The prevalence of non-pharmacological interventions in older homecare recipients: an overview from six European countries.

PURPOSE: Non-pharmacological interventions (NPIs) play an important role in the management of older people receiving homecare. However, little is known about how often specific NPIs are being used and to what extent usage varies between countries. The aim of the current study was to investigate the prevalence of NPIs in older homecare recipients in six European countries. METHODS: This is a cross-sectional study of older homecare recipients (65+) using baseline data from the longitudinal cohort study 'Identifying best practices for care-dependent elderly by Benchmarking Costs and outcomes of community care' (IBenC). The analyzed NPIs are based on the interRAI Home Care instrument, a comprehensive geriatric assessment instrument. The prevalence of 24 NPIs was analyzed in Belgium, Germany, Finland, Iceland, Italy and the Netherlands. NPIs from seven groups were considered: psychosocial interventions, physical activity, regular care interventions, special therapies, preventive measures, special aids and environmental interventions. RESULTS: A total of 2884 homecare recipients were included. The mean age at baseline was 82.9 years and of all participants, 66.9% were female. The intervention with the highest prevalence in the study sample was 'emergency assistance available' (74%). Two other highly prevalent interventions were 'physical activity' (69%) and 'home nurse' (62%). Large differences between countries in the use of NPIs were observed and included, for example, 'going outside' (range 7-82%), 'home health aids' (range 12-93%), and 'physician visit' (range 24-94%). CONCLUSIONS: The use of NPIs varied considerably between homecare users in different European countries. It is important to better understand the barriers and facilitators of use of these potentially beneficial interventions in order to design successful uptake strategies.

Heart rate variability, perceived stress and willingness to seek counselling in undergraduate students.

OBJECTIVE: The primary aim was to determine the level of stress in Czech pharmacy students using both subjective and physiological markers of stress throughout their study. The secondary aim was to investigate association of stress with sociodemographic and clinical characteristics, and to determine the predictors of the likelihood of enrolling in psychotherapy counselling. METHODS: Design: A prospective observational study. SETTING: Faculty of Pharmacy in Hradec Kralove, Czech Republic. SUBJECTS: 175 s-year pharmacy students in 2016, 149 students in 2017, and 51 students in 2018. OUTCOME MEASURES: Perceived stress scale (PSS-10), heart rate variability (HRV, emWavePro), a self-administered survey (sociodemographic and clinical data, likelihood of enrolling in psychotherapy counselling). RESULTS: The average PSS score was 18.3 ± 6.7. There were no significant changes in PSS-10 and HRV parameters between 2016 and 2018. There was a significant negative correlation between PSS-10 and LF power (p = 0.012). Female gender and poor health status were more frequently observed among the respondents with impaired HRV (p = 0.026 for female gender and p = 0.025 and p = 0.042 for poor health status). Fifty-nine percent of students would be likely to enroll in psychotherapy counselling, with men being significantly less inclined to participate compared to women (p = 0.01). CONCLUSION: Czech pharmacy students experience moderate levels of stress throughout their studies, which correlates with physiological markers of stress as well as their overall health. Push and pull factors of using mind-body interventions to manage stress should be further examined, especially in high risk groups.

The use of complementary and alternative medicine by adults with allergies: a Czech national representative survey.

BACKGROUND: The prevalence rates of the use of Complementary and Alternative Medicine (CAM) in allergy patients range from 42% in the United States up to 50% in Europe. In the Czech Republic, no such data exists. Our aim was to examine patterns in CAM use in populations with self-reported allergies in the Czech Republic. METHODS: A cross-sectional survey was conducted. A sample of citizens aged 15 years and older, sex, age, and region-stratified, was randomly selected from the 2014 voter registration lists (n = 8,395,132). Respondents with self-reported allergies were further analyzed. RESULTS: Overall, 93% of the respondents with self-reported allergies reported the use of 1 or more CAM modalities during the past 30 days. Herbal teas, relaxation techniques, a detoxifying diet, dietary supplements (excluding vitamins and minerals), and reflexology were used in respondents with allergies. Females, under age 30, with higher education, higher income, and self-reported poor health, were significantly associated with the use of CAM among respondents with allergies. CONCLUSIONS: The prevalence of CAM use among people with self-reported allergies in the Czech Republic is higher compared to other countries, with determinants of CAM varying across specific CAM categories. More attention to existing use is needed to promote the healthy adoption of CAM by raising awareness of its safe and effective use, both for CAM users as well as for health care providers.

