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This post-hoc analysis of the SABINA III study evaluated the association of short-acting β 2 -agonist (SABA) prescriptions and self-reported over-the-counter (OTC) SABA purchase in the previous 12 months with asthma-related outcomes using multivariable regression models in 4556 patients (mean age, 48.9 years). Of the 2810 patients prescribed ≥3 SABA canisters, 776 (27.6%) also purchased ≥1 SABA OTC. This subset of 776 patients reported the highest disease burden; 73.2% had ≥1 severe exacerbation and 55.7% had uncontrolled asthma. Asthma-related outcomes worsened with any SABA OTC purchase, regardless of SABA prescriptions; disease burden was the highest in patients with ≥3 SABA prescriptions and ≥1 SABA OTC purchase vs 1-2 SABA prescriptions only (86% lower odds of having at least partly controlled asthma and 124% increased incidence of severe asthma (both P < 0.001). These findings emphasize the need to implement policy changes to restrict SABA purchase without prescriptions and ensure access to affordable asthma care., (© 2024. The Author(s).)

Objectives: Despite the profound impact of menopausal symptoms on women, treatment utilization is low, and many seek alternative therapies. The REALISE study aimed to evaluate the treatment landscape - that is, pharmacological treatment, lifestyle changes (LC), and use of over-the-counter (OTC) products - for women from six high-income countries experiencing vasomotor symptoms (VMS) and receiving healthcare., Study Design: Analysis of a secondary dataset, the Adelphi Real World Disease Specific Programme™, a large, cross-sectional, point-in-time survey conducted in the United States and five European countries (February-October 2020). Physicians provided demographic, clinical, and treatment data; women were stratified by VMS severity (mild; moderate-severe) and presence of concomitant sleep/mood symptoms. Women completed forms on VMS severity, concomitant symptoms, LC, and OTC product use. Two subgroups were identified: VMS-only and VMS + sleep/mood., Main Outcome Measures: Prescription treatment, LC, and OTC product utilization., Results: Physicians (n = 233) provided data on 1767 women; 825 (46.7 %) completed a self-completion form. Physicians rated 60 % of women with moderate-severe VMS, of whom 709 (66.8 %) were currently prescribed pharmacological treatment; 27.1 % had never been prescribed. Hormone therapy was most frequently prescribed in the moderate-severe group (overall, 49.8 %; VMS-only, 57.4 %; VMS + sleep/mood, 47.3 %), followed by serotonergic antidepressants (15.7 %; 9.7 %; 17.6 %, respectively). Most women (78.3 %) with moderate-severe VMS adopted LC, and 57.6 % used at least one OTC product for VMS relief., Conclusions: Nearly a third of women with moderate-severe VMS had never received treatment despite access to healthcare. This, combined with the prevalent use of LC/OTC products, suggests an unmet need for new treatment options to manage VMS and concomitant sleep/mood symptoms., Competing Interests: Declaration of competing interest S.K. is an employee of University Hospitals Cleveland Medical Center and has received consulting fees or honoraria from: Astellas, Alloy, Bayer, Daré, Freya, Reunion Neuroscience, Materna Medical, Madorra, Ms. Medicine, Mithra, Palatin Technologies, Pfizer, Sprout, Strategic Science Technologies, and Vella; and stock options from Alloy. N.S., C.M., and S.S. are employees of Bayer AG, Germany. C.C. and C.J. are employees of Bayer Consumer Care, Switzerland. M.S. and M.H. are employees of Adelphi Real World, UK. L.H. is an employee of Bayer US. V.B. was an employee of Bayer, UK at the time of the study. R.E.N. has past financial relationships (lecturer, member of advisory boards, and/or consultant) with Boehringer Ingelheim, Eli Lilly, Endoceutics, MSD, Palatin Technologies, Pfizer, Procter & Gamble, Teva Women's Health, and Zambon; has ongoing relationships with Abbott, Astellas, Bayer HealthCare, Besins Healthcare, Exeltis, Fidia, Gedeon Richter, HRA Pharma, Merck & Co, Novo Nordisk, Organon, Shionogi, Theramex, and Viatris; and serves as President-Elect of the International Menopause Society (IMS)., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Objectives: The phenomenon of self-medication is a noteworthy public health concern that is increasingly prevalent on a global level, particularly in developing nations. This study aims to explore the prevalence of self-medication of over-the-counter (OTC) medications among the general public in Jordan., Materials and Methods: This cross-sectional online survey study was conducted in Jordan between November and December 2022. An