Comparative study on registration application of proprietary Chinese medicine in the Guangdong-Hong Kong-Macau Greater Bay Area of China.

Background: Proprietary Chinese medicine (PCM) is widely used in the Guangdong-Hong Kong-Macau Greater Bay Area (GBA) of China. However, the regulatory frameworks and procedures for PCM registration in the region are not well-established, and there are differences among the three jurisdictions. The study is aimed to compare the legal basis, regulatory guidelines, application requirements, and evaluation criteria in each jurisdiction. Methods: We conducted a comprehensive review of the registration application processes for PCMs in the Chinese mainland, Hong Kong, and Macau based on publicly available information from respective regulators. Results: The study found that the registration application process in the GBA was complex and time-consuming, with differences in requirements and procedures among the three jurisdictions. The study also identified several challenges faced by PCM manufacturers, such as the lack of harmonisation of regulatory requirements and procedures and the requirement of package inserts and labelling for PCM products. The study proposed recommendations for improving the registration process and promoting the development of the PCM industry in the GBA. Conclusion: This study provides a comprehensive understanding of the PCM product license application procedures and requirements in the GBA, coupled with discernment of their similarities and disparities, equips applicants with the knowledge to formulate an appropriate strategy for obtaining product approval. Exploring potential methods for harmonising the regulatory process stands to benefit manufacturers, regulators, and patients by improving efficiency and curtailing costs.

Health technology assessment in traditional and complementary medicine: a scoping review of international activity and examples of acupuncture.

BACKGROUND: Traditional therapies are crucial in maintaining and improving human well-being. China's healthcare policymakers are attempting to use health technology assessment (HTA) as a decision-making supportive tool. The value assessment framework for Chinese patent medicine (CPM) has been developed and is being adopted and validated widely by research institutions. Subsequently, the healthcare decision-makers particularly hanker for the value framework of traditional non-pharmacological therapies. METHODS: To construct a practical value framework for traditional non-pharmacological therapies, a scoping review methodology was adopted to identify the evaluation domains and obstacles. A search, screening, and analysis process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Evidence was retrieved from scientific databases and HTA agencies' websites. RESULTS: The search strategy identified 5 guidelines records and 17 acupuncture HTA reports. By synthesizing the valuable reports of CPM and acupuncture evaluation in representative countries, this study found that Mainland China was promoting the comprehensive value assessment of CPM, whereas the United Kingdom, Singapore, Canada, the United States, and Malaysia had carried out the HTA evaluation of acupuncture for various conditions among which chronic pain was the most common. UK and Singapore applied the HTA results to support acupuncture reimbursement decisions. Three domains, including safety, effectiveness, and economy, were commonly adopted. The identified biggest challenge of evaluating traditional non-pharmacological therapies is the scarce high-quality clinical evidence. CONCLUSIONS: This study identified value domains and issues of traditional therapies, and pointed out future research implications, to promote the development value framework of traditional therapies.

Perception and Use of Herbal Medicine in General Practice Patients: A Cross-Sectional Study in Saudi Arabia.

BACKGROUND: In Saudi Arabia, herbal medicine is an essential component of traditional health practices, reflecting a deep cultural appreciation for natural remedies. Despite widespread use, comprehensive data on perceptions and utilization among general practice patients are scarce. This study aims to elucidate the patterns of herbal medicine use, associated beliefs, and communication with healthcare professionals in this context. METHODS: A cross-sectional survey was conducted using an online questionnaire distributed through social media and professional networks, targeting adult residents of Saudi Arabia. The survey encompassed questions on demographic characteristics, use of herbal medicine, reasons for use, sources of herbal products, perceptions of efficacy and safety, and discussions with healthcare professionals about herbal medicine usage. RESULTS: The survey was completed by 1,184 participants, with 736 (62%) reporting the use of herbal medicines in the past 12 months. Among these users, the age group 30-39 was most represented (328/1,184, 27.8%), while participants over 60 were the least (66/1,184, 5.6%). Herbal medicines were primarily used for general wellness (332/736, 45%) and treatment of specific ailments (221/736, 30%). The majority obtained their herbal medicines from pharmacies (427/736, 58%), and 294 (40% of users) used them as alternatives to prescribed medications. Only 259 (35% of herbal medicine users) had discussed their usage with healthcare professionals. Most users believed in the safety (515/736, 70%) and effectiveness (478/736, 65%) of herbal remedies, with a significant portion (626/736, 85%) advocating for more scientific research. CONCLUSION: This study reveals a significant engagement with and positive perception of herbal medicine among general practice patients in Saudi Arabia, alongside a notable gap in communication between patients and healthcare providers. The findings highlight the need for integrating discussions on herbal medicine into patient care, encouraging evidence-based, safe use through better-informed healthcare practices.

