Patients' perspectives on prescription cannabinoid therapies: a cross-sectional, exploratory, anonymous, one-time web-based survey among German patients.

Introduction: Since cannabinoids were partially legalized as prescription medicines in Germany in 2017, they are mostly used when conventional therapies do not suffice. Ambiguities remain regarding use, benefits and risks. This web-based survey explored the perspectives of patients whose experiences are not well enough known to date. Methods: In an anonymous, exploratory, cross-sectional, one-time web-based observational study, participants receiving cannabinoid therapy on prescription documented aspects of their medical history, diagnoses, attitudes toward cannabinoids, physical symptoms, and emotional states. Participants completed the questionnaires twice here: first regarding the time of the survey and then, retrospectively, for the time before their cannabinoid therapy. Participants were recruited in a stratified manner in three German federal states. Results: N = 216 participants (48.1% female, aged 51.8 ± 14.0) completed the survey, most of which (72%, n = 155) reported pain as their main reason for cannabinoid therapy. When comparing the current state with the retrospectively assessed state, participants reported greater satisfaction with their overall medical therapy (TSQM II: +47.9 ± 36.5, p < 0.001); improved well-being (WHO-5: +7.8 ± 5.9, p < 0.001) and fewer problems in PROMIS subscales (all p < 0.001). Patients suffering primarily from pain (72%, n = 155) reported a reduction of daily pain (NRS: -3.2 ± 2.0, p < 0.001), while participants suffering mainly from spasticity (8%, n = 17) stated decreased muscle spasticity (MSSS: -1.5 ± 0.6, p < 0.001) and better physical mobility (-0.8 ± 0.8, p < 0.001). Data suggests clinically relevant effects for most scores. Participants' attitudes toward cannabinoids (on a 5-point scale) improved (+1.1 ± 1.1, p < 0.001). Most patients (n = 146, 69%) did not report major difficulties with the cannabinoid prescription process, while (n = 27; 19%) had their cannabinoid therapy changed due to side effects. Discussion: Most participants experienced their therapy with cannabinoids as more effective than their previous therapy. There are extensive limitations to this cross-sectional study: the originally intended representativeness of the dataset was not reached, partly due to the SARS-CoV-2 pandemic; the sample has a larger proportion of privately insured and self-paying patients. Results does not suggest that cannabinoid patients belong to a particular clientele. Effect sizes observed for pain reduction, quality of life, social participation, and other outcomes suggest a therapeutic potential, particularly in the treatment of chronic pain.

A Case Report of Acute Hepatitis Involving the Medicinal Herb Tinospora cordifolia Along with Other Variables.

This is a 54-year-old woman from Germany of central European origin who developed an acute hepatitis while orally taking Ayurvedic herbal remedies, among those was the medicinal herb Tinospora cordifolia. She took the plant powders from July 1, 2021, to October 1, 2021, with the intention of relieving the symptoms of her subjectively irritated gastrointestinal tract. The patient's main symptoms of acute hepatitis were progressively increasing general fatigue, nausea, and exhaustion. During an inpatient hospital admission from November 4, 2021, to November 9, 2021, she was under clinical observation, but no specific therapeutic measures were deemed necessary; however, blood chemistry showed an acute toxic hepatitis. There was no clinical or laboratory evidence of acute liver failure. Aminotransferase values decreased to normal values on December 14, 2021, by themselves. This case report contributes to the ongoing discussion about the potential risks of triggering an acute hepatitis due to the intake of herbal remedies from the Tinospora genus in rare cases, differentiating other involved risk factors. The case also shows that causality assignments are not trivial in the context of multivariate clinical scenarios. In the case of known hepatic metabolism-associated risk factors, T. cordifolia should be used with more caution based on available case reports. At the same time, no hasty and exaggerated prejudgments should be made about this medicinal herb, which has been very successfully used in traditional South Asian systems of medicine for many centuries.

Ayurvedic vs. Conventional Nutritional Therapy Including Low-FODMAP Diet for Patients With Irritable Bowel Syndrome-A Randomized Controlled Trial.

