Complementary Medicine in Acute Care Hospitals: Questionnaire Survey with Heads of Bavarian Hospitals.

INTRODUCTION: The demand for complementary medicine (CM) is well studied in the outpatient sector, but representative data on type and extent of inpatient care using CM are missing. Therefore, our aim was to examine the range of CM treatments offered and the types of indications for using CM in acute care hospitals in the German state of Bavaria. METHODS: We conducted a cross-sectional questionnaire survey by contacting the medical heads of all 388 Bavarian acute care hospitals between November 2020 and April 2021. The questionnaire included a wide range of CM to assessed availability of CM supply, most frequent indications, and medical specialities. Furthermore, we assessed basic information about the hospital and the participating medical staff. RESULTS: A total of 101 (26%) hospitals participated in the survey. At least one CM treatment was offered by 92% of the responding hospitals and 75% offered at least 5 therapy modalities (mean of 10 treatments, range: 0-25). These were most commonly massage therapies (68%), relaxation techniques (63%), phytotherapy (60%), mindfulness-based treatments (53%), art, diet, and exercise therapies (each 48%), aromatherapy (46%), acupuncture, and compresses/poultices (both 42%). The most reported medical conditions for CM treatments (in descending order) were chronic pain, mental disorders, degenerative affections, sleep disorders, fatigue syndrome, functional gastrointestinal disorders, and acute pain. CONCLUSION: According to the Bavarian acute care hospitals that participated in our postal survey, a considerable part offered CM. Further research should include personal interviews and more detailed assessments of indications and attitudes for the use of CM in acute care hospital settings.Die Nachfrage nach Komplementärmedizinischen Verfahren (CM) ist für den ambulanten Sektor gut untersucht, aber es fehlen Daten über Art und Umfang der komplementärmedizinischen Versorgung im stationären Bereich. Unser Ziel war es daher, das CM-Angebot und die medizinischen Indikationen in Akutkrankenhäusern im Bundesland Bayern zu untersuchen.Wir führten eine Querschnittsbefragung durch, bei der die klinischen Leitungen aller 388 bayerischen Akutkrankenhäuser zwischen November 2020 und April 2021 angeschrieben wurden. Der Fragebogen inkludierte ein breites Spektrum an CM-Verfahren und erfasste deren Verfügbarkeit, die häufigsten Indikationen und Anwendungsgebiete. Ergänzend wurden grundlegende Informationen des Krankenhauses und des medizinischen Personals erfragt.Insgesamt nahmen 101 (26%) Krankenhäuser an der Befragung teil. Die meisten Ausfüllenden hatten mindestens zwei Jahrzehnte klinische Berufserfahrung. Mindestens eine CM Behandlung wurde von 92% der teilnehmenden Krankenhäuser angeboten und 75% boten mindestens 5 Therapiemodalitäten an (Mittelwert: 10 Behandlungen; Spanne: 0­25). Dabei handelte es sich am häufigsten um Massagen (68%), Entspannungstechniken (63%), Phytotherapie (60%), achtsamkeitsbasierte Behandlungen (53%), Kunst-, Ernährungs-und Bewegungstherapie (jeweils 48%), Aromatherapie (46%), Akupunktur und Kompressen/Umschläge (jeweils 42%). Die häufigsten genannten Indikationen für CM-Behandlungen waren (in absteigender Reihenfolge) chronische Schmerzen, psychische Störungen, degenerative Erkrankungen, Schlafstörungen, Erschöpfungssyndrom, funktionelle Magen-Darm-Beschwerden und akute Schmerzen.Nach Angaben der bayerischen Akutkrankenhäuser, die an unserer postalischen Umfrage teilgenommen haben, bietet ein erheblicher Teil CM an. Weitere Untersuchungen sollten persönliche Interviews und detailliertere Bewertungen der Indikationen und Einstellungen für den Einsatz von CM in Akutkrankenhäusern umfassen.

[How Common are Complementary Medicine Procedures in Bavarian Acute Care Hospitals? Results of A Bavarian-wide Website Screening]. / Wie verbreitet sind komplementärmedizinische Verfahren in bayerischen Krankenhäusern? Eine Vollerhebung für Bayern mittels Website-Screening.