online questionnaire link was distributed to the study participants through social media platforms (Facebook, WhatsApp, and Instagram). The questionnaire tool for this study was adapted from a previously developed questionnaire by Tesfamariam et al. The questionnaire tool comprised four sections that examined participants' demographic characteristics, knowledge of OTC self-medication, attitudes toward OTC self-medication, and associated practices. Binary logistic regression analysis was used to identify predictors of OTC self-medication practice., Results: A total of 1,218 individuals participated in this study. More than half of the study participants (56.9%) confirmed that they were currently using or had in the past year used medication(s) not prescribed by a healthcare specialist. Participants' agreement level on statements that reflected a positive attitude toward self-medication practice ranged between 13.1 and 33.0%. The statement most commonly agreed with was that 'OTC medications are safe but I would seek a physician's advice before using them' (57.7%). Individuals aged 36-40 years and 51 years and over, those who were married or divorced, those who were employed, and those who had chronic diseases were more likely to practice self-medication compared to others ( p  < 0.05)., Conclusion: The current study findings suggest a significant lack of awareness among the general population in Jordan regarding the expected efficacy of OTC medications. A restricted level of agreement was observed among the participants concerning the behavior of self-medication., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Abuhamdah and Naser.)

Introduction: Non-prescription antibiotic dispensing is prevalent among community pharmacies in several low- and middle-income countries. We evaluated the impact of a multi-faceted intervention to address this challenge in urban community pharmacies in Indonesia., Methods: A pre-post quasi-experimental study was carried out in Semarang city from January to August 2022 to evaluate a 7-month long intervention comprising: (1) online educational sessions for pharmacists; (2) awareness campaign targeting customers; (3) peer visits; and (4) pharmacy branding and pharmacist certification. All community pharmacies were invited to take part with consenting pharmacies assigned to the participating group and all remaining pharmacies to the non-participating group. The primary outcome (rate of non-prescription antibiotic dispensing) was measured by standardised patients displaying symptoms of upper respiratory tract infection, urinary tract infection (UTI) and seeking care for diarrhoea in a child. χ 2 tests and multivariate random-effects logistic regression models were conducted. Thirty in-depth interviews were conducted with pharmacists, staff and owners as well as other relevant stakeholders to understand any persistent barriers to prescription-based dispensing of antibiotics., Findings: Eighty pharmacies participated in the study. Postintervention, non-prescription antibiotics were dispensed in 133/240 (55.4%) consultations in the participating group compared with 469/570 (82.3%) in the non-participating group (p value <0.001). The pre-post difference in the non-prescription antibiotic dispensing rate in the participating group was 20.9% (76.3%-55.4%) compared with 2.3% (84.6%-82.3%) in the non-participating group (p value <0.001).Non-prescription antibiotics were less likely to be dispensed in the participating group (OR=0.19 (95% CI 0.09 to 0.43)) and more likely to be dispensed for the UTI scenario (OR=3.29 (95% CI 1.56 to 6.94)). Barriers to prescription-based antibiotic dispensing included fear of losing customers, customer demand, and no supervising pharmacist present., Interpretation: Multifaceted interventions targeting community pharmacies can substantially reduce non-prescription antibiotic dispensing. Future studies to evaluate the implementation and sustainability of this intervention on a larger scale are needed., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Abstract: Allergic rhinitis (AR), commonly called hay fever, is primarily caused by the release of histamine after exposure to an allergen. This article reviews over-the-counter nasal spray options for the prevention and treatment of AR, including mechanisms of action, risks and benefits, and patient education., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Codeine was rescheduled in Australia to prescription only in February 2018. Initial studies reported an increase in population level paracetamol and ibuprofen sales following codeine upscheduling. However, to date no study has been able to investigate changes in