Effects of a therapeutic lifestyle modification intervention on cardiometabolic health, sexual functioning and health-related quality of life in perimenopausal Chinese women: protocol for a randomised controlled trial.

INTRODUCTION: Perimenopause is a critical transitional period in reproductive ageing. A set of physiological and psychological changes can affect perimenopausal women's quality of life and further threaten their older adult health conditions. In China, less than one-third of midlife women with menopausal symptoms have actively sought professional healthcare. Regarding the public health significance of comprehensive menopause management, the current study aims to investigate the effects of a therapeutic lifestyle modification (TLM) intervention on cardiometabolic health, sexual functioning and health-related quality of life among perimenopausal Chinese women. METHOD AND ANALYSIS: A randomised controlled trial with two parallel arms will be conducted at the gynaecology outpatient department of Yunnan Provincial Hospital of Traditional Chinese Medicine in China. 94 eligible perimenopausal women aged between 40 and 55 years will be recruited for the study. The TLM intervention consists of four elements: menopause-related health education, dietary guidance, pelvic floor muscle training and Bafa Wubu Tai Chi exercise. Participants will be randomly assigned (1:1) to receive either the 12-week TLM intervention or routine care via stratified blocked randomisation. The primary outcome is quality of life; secondary outcomes of interest include sexual functioning and cardiometabolic health. The outcome measures will be assessed at baseline and post-intervention. To explore the effects of the intervention, linear mixed models will be applied to test the changes between the two groups over time in each outcome based on an intention-to-treat analysis. ETHICS AND DISSEMINATION: The Research Ethics Review Committee of Chulalongkorn University (COA No 178/66) and the Medical Ethics Committee of Yunnan Provincial Hospital of Traditional Chinese Medicine (IRB-AF-027-2022/02-02) approved the study protocol. Written informed consent will be obtained from all participants. Results will be published in peer-reviewed journals and disseminated through conferences. TRIAL REGISTRATION NUMBER: ChiCTR2300070648.

The clinical effect of an electric massage chair on chemotherapy-induced nausea and vomiting in cancer patients: randomized phase II cross-over trial.

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) is a common adverse events in cancer patients and can negatively affect their quality of life (QoL). This study aimed to evaluate the clinical efficacy of an electric massage chair (EMC) for the treatment of CINV. METHODS: A randomized phase II cross-over trial was conducted on solid cancer patients who received moderate (MEC) to high emetogenic chemotherapy (HEC). The participants were randomly assigned to receive their first chemotherapy either on a standard bed (Group A) or in an EMC (Group B) during the infusion. The patients were then crossed over to the next cycle. CINV and QoL questionnaires were collected from the participants. RESULTS: A total of 59 patients completed the trial protocol and were included in the analysis, with 29 and 30 patients in Groups A and B, respectively. The mean INVR (Index of Nausea, Vomiting, and Retching) score in the 2nd day of the first cycle was higher in Group B (3.63 ± 5.35) than Group A (2.76 ± 4.78), but the difference was not statistically significant (p = 0.5367). The complete response rate showed little difference between the groups. Among the high-emetic risk subgroups, patients who received HEC (p = 0.04595), younger patients (p = 0.0108), and non-colorectal cancer patients (p = 0.0495) presented significantly lower CINV scores when EMC was applied. CONCLUSION: Overall, there was no significant difference in INVR scores between standard care and EMC. Applying EMC at the first chemotherapy infusion may help preserve QoL and reduce CINV in high-risk patients. TRIAL REGISTRATION: KCT0008200, 17/02/2023, Retrospectively registered.

Effects of Prolonged Medical Fasting during an Inpatient, Multimodal, Nature-Based Treatment on Pain, Physical Function, and Psychometric Parameters in Patients with Fibromyalgia: An Observational Study.