Development and Validation of the Ethicotherapy Quality of Life Questionnaire.

At present, no standardized tool to measure therapeutic outcomes of a central European traditional healing system called Ethicotherapy exists. Ethicotherapy focuses on the relationship between physical health and moral health. The aim was to develop and validate the Ethicotherapy quality of life questionnaire (EQLQ) using a sequential exploratory mixed-method study design. An EQLQ with good psychometric properties was developed. An exploratory factor analysis identified eight domains consisting of 30 items. Future research investigating a relationship between EQLQ, health, and physical illness in different populations and cultural settings is recommended.

The use of dietary supplements by patients in the pre-operative period in the Czech Republic.

Background The prevalence of dietary supplement use in the pre-operative period ranges from 4.8 to 80%. According to the Food and Drug Administration, some dietary supplements may show side effects before, during and after surgery. Objective The main aim of the study was to determine the prevalence of dietary supplement use in patients before surgery at University Hospital Hradec Kralove and the predictors of use. The secondary aim was to determine patient awareness regarding the correct use of and possible risks associated with dietary supplements. Setting University Hospital Hradec Kralove. Methods Between March 2017 and June 2018, a cross-sectional study focused on patients in the pre-operative period in different departments at University Hospital Hradec Kralove was conducted. The questionnaires were anonymous and entirely voluntary. The obtained data were evaluated using descriptive statistics and a regression model in Microsoft Excel 2016 and IBM SPSS version 24. Main outcome measure The prevalence and predictors of dietary supplement use in patients before surgery. Results 256 questionnaires were returned (a response rate of 77.41%). 111 dietary supplements were used by a total of 42% of the respondents in the 30-day period prior to surgery. Patients with a higher probability of dietary supplement use included patients with urogenital (OR 3.8, 95% CI 1.2, 12.1), otorhinolaryngological (OR 3.9, 95% CI 1.1, 13.8) and musculoskeletal health problems (OR 3.9, 95% CI 1.1, 13.8). The proportion of dietary supplement users increased with the number of drugs taken concomitantly, with the probability of use being more than three times higher compared with non-dietary supplement users (OR 3.4, 95% CI 1.2, 9.4). A total of 45.8% of the respondents thought there was no risk associated with their current use of dietary supplements and drugs. Conclusions There is a high prevalence of dietary supplement use in hospitalized patients, with independent predictors being comorbidity and polypharmacy. No official recommendations or guidelines exist for physicians and anaesthesiologists in the Czech Republic which focus on patients that use dietary supplements in the pre-operative period. National guidelines focusing on dietary supplement use in the pre-operative period would be appropriate.

Provision of complementary and alternative medicine: Compliance with the health professional requirements.

BACKGROUND: Despite an increased prevalence of complementary and alternative medicine (CAM), its regulation varies from country to country, and no common approach has been adopted. A comprehensive overview is currently lacking of the ways the CAM therapies are regulated based on the criteria derived from the regulations relevant to particular medical professions. METHODS: The level of regulation of 100 most commonly used CAM modalities was evaluated according to the criteria based on the requirements for health professionals. A maximum of 10 points were obtainable. Internet searches were conducted from December 2016 to April 2017. RESULTS: Seventy-two of a total of 98 CAM modalities were selected and evaluated according to the predefined criteria. More than 50 % of criteria were met by 29 % of the CAM modalities. One of the most frequently met criteria was compliance with the requirements for professional practice, and the least often met criterion was registration obligation with a professional organization. The highest average score of 5.6 was received by the CAM category biologically based therapies. The lowest average score of one point was obtained by energy-based medicine. CONCLUSION: There is a lack of monitoring and regulating of CAM providers and monitoring the safety of CAM practices based on criteria for health care providers. Professional regulatory guidance is required to ensure the safety and quality of CAM therapies.