Aims: To compare the effects of Ayurvedic and conventional nutritional therapy in patients with irritable bowel syndrome (IBS). Methods: Sixty-nine patients with IBS were randomized to Ayurvedic (n = 35) or conventional nutritional therapy according to the recommendations of the German Nutrition Society including the low-FODMAP diet (n = 34). Study visits took place at baseline and after 1, 3, and 6 months. The primary outcome was IBS symptom severity (IBS-SSS) after 3 months; secondary outcomes included stress (CPSS), anxiety and depression (HADS), well-being (WHO-5) and IBS-specific quality of life (IBS-QOL). A repeated measures general linear model (GLM) for intent-to-treat-analyses was applied in this explorative study. Results: After 3 months, estimated marginal means for IBS-SSS reductions were 123.8 [95% confidence interval (95% CI) = 92.8-154.9; p < 0.001] in the Ayurvedic and 72.7 (95% CI = 38.8-106.7; p < 0.001) in the conventional group. The IBS-SSS reduction was significantly higher in the Ayurveda group compared to the conventional therapy group (estimated marginal mean = 51.1; 95% CI = 3.8-98.5; p = 0.035) and clinically meaningful. Sixty-eight percentage of the variance in IBS-SSS reduction after 3 months can be explained by treatment, 6.5% by patients' expectations for their therapies and 23.4% by IBS-SSS at pre-intervention. Both therapies are equivalent in their contribution to the outcome variance. The higher the IBS-SSS score at pre-intervention and the larger the patients' expectations, the greater the IBS-SSS reduction. There were no significant group differences in any secondary outcome measures. No serious adverse events occurred in either group. Conclusion: Patients with IBS seem to benefit significantly from Ayurvedic or conventional nutritional therapy. The results warrant further studies with longer-term follow-ups and larger sample sizes. Clinical Trial Registration:https://clinicaltrials.gov/ct2/show/NCT03019861, identifier: NCT03019861.

Qualitative study of yoga for Young adults in school sports.

OBJECTIVES: Distress and stress-related diseases are an increasing public health problem at schools. This qualitative study was nested in a non-randomized, controlled trial studying the effects of a 10-week yoga course as an alternative for regular school sports in two secondary schools in Germany. METHODS: We conducted a qualitative evaluation in 3 focus groups with 6 participants each. The focus groups were audio-recorded, transcribed verbatim, pseudonymised and analysed using qualitative content analysis. Furthermore open questions were asked in questionnaires. RESULTS: The analysis of the participants' interviews (mean age 19.6 ± 2.9 years, n = 10 female, n = 8 male) resulted in 4 key topics: 1. encountering yoga, 2. yoga practice, 3. effects and benefits of yoga, and 4. yoga in the school context. Yoga was very well accepted by most participants. They reported a variety of physical and psychological benefits as well as overall restorative effects. The relief of pain or other physical ailments, higher mobility and flexibility, improved posture and improved sleep were mentioned by the participants. Some participants used the new exercises and experiences (e.g. working with the breath) in their everyday life. The possibility for self-responsible action was a welcome change from the perceived pressure and heteronomy in normal (school) life. Controversial was the question of whether yoga - if it is part of school sport - should be assessed or graded, and whether it should be compulsory or voluntary. CONCLUSION: Yoga can offer both physical and psychological benefits in young adults as well as offer general regenerative effects. Yoga by sensitizing the participants to negative patterns of behaviour can encourage healthy behaviour.

Reliability of Ayurvedic Diagnosis for Knee Osteoarthritis Patients: A Nested Diagnostic Study Within a Randomized Controlled Trial.