Fibromyalgia syndrome (FMS) is a common chronic pain disorder and often occurs as a concomitant disease in rheumatological diseases. Managing FMS takes a complex approach and often involves various non-pharmacological therapies. Fasting interventions have not been in the focus of research until recently, but preliminary data have shown effects on short- and medium-term pain as well as on physical and psychosomatic outcomes in different chronic pain disorders. This single-arm observational study investigated the effects of prolonged fasting (3-12 days, <600 kcal/d) embedded in a multimodal treatment setting on inpatients with FMS. Patients who were treated at the Department of Internal Medicine and Nature-Based Therapies of the Immanuel Hospital Berlin, Germany, between 02/2018 and 12/2020 answered questionnaires at hospital admission (V0) and discharge (V1), and then again three (V2), six (V3), and 12 (V4) months later. Selected routine blood and anthropometric parameters were also assessed during the inpatient stay. A total of 176 patients with FMS were included in the study. The Fibromyalgia Impact Questionnaire (FIQ) total score dropped by 13.7 ± 13.9 (p < 0.001) by V1, suggesting an improvement in subjective disease impact. Pain (NRS: reduction by 1.1 ± 2.5 in V1, p < 0.001) and quality of life (WHO-5: +4.9 ± 12.3 in V1, p < 0.001) improved, with a sustainable effect across follow-up visits. In contrast, mindfulness (MAAS: +0.3 ± 0.7 in V1, p < 0.001), anxiety (HADS-A: reduction by 2.9 ± 3.5 in V1, p < 0.0001), and depression (HADS-D: reduction by 2.7 ± 3.0 in V1, p < 0.0001) improved during inpatient treatment, without longer-lasting effects thereafter. During the study period, no serious adverse events were reported. The results suggest that patients with FMS can profit from a prolonged therapeutic fasting intervention integrated into a complex multimodal inpatient treatment in terms of quality of life, pain, and disease-specific functional parameters. ClinicalTrials.gov Identifier: NCT03785197.

Asian herbal medicine for atopic dermatitis: a systematic review.

Asian herbal medicines have been known for decades, and some have been used to treat atopic dermatitis (AD). This chronic and persistent inflammatory skin condition causes severe morbidity and negatively impacts the quality of life. In numerous trials, traditional Chinese medicines have demonstrated clinical efficacy for AD. However, there is no well-documented summary of the wide variety of Asian herbal medicines used in treating AD. We aimed to systematically summarize the use of Asian herbal medicine in AD. An English-language literature search was performed in three electronic medical databases: PubMed, Cochrane Library, and EBSCOhost using keywords [("atopic dermatitis" OR "atopic eczema") AND ("traditional" OR "herbal")] and limited to references published between January 2015 and December 2022. The literature included newborns, infants, children, adolescents, and adults. The review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension to determine the main criteria. The content and inclusiveness of the search were filtered using relevant terms (MeSH/Emtree), keywords, titles, and abstracts. Thirteen articles (12 randomized clinical trial + 1 clinical trial) reported a variety of herbal medicine compounds to treat AD with various efficacy. Most studies reported significant improvement when comparing the herbal medicine with a placebo, but only 1 study reported substantial improvement of SCORAD compared to corticosteroids. Asian herbal medicines have been studied and may be used as an alternative treatment in treating AD with fewer adverse effects. However, its role did not change the position of standard treatment in treating atopic dermatitis.

Digital roots: harnessing digital platforms in advancing traditional and complementary medicine for cancer care in Sub-Saharan Africa.

The rise in cancer rates in Sub-Saharan Africa (SSA), combined with limited access to Western pharmaceuticals, has sparked growing adoption of traditional and complementary medicine (T&CM) for cancer treatment in the region. However, many challenges exist, including the lack of reliable evidence-based research on these products, scarcity of standardized documentation as part of cancer registries, limited physician expertise, and negative effects on mortality. Nonetheless, herbal medicines also present opportunities for further research, development, and stakeholder education, potentially benefiting the regional healthcare systems in SSA countries and global health as whole. Recent trends highlight the willingness of patients to use mobile-based applications that provide accurate information on herbal therapeutics, reflecting the increasing adoption of internet and smart/mobile phone services in SSA. To maximize the potential benefits of traditional and complementary medicine, it is necessary to bridge the trust gap between the public, local practitioners, and Western healthcare providers. Sustained funding and policy support are needed to complement these initiatives. Our preliminary survey hopes to inspire the community and policymakers to embrace innovative solutions, fostering a forward-looking approach to cancer care in SSA.

Efficacy of electro-acupuncture versus sham acupuncture for diabetic peripheral neuropathy: study protocol for a three-armed randomised controlled trial.