non-opioid analgesic use at the individual patient level to determine if sales data reflect actual consumption patterns., Aim: To address this gap, we aimed to determine the impact of codeine rescheduling on non-opioid analgesic use in people who regularly used over-the-counter codeine, primarily for pain, prior to the rescheduling change., Method: We conducted a prospective cohort study with 260 participants who reported regular over-the-counter codeine consumption at cohort entry. Surveys were completed at baseline (November 2017, 3 months before rescheduling) and at 1 month (February 2018), 4 months (June 2018), and 12 months (February 2019), following rescheduling. The primary outcomes were mean daily doses of non-opioid analgesics, captured through a 7 day medication diary., Results: The mean daily paracetamol dose decreased from 1754.4 mg (95% CI 1300.5-2208.3) at baseline to 1023.8 mg (95% CI 808.5-1239.1) at the final time-point (+ 12 months) (p = .009). The mean daily ibuprofen dose decreased from 305.1mg (95% CI 217.9-392.4) at baseline to 161.2 mg (95% CI 98.5-224.0) 12 months after rescheduling (p = .03). No significant change in doses of other medications remained was found., Conclusion: In people who regularly consumed over-the-counter codeine, doses of non-opioid analgesics either reduced or remained stable following codeine rescheduling, suggesting concerns of medication substitution or overuse following the change were not realised., (© 2024. The Author(s).)

Objectives: Vasomotor symptoms induced by endocrine therapy are common in breast cancer survivors and a risk factor for therapy discontinuation and lower quality of life. The REALISE study evaluated the real-world treatment landscape in breast cancer survivors with vasomotor symptoms taking endocrine therapy, including pharmaceuticals, lifestyle changes, and over-the-counter products., Study Design: Secondary analysis of the Adelphi Vasomotor Disease Specific Programme™, a large cross-sectional point-in-time survey and chart review conducted in the US and five European countries (February-October 2020). Oncologists provided demographic, clinical, and treatment data for adult breast cancer survivors with induced vasomotor symptoms taking endocrine therapy (tamoxifen or aromatase inhibitors); patients voluntarily completed self-report surveys on their symptom severity, concomitant sleep and/or mood symptoms, lifestyle changes, and use of over-the-counter products., Main Outcome Measures: Patient characteristics; vasomotor symptom severity; use of pharmaceuticals, lifestyle changes, and over-the-counter products (from pre-defined lists); lines of treatment., Results: Overall, 77 oncologists reported data for 618 breast cancer survivors, of whom 183 (29.6 %) completed self-report forms. Physicians classified 420 (68.0 %) women as experiencing moderate-severe vasomotor symptoms, of whom 66.9 % were receiving treatment. In total, 15.2 % of all breast cancer survivors were prescribed systemic hormone therapy. Venlafaxine (24.7 %), citalopram (16.5 %), and paroxetine (13.6 %) were the most commonly prescribed nonhormonal medications. Lifestyle changes (77.8 %) and over-the-counter products (61.6 %) were common, especially in patients with concomitant sleep and/or mood symptoms., Conclusions: Despite contraindications, a relatively large proportion of treatment-seeking breast cancer survivors with vasomotor symptoms were prescribed systemic hormone therapy. This, combined with high patient-reported use of lifestyle changes and over-the-counter products, suggests a need for symptomatic relief and demand for new nonhormonal alternatives with established safety profiles in this population., Competing Interests: Declaration of competing interest S.K. is an employee of University Hospitals Cleveland Medical Center and has received consulting fees or honoraria from: Astellas, Alloy, Bayer, Daré, Freya, Reunion Neuroscience, Materna Medical, Madorra, Ms. Medicine, Palatin Technologies, Pfizer, Sprout, Strategic Science Technologies, and TherapeuticsMD; and stock options from Reunion Neuroscience, Alloy, and Materna Medical. N.S., C.M., and S.S. are employees of Bayer AG, Germany. C.C. and C.J. are employees of Bayer Consumer Care, Switzerland. M.S. and M.H. are employees of Adelphi Real World, UK. L.H. is an employee of Bayer US. V.B. was an employee of Bayer, UK at the time of the study. Rossella E. Nappi had past financial relationships (lecturer, member of advisory boards and/or consultant) with Boehringer Ingelheim, Ely Lilly, Endoceutics, Palatin Technologies, Pfizer Inc., Procter & Gamble Co, TEVA Women's Health Inc. and Zambon SpA. At present, she has on-going