Background: Ayurveda is a traditional Indian system of medicine. The customized Ayurvedic approach consists of a combination of several diagnostic procedures and subsequent individualized therapeutic interventions. Evaluation of inter-rater reliability (IRR) of Ayurvedic diagnoses has rarely been performed. The aim of this study was to evaluate IRR of Ayurvedic diagnosis for patients with knee osteoarthritis. Methods: A diagnostic reliability study of 30 patients and 4 Ayurvedic experts was nested in a randomized controlled trial. Patients were diagnosed in a sequential order by all experts utilizing a semistructured patient history form. A nominal group technique as consensus procedure was performed to reach agreement on the items to be diagnosed. An IRR analysis using Fleiss' and Cohen's kappa statistics was performed to determine a chance-corrected measure of agreement among raters. Results: One hundred and twenty different ratings and 30 consensus ratings were performed and analyzed. While high percentages of agreement for main diagnostic entities and the final Ayurveda diagnosis (95% consensus agreement on main diagnosis) could be observed, this was not reflected in the corresponding kappa values, which largely yielded fair-to-poor inter-rater agreement kappas for central diagnostic aspects such as prakriti and agni (κ values between 0 and 0.4). Notably, agreement on disease-related entities was better than that on constitutional entities. Conclusions: This is the first diagnostic study embedded in a clinical trial on patients with knee osteoarthritis utilizing a multimodality whole systems approach. Results showed a contrast between the high agreement of the consented final diagnosis and disagreement on certain diagnostic details. Future diagnostic studies should have larger sample sizes and a methodology more tailored to the specificities of traditional whole systems of medicine. Equal emphasis will need to be placed on all core diagnostic components of Ayurveda, both constitutional and disease specific, using detailed structured history taking forms.

The influence of communication and information sources upon decision-making around complementary and alternative medicine use for back pain among Australian women aged 60-65 years.

This study examined factors influencing decision-making on complementary and alternative medicine (CAM) use for back pain and back pain sufferers' communication about CAM use. A cross-sectional postal survey was conducted in 2011/2012 as a sub-study of the Australian Longitudinal Study on Women's Health (ALSWH). The sample contained 1620 women from the 1945-1951 cohort of the ALSWH, aged 60-65 years who were eligible for the sub-study, as they had experienced back pain during 12 months prior to the survey. Of these, 1310 (80.9%) returned completed questionnaires. A significant proportion of women consulted a CAM practitioner (76%, n = 1001) and/or had self-prescribed CAM treatment (75%, n = 985). Of the women who used CAM for their back pain, 20% consulted their general practitioner (GP) prior to using CAM and 34% always informed their GP following CAM use. Forty-three per cent of the women were influenced by their doctors, 39% by friends/colleagues, 36% by family/relatives, 33% by their partner, 30% by a CAM practitioner, 20% by a pharmacist, 16% by a book/magazine, 11% by mass media, 10% by an allied health worker and 6% by the Internet. Our results show that information sources used by women for their decision-making on CAM use differed according to the symptoms. While non-professional information sources (e.g. family/relatives) positively influenced women in their decision to use CAM for a range of back pain-related symptoms (e.g. headaches/migraines), doctors and allied health workers (e.g. nurses) negatively influenced women in their decision to consult a CAM practitioner for a range of back pain-related symptoms (e.g. headaches/migraines, neck pain). Women seek information from a wide range of professional and non-professional sources with regard to their decision-making around CAM use for back pain. Back pain care providers need to ensure effective communication with their back pain patients regarding safe, effective and co-ordinated back pain care options.

Back pain sufferers' attitudes toward consultations with CAM practitioners and self- prescribed CAM products: A study of a nationally representative sample of 1310 Australian women aged 60-65 years.