INTRODUCTION: Specific treatment for diabetic peripheral neuropathy (DPN) is still lacking, and acupuncture may relieve the symptoms. We intend to investigate the efficacy and safety of electro-acupuncture (EA) in alleviating symptoms associated with DPN in diabetes. METHODS AND ANALYSIS: This multicentre, three-armed, participant- and assessor-blind, randomised, sham-controlled trial will recruit 240 eligible participants from four hospitals in China and will randomly assign (1:1:1) them to EA, sham acupuncture (SA) or usual care (UC) group. Participants in the EA and SA groups willl receive either 24-session EA or SA treatment over 8 weeks, followed by an 8-week follow-up period, while participants in the UC group will be followed up for 16 weeks. The primary outcome of this trial is the change in DPN symptoms from baseline to week 8, as rated by using the Total Symptom Score. The scale assesses four symptoms: pain, burning, paraesthesia and numbness, by evaluating the frequency and severity of each. All results will be analysed with the intention-to-treat population. ETHICS AND DISSEMINATION: The protocol has been approved by the Ethics Committee of the Beijing University of Chinese Medicine (Identifier: 2022BZYLL0509). Every participant will be informed of detailed information about the study before signing informed consent. The results of this trial will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ChiCTR2200061408.

Effectiveness of naturopathy for pregnancy in women with diminished ovarian reserve: feasibility randomized controlled trial.

RESEARCH QUESTION: Is conducting a randomized control trial (RCT) to assess the effectiveness of whole-system naturopathy in improving pregnancy rates among women with diminished ovarian reserve (DOR) feasible? DESIGN: A two-arm, parallel group, assessor-blinded feasibility RCT was conducted. Women with DOR, trying to conceive naturally or by ART, were randomly assigned to naturopathy plus usual care, or usual care alone for 16 weeks. Primary outcomes were feasibility (recruitment, adherence, retention rates), acceptability and safety. Secondary outcomes included ongoing pregnancy rates, live birth rates and health-related outcomes (mental health, quality of life, diet, exercise, sleep and weight). Statistical significance of the differences between the two groups (P-values) were exploratory. RESULTS: One hundred and fifteen women completed the screening survey between March and November 2022. Of these, 66 women were assessed for eligibility and 41 (62%) consented. Recruitment resulted in seven enrolments each month. All 41 participants (100%) adhered to the intervention, 38 (93%) completed end-point questionnaires, 32 (78%) found study participation to be acceptable and 18 out of 21 (86%) from the intervention group would recommend a naturopathic intervention to other women with DOR. The naturopathic treatment was associated with only mild and temporary adverse events. No between-group differences were observed for pregnancy and live birth rates. CONCLUSION: The evaluation of whole-system naturopathy through a RCT was feasible and the treatment was acceptable and well tolerated according to women with DOR. Outcomes from this study will help inform sample size calculations powered for fertility outcomes for future RCTs on this topic.

Use of complementary and alternative medicine in vitiligo: a cross-sectional survey.

Vitiligo is characterized by skin depigmentation, which can lead to profound psychological effects and decreased quality of life, especially for those with skin of color. Individuals with vitiligo may utilize complementary and alternative medicine (CAM) due to limited treatment options with varying efficacy.An anonymous, multiple-choice, cross-sectional questionnaire was distributed to participants with vitiligo in the United States through online forums. Data on disease characteristics, use of prescription medications, use of topical therapies, supplements, and diets, and perceptions of CAM were collected.In total, 625 respondents completed the survey. Overall, 32.5% of participants (203/625) have tried CAM. Commonly reported CAM include supplements of vitamin D (57.7%, 116/203), vitamin B12 (46.3%, 93/203), vitamin C (27.4%, 55/203), topical Nigella sativa oil (26.4%, 53/203), oral omega-3 fatty acids (24.9%, 50/203), folic acid (22.9%, 46/203), and vitamin E (22.9%, 46/203). Frequently cited reasons for CAM use include desire to try "new" (40.4%, 82/203) or "more natural" (26.6%, 54/203) therapies, "frustration with conventional medicine" (24.6%, 50/203), and fear of "adverse side effects of conventional medicine" (23.6%, 48/203). Non-White participants were more likely than their White counterparts to report CAM use and have more positive perceptions of CAM therapies. Less than half (43.3%, 88/203) of CAM users reported that they disclosed their use of CAM with their physician.Dermatologists should be mindful of CAM and ask patients about their use. Further investigation of the role of CAM as adjuvant therapy for vitiligo is warranted to better advise patients.