relationships with Abbott, Astellas, Bayer HealthCare AG, Besins Healthcare, Exeltis, Fidia, Gedeon Richter, HRA Pharma, Merck & Co, Novo Nordisk, Organon & Co, Shionogi Limited, Theramex, and Viatris., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Objectives: To analyze the methodology, evidence, recommendations, quality, and implementation of traditional Chinese patent medicine (CPM) guidelines., Methods: We retrieved clinical application guidelines of CPM published from 2019 to 2022. Independent screening and data extraction were performed by two evaluators. The basic information about the guidelines, including evidence and recommendations, were extracted and statistically analyzed. Quality and implementation were evaluated using the Implementation Evaluation Tool and Appraisal of Guidelines for Research & Evaluation (AGREE) II., Results: In total, 29 guidelines were analyzed, including 262 recommendations and 2308 references. All the CPM guidelines followed the principle of "evidence as a core, consensus as a supplement, and experience as a reference" and the methods provided by WHO Handbook. An average of 89 references were cited in each guideline and 8 in each recommendation. Randomized controlled trials and systematic reviews constituted 89 % and 0.9 %, respectively, of all references. Low or very low-quality evidence characterized 74.5 % and weak recommendations characterized 83.6 %. Of all recommendations, 13.7 % were based on expert consensus, and 9.5 % of strong recommendations were based on low or very low-quality evidence. The AGREE II scores for each domain were: scope and purpose (79.63 %) and editorial independence (79.27 %), followed by clarity of presentation (72.59 %), stakeholder involvement (69.99 %), rigor of development (53.97 %) and applicability (5.11 %). The implementation quality of most guidelines was either high (44.8 %) or moderate (55.2 %)., Conclusions: The results for CPM guidelines were impressive in terms of methodology, quality, and implementation. However, confidence in CPM recommendations was downgraded by low quality of evidence., Competing Interests: Declaration of Competing Interest All the members of this guideline have signed a conflict of interest statement, stating that there was no commercial, professional, or other interest related to this guideline's topic, nor was there any interest associated with the possible impact of the outcomes of this guideline., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: The Centers for Disease Control and Prevention (CDC) recommends oseltamivir phosphate for children <2 years old with confirmed or suspected influenza as they are at high risk for complications. We analyzed infant characteristics associated with nonprescription of oseltamivir over 9 years., Methods: We conducted a retrospective electronic health record (EHR) review of infants <12 months old born between January 1, 2012 and December 31, 2019 within the University of Pittsburgh Medical Center health system in Southwestern Pennsylvania who had >2 well-child visits during their first year. Infants with a confirmed positive test for influenza were included in the analysis. Factors associated with infant oseltamivir nonprescription were assessed using multivariable logistic regression., Results: Of 457 infants with confirmed influenza, 86% were prescribed oseltamivir. The proportion of infants prescribed oseltamivir increased from an average of 64.6% during the 2012-2016 influenza seasons to 90.4% during the 2016-2020 influenza seasons. Infants were more likely to not be prescribed oseltamivir if they experienced >2 days of influenza symptoms (odds ratio (OR): 9.4, 95% CI: 4.8, 18.7, P < .001), were diagnosed during the 2012-2016 influenza seasons (OR: 4.2, 95% CI: 1.8, 9.5, P < .001), tested positive for influenza via a multiplex/reverse transcriptase polymerase chain reaction test (OR: 6.7, 95% CI: 2.7, 16.3, P < .001; OR: 2.7, 95% CI: 1.1, 7.1; P = .04), or did not have a fever at point-of-care (OR: 2.3, 95% CI: 1.2, 4.6, P = .01)., Conclusion: Adherence to CDC influenza antiviral treatment guidelines for infants is high and improved over time. However, the provision of targeted education to providers may further improve oseltamivir prescribing practices for high-risk children <12 months of age., (© The Author(s) 2024. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