OBJECTIVE: To analyze back pain sufferers' attitudes toward consultations with complementary and alternative medicine (CAM) practitioners and self-prescribed CAM products. METHODS: A cross-sectional survey of a nationally representative sample of Australian women aged 60-65 years. RESULTS: A significant number of women with back pain consulted a massage therapist (41.4%, n=578), a chiropractor (37.3%, n=488), an acupuncturist (13.3%, n=174), used self-prescribed supplements (59.2%, n=776), vitamins/minerals (45.2%, n=592) and/or herbal medicines (13.1%, n=172). Women who perceived CAM as providing greater control over their body/health were more likely to have consulted a chiropractor (OR=4.21; 95% CI; 2.16, 8.19) and/or self- prescribed supplements (OR=2.38; 95% CI: 1.05, 3.49) than those who did not perceive CAM as providing greater control over their body/health. Women who perceived CAM as natural (OR=1.56; 95% CI: 1.02, 2.37) or promoting a holistic approach to health (OR=2.73; 95% CI: 1.60, 4.64) were more likely to have self-prescribed vitamins/minerals than those who did not perceive CAM as natural and promoting a holistic approach to health. Women who expressed that knowledge about evidence of CAM as important to them were more likely to have self-prescribed herbal medicines (OR=7.15; 95% CI: 1.72, 29.64) than those who did not express an interest in knowledge about evidence of CAM. CONCLUSION: Certain key attitudes toward CAM influence back pain sufferers' choice of CAM use, highlighting the need for back pain care providers to ensure appropriate enquiry and discussion with their patients regarding consulting CAM practitioners and/or self-prescribing CAM products for back pain.

An integrative review of complementary and alternative medicine use for back pain: a focus on prevalence, reasons for use, influential factors, self-perceived effectiveness, and communication.

BACKGROUND CONTEXT: Back pain is the most prevalent of musculoskeletal conditions, and back pain sufferers have been identified as high users of complementary and alternative medicine (CAM). Despite lacking evidence, CAM treatments (e.g., acupuncture, chiropractic, and massage) and CAM products (eg, vitamins, supplements, and aromatherapy oils) for back pain care have become widely available internationally, and CAM use by back pain sufferers has become a significant health service issue. However, to date, there has been no integrative review on CAM use for back pain. PURPOSE: This study aims to conduct an integrative review on CAM use for back pain focusing on prevalence of use, commonly used CAM, characteristics of users, factors influencing decision making, self-perceived effectiveness, and communication with health-care providers. STUDY DESIGN/SETTING: The study is based on an integrative literature review. METHODS: A comprehensive search of international literature from 2000 to 2014 in MEDLINE, CINHAL, AMED, DARE, EMBASE, ExceptaMedica, psycINFO, and SCOPUS databases was conducted. The search was limited to peer-reviewed articles published in English language and reporting empirical research findings on CAM use for back pain. RESULTS: The review reveals a considerable variation in prevalences of CAM use for back pain internationally. Acupuncture, chiropractic, osteopathy, and massage therapy are the commonly used CAM treatments besides a range of self-prescribed CAM, and back pain sufferers use CAM alongside conventional medical treatments. Female gender, chronicity of back pain, and previous exposure to CAM are key predictors of CAM use for back pain as highlighted from the reviewed literature. Family, friends, and recommendation by doctors appear to influence decision making on CAM use for back pain. The review reveals that users of CAM for back pain tend to report CAM as beneficial, but there is little knowledge on communication between CAM users with back pain and health-care providers about such use. Existing literature is largely based on the research investigating CAM use for back pain among a range of other health conditions. Further rigorous research is needed to investigate the use of a wider range of CAM treatments, particularly self-prescribed CAM for back pain. CONCLUSIONS: The review findings provide insights for health-care providers and policy makers on the range of CAM treatments used by back pain sufferers. Conventional medical and CAM practitioners should be aware of back pain sufferers' decision making regarding a range of CAM treatments and be prepared to communicate with patients on safe and effective CAM treatments for back pain.

Self-prescribed complementary and alternative medicine use for back pain amongst a range of care options: results from a nationally representative sample of 1310 women aged 60-65 years.