The relationship between medication adherence and complementary medicine use in epilepsy patients.

OBJECTIVE: The aim of this research is to examine the usage of Complementary and Integrated Medicine (CIM) in individuals with epilepsy and the impact of CIM usage on medication adherence. MATERIALS AND METHODS: This descriptive and cross-sectional study was conducted in a university hospital in northern Turkey between July and October 2023, involving 101 individuals with epilepsy (PWE). Descriptive information forms and the Morisky Medication Adherence Scale-4 (MMS-4) were used as data collection tools. Descriptive statistics, t-tests, ANOVA, and post-hoc LSD analyses were employed for data evaluation. RESULTS: The participants consisted of 65.3 % males, 25.7 % were not working due to epilepsy, and 61.4 % with generalized epilepsy. The average MMS-4 score was found to be 3.08 ± 0.96. MMS-4 scores showed significant differences based on epilepsy type (F = 3.998, p = 0.021; η2 = 0.07). 76.2 % (n = 21) of the participants who used at least one CIM technique preferred "having a religious person read a prayer." CONCLUSION: Medication adherence in PWE was at a moderate level. Individuals with focal and secondary generalized epilepsy showed better medication adherence compared to those with generalized types. Of those participant who used at least one CIM technique to improve their general health or control seizures, the most common was "having a religious person read a prayer."

A complementary medicine student-led telehealth clinic: evaluating learning & teaching perceptions.

OBJECTIVES: This study evaluates a multi-centered complementary medicine (CM) student-led telehealth clinic during the COVID-19 pandemic. Likert and qualitative responses explore student and educator learning and teaching perceptions of the implementation of a successful telehealth clinic. RESULTS: 51 students and 17 educators completed the survey. Respondents agreed that support from educators (90%) and orientation (70%) assisted effective performance. Over 90% (93%) of all respondents supported telehealth in student-led clinics, whilst 87% encountered barriers such as technical and infrastructure issues. Respondents agreed that telehealth practice skills improved in case history taking (90%), treatment (90%) and building patient rapport (60%). Respondents (61%) disagreed that physical examination was effectively performed, and 100% of respondents agreed telehealth was a valuable learning experience. This study is the first to explore student and educator perceptions of telehealth in an Australian University multi-centered CM student-led clinic. To be successful in an educational environment, students and educators require digital literacy and adequate telehealth practice infrastructure. Whilst some in-person practice skills are transferable to telehealth, educators need to adapt curriculum to ensure counselling and physical examination skills are specifically taught for virtual consultations. Telehealth in clinical practice requires continued investigation and educational development.

Effect of Hita Tenryo Water™, a natural mineral water, on allergic symptoms induced by cedar in mice.

The number of patients with allergies to pollen and food is increasing worldwide. In Japan, the prevalence of cedar pollinosis, a type I allergy, is nearly 30% and accounts of hay fever are rising. A potential natural remedy for these allergic diseases may be Hita Tenryo Water™ (referred to simply as Hita Tenryo water), water that is pumped from deep underground in the Hita region of Oita, Japan, which has been the subject of various research reports. Here, we investigated the potential of using Hita Tenryo water to suppress the onset of cedar pollinosis in a mouse model and explored the immunological mechanism of the suppression. Test model mice were given Hita Tenryo water ad libitum to drink and received intraperitoneal administration of (i) tap water (Hw1), (ii) 25% Hita Tenryo water (Hw2) or (iii) 100% Hita Tenryo (Hw3). There were no significant differences in body weight change, feed intake, or water intake among the groups during the experimental period. We examined nose rubbing and sneezing as allergic symptoms. The frequency of rubbing and sneezing tended to decrease in the Hw1 and Hw2 group, and significantly decreased in the Hw3 group compared to control. Total IgE levels in serum were also significantly reduced in Hita Tenryo water intraperitoneal administration groups. In vitro examination of the rate of release of ß-hexosaminidase from BL-2H3 cells showed that there were no significantly differences between Hita Tenryo water-treated and control cells. In addition, measurement of Th2-related cytokine levels in concanavalin A-stimulated peripheral blood mononuclear cells revealed a significant decrease in IL-4, IL-6, and IL-10 levels in medium (p < 0.01). In contrast, production of IFN-γ significantly increased (p < 0.01). These results indicate that Hita Tenryo water may alleviate and/or suppress allergic symptoms.