Economic analysis of acupuncture for migraine prophylaxis.

BACKGROUND: Acupuncture has become a viable option for migraine prophylaxis in Europe; however, despite its wide use, more data on the short- and long-term cost-effectiveness are needed when considering the perspectives of a paying third-party, the patient, and of society in general. The aim was to evaluate the cost and effectiveness of adjuvant acupuncture to pharmacologic treatment vs pharmacologic treatment alone in migraine patients after a 3-month acupuncture course and a 6-month follow-up from all perspectives. METHODS: The study involved an open-label randomized clinical trial of patients receiving acupuncture (n=42), and a waiting list control group (n=44). The number of migraine days during the last 28 days, as well as direct and indirect costs were considered. The trial was registered under DRKS00009803. RESULTS: The total cost per patient reached €696 vs €285 after 3 months of acupuncture and €66 vs €132 in the acupuncture and control groups after a 6-month follow-up, respectively (P=0.071). The trends observed in effectiveness and costs from all perspectives are discussed. CONCLUSION: The inclusion of acupuncture in health care results beneficial mainly for its observed trend in reduced losses of productivity and income, with the latter often exceeding the costs of acupuncture treatment. As such, acupuncture may be recommended as an adjuvant treatment in migraine prophylaxis to standard pharmacotherapy.

Acupuncture in migraine prophylaxis in Czech patients: an open-label randomized controlled trial.

BACKGROUND: Adjuvant acupuncture for the symptomatic treatment of migraine reduces the frequency of headaches and may be at least similarly effective to treatment with prophylactic drugs. METHODS: This article describes an open-label randomized controlled clinical trial with two groups: the intervention group (n=42) and the waiting-list control group (n=44). This study occurred at the Czech-Chinese Center for Traditional Chinese Medicine at the University Hospital Hradec Kralove between October 2015 and April 2017. RESULTS: After 12 weeks of acupuncture, the number of migraine days was reduced by 5.5 and 2.0 days in the acupuncture and the waiting-list control groups, respectively, with a statistically significant inter-group difference of 2.0 migraine days (95% CI: -4 to -1). A significantly greater reduction in the number of migraine days per 4 weeks was reached at the end of the 6-month follow-up period in the acupuncture vs. control groups (Δ -4.0; 95% CI: -6 to -2). A statistically significant difference was observed in the number of responders to treatment (response defined as at least a 50% reduction in average monthly migraine day frequency) in the acupuncture vs waiting-list control groups (50% vs 27%; p<0.05) at the end of the intervention. A significantly greater percentage of responders to treatment was noted in the intervention vs control groups at the 6-month follow-up (81% vs 36%; p<0.001). CONCLUSION: Acupuncture can reduce symptoms and medication use, both short term and long term, as an adjuvant treatment in migraine prophylaxis in Czech patients.

The Use of Complementary and Alternative Medicine by the General Population in the Czech Republic: A Follow-Up Study.