OBJECTIVE: To examine the prevalence and characteristics of women who self-prescribe complementary and alternative medicine (CAM) for back pain. METHODS: A cross-sectional survey of a nationally-representative sample of women aged 60-65 years from the Australian Longitudinal Study on Women's Health (ALSWH). RESULTS: A significant number of women (75.2%, n=985) self-prescribed one or more CAM for back pain in the previous twelve months. Use of self-prescribed CAM for back pain was not associated with socio-economic status. The most common self-prescribed CAM used by women was supplements (n=776, 59.2%), vitamins/minerals (n=592, 45.2%), yoga/meditation (n=187, 14.3%), herbal medicines (n=172, 13.1%) and aromatherapy oils (n=112, 8.6%). Women who visited general practitioners (GPs) more than three times in the previous twelve months were 1.59 times (95% CI: 1.14, 2.22) more likely to self-prescribe CAM for back pain than those women who did not visit GPs. Women who visited a pharmacist three or more times in the previous twelve months were 2.90 times (95% CI: 1.65, 5.09) more likely to self-prescribe CAM for back pain than those women who did not visit a pharmacist. CONCLUSION: This study identifies substantial use of self-prescribed CAM by women for back pain regardless of their education, income or urban/rural residency. In order to ensure safe, effective practice it is important that all providing and managing health services for back pain sufferers remain mindful of patients' possible use of self-prescribed CAM.

Consultations with complementary and alternative medicine practitioners amongst wider care options for back pain: a study of a nationally representative sample of 1,310 Australian women aged 60-65 years.

Back pain is a significant health service issue in Australia and internationally. Back pain sufferers can draw upon a range of health care providers including complementary and alternative medicine (CAM) practitioners. Women are higher users of health services than men and tend to use CAM frequently for musculoskeletal conditions. However, there remain important gaps in our understanding of women's consultation patterns with CAM practitioners for back pain. The objective of this study is to examine the prevalence of use and characteristics of women who use CAM practitioners for back pain. The method used was a survey of a nationally representative sample of women aged 60-65 years from the Australian Longitudinal Study on Women's Health. Women consulted a massage therapist (44.1 %, n = 578) and a chiropractor (37.3 %, n = 488) more than other CAM practitioners for their back pain. Consultations with a chiropractor for back pain were lower for women who consulted a General Practitioner (GP) (OR, 0.56; 95 % CI 0.41, 0.76) or a physiotherapist (OR, 0.53; 95 % CI 0.39, 0.72) than for those who did not consult a GP or a physiotherapist. CAM practitioner consultations for back pain were greater for women who visited a pharmacist (OR, 1.99; 95 % CI 1.23, 3.32) than for women who did not visit a pharmacist. There is substantial use of CAM practitioners alongside conventional practitioners amongst women for back pain, and there is a need to provide detailed examination of the communication between patients and their providers as well as across the diverse range of health professionals involved in back pain care.

The prevalence and determinants of Chinese medicine use by Australian women: analysis of a cohort of 10,287 women aged 56-61 years.

This study aimed to examine the factors associated with Chinese medicine use amongst a sample of 10,287 Australian women aged 56-61 years. Data was obtained from a cross-sectional postal questionnaire conducted in 2007, this being the fifth survey of the Australian Longitudinal Study on Women's Health. This representative sample of 10,287 women was randomly selected from the Health Insurance Commission (Medicare) database. The outcome measure was the use of Chinese medicine in the previous 12 months. The predictive factors included demographics, health status measures and health service utilization measures. Statistical analyses included univariate chi-square and ANOVA tests and backward stepwise multiple logistic regression modelling. The use of Chinese medicine amongst women aged 56-61 years appears to be strongly influenced by their country of birth, consultation with a range of CAM practitioners, and the use of some self-prescribed CAM. Interestingly, severe tiredness was the only symptom or diagnosis that predicted Chinese medicine use. Given the substantial prevalence of Chinese medicine use and the finding that the use of Chinese medicine is heavily integrated alongside the use of many other CAM and conventional treatments, it is imperative for the safety of patients that health professionals (across complementary and conventional healthcare) fully recognise the possible Chinese medicine use amongst their practice populations. In order to help inform relevant practice and policy development it is also important that future research further examining women's decision-making, motivations and evaluations regarding Chinese medicine use considers such issues within the context of broader CAM and conventional health care utilization.