Efficacy and safety of traditional Chinese manual therapy (Tuina) in patients with non-specific chronic low back pain: a study protocol for a randomised controlled trial.

INTRODUCTION: Non-pharmacological interventions play a crucial role in the management of non-specific chronic low back pain (NSCLBP). One prime example is Tuina, a traditional Chinese manual therapy that incorporates pressing, kneading and rubbing techniques to alleviate physical discomfort and enhance overall well-being. It serves as a widely used technique in China and other East Asian countries. However, the effectiveness and safety of Tuina for managing NSCLBP have not been substantiated through rigorous clinical research. We sought to carry out a randomised controlled trial with an open-label design, blinded assessors and parallel arms to assess the effectiveness and safety of Tuina as a treatment for NSCLBP. The trial aims to provide high-quality evidence regarding the efficacy and safety of Tuina in improving outcomes for patients with NSCLBP. METHODS AND ANALYSIS: A total of 150 patients aged 18-60 years with NSCLBP will be recruited. Participants will be randomly assigned to one of the two groups. Both groups will receive standard health education. In addition, the treatment group will receive Tuina therapy, while the control group will participate in core stability exercises. Each group will undergo a total of 18 interventions over 6 weeks, with the interventions administered three times per week. The primary outcome measure is the patient's pain intensity, assessed using the Numerical Rating Scale, at week 6 following randomisation. Secondary outcomes encompass disability (measured by the Roland-Morris Disability Questionnaire), quality of life (assessed using the EuroQoL-5 dimensions questionnaire), adverse emotions (evaluated with the Pain Catastrophizing Scale, Tampa Scale of Kinesiophobia and Depression Anxiety Stress Scale), biomechanical outcomes, socioeconomic indicators (medication use, healthcare utilisation and absenteeism), patient satisfaction, treatment adherence and other relevant factors.The statistical analysis will follow the intention-to-treat principle. Two-way repeated measures analysis of variance will be used to compare the clinical data across different time points within both groups. ETHICS AND DISSEMINATION: The study protocol has received approval from the Ethics Committee of Shuguang Hospital, Shanghai University of Traditional Chinese Medicine (2023-1366-133-01). All study participants will be required to give written informed consent. The findings of the study will be submitted to a peer-reviewed journal for publication and presented at scientific conferences. Additionally, the participants will receive copies of the results. TRIAL REGISTRATION NUMBER: ChiCTR2300076257.

Use and acceptance of traditional, complementary and integrative medicine in Germany-an online representative cross-sectional study.

Background: Older representative surveys show that Traditional, Complementary and Integrative Medicine (TCIM) is used by about 60% of the German population. However, no data exists for the current nationwide situation. The main aim of this cross-sectional study is to investigate the current use and acceptance of TCIM in Germany. Methods: This study is based on a representative sample of the German population aged 18-75 years. Participants were asked about the use and acceptance of TCIM. The survey was conducted online using Computer Assisted Web Interview (CAWI) in 2022 by three renowned German market research institutes on behalf of and in close coordination with the working group. The data set was analyzed descriptively and inferentially. Results: In total, 4,065 participants (52% female, 48% male, 0.4% diverse) responded completely (response rate: 21.5%). Among participants, 70% stated that they had used TCIM at some point in their lives, with 32% doing so in the last 12 months and 18% currently. The most common reason given (17%) was musculoskeletal pain. For their own health, 39% stated that TCIM is important. Traditional European Medicine was rated as very/mainly effective by 27% of participants and as partly effective by 44% (conventional medicine: 69% very/mainly effective, 19% partly effective). As a complementary treatment strategy to conventional medicine, 35% considered TCIM to be optimal ("Complementary Medicine"), 33% in combination with conventional medicine ("Integrative Medicine") and 5% without conventional medicine ("Alternative Medicine"). The majority of the participants were in favor of more research on TCIM and stated that the costs of TCIM services should be covered by health insurance companies (71% and 69%, respectively). Conclusion: These results from a representative online-population suggest that the use of TCIM in Germany remains at a high level. The nationwide relevance of TCIM should be given greater consideration in German health care policy making. TCIM should be systematically investigated using appropriate study designs and methods including high quality randomized clinical trials to investigate their effectiveness, efficacy, therapeutic safety and costs in the future.