BACKGROUND: In Germany, complementary medicine is used by up to 62% of patients, but type and extent of in-patient complementary care are not known. The objective of this study was, therefore, to conduct a survey on complementary medicine procedures in Bavarian acute care hospitals by screening the websites of all respective facilities in order to cover a broad range of complementary procedures. METHODS: In 2020, an independent and comprehensive website screening of all 389 Bavarian acute hospitals, including all departments, was conducted by two independent raters. Complementary medicine procedures offered were analysed in total as well as separately by specialty. RESULTS: Among all 389 Bavarian acute care hospitals, 82% offered at least one and 66% at least three different complementary procedures on their website. Relaxation techniques (52%), acupuncture (44%), massage (41%), movement-, art-, and music therapy (33%, 30%, and 28%), meditative movement therapies like yoga (30%), and aromatherapy (29%) were offered most frequently. Separated by specialty, complementary procedures were most common in psychiatry/psychosomatics (relaxation techniques 69%, movement and art therapy 60% each) at 87%, and in gynaecology/obstetrics (most common acupuncture 64%, homeopathy 60%, and aromatherapy 41%) at 72%. CONCLUSION: The vast majority of Bavarian acute care hospitals also seem to conduct complementary medicine procedures in therapy, especially for psychological indications and in obstetrics and gynaecology, according to the hospital websites. How often these procedures are used in inpatient or outpatient settings as well as evidence on effectiveness of the applied procedures should be investigated in further studies.

Experiencing COVID-19, home isolation and primary health care: A mixed-methods study.

Objectives: Although the vast majority of COVID-19 cases are treated in primary care, patients' experiences during home isolation have been little studied. This study aimed to explore the experiences of patients with acute COVID-19 and to identify challenges after the initial adaptation of the German health system to the pandemic (after first infection wave from February to June 2020). Methods: A mixed-method convergent design was used to gain a holistic insight into patients experience. The study consisted of a cross-sectional survey, open survey answers and semi-structured telephone interviews. Descriptive analysis was performed on quantitative survey answers. Between group differences were calculated to explore changes after the first infection wave. Qualitative thematic analysis was conducted on open survey answers and interviews. The results were then compared within a triangulation protocol. Results: A total of 1100 participants from all German states were recruited by 145 general practitioners from August 2020 to April 2021, 42 additionally took part in qualitative interviews. Disease onset varied from February 2020 to April 2021. After the first infection wave, more participants were tested positive during the acute disease (88.8%; 95.2%; P < 0.001). Waiting times for tests (mean 4.5 days, SD 4.1; 2.7days, SD 2.6, P < 0.001) and test results (mean 2.4 days, SD 1.9; 1.8 days, SD 1.3, P < 0.001) decreased. Qualitative results indicated that the availability of repeated testing and antigen tests reduced insecurities, transmission and related guilt. Although personal consultations at general practices increased (6.8%; 15.5%, P < 0.001), telephone consultation remained the main mode of consultation (78.5%) and video remained insignificant (1.9%). The course of disease, the living situation and social surroundings during isolation, access to health care, personal resilience, spirituality and feelings of guilt and worries emerged as themes influencing the illness experience. Challenges were contact management and adequate provision of care during home isolation. A constant contact person within the health system helped against feelings of care deprivation, uncertainty and fear. Conclusions: Our study highlights that home isolation of individuals with COVID-19 requires a holistic approach that considers all aspects of patient care and effective coordination between different care providers.

Herbal treatment with uva ursi extract versus fosfomycin in women with uncomplicated urinary tract infection in primary care: a randomized controlled trial.

OBJECTIVE: We explored whether initial treatment with the herbal drug uva ursi (UU) reduces antibiotic use in women with uncomplicated urinary tract infection (UTI) without increasing symptom burden and complication frequency compared with antibiotic treatment. METHODS: A double-blind randomized controlled trial was conducted in 42 family practices in Germany. The participants were adult women with suspected uncomplicated UTIs receiving either UU 105 mg 3 × 2 tablets for 5 days (intervention) or fosfomycin a 3-g single dose (control), and their respective placebos. Participants and investigators were blinded. The primary outcome included (1) antibiotic courses day 0-28 as superiority, and (2) symptom burden (sum of daily symptom scores) day 0-7, as non-inferiority outcome (margin 125%). Clinicaltrials.gov: NCT03151603. RESULTS: Overall, 398 patients were randomly allocated to groups receiving UU (n = 207) and fosfomycin (n = 191). The number of antibiotic courses was 63.6% lower (95% CI 53.6%-71.4%; p < 0.0001) in the UU group than in the fosfomycin group. The ratio of total symptom burden in the UU group compared with control was 136.5% (95% CI 122.7-151.9; p 0.95), failing non-inferiority. Eight women developed pyelonephritis in the UU group compared with two in the fosfomycin group (mean difference 2.8; 95% CI 0.2-5.9; p 0.067). Adverse events were similar between the groups. DISCUSSION: In women with uncomplicated UTIs, initial treatment with UU reduced antibiotic use but led to a higher symptom burden and more safety concerns than fosfomycin.

