICSI and SC children of preschool age were examined with the Wechsler Preschool and Primary Scale of Intelligence (WPSSI-III-NL) and the Movement ABC (M ABC). The WPSSI-III-NL revealed scores for Full IQ, Verbal IQ and Performance IQ. The M ABC yields a total score and comprising scores for measurements of balance, dexterity and ball skills. Since embryo biopsy is the only technical difference between the PGD and ICSI procedures, ICSI children were included as controls. These children were part of a Dutch-speaking cohort of children conceived after assisted reproduction technology (ART) at the Universitair Ziekenhuis Brussel (UZ Brussel) who received longitudinal follow-up. The SC children acted as a second control group similar to the fertile PGD sample and in contrast to the ICSI group. The SC group was recruited through announcements in a variety of media. The children were matched for age, gender, birth order and educational level of the mother. The assessments carried out for the ART groups were blinded whenever possible. The data were analysed using analysis of covariance (ANCOVA) and partial eta squared (η(2)), which was used as a measurement of effect size. MAIN RESULTS AND THE ROLE OF CHANCE: The overall cognitive development of PGD singletons did not differ from controls [P = 0.647, η(2) = 0.006; 95% confidence interval (CI) (0, 0.043)]. The partial IQ scores for Verbal and Performance intelligence revealed similar results. Analysis of motor development based on the total score as well as subscales did indicate a significant difference between the three conception groups [P = 0.033, η(2) = 0.050, 95% CI (0, 0.124)]. Post hoc analysis indicated that the significant difference was situated between performances of ICSI and SC children. Balance capacities [P = 0.004, η(2) = 0.079, 95% CI (0.025, 0.163)] and its post hoc analysis yielded equivalent results. Motor capacities of PGD singletons, however, did not differ from any of the two other conception groups. LIMITATIONS, REASONS FOR CAUTION: Given that we only assessed Caucasian singletons born after PGD, caution is required when drawing more general inferences from our results. The small sample size may be a limitation. A priori power analysis, however, revealed that at least 52 children per group were needed to detect a medium effect and 80% power using ANCOVA. Originally our sample met this threshold but we had to exclude six cases in order to remove outliers and due to missing data. WIDER IMPLICATIONS OF THE FINDINGS: Long-term follow-up of children born after embryo biopsy, in this case for PGD, is needed to confirm that the development of these children remains comparable to ICSI and SC children. Our findings do support the safety of the PGD technique and will reassure patients with hereditary genetic diseases regarding the health of their future offspring conceived with PGD. STUDY FUNDING/COMPETING INTERESTS: Funding for this study was obtained from the OZR (Research group of the Vrije Universiteit Brussel), the FWO (Fonds Wetenschappelijk Onderzoek) and the Wetenschappelijk Fonds Willy Gepts. The UZ Brussel and the Centre of Medical Genetics received funding from pharmaceutical firms for data collection. UZ Brussel and the Centre for Medical Genetics have received many educational grants for organizing the data collection, from IBSA, Ferring, Organon, Shering-Plough, Merck and Merck Belgium. M.B. has received consultancy and speaker's fees from Organon, Serono Symposia and Merck.

Pediatric homeopathy: a prospective observational survey based on parent proxy-reports of their children's health-related Quality of Life in six European countries and Brazil.