We analyzed data from positively tested COVID-19 outpatients to describe self-medication with OTC drugs and use of other remedies against symptoms of SARS-CoV-2 infection. We specifically considered their type and frequency, as well as associations with patient characteristics, and reasons for use. Data were collected between May 1, 2020 and February 22, 2021 with two questionnaires in an observational cohort study with PCR-confirmed SARS-CoV-2-positive adult outpatients in the district of Western Pomerania in Germany. 523 out of 710 outpatients (74%; 340 women and 183 men) reported using drugs and other remedies to relieve COVID-19-symptoms. Overall, participants reported utilization of 1282 finished dosage products or remedies, including 213 different ingredients. In the population of 710 outpatients, utilization of ibuprofen (26%), acetaminophen (21%), metamizole (14%), and acetylsalicylic acid (10%) was most commonly reported. Phytopharmaceuticals, herbal and animal products as well as vitamins and minerals were also frequently reported. Among the 523 participants who used drugs and other remedies, most commonly mentioned reasons for use were headache (40%), other kinds of pain (e.g. myalgia; 37%), fever (24%) and cough (16%). Our analysis showed that a majority of the participants tried to alleviate COVID-19-symptoms using drugs and other remedies. Especially analgesic and antipyretic agents, followed by herbal medicines, were used very frequently.Trial registration: German Register for Clinical Studies DRKS00021672, first registration on December 1st, 2020., (© 2024. The Author(s).)

Objectives: Nonpharmacy outlets are common medication suppliers in Indonesia, yet little is known regarding their practices. This study aimed to evaluate the medication selling practices occurring in kiosks and minimarkets during the coronavirus disease 2019 pandemic., Methods: A cross-sectional study included all minimarkets (N = 101) and a convenience sample of kiosks (a minimum sample size, N = 67) in District X, Indonesia. A validated tool was used to collect data on the characteristics of kiosks/minimarkets and their medication selling practices (i.e. drug management and drug information)., Key Findings: A sample of 67 kiosks and 52 minimarkets (response rate 51.5%) consented to participate in this study. Kiosks and minimarkets generally stocked nonprescription drugs, particularly cough and/or common cold products or analgesic-antipyretics; while >90% of kiosks and 15.4% of minimarkets provided prescription medicines. Medications in kiosks and minimarkets were mainly obtained from pharmacies (94.0% vs. 17.0%, respectively) or pharmaceutical wholesale representatives (68.7% vs. 96.0%, respectively). Most minimarkets or kiosks satisfied drug storage standards (100.0% vs. 88.1%, respectively). During the previous week, >80% of kiosks and minimarkets reported purchases of nonprescription drugs, and approximately 5% reported sales of prescription drugs. No drug information was provided by kiosk or minimarket staff., Conclusions: Minimarkets and kiosks may improve access to basic medications, but no information is provided regarding their use. These outlets should be licensed and policed to ensure the range and quality of drugs, and information provided to the Indonesian community is appropriate., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Royal Pharmaceutical Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Background: Tinea pedis is one of the most prevalent superficial fungal infections. Initial antifungal treatment is often acquired over-the-counter (OTC) without previous consultation with a physician., Objective: Lately, increasing antifungal terbinafine resistance has been documented in Denmark and globally and it is therefore of interest to assess how Danish pharmacies advise customers with tinea pedis., Methods: One hundred Danish pharmacies were randomly selected and an employee interviewed from each. A structured question guide was followed, with the possibility to add further comments., Results: Interviews of 94 pharmacies were conducted. Six pharmacies never replied. Terbinafine as standard dose or cutaneous solution terbinafine one time application (Lamisil Once (R)) were recommended by 99% of the pharmacy employees as first-line treatment. The customer was advised to seek medical attention when tinea pedis was recurring (93%), or when treatment duration was > 2 weeks (77%). The majority (88%) of the pharmacy employees had no knowledge about antifungal resistance., Conclusion: Only few pharmacy employees were aware of the current problem of antifungal resistance and the majority advised costumers to initiate treatment using OTC topical terbinafine. The problem of emerging antifungal resistance requires attention in order to provide customers with tinea pedis effective treatment and prevent further societal spread of resistance to antifungals., (© 2024 The Author(s). Mycoses published by Wiley‐VCH GmbH.)