BACKGROUND: The prevalence of complementary and alternative medicine (CAM) ranges between 0.3% and 86% in most highly developed countries. In the Czech Republic, CAM is used by 76% of the general population. Our aim was to examine patterns in CAM use among a representative sample of the general population in the Czech Republic, for 2011 and 2014. MATERIAL AND METHODS: A cross-sectional survey was conducted. A sex-, age- and region-stratified sample of citizens aged 15 years and older was randomly selected from the 2014 voter registration lists (n = 8,395,132). A comparative analysis of data collected in 2011 and 2014 was performed. RESULTS: Overall, 76.0% (N = 1,365) versus 87.0% (N = 1,565) of the respondents reported use of 1 or more CAM modalities during the past 30 days, in 2011 and 2014, respectively (p < 0.001). In both years, the top 4 CAM modalities used were vitamins/minerals, herbal teas, massage, and relaxation. Yoga replaced dietary supplements excluding vitamins/minerals in the 5th position. Nevertheless, only herbal teas (48.0% vs. 53.0%, p = 0.002), massage (20.0% vs. 26.0%, p < 0.001), relaxation (10.0% vs. 19.0%, p < 0.001), and yoga (3.7% vs. 7.1%, p < 0.001) showed a significant increase in use. CONCLUSIONS: The prevalence of CAM use in the Czech Republic is increasing, especially among people who use biological, body- and mind-based CAM therapies. There is a great need to educate students and health care professionals about the efficacy and safety of CAM in order to meet the patients' demands on CAM.

Allergy-like immediate reactions with herbal medicines in children: A retrospective study using data from VigiBase®.

BACKGROUND: The use of herbal medicines in children and the general population is continually on the rise with an overall herbal lifetime and current use ranging between 0.8%-85.5% and 2.2%-8.9%, respectively. Although acute hypersensitivity reactions are generally considered to be rare, little knowledge exists on the frequency and type of these reactions especially in specific populations like children. OBJECTIVES: To assess the patterns of acute hypersensitivity reactions to herbal medicines reported to the WHO global individual case safety report (ICSR) database VigiBase® in children. STUDY DESIGN: From the original VigiBase® extract for the time between 1968 and 2014, we included all reports with adverse drug reactions (ADR) associated with herbal medicines in children where WHO-ART reaction terms were indicative of acute hypersensitivity reactions. RESULTS: VigiBase® contained 2646 ICSRs with 14 860 distinct adverse reactions reported in association with herbal medicine in children. Among those, 79 cases with 107 allergy-like reactions met our inclusion criteria. The most commonly reported WHO-ART terms were urticaria or rash/rash erythematous (59.8%), and allergic reaction (8.4%). The most frequently reported suspected herbal medicines were mixed herbal products (51.4%), Hedera helix (15.0%), and Echinacea purpurea (5.6%). Most frequent routes of administration were oral (75.9%), topical (8.9%), and rectal (3.8%). Over 30% of cases were reported in the age group from 7 to 12 years. The majority of reports were received from Germany (29.1%), Thailand (21.5%), and Australia (11.4%). CONCLUSION: VigiBase® contains a considerable number of acute hypersensitivity reactions in children associated with herbal medicines, including life-threatening reactions such as anaphylactic shock.

Allergy-Like Immediate Reactions with Herbal Medicines: A Retrospective Study Using Data from VigiBase®.

INTRODUCTION: Herbal medicines are used worldwide and with an increasing popularity in Western countries. Although often perceived as 'naturally safe', herbals may cause severe adverse drug reactions (ADRs), with immediate allergic reactions being particularly life threatening. OBJECTIVES: The aim of this study was to analyse immediate allergy-like ADRs to herbals documented in VigiBase®, the WHO international pharmacovigilance database. METHODS: The documentation of all suspected ADRs in association with herbal exposure reported to VigiBase® from 1969 to August 2014 was retrieved. Among all reports in which WHO-ART reaction terms were indicative of acute allergic reactions, those classified as 'suspect' with a documented causality assessment and latency time of ≤1 day were selected. For the most frequent specific herbal-ADR combinations, the information component (IC) as a measure of disproportionality based on Bayesian statistics was calculated. RESULTS: We identified 757 reports out of 1039 ADRs. Products with mixed herbals (36.0 %) as well as those administered orally (63.2 %) were predominant. The most frequent reactions were urticaria and rash (49.2 %). Anaphylactic reactions accounted for 9.5 %. Disproportionally frequent reporting of mouth edema (IC = 1.81) and anaphylactic reactions (IC = 1.24) to Phleum pretense were noted. CONCLUSION: Our findings indicate that herbal medicines for oral use carry a risk of causing immediate allergy-like ADRs. Studies using the Vigibase® database can identify specific combinations of particular herbs and adverse reactions. Healthcare professionals and patients should be aware of these risks and report any serious adverse experiences.

