A randomized controlled trial of acupuncture and receptive music therapy for sleep disorders in the elderly-ELAMUS: study protocol.

BACKGROUND: Globally, the demographic shift towards an aging population leads to significant challenges in healthcare systems, specifically due to an increasing incidence of multimorbidity resulting in polypharmacy among the elderly. Simultaneously, sleep disorders are a common complaint for elderly people. A treatment with pharmacological therapies often leads to side effects causing a high potential for dependency. Within this context, there is a high need to explore non-pharmacological therapeutic approaches. The purpose of this study is to evaluate the effectiveness of acupuncture and music therapy, both individually and combined as a multimodal therapy, in the treatment of sleep disorders in individuals aged 70 years and older. METHODS: We conduct a confirmatory randomized controlled trial using a two-factorial study design. A total of n = 100 elderly people receive evidence-based standard care information for age-related sleep disorders. Beyond that, patients are randomly assigned into four groups of n = 25 each to receive acupuncture, receptive music therapy with a monochord, multimodal therapy with both acupuncture and music therapy, or no further therapy. The study's primary outcome measurement is the improvement in sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) (global score), at the end of intervention. Additionally, depression scores (Geriatric Depression Scale), health-related quality of life (Short-Form-Health Survey-12), neurovegetative activity measured via heart rate variability, and safety data are collected as secondary outcomes. Using a mixed-methods approach, a qualitative process evaluation will be conducted to complement the quantitative data. DISCUSSION: The study is ongoing and the last patient in is expected to be enrolled in April 2024. The results can provide valuable insights into the effectiveness of non-pharmacological interventions for sleep disorders among the elderly, contributing to a more personalized and holistic approach in geriatric healthcare. TRIAL REGISTRATION: German Clinical Trials Register (DRKS00031886).

Homeopathy for seasonal allergic rhinitis: rationale, design and methods of the three-armed randomized controlled HOMEOSAR trial.

BACKGROUND: Patients with seasonal allergic rhinitis (SAR) frequently use homeopathic therapy. Although there is some evidence that homeopathy may be effective in treating symptoms of SAR, there is a lack of high-quality clinical trials. Therefore, the aim of the homeopathy for SAR (HOMEOSAR) trial is to determine the efficacy of individualized or standardized homeopathic drug treatment compared to placebo regarding rhinitis-related quality of life in patients with SAR. METHODS: This randomized, placebo-controlled, double-blind, three-armed intervention study will be conducted at two university hospital outpatient clinics for complementary and integrative medicine in Berlin and in 12 office-based practices specializing in homeopathic treatment in Germany. A total of 270 patients with clinical symptoms of SAR and positive allergy test to birch and grass pollen will receive homeopathic anamnesis and subsequently be randomized into (a) standardized homeopathic drug treatment with Galphimia Glauca (potency D6), (b) individualized homeopathic drug treatment (D6), or (c) placebo. All three groups can receive on-demand rescue medication as needed. Treatment will consist of two consultations and daily intake of the study medication for 4 weeks during the pollen season. The primary outcome is the mean overall score of the Rhinitis Quality of Life Questionnaire (RQLQ) in weeks 3 and 4, analyzed using analysis of covariance (adjusted for baseline RQLQ overall score and study center). A closed testing procedure will be used to control the overall type I error comparing the 3 treatment groups. Secondary outcomes include the overall RQLQ and its seven domain scores, responder status (decrease in RQLQ overall score of at least 0.5 points compared to the baseline value), use of rescue medication, intensity of total and individual SAR symptoms based on visual analog scale, generic health-related quality of life, safety, utilization of health care resources and associated costs. In addition, a qualitative data analysis is planned. CONCLUSION: The results of our study will contribute to clarifying the possible therapeutic effects of homeopathic drug treatment for patients with SAR. TRIAL REGISTRATION: This study has been registered in the German Clinical Trial Registry with trial ID DRKS00018081 on June 09, 2020.

Efficacy of Persian barley water on clinical outcomes of hospitalized moderate-severity COVID-19 patients: a single-blind, add-on therapy, randomized controlled clinical trial.