BACKGROUND: Many European citizens regularly consult homeopathic doctors. Especially for children there is very little data available about the reasons they visit a homeopathic doctor. What are the expectations of the parents consulting a Homeopath MD with their child, who are they and last but not least are they satisfied with their initiative? This study including 773 children from six European countries and Brazil is aimed to look at parent-proxy satisfaction with homeopathic treatment prescribed for their children by a homeopathic doctor after a follow-up of two months. The questionnaire was developed from the methodology used in a survey of adults published in 2002. METHOD: An initial questionnaire included demographic information and questions for assessing health-related Quality of Life (QoL). A follow-up questionnaire collected data on changes in QoL. RESULTS: The demographic characteristics of respondents showed more male children (53.1%) but more female parent-proxies (93.4%). 73.7% of respondents had previously tried conventional treatments; 26.3% non-conventional approaches. Satisfaction with the medical homeopathic consultation was high. Reported differences between baseline and final QoL ondexes are positive for all four studied conditions. It range from 3.206 to 10.188. Considering 7% as a reference value for "minimal clinical difference", this is reached for 2 on 4 conditions (8.473 and 10.188). Changes in complaint limitations visual scales are positive, even if uncertain for skin complaints and influenced parents satisfaction. Conclusions on clinical impact must be cautious. 4.2% of patients experienced side-effects which they attribute to homeopathic treatment. 10.1% of patients reported significant aggravation at the beginning of homeopathic treatment, 19% slight aggravation of symptoms. CONCLUSIONS: The satisfaction of parents using a medical homeopathic approach for their children is linked to the perceived competence of the doctor homeopath, the perceived improvement of the main complaint limitations and the completeness of the received information.

Practice of complementary and alternative medicine use in North Indian children with type 1 diabetes: an exploratory study.

Purpose: Intermittent or concurrent use of Complementary and Alternative medicines (CAM) with insulin may have adverse effects in children with Type 1 Diabetes (T1DM). This study explores the practices of CAM use in children with T1DM. Methods: An exploratory study was conducted among parents of children with T1DM attending a tertiary-level diabetes clinic. Data were collected using a structured pre-tested questionnaire. Results: Two-hundred parents were invited; 183 (91.5%) completed the study. The mean age of the children was lower among CAM users than others (7.9 ± 4.3 vs 9.3 ± 4.3 years, p 0.032). The two groups were similar in gender, family income, parental education, and age at diagnosis. Sixty-seven (36.6%) had used CAM. The parents' reasoning for CAM use was to cure diabetes (62.7%), to improve glycemic control (28.3%), or considering it harmless (17.9%). The most commonly used CAMs were Ayurveda (32.8%) and homeopathic preparations (31.3%). The time interval between diagnosis and CAM use ranged from 1 day to 4 years. The duration of CAM use varied widely; 50.7% used CAM for < 1 month. Only 10 CAM users had HbA1C estimated during CAM use; their mean HbA1C was 12.4 ± 3.6%. Twenty-seven CAM users (40.2%) reported poorer glycemic control; 26.8% had no effect, and the rest had undefined effects due to too short duration of use. Conclusion: CAM, mostly herbal, is frequently used among children with T1DM in North India and has detrimental effects on glycemic control. This information should be used during diabetes education to avoid medical emergencies related to sub-optimal insulin dosing. Supplementary Information: The online version contains supplementary material available at 10.1007/s13340-023-00663-9.

Well-being in chronic pediatric inflammatory rheumatic diseases: the experience of a French healthcare network.

OBJECTIVE: Current management of patients with pediatric rheumatic diseases (PRD) should aim at achieving the best possible well-being. To identify sociodemographic/clinical characteristics, needed paramedical services and school accommodations associated with well-being in patients at inclusion in a French health network Réseau pour les Rhumatismes Inflammatoires Pédiatriques (RESRIP) that supports coordination of the patient's health pathway. To evaluate the evolution of well-being over time in this patients benefiting from such support. METHODS: Patients > 3 years old enrolled in RESRIP (2013-2020) were included. At enrollment, data were collected on sociodemographic/clinical characteristics, ongoing medications, and paramedical and educational actions to be implemented by RESRIP. Well-being during the last 6 months was reported with a standardized questionnaire at enrollment and every 6 months. A well-being score was calculated with scores ranging from 0 to 18, 18 corresponding to absolute well-being. Patients were followed up from inclusion until June 2020. RESULTS: In total, 406 patients were included and followed up for 36 months on average: 205 juvenile idiopathic arthritis, 68 connective tissue diseases, 81 auto-inflammatory diseases and 52 other diseases. The well-being score did not differ between the groups and improved significantly, by 0.04 score units, every 6 months (95% confidence interval [0.03; 0.06]). At inclusion, use of homeopathy, need for implementation of hypnosis or psychological support, occupational therapy or for adjustment of school tests were associated with worse well-being score. CONCLUSION: Well-being seems associated more with the impact of chronic illness than the type of PRD underlining the importance of a comprehensive patient care.