Prevalence of Complementary and Alternative Medicine Use in the General Population in the Czech Republic.

BACKGROUND: Prevalence rates of complementary and alternative medicine (CAM) use are still missing for some European countries, especially in the East. Thus, we measured patterns and determinants of CAM use among a representative sample of the general population in the Czech Republic. METHODS: A cross-sectional survey was conducted. A sex-, age- and region-stratified sample of citizens aged 15 and older were randomly selected from voter registration lists (n = 8,639,375). RESULTS: Overall, 76.0% (n = 1,365) of the respondents reported use of one or more CAM modalities during the past 30 days. The top five CAM modalities used were vitamins/minerals (54.6%), herbal remedies (47.8%), massage (19.9%), relaxation techniques (9.5%), and dietary supplements excluding vitamins/minerals (9.2%). Prevention (82.0%) was the primary reason for CAM use. Only 15.9% of CAM users employed it for therapeutic purposes. The most commonly treated ailments were respiratory (35.0%) and musculoskeletal (33.6%) disorders. CONCLUSION: The prevalence of CAM use in the Czech Republic is high, especially among people who apply CAM for self-treatment prior to seeing a doctor. Half of the study population combined CAM with conventional medical treatment, which may result in potential harm to the patient. Healthcare providers as well as the public should be educated about effective and safe use of CAM.

Effectiveness of a comprehensive lifestyle modification program for asthma patients: a randomized controlled pilot trial.

OBJECTIVE: The aim of the study was to investigate the effectiveness and feasibility of conducting a complementary 8-week comprehensive lifestyle modification program (CLMP) compared to standard care in patients with bronchial asthma over a 6-month period. METHODS: This was a randomized controlled pilot trial with two groups: intervention (N = 15) group and attention-placebo control (N = 14) group. The intervention group received an 8-week CLMP in addition to standard care. Quality of life, asthma control, lung function, reduction of rescue medication, perceived stress, and psychosocial and spiritual status were measured at the end of the intervention and at the 4-month follow-up. RESULTS: In the intervention group, there was a statistically significant difference in the improvements of quality of life, asthma control, lung function, and the reduction of rescue medication intake at both the end of the intervention and at the 4-month follow-up, with no change being observed in the control group. Significant stress reduction and greater psychosocial and spiritual well-being were observed during the 8-week CLMP in the intervention group. At the end of the intervention, the measures of stress and psychological and spiritual well-being reached statistical significance. CONCLUSIONS: Preliminary findings suggest that adding a CLMP to standard care in patients with bronchial asthma offers greater clinical benefit than standard care alone and also suggest that conducting a large randomized clinical trial is feasible.

Intranasally administered corticosteroids and neuropsychiatric disturbances: a review of the international pharmacovigilance programme of the World Health Organization.