OBJECTIVE: Coronavirus disease 2019 (COVID-19) is a debilitating disease with numerous medical and non-medical consequences. Our study aimed to evaluate the efficacy of Persian barley water in controlling the clinical outcomes of hospitalized COVID-19 patients. PATIENTS AND METHODS: This was a single-blind, add-on therapy, randomized controlled clinical trial conducted in Shiraz, Iran, from January to March 2021. One hundred hospitalized COVID-19 patients with moderate disease severity were randomly allocated to receive routine treatment (per local protocols) with or without 250 ml of Persian barley water (PBW) daily for two weeks. Clinical outcomes and blood tests were recorded before and after the study period. Multivariable modeling was applied using Stata software for data analysis. RESULTS: The PBW product passed our standardization and safety assessments. Length of hospital stay (LHS) was 4.5 days shorter in the intervention group than the control group regardless of history of cigarette smoking (95% confidence interval: -7.22, -1.79 days). Also, body temperature, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and creatinine significantly dropped in the intervention group compared to the control group. No adverse events related to PBW occurred. CONCLUSIONS: This clinical trial demonstrated the efficacy of PBW in minimizing the LHS, fever, and levels of ESR, CRP, and creatinine among hospitalized COVID-19 patients with moderate disease severity. More robust trials can help find safe and effective herbal formulations as treatments for COVID-19.

Evidence on yoga for health: A bibliometric analysis of systematic reviews.

OBJECTIVE: To support the research agenda in yoga for health by comprehensively identifying systematic reviews of yoga for health outcomes and conducting a bibliometric analysis to describe their publication characteristics and topic coverage. METHODS: We searched 7 databases (MEDLINE/PubMed, Embase, PsycINFO, CINAHL, AMED, the Cochrane Database of Systematic Reviews, and PROSPERO) from their inception to November 2019 and 1 database (INDMED) from inception to January 2017. Two authors independently screened each record for inclusion and one author extracted publication characteristics and topics of included reviews. RESULTS: We retrieved 2710 records and included 322 systematic reviews. 157 reviews were exclusively on yoga, and 165 were on yoga as one of a larger class of interventions (e.g., exercise). Most reviews were published in 2012 or later (260/322; 81 %). First/corresponding authors were from 32 different countries; three-quarters were from the USA, Germany, China, Australia, the UK or Canada (240/322; 75 %). Reviews were most frequently published in speciality journals (161/322; 50 %) complementary medicine journals (66/322; 20 %) or systematic review journals (59/322; 18 %). Almost all were present in MEDLINE (296/322; 92 %). Reviews were most often funded by government or non-profits (134/322; 42 %), unfunded (74/322; 23 %), or not explicit about funding (111/322; 34 %). Common health topics were psychiatric/cognitive (n = 56), cancer (n = 39) and musculoskeletal conditions (n = 36). Multiple reviews covered similar topics, particularly depression/anxiety (n = 18), breast cancer (n = 21), and low back pain (n = 16). CONCLUSIONS: Further research should explore the overall quality of reporting and conduct of systematic reviews of yoga, the direction and certainty of specific conclusions, and duplication or gaps in review coverage of topics.

Pathways to post-traumatic growth in cancer patients: moderated mediation and single mediation analyses with resilience, personality, and coping strategies.

BACKGROUND: Cancer diagnosis is a potentially traumatic experience, which could generate significant long-lasting emotional distress, but also positive changes linked to post-traumatic growth (PTG). This study aimed to analyze the role of resilience, coping, and personality in determining PTG or post-traumatic symptoms, and to test a moderated mediation model and a single mediation model in a sample of individuals diagnosed with cancer. METHODS: A sample of 154 individuals diagnosed with cancer (Mage = 51.4, SD = 11.25) completed the Post-Traumatic Growth Inventory, Impact of Event Scale, Connor-Davidson Resilience Scale, Ten Item Personality Inventory, and Coping Orientation to Problems Experienced after providing written informed consent. RESULTS: Results showed that the impact of resilience in PTG is partially mediated by positive attitude, with a significant and negative moderating effect of openness on the relationship between resilience and positive attitude. Furthermore, resilience negatively predicted the impact of trauma, with a partial mediation of avoidance strategies. LIMITATIONS: The cross-sectional nature of the study, the use of only self-report measures, heterogeneity of the sample, and the risk of influence of unobserved prognostic variables should be kept in mind while interpreting the results. CONCLUSIONS: The findings showed that the level of resilience predicted PTG or post-traumatic symptoms, both directly and indirectly, with different coping strategies as mediators. Furthermore, the lower the level of openness reported by participants, the higher the resilience induced by positive attitude. These findings may significantly contribute toward tailoring interventions for improving the mental health of cancer patients.