Reducing antibiotic use for uncomplicated urinary tract infection in general practice by treatment with uva-ursi (REGATTA) - a double-blind, randomized, controlled comparative effectiveness trial.

BACKGROUND: Uncomplicated urinary tract infections (UTI) are common in general practice and usually treated with antibiotics. This contributes to increasing resistance rates of uropathogenic bacteria. A previous trial showed a reduction of antibiotic use in women with UTI by initial symptomatic treatment with ibuprofen. However, this treatment strategy is not suitable for all women equally. Arctostaphylos uva-ursi (UU, bearberry extract arbutin) is a potential alternative treatment. This study aims at investigating whether an initial treatment with UU in women with UTI can reduce antibiotic use without significantly increasing the symptom burden or rate of complications. METHODS: This is a double-blind, randomized, and controlled comparative effectiveness trial. Women between 18 and 75 years with suspected UTI and at least two of the symptoms dysuria, urgency, frequency or lower abdominal pain will be assessed for eligibility in general practice and enrolled into the trial. Participants will receive either a defined daily dose of 3 × 2 arbutin 105 mg for 5 days (intervention) or fosfomycin 3 g once (control). Antibiotic therapy will be provided in the intervention group only if needed, i.e. for women with worsening or persistent symptoms. Two co-primary outcomes are the number of all antibiotic courses regardless of the medical indication from day 0-28, and the symptom burden, defined as a weighted sum of the daily total symptom scores from day 0-7. The trial result is considered positive if superiority of initial treatment with UU is demonstrated with reference to the co-primary outcome number of antibiotic courses and non-inferiority of initial treatment with UU with reference to the co-primary outcome symptom burden. DISCUSSION: The trial's aim is to investigate whether initial treatment with UU is a safe and effective alternative treatment strategy in women with UTI. In that case, the results might change the existing treatment strategy in general practice by promoting delayed prescription of antibiotics and a reduction of antibiotic use in primary care. TRIAL REGISTRATION: EudraCT: 2016-000477-21 . Clinical trials.gov: NCT03151603 (registered: 10 May 2017).

Resistance profiles of urinary tract infections in general practice--an observational study.

BACKGROUND: Guideline recommendations on therapy in urinary tract infections are based on antibiotic resistance rates. Due to a lack of surveillance data, little is known about resistance rates in uncomplicated urinary tract infection (UTI) in general practice in Germany. In a prospective observational study, urine cultures of all women presenting with urinary tract infections in general practice were analysed. Resistance rates against antibiotics recommended in German guidelines on UTI are presented. METHODS: In a prospective, multi-center observational study general practitioner included all female patients ≥ 18 years with clinically suspected urinary tract infection. Only patients receiving an antibiotic therapy within the last two weeks were excluded. RESULTS: 40 practices recruited 191 female patients (mean age 52 years; range 18-96) with urinary tract infections. Main causative agent was Escherichia coli (79%) followed by Enterococcus faecalis (14%) and Klebsiella pneumoniae (7.3%).Susceptibility of E.coli as the main causative agent was highest against fosfomycin and nitrofurantoin, with low resistance rates of 4,5%; 2,2%. In 17,5%, E.coli was resistant to trimethoprim and in 8,5% to ciprofloxacin. CONCLUSIONS: Resistance rates of uropathogens from unselected patients in general practice differ from routinely collected laboratory data. These results can have an impact on antibiotic prescribing and treatment recommendations.

Practices, patients and (im)perfect data--feasibility of a randomised controlled clinical drug trial in German general practices.