Comparison of the Efficacy of Homeopathic Drug Arnica and Ibuprofen on Postextraction Pain in Children: A Triple-blind Randomized Controlled Trial.

Aim: To compare the homeopathic drug Arnica with ibuprofen as an analgesic for postextraction pain control in children. Materials and methods: Forty-four healthy children between 8 and 12 years of age requiring two clinical sessions of tooth extraction in two different quadrants of the oral cavity were selected for the study. All the children received both the drugs in this crossover trial with a washout of 10 days. Patient-rated and operator-assessed pain was compared to a 10-point validated Visual Analog Scale at baseline, 24, 48, and 72 hours using the paired t-test. Acceptance to taste and frequency of dosing was recorded at the end of three days using a five-point Likert scale and were compared using the Chi-squared test. Kappa statistics were performed to assess intraoperator variability. Results: Pain reduction by Ibuprofen was significantly more than Arnica only at 48 hours with respect to both patient-reported and operator-assessed pain [(t = 3.567, p < 0.05), (t = 2.834, p < 0.05)]. As the age of the child increased, patient-reported pain significantly decreased. Children preferred the taste of Arnica over that of Ibuprofen (x 2 = 56.76, p < 0.0001). Conclusion: There was no difference between Arnica and Ibuprofen in the postextraction pain management in 8-12-year-old children. Clinical significance: The results of this study suggest that Arnica may be considered as an alternative to ibuprofen in managing postextraction pain in 8-12-year-old children, especially those with asthma, COPD, or known allergy to ibuprofen. How to cite this article: Thakur JH, Katre AN. Comparison of the Efficacy of Homeopathic Drug Arnica and Ibuprofen on Postextraction Pain in Children: A Triple-blind Randomized Controlled Trial. Int J Clin Pediatr Dent 2022;15(3):332-337.

A Study on the Profile of Poisoning in the Paediatric Population in a Tertiary Care Teaching Hospital of Chitradurga Region.

Background Most poisoning events among children are preventable and the major reason is lack of supervision by adults, including poor knowledge and attitude toward storage of such items. So, the prevention policy on children's poisoning shall take into account the age group, gender, socioeconomic status, residence, and other aspects such as the knowledge and attitude of adults. The present study was conducted to describe the profile of poisoning in the paediatric population in a tertiary care teaching hospital. Methods Our observational study was retrospective and was conducted at Basaveshwara Medical College and Hospital (BMCH), Chitradurga, Karnataka, under the Department of Forensic Medicine for a duration of three months (February 2021 to April 2021). Institutional ethical approval was obtained prior to the start of the study. As our study participants were paediatric patients (0-17 years) with acute poisoning (excluding homeopathic drug ingestion), a total of 81 paediatric patients' case sheets were finally reviewed and analysed. The data of paediatric poisoning cases were collected in a predesigned study proforma and included details about children's age (in years), gender (male, female), residence (rural, urban), outcome (death, discharge), nature of poisoning (accidental, suicidal), and toxic agents in poisoning. The collected data were entered and analysed in the Microsoft Excel spreadsheet (Microsoft Corporation, Redmond, WA). Results The incidence of acute poisoning among the paediatric population in our teaching hospital was 1.4%. The most common age group with acute poisoning was 13-17 years (30.9%). The prevalence of acute poisoning was higher in male children (56.8%) when compared to female children (43.2%). Around three-fourths of paediatric cases (71.6%) with acute poisoning were having a rural residence. The overall mortality rate among children due to acute poisoning was 9.9%. The most common toxic agents involved in acute poisoning among children were organophosphate compounds (35.8%), followed by organochlorine compounds (30.9%) and pyrethrum compounds (11.1%). Conclusion From this study, we concluded that acute poisoning among children is mainly accidental, and the most common toxic agent responsible for the poisoning is pesticide or insecticide. Most poisoning events among children are preventable, and the major reason is a lack of supervision by adults, including poor knowledge and attitude toward storage of such items.