Understanding and optimising patient and public involvement in trial oversight: an ethnographic study of eight clinical trials.

BACKGROUND: Trial oversight is important for trial governance and conduct. Patients and/or lay members of the public are increasingly included in trial oversight committees, influenced by international patient and public involvement (PPI) initiatives to improve the quality and relevance of research. However, there is a lack of guidance on how to undertake PPI in trial oversight and tokenistic PPI remains an issue. This paper explores how PPI functions in existing trial oversight committees and provides recommendations to optimise PPI in future trials. This was part of a larger study investigating the role and function of oversight committees in trials facing challenges. METHODS: Using an ethnographic study design, we observed oversight meetings of eight UK trials and conducted semi-structured interviews with members of their trial steering committees (TSCs) and trial management groups (TMGs) including public contributors, trial sponsors and funders. Thematic analysis of data was undertaken, with findings integrated to provide a multi-perspective account of how PPI functions in trial oversight. RESULTS: Eight TSC and six TMG meetings from eight trials were observed, and 66 semi-structured interviews conducted with 52 purposively sampled oversight group members, including three public contributors. PPI was reported as beneficial in trial oversight, with public members contributing a patient voice and fulfilling a patient advocacy role. However, public contributors were not always active at oversight meetings and were sometimes felt to have a tokenistic role, with trialists reporting a lack of understanding of how to undertake PPI in trial oversight. To optimise PPI in trial oversight, the following areas were highlighted: the importance of planning effective strategies to recruit public contributors; considering the level of oversight and stage(s) of trial to include PPI; support for public contributors by the trial team between and during oversight meetings. CONCLUSIONS: We present evidence-based recommendations to inform future PPI in trial oversight. Consideration should be given at trial design stage on how to recruit and involve public contributors within trial oversight, as well as support and mentorship for both public contributors and trialists (in how to undertake PPI effectively). Findings from this study further strengthen the evidence base on facilitating meaningful PPI within clinical trials.

Disclosure of complementary medicine use to medical providers: a systematic review and meta-analysis.

Concomitant complementary medicine (CM) and conventional medicine use is frequent and carries potential risks. Yet, CM users frequently neglect to disclose CM use to medical providers. Our systematic review examines rates of and reasons for CM use disclosure to medical providers. Observational studies published 2003-2016 were searched (AMED, CINAHL, MEDLINE, PsycINFO). Eighty-six papers reporting disclosure rates and/or reasons for disclosure/non-disclosure of CM use to medical providers were reviewed. Fourteen were selected for meta-analysis of disclosure rates of biologically-based CM. Overall disclosure rates varied (7-80%). Meta-analysis revealed a 33% disclosure rate (95%CI: 24% to 43%) for biologically-based CM. Reasons for non-disclosure included lack of inquiry from medical providers, fear of provider disapproval, perception of disclosure as unimportant, belief providers lacked CM knowledge, lacking time, and belief CM was safe. Reasons for disclosure included inquiry from medical providers, belief providers would support CM use, belief disclosure was important for safety, and belief providers would give advice about CM. Disclosure appears to be influenced by the nature of patient-provider communication. However, inconsistent definitions of CM and lack of a standard measure for disclosure created substantial heterogeneity between studies. Disclosure of CM use to medical providers must be encouraged for safe, effective patient care.

[Herbal medicines for psychiatric disorders]. / Phytotherapie bei psychiatrischen Erkrankungen.

BACKGROUND: In Germany herbal medicines are traditionally frequently used. They represent an important therapeutic option, especially in self-medication. METHODS: Current systematic review articles and meta-analyses were evaluated and summarized with respect to the evidence of phytotherapeutic drugs for selected psychiatric indications. RESULTS: Apart from the use of St. John's wort for depression, no other herb has so far shown convincing evidence. CONCLUSION: Due to the promising effects and the low side effect potential within the existing studies, further randomized controlled trials (e. g. for Passiflora incarnata, Rhodiola rosea and Lavendula officinalis) are definitely indicated.