BACKGROUND: Randomised controlled clinical (drug) trials supply high quality evidence for therapeutic strategies in primary care. Until now, experience with drug trials in German general practice has been sparse. In 2007/2008, the authors conducted an investigator-initiated, non-commercial, double-blind, randomised controlled pilot trial (HWI-01) to assess the clinical equivalence of ibuprofen and ciprofloxacin in the treatment of uncomplicated urinary tract infection (UTI). Here, we report the feasibility of this trial in German general practices and the implementation of Good Clinical Practice (GCP) standards as defined by the International Conference on Harmonisation (ICH) in mainly inexperienced general practices. METHODS: This report is based on the experience of the HWI-01 study conducted in 29 German general practices. Feasibility was defined by 1) successful practice recruitment, 2) sufficient patient recruitment, 3) complete and accurate data collection and 4) appropriate protection of patient safety. RESULTS: The final practice recruitment rate was 18%. In these practices, 79 of 195 screened UTI patients were enrolled. Recruitment differed strongly between practices (range 0-12, mean 2.8 patients per practice) and was below the recruitment goal of approximately 100 patients. As anticipated, practice nurses became the key figures in the screening und recruitment of patients. Clinical trial demands, in particular for completing symptom questionnaires, documentation of source data and reporting of adverse events, did not agree well with GPs' documentation habits and required support from study nurses. In many cases, GPs and practice staff seemed to be overwhelmed by the amount of information and regulations. No sudden unexpected serious adverse reactions (SUSARs) were observed during the trial. CONCLUSIONS: To enable drug trials in general practice, it is necessary to adapt the setup of clinical research infrastructure to the needs of GPs and their practice staff. Risk adaption of clinical trial regulations is necessary to facilitate non-commercial comparative effectiveness trials in primary health care. TRIAL REGISTRATION NUMBER: ISRCTN00470468.

Symptomatic treatment (ibuprofen) or antibiotics (ciprofloxacin) for uncomplicated urinary tract infection?--results of a randomized controlled pilot trial.

BACKGROUND: Uncomplicated lower urinary tract infections (UTI) are usually treated with antibiotics. However, there is little evidence for alternative therapeutic options.This pilot study was set out 1) to make a rough estimate of the equivalence of ibuprofen and ciprofloxacin for uncomplicated urinary tract infection with regard to symptom resolution, and 2) to demonstrate the feasibility of a double-blind, randomized controlled drug trial in German general practices. METHODS: We performed a double-blind, randomized controlled pilot trial in 29 German general practices. Eighty otherwise healthy women aged 18 to 85 years, presenting with at least one of the main UTI symptoms dysuria and frequency and without any complicating factors, were randomly assigned to receive either ibuprofen 3 x 400 mg oral or ciprofloxacin 2 x 250 mg (+1 placebo) oral, both for three days.Intensity of main symptoms--dysuria, frequency, low abdominal pain--was recorded at inclusion and after 4, 7 and 28 days, scoring each symptom from 0 (none) to 4 (very strong). The primary endpoint was symptom resolution on Day 4. Secondary outcomes were the burden of symptoms on Days 4 and 7 (based on the sum score of all symptoms), symptom resolution on Day 7 and frequency of relapses. Equivalence margins for symptom burden on Day 4 were pre-specified as +/- 0.5 sum score points. Data analysis was done by intention to treat and per protocol. Randomization was carried out on patient level by computer programme in blocks of six. RESULTS: Seventy-nine patients were analyzed (ibuprofen n = 40, ciprofloxacin n = 39). On Day 4, 21/36 (58.3%) of patients in the ibuprofen-group were symptom-free versus 17/33 (51.5%) in the ciprofloxacin-group. On Day 4, ibuprofen patients reported fewer symptoms in terms of total sum score (1; SD 1,42) than ciprofloxacin patients (1,3; SD 1,9), difference -0,33 (95% CI (-1,13 to +0,47)), PP (per protocol) analysis. During Days 0 and 9, 12/36 (33%) of patients in the ibuprofen-group received secondary antibiotic treatment due to ongoing or worsening symptoms, compared to 6/33 (18%) in the ciprofloxacin-group (non significant). A total of 58 non-serious adverse events were reported, 32 in the ibuprofen group versus 26 in the ciprofloxacin group (non significant). CONCLUSIONS: Our results support the assumption of non-inferiority of ibuprofen compared to ciprofloxacin for treatment of symptomatic uncomplicated UTI, but need confirmation by further trials. TRIAL REGISTRATION NUMBER: ISRCTN00470468. See Commentary http://www.biomedcentral.com/1471-2296/11/42.