Background: Prescribing by pharmacists is an increasingly common practice worldwide. In Brazil regulation of this practice began in 2013, and the practice remains unexplored as a research topic., Objective: We aimed to explore and gain insights into pharmacist prescribing practices in Brazil and assessing pharmacist's perceptions of their training and preparedness to prescribe medications., Methods: A cross-sectional survey was conducted between October 2022 and March 2023 via convenience sampling. Data were collected using an online questionnaire covering sociodemographic issues, academic training, prescribing practices, and perceptions regarding the provision of pharmacist prescribing in ambulatory care. Exploratory descriptive analysis and Poisson regression were performed to estimate the associations between pharmacist characteristics and their practices in prescribing medicines., Results: Among the 305 valid responses, 58.7% of the outpatient pharmacists stated that they had not prescribed any medication in the previous three years. Over-the-counter medication prescriptions were most common (42.0%). Only 4.6% of respondents had prescribed prescription-only medicines provided through collaborative agreement, with 2.6% reporting that they had adjusted doses, and 2.3% played a role in prescription renewal. Pharmacists living in Northeast regions tended to be more active prescribers (PR = 1.42; 95%CI 1.03-2.18), whereas those in primary healthcare (PR = 0.61; 95%CI 0.39-0.96) and self-declared Black pharmacists (PR = 0.30; 95%CI 0.10-0.97) prescribed less. Respondents strongly believed in the pharmacist's role as a prescriber, although they remained ambivalent regarding their responsibility for patient outcomes. Progress barriers include infrastructure gaps and strained relationships with physicians., Conclusions: This study suggests that pharmacists in Brazil predominantly prescribe over-the-counter medications, and variations in setting, region, and race can influence prescribing by pharmacist in ambulatory care., Competing Interests: Declaration of competing interest The authors have no relevant conflict of interests to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Context: Diabetic peripheral neuropathy (DPN) is the most common complication of diabetes mellitus. Chinese patent medicines (CPMs) are widely used in clinical practice to treat DPN., Objective: This study aims to summarize the latest evidence on the harms and benefits of CPMs as adjunctive therapy for DPN., Materials and Methods: We conducted searches for randomized controlled trials (RCTs) evaluating CPMs in conjunction with mecobalamin (Mec) or alpha-lipoic acid (αLA) across eight databases up to July 2024. The surface under the cumulative ranking area (SUCRA) was utilized to assess the clinical efficacy rate (CER), the peroneal motor nerve conduction velocity (pMNCV), the peroneal sensory nerve conduction velocity (pSNCV), the median motor nerve conduction velocity (mMNCV), and the median sensory nerve conduction velocity (mSNCV)., Results: The search yielded 128 eligible studies with 31 CPMs with Mec and 39 eligible studies with 17 CPMs with αLA. SUCRA rankings indicated that, when combined with Mec, Mailuoning liquid (lMLN) was the most effective regimen for CER, Honghua injection (iHH) for pMNCV, Maixuekang capsule (cMXK) for pSNCV, Dengzhanxixin injection (iDZXX) for mMNCV, and Tongxinluo capsule (cTXL) for mSNCV. Combined with αLA, Danhong injection (iDH) showed the highest efficacy for CER, pSNCV, and mSNCV, while Xueshuantong injection (iXShT) was the most effective for pMNCV and mMNCV., Conclusion: This network meta-analysis confirms the efficacy and safety of 37 CPMs combined with Mec or αLA for treating DPN. However, given the potential risk of bias and the very low certainty of the evidence, these recommendations should be adopted with caution.

Background: Chinese patent medicines (CPMs) are widely used in China as an adjuvant treatment in dilated cardiomyopathy with heart failure (DCM-HF). However, comprehensive and systematic evidence supporting the beneficial effects of CPMs combined with current complementary and alternative medicine (CAM) treatments against DCM-HF was limited. This network meta-analysis (NMA) aimed to assess and rank the relative efficacy of eight different CPMs for DCM-HF., Methods: To retrieve randomized controlled trials (RCTs) focusing on the use of CPMs combined with CAM for DCM-HF, the databases of PubMed, Embase, Web of Science