Randomised clinical trial: yoga vs a low-FODMAP diet in patients with irritable bowel syndrome.

BACKGROUND: Irritable bowel syndrome is the most frequent gastrointestinal disorder. It is assumed that lifestyle interventions might be a rational treatment approach. AIM: To examine the effect of a yoga-based intervention vs a low-FODMAP diet on patients with irritable bowel syndrome. METHODS: Fifty-nine patients with irritable bowel syndrome undertook a single-blind, randomised controlled trial involving yoga or a low-FODMAP diet for 12 weeks. Patients in the yoga group received two sessions weekly, while patients in the low-FODMAP group received a total of three sessions of nutritional counselling. The primary outcome was a change in gastrointestinal symptoms (IBS-SSS). Secondary outcomes explored changes in quality of life (IBS-QOL), health (SF-36), perceived stress (CPSS, PSQ), body awareness (BAQ), body responsiveness (BRS) and safety of the interventions. Outcomes were examined in weeks 12 and 24 by assessors "blinded" to patients' group allocation. RESULTS: No statistically significant difference was found between the intervention groups, with regard to IBS-SSS score, at either 12 (Δ = 31.80; 95%CI = -11.90, 75.50; P = .151) or 24 weeks (Δ = 33.41; 95%CI = -4.21, 71.04; P = .081). Within-group comparisons showed statistically significant effects for yoga and low-FODMAP diet at both 12 and 24 weeks (all P < .001). Comparable within-group effects occurred for the other outcomes. One patient in each intervention group experienced serious adverse events (P = 1.00) and another, also in each group, experienced nonserious adverse events (P = 1.00). CONCLUSIONS: Patients with irritable bowel syndrome might benefit from yoga and a low-FODMAP diet, as both groups showed a reduction in gastrointestinal symptoms. More research on the underlying mechanisms of both interventions is warranted, as well as exploration of potential benefits from their combined use.

Randomised clinical trial: yoga vs written self-care advice for ulcerative colitis.

BACKGROUND: Perceived stress seems to be a risk factor for exacerbation of ulcerative colitis. Yoga has been shown to reduce perceived stress. AIMS: To assess the efficacy and safety of yoga for improving quality of life in patients with ulcerative colitis. METHODS: A total of 77 patients (75% women; 45.5 ± 11.9 years) with ulcerative colitis in clinical remission but impaired quality of life were randomly assigned to yoga (12 supervised weekly sessions of 90 min; n = 39) or written self-care advice (n = 38). Primary outcome was disease-specific quality of life (Inflammatory Bowel Disease Questionnaire). Secondary outcomes included disease activity (Rachmilewitz clinical activity index) and safety. Outcomes were assessed at weeks 12 and 24 by blinded outcome assessors. RESULTS: The yoga group had significantly higher disease-specific quality of life compared to the self-care group after 12 weeks (Δ = 14.6; 95% confidence interval=2.6-26.7; P = 0.018) and after 24 weeks (Δ = 16.4; 95% confidence interval=2.5-30.3; P = 0.022). Twenty-one and 12 patients in the yoga group and in the self-care group, respectively, reached a clinical relevant increase in quality of life at week 12 (P = 0.048); and 27 and 17 patients at week 24 (P = 0.030). Disease activity was lower in the yoga group compared to the self-care group after 24 weeks (Δ = -1.2; 95% confidence interval=-0.1-[-2.3]; P = 0.029). Three and one patient in the yoga group and in the self-care group, respectively, experienced serious adverse events (P = 0.317); and seven and eight patients experienced nonserious adverse events (P = 0.731). CONCLUSIONS: Yoga can be considered as a safe and effective ancillary intervention for patients with ulcerative colitis and impaired quality of life. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02043600.

The Efficacy and Safety of Yoga in Managing Hypertension.