BACKGROUND: The systemic use of corticosteroids is connected with a variety of psychiatric and neurologic effects. Corticosteroids for intranasal administration (INCs) are considered to act locally and to exert minimal systemic effects. An unexpected cluster of case reports of neuropsychiatric disorders during intranasal corticosteroid use was reported to the World Health Organization Uppsala Monitoring Centre. OBJECTIVE: To investigate the possible connection between intranasal corticosteroid use and the development of neuropsychiatric disorders, as reported to the International Pharmacovigilance Programme. METHODS: All reports containing adverse event terms indicating neuropsychiatric disturbances in suspected connection with intranasal corticosteroids were retrieved from Vigibase and evaluated (April 2006). The case reports are heterogeneous and vary regarding source, documentation quality, and relationship likelihood. RESULTS: A total of 429 reports were received from 16 countries (1980-April 2006), of neuropsychiatric events occurring in patients using INCs, representing 7.6% of the total of reports regarding these drugs in the same period. Frequently reported events were nervousness, anxiety, agitation, insomnia, emotional lability, depression, somnolence, confusion, convulsions, and migraine. Most reports concerned fluticasone propionate, beclometasone dipropionate, mometasone furoate, or budesonide. In 370 reports (86.2%), the INC was the sole suspect drug and in 220 (51.3%) it was the only drug used. In 97 of 108 patients who had discontinued use of the intranasal corticosteroid, the reaction abated. Of 41 patients, 32 had a relapse when the drug was reintroduced. CONCLUSIONS: The data collected by the International Pharmacovigilance Programme suggest that the intranasal use of corticosteroids can be complicated by neuropsychiatric adverse reactions. Further study is needed to confirm the connection and to determine the frequency and risk factors of such reactions.

Economic evaluation of sublingual vs subcutaneous allergen immunotherapy.

BACKGROUND: Sublingual allergen immunotherapy (SLIT) is a commonly used alternative route of administration to standard subcutaneous immunotherapy (SCIT) in Europe. Despite its wide use, the cost-effectiveness of SLIT vs SCIT has not been well established. OBJECTIVE: To evaluate the cost and effectiveness of SLIT compared with SCIT in patients with allergic rhinoconjunctivitis during a 3-year specific allergen immunotherapy (SIT) from a third-party payer's, a patient's, and society's perspectives. METHODS: We performed an open-label randomized clinical trial of patients receiving SLIT (n = 19), patients receiving SCIT (n = 23), and a control group (n = 22). The outcome measures were Rhinoconjunctivitis Quality of Life Questionnaire score, visual analog scale score, symptomatic medication reduction, and direct and indirect costs. RESULTS: SLIT offered clinical benefits to patients comparable to those provided by SCIT. From the perspective of a third-party payer, the total average direct medical cost per patient of 3-year SIT was estimated at Euro 416 vs Euro 482 in the SLIT and SCIT groups, respectively. A patient who received SLIT paid less than a patient who received SCIT for all out-of-pocket costs (Euro176 for SLIT vs Euro 255 for SCIT) but more for sole allergen extracts (Euro 72 for SLIT vs Euro 55 for SCIT). When both direct and indirect costs were considered, the 3-year SIT expenditures per patient reached Euro 684 vs Euro 1,004 in the SLIT and SCIT groups, respectively. CONCLUSIONS: SLIT represents a less expensive alternative relative to subcutaneous administration from all perspectives. However, from a patient's perspective, SCIT offers a less expensive alternative for patients who do not experience loss of income and travel costs associated with treatment.

Comparison of attitudes, beliefs, and resource-seeking behavior for CAM among first- and third-year Czech pharmacy students.

OBJECTIVES: To assess and compare first- and third-year Czech pharmacy students' attitudes toward CAM, CAM use, CAM evidence, recommending CAM to patients, and including CAM in the pharmacy curricula. METHODS: The CAM Health Belief Questionnaire (CHBQ) was translated from English to Czech and administered to 250 first-year and 187 third-year students. RESULTS: The students' mean CHBQ score was 48.5, affirming positive attitudes toward CAM. Vitamins, herbs, massage, and relaxation were the most commonly used therapies among students. Czech students reported significantly low use of evidence-based resources on CAM. Ninety percent of the pharmacy students surveyed would recommend CAM and 89% believed pharmacists should be knowledgeable of CAM. Ninety-one percent of first-year vs 78% of third-year students supported CAM education (p = 0.01). CONCLUSIONS: Czech students have positive attitudes about CAM, but are less likely to access evidence-based information. They agree pharmacists should be educated about CAM.