Efficacy of acupuncture (Jin's three-needle) on motor symptoms and anxiety in patients with Parkinson's disease: protocol for a multicentre, randomised, assessor-blinded clinical trial.

INTRODUCTION: Parkinson's disease (PD) has a significant impact on a substantial number of individuals in China. Notably, 31% of patients with PD also grapple with the additional burden of anxiety. This dual challenge of managing both PD and anxiety underscores the complexity of the condition and the diverse range of symptoms patients may experience. Considering the circumstances, the cost and potential drawbacks associated with traditional antiparkinsonian drugs become increasingly relevant. Acupuncture emerges as a significant non-pharmacological adjunct therapy. Offering a potentially safer and more cost-effective option, acupuncture addresses the pressing need for holistic and complementary treatments that may alleviate both the motor symptoms of PD and the accompanying anxiety. METHODS AND ANALYSIS: This is a multicentre, randomised controlled and assessor-blind trial. A total of 210 eligible patients with PD will be randomly assigned (1:1) to Jin's three-needle (JTN) acupuncture group or waitlist (WL) group. Patients in the JTN group will receive acupuncture therapy three times per week for 4 weeks. Patients in the WL group will maintain their original dosage of antiparkinsonian drugs and receive acupuncture therapy after the observation period. The primary outcome measure will be the Unified Parkinson's Disease Rating Scale score. The secondary outcome measures will be the scores of the Hoehn-Yahr Rating Scale, Unified Dyskinesia Rating Scale, Non-Motor Symptoms Scale, 39-item Parkinson's Disease Questionnaire, Parkinson Anxiety Scale, Hamilton Anxiety Scale, Hamilton Depression Scale, Zarit burden interview and the level of cortisol and adrenocorticotropic hormone. The evaluation will be executed at baseline, the end of the treatment and a follow-up period. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine (K[2023]014). All patients have to provide written, informed consent. The study will be disseminated through presentations in peer-reviewed international journals and at national and international conferences. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry; ChiCTR2300074675.

Course of Vitamin D Levels in Newly Diagnosed Non-Metastatic Breast Cancer Patients over One Year with Quarterly Controls and Substitution.

(1) Background: Vitamin D levels in patients remain inadequately understood, with research yielding inconsistent findings. Breast cancer patients, particularly due to oncological therapies, face an increased risk of osteopenia, which can be exacerbated by a vitamin D deficiency. (2) Methods: The prospective observational "BEGYN-1" study assessed serum 25(OH)D levels at baseline and quarterly thereafter. Clinical, pathological, nutritional, vitamin supplementation, and lifestyle data were recorded. (3) Results: Before treatment, 68.5% of patients were vitamin D deficient (<30 ng/mL), with 4.6% experiencing severe deficiency (<10 ng/mL). The median baseline 25(OH)D levels were 24 ng/mL (range: 4.8 to 64.7 ng/mL). Throughout the study, the median vitamin D levels increased to 48 ng/mL (range: 22.0 to 76.7 ng/mL). Before diagnosis, 16.7% received vitamin D substitution, and 97.8% received vitamin D substitution throughout the year with a median weekly dose of 20,000 IU. It took at least three quarterly assessments for 95% of patients to reach the normal range. A multiple GEE analysis identified associations between 25(OH)D levels and supplementation, season, age, VLDL, magnesium levels, and endocrine therapy. (4) Conclusions: Physicians should monitor 25(OH)D levels before, during, and after oncological therapy to prevent vitamin D deficiency and to adjust substitution individually. While variables such as seasons, age, VLDL, magnesium, diet, and oncological interventions affect 25(OH)D levels, supplementation has the greatest impact.

A Case of Acupuncture Induced Pneumothorax.

With various forms of alternative medicinal practices gaining popularity, there is an increase in complications arising from these practices. Acupuncture, which originated in China, and now practiced worldwide as a form of traditional medicine, is generally considered safe; however, rare life-threatening complications can occur following its practice. Here we present the case of a 63-year-old male who presented to the emergency department with symptoms suggestive of pneumothorax. Upon further history, the patient disclosed that he had recently undergone acupuncture treatment for chronic elbow pain.

Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol.

INTRODUCTION: Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed 'prehabilitation') may mitigate these side effects and improve quality of life.During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that 'packaged' care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme. METHODS AND ANALYSIS: This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20-30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them. ETHICS AND DISSEMINATION: The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences. TRIAL REGISTRATION NUMBER: ACTRN12622000584730.