Hypertension is a major public health problem and one of the most important causes of premature morbidity and mortality. Yoga is a traditional Indian practice that has been adapted for use in complementary and alternative medicine and mainly includes physical postures, breathing techniques, and meditation. The impact of yoga as a complementary intervention for hypertension has been investigated in a number of randomized controlled trials; with an overall effect of about 10 mmHg reduction in systolic and about 8 mmHg reduction in diastolic blood pressure. Yoga seems to be effective only for hypertension but not for prehypertension; and only as an adjunct to antihypertensive pharmacological treatment but not as an alternative therapy. Breathing and meditation rather than physical activity seem to be the active part of yoga interventions for hypertensive patients. These practices can increase parasympathic activity and decrease sympathetic activity, arguably mainly by increasing GABA activity; thus counteracting excess activity of the sympathetic nervous system which has been associated with hypertension. Although yoga has been associated with serious adverse events in single case reports, population-based surveys as well as clinical trials indicate that yoga is a relatively safe intervention that is not associated with more adverse events than other forms of physical activity. Yoga can thus be considered a safe and effective intervention for managing hypertension. Given the possibly better risk/benefit ratio, it may be advisable to focus on yogic meditation and/or breathing techniques.

Effects of high phenolic olive oil on cardiovascular risk factors: A systematic review and meta-analysis.

BACKGROUND: Cardiovascular diseases are the world's leading cause of death. Prevention by nutrition is an easy and effective approach especially by advising foods with nutraceutic properties like high phenolic olive oil (HPOO). AIM: The aim of this review was to systematically access and meta-analyse the effects of HPOO on risk factors of the cardiovascular system and thusly to evaluate its use as a nutraceutical in prevention. DATA SYNTHESIS: Medline/PubMed, EMBase, the Cochrane Library, CAMbase and CAM-QUEST were searched through July 2013. Randomized controlled trials (RCTs) comparing high vs. low (resp. non) phenolic olive oils in either healthy participants or patients with cardiovascular diseases were included. For study appraisal the Cochrane Collaboration's risk of bias tool was used. Main outcomes were blood pressure, serum lipoproteins and oxidation markers. Standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated and analysed by the generic inverse variance methods using a random effects model. Eight cross over RCTs comparing ingestion (21-90 d) of high vs. low (resp. non) phenolic olive oils with a total of 355 subjects were included. RESULTS: There were medium effects for lowering systolic blood pressure (n = 69; SMD -0.52; CI -0.77/-0.27; p < 0.01) and small effects for lowering oxLDL (n = 300; SMD -0.25; CI [-0.50/0.00]; p = 0.05). No effects were found for diastolic blood pressure (n = 69; SMD -0.20; CI -1.01/0.62; p = 0.64); malondialdehyde (n = 71; SMD -0.02; CI [-0.20/0.15]; p = 0.79), total cholesterol (n = 400; SMD -0.05; CI [-0.16/0.05]; p = 0.33); HDL (n = 400; SMD -0.03; CI [-0.14/0.08]; p = 0.62); LDL (n = 400; SMD -0.03; CI [-0.15/0.09]; p = 0.61); and triglycerides (n = 360; SMD 0.02; CI [-0.22/0.25]; p = 0.90). LIMITATIONS: The small number of studies/participants limits this review. CONCLUSIONS: HPOO provides small beneficial effects on systolic blood pressure and serum oxidative status (oxLDL). HPOO should be considered as a nutraceutical in cardiovascular prevention.

Systematic review of complementary and alternative medicine treatments in inflammatory bowel diseases.

OBJECTIVE: We performed a systematic review for Complementary and Alternative Medicine [CAM] as defined by the National Institute of Health in Inflammatory Bowel Disease [IBD], ie Crohn's disease [CD] and ulcerative colitis [UC], with the exception of dietary and nutritional supplements, and manipulative therapies. METHODS: A computerized search of databases [Cochrane Library, Pubmed/Medline, PsychINFO, and Scopus] through March 2014 was performed. We screened the reference sections of original studies and systematic reviews in English language for CAM in IBD, CD and UC. Randomized controlled trials [RCT] and controlled trials [CT] were referred and assessed using the Cochrane risk of bias tool. RESULTS: A total of: 26 RCT and 3 CT for herbal medicine, eg aloe-vera gel, andrographis paniculata, artemisia absinthium, barley foodstuff, boswellia serrata, cannabis, curcumin, evening primrose oil, Myrrhinil intest®, plantago ovata, silymarin, sophora, tormentil, wheatgrass-juice and wormwood; 1 RCT for trichuris suis ovata; 7 RCT for mind/body interventions such as lifestyle modification, hypnotherapy, relaxation training and mindfulness; and 2 RCT in acupuncture; were found. Risk of bias was quite heterogeneous. Best evidence was found for herbal therapy, ie plantago ovata and curcumin in UC maintenance therapy, wormwood in CD, mind/body therapy and self-intervention in UC, and acupuncture in UC and CD. CONCLUSIONS: Complementary and alternative therapies might be effective for the treatment of inflammatory bowel diseases; however, given the low number of trials and the heterogeneous methodological quality of trials, further in-depth research is necessary.