A Comparative Evaluation of the Anxiolytic Effect of Oral Midazolam and a Homeopathic Remedy in Children During Dental Treatment.

Background Midazolam is recommended by many health standards. However, there is no compelling evidence that midazolam has anti-anxiety effects in children. Homeopathy can be one of the mainstays for effective child management while reducing negative side effects. The aim of the study was to evaluate the anxiolytic efficacy of midazolam (oral) and homeopathic remedies in children during dental treatments. Methodology The current ex-vivo study was conducted in the department of Pedodontics and Preventive Dentistry department of a private dental institution. A total of 48 children aged four to 14 years were selected based on the inclusion and exclusion criteria. The participants were evenly and randomly divided into groups A and B using the lottery method. Group A: 20 minutes previous to the treatment, a right blend of an equal volume of 0.5mg/kg injectable solution of midazolam hydrochloride. Group B: Received Aconite napellus (homeopathic remedy). Results During anxiety, the hypothalamic pituitary adrenal axis gets activated which causes a release of body fluids including salivary cortisol levels. Salivary amylase also responds quickly during stress and anxiety by increasing its levels. Midazolam is used in Dentistry to reduce anxiety as it is able to reduce salivary cortisol and amylase levels. Aconite napellus being homeopathic remedy is useful in Dentistry to reduce salivary cortisol and amylase levels which is observed in the present study. There was a decrease in salivary cortisol and amylase concentrations following midazolam (8.51 ± 6.7) (41.48 ± 23.8) and Aconite napellus (homeopathic remedy) (7.53 ± 5.2) (37.08± 22.8) administration, as well as a decrease in heart rate, systolic and diastolic blood pressure. Furthermore, all of the differences were statistically significant (p<0.05). Conclusion In children with behavioral difficulties, homeopathic remedy was marginally more successful than oral midazolam in lowering anxiety during dental treatment.

Assessments and Interventions for Spasticity in Infants With or at High Risk for Cerebral Palsy: A Systematic Review.

BACKGROUND: The majority of children with cerebral palsy develop spasticity, which interferes with motor development, function, and participation. This systematic review appraised current evidence regarding assessments and interventions for spasticity in children aged less than two years with or at high risk for cerebral palsy and integrated findings with parent preferences. METHODS: Five databases (CINAHL, EMBASE, OVID/Medline, SCOPUS, and PsycINFO) were searched. Included articles were screened using PRISMA guidelines. Quality of the evidence was reviewed by two independent reviewers using Quality Assessment of Diagnostic Accuracy Studies, second edition (QUADAS-2), the RTI Item Bank on Risk of Bias and Precision of Observational Studies (RTI), or The Cochrane Collaboration's tool for assessing risk of bias in randomized trials (RoB). An online survey was conducted regarding parent preferences through social media channels. RESULTS: Twelve articles met inclusion criteria. No high-quality assessment tool emerged for this population. Six interventions (botulinum toxin-A, orthotic use, radial extracorporeal shock wave therapy, erythropoietic stimulating agents, medical cannabis, and homeopathy) were identified. There was low-quality evidence for the use of botulinum toxin-A and radial extracorporeal shock wave therapy to improve short-term outcomes. Survey respondents indicated that spasticity assessments and interventions are highly valued, with nonpharmacologic interventions ranked most preferably. CONCLUSIONS: Further research is needed to validate assessments for spasticity in children younger than two years. Conditional recommendations can be made for botulinum toxin-A and radial extracorporeal shock wave therapy based on low level of evidence to reduce spasticity in children aged less than two years.

Homeopathic medicine of Melissa officinalis combined or not with Phytolacca decandra in the treatment of possible sleep bruxism in children: A crossover randomized triple-blinded controlled clinical trial.

PURPOSE: The present randomized controlled clinical trial evaluated the efficacy of homeopathic medicines of Melissa officinalis (MO), Phytolacca decandra (PD), and the combination of both in the treatment of possible sleep bruxism (SB) in children. STUDY DESIGN: Patients (n = 52) (6.62 ± 1.79 years old) were selected based on the parents report of SB. The study comprised a crossover design that included 4 phases of 30-day treatment (Placebo; MO 12c; PD 12c; and MO 12c + PD 12c), with a wash-out period of 15 days between treatments. METHODS: At baseline and after each phase, the Visual Analogic Scale (VAS) was used as the primary outcome measure to evaluate the influence of treatments on the reduction of SB. The following additional outcome measures were used: a children's sleep diary with parent's/guardian's perceptions of their children's sleep quality, the trait of anxiety scale (TAS) to identify changes in children's anxiety profile, and side effects reports. Data were analyzed by ANOVA with repeated measures followed by Post Hoc LSD test. RESULTS: Significant reduction of SB was observed in VAS after the use of Placebo (-1.72 ± 0.29), MO (-2.36 ± 0.36), PD (-1.44 ± 0.28) and MO + PD (-2.21 ± 0.30) compared to baseline (4.91 ± 1.87). MO showed better results compared to PD (p = 0.018) and Placebo (p = 0.050), and similar result compared to MO+PD (p = 0.724). The sleep diary results and TAS results were not influenced by any of the treatments. No side effects were observed after treatments. CONCLUSION: MO showed promising results in the treatment of possible sleep bruxism in children, while the association of PD did not improve MO results.

Safety of complementary and alternative medicine in children: A 16-years retrospective analysis of the Italian Phytovigilance system database.

BACKGROUND: Dietary supplements and homeopathic medicines are largely used in children as complementary and alternative medicine (CAM) to treat different health conditions. Safety of CAM is unknown when they are marketed. This study analysed suspected CAM-related adverse reaction (AR) in pediatric population. METHODS: The Italian Phytovigilance system was searched for reports of suspected AR related to CAM use in children (0-18 years) from 2002 to 2018. AR reports were evaluated and information about patient's demographic characteristics, suspected CAM, conventional medications, and ARs were collected. In particular, we evaluated whether patient's and CAM characteristics, and concomitant drugs could be potential predictors of ARs seriousness. RESULTS: We evaluated 206 pediatric CAM-related AR reports, of which 69 were serious. Patients were mostly treated with only one CAM (n = 193), and 39% of AR reports were related to products containing 2-5 components. Most reported ARs were related to dietary supplements (57.18%), and skin and subcutaneous tissue disorders (40.29%) were the most involved System Organ Class. CAM-related AR reported as serious were higher in subjects exposed to homeopathic medicines (ROR 3.13 [1.88-5.22]), to CAM in presence of concomitant medications (ROR 1.77 [1.01-3.10]), to CAM containing 2-4 components (ROR 2.18 [1.13-4.22]), and to more than three concomitant CAM (ROR 7.81 [1.97-32.69]). CONCLUSION: We provide new insights on factors that might increase the risk of serious AR associated with CAM use in children: products containing more than two components and simultaneously administered with conventional medications can represent a potential risk in children.

Acute cough in Italian children: parents' beliefs, approach to treatment, and the family impact.

BACKGROUND: Acute cough is the most common symptom among children in primary care, but the impact of cough episodes was never investigated in Italian families. METHODS: A cross-sectional telephone survey was conducted on a representative sample of Italian families, randomly selected from general population; a specific and validated questionnaire was used. RESULTS: The sample (604 calls) was uniform by geographical distribution, and by children age and gender. Mean cough episode was 3.1/year, they were short lasting (only 4.7% > 2 weeks). Independent predictors of children cough episodes were parents' active smoking habit and work (p < 0.05). The mean nursery/school absenteeism was mostly < 7 days, but of a 7-15-day duration in near 30% of cases. The pediatrician was contacted immediately only by 25% of parents and a second consultation (mostly a lung physician) usually occurred after 2-3 weeks of cough. Meanwhile, home/pharmacist suggested remedies were adopted in 50-70% of cases. Usual prescriptions were mucolytics (85.8%), antitussive agents (55.6%), non-steroideal anti-inflammatory drugs (33.8%), antibiotics (regularly or episodically 80%), and corticosteroids (systemic steroids in less than 50%, but via aerosol in more than 80% of cases). Moreover, pediatricians claimed to use homeopathic drugs regularly or episodically in almost 50%. The respondents' willingness to spend out-of-pocket for an "effective remedy" against cough was of € 20 (>€ 30 in 18.4% of cases). CONCLUSIONS: Parents' actions against cough episodes were variable, depending on their beliefs, smoking habit, and occupational status. The parents' perceived efficacy of usual prescriptions is poor, and their willingness to pay out-of-pocket for an "effective remedy" against cough is high. The interest for alternative treatments is not negligible in these circumstances.

[Management of Acute Gastroenteritis in Children: A Systematic Review of Anthroposophic Therapies].

BACKGROUND: Acute gastroenteritis in children accounts for about 10% of hospital admissions and is still one of the major causes of death worldwide. As many children are treated with complementary and alternative medicine (CAM) and anthroposophic medicine, respectively, especially in Europe, the aim of this review was to descriptively present published anthroposophic therapies applied for the treatment of acute gastroenteritis in childhood. METHODS: A complex search strategy recording a broad spectrum of CAM therapies was developed to identify anthroposophic therapy options for the treatment of gastroenteritis in children. The search was conducted in 4 general scientific as well as 3 CAM-specific databases. RESULTS: In total, 3,086 articles were identified and screened for anthroposophic related content. The majority of hits deal with nutritional/dietary therapies. Articles considering anthroposophic approaches constitute only 3.1% (7/227) of all CAM-related articles. Among these articles 2 observational studies, 3 experience reports and 2 reviews were identified. In the experience reports, a variety of anthroposophic remedies was recommended but mostly unsupported by scientific evidence. However, observational studies for the anthroposophic medications, Bolus alba comp. and Gentiana comp., were detected. Additionally, studies investigating the efficacy and safety of Chamomilla, Ipecacuanha, Podophyllum or Tormentilla preparations in homeopathy and phytomedicine, respectively, were presented. CONCLUSIONS: Most CAM-associated therapies for gastroenteritis in childhood comprise dietary recommendations. Studies concerning anthroposophic approaches and medications, respectively, are deficient. The results of this study underline that effort is needed to evaluate anthroposophic therapies in a clinical setting.

Complementary Medicine: Risks to Infants and Children.

Complementary Alternative Medicine (CAM) that targets infants and children can place them at grave risk. Our plan is to review some of the major cases of CAM used by parents, and by unlicensed and even licensed health professionals. Complications from CAM are rarely the focus of regulatory bodies, or even the courts. Even regulated health professionals, who have profited by misrepresenting science-based evidence for treatment or prevention of disease, have been rarely sanctioned by their respective Boards or Colleges. This must change. In addition, there is a dire need for regulators, including the governments, who allow quack products and devices to be marketed in their respective countries, to prosecute them. Existing regulations must be coupled with more effective enforcement. Some of these cases have had a direct connection to me personally, while others are examples of just plain dangerous quackery.