Responsiveness of stem-like human glioma cells to all-trans retinoic acid and requirement of retinoic acid receptor isotypes α, ß and γ.

Retinoic acid (RA) is required for development and homeostasis of the normal mammalian brain and may play a role in the initiation and progression of malignant brain tumors, such as the glioblastoma multiforme (GBM) and the gliosarcoma (Gsarc). The subpopulation of stem-like glioma cells (SLGCs) was shown to resist standard glioma radio-/chemotherapy and to propagate tumor regrowth. We used phenotypically distinct, self-renewing SLGC lines from six human GBMs, two Gsarcs, and two subcloned SLGC derivatives in order to investigate their responsiveness to all-trans retinoic acid (atRA) and to identify the RA-receptor (RAR) isotypes involved. In general, atRA exerted a pro-proliferative and pro-survival effect on SLGCs, though the efficacy was distinct. By means of RAR isotype-selective retinoids we disclosed that these effects were mediated by RARα and RARγ, except for one SLGC line, in which the pro-proliferative signal was induced by the RARß-selective retinoid. Only one GBM-derived cell line (T1338) and a subpopulation of another (T1389) displayed neural differentiation in response to atRA. Differentiation of T1338 was induced by RARα and RARγ isotype-selective retinoids, associated with down-regulation of Sox2, and the failure to induce orthotopic tumors in the brains of SCID mice. The differential responsiveness of the SLGC lines appeared unrelated to the expression of RARß, as (i) atRA augmented RAR isotype mRNA expression and particularly rarß mRNA in all SLGC lines, (ii) rarß promoter hypomethylation in the SLGC lines was not related to differentiation and (iii) the induction of T1338 differentiation was by RARα- and RARγ-selective ligands.

EUS-guided FNA cytology of pancreatic neuroendocrine tumour (PanNET): a retrospective study of 132 cases over an 18-year period in a single institution.

OBJECTIVE: To determine the diagnostic accuracy and pitfalls of endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) cytology of pancreatic neuroendocrine tumour (PanNET). METHODS: A search of our laboratory information system was performed from July 1992 to June 2010 to identify all FNA cytology and corresponding surgical specimens in which the diagnosis of PanNET was rendered or considered. RESULTS: One hundred and thirty-two cases diagnosed by EUS-guided FNA were collected. Histological correlation was available for 77 (58%) of FNAs; 55 patients may have been treated elsewhere or had no surgery because of advanced disease or co-morbidity. Among 56 cases diagnosed as PanNET on FNA, 54 (96%) were confirmed histologically; the remaining two were poorly differentiated adenocarcinoma with focal neuroendocrine features in one case and no tumour was found in the other. Follow-up histology of nine patients diagnosed as suspicious for PanNET on FNA showed four PanNETs, two pancreatic ductal adenocarcinomas (PDA), one solid pseudopapillary tumour (SPT) and two cases of chronic pancreatitis. Nine cases rendered by FNA as atypical (n = 3), no atypical cells identified (n = 4) or unsatisfactory (n = 2) were PanNETs on histology. Lastly, three cases of oncocytic variant of PanNET were misdiagnosed on FNA as either adenocarcinoma (n = 2) or as suspicious for carcinoma (n = 1). CONCLUSIONS: Overall, 54 of the 70 histologically confirmed PanNET cases (77%) were correctly diagnosed by preoperative FNA as PanNET. FNA cases designated as no atypical cells identified and unsatisfactory (7/132, 5%) were attributable to sampling error. Diagnostic pitfalls in our study mainly included PDA, SPT and chronic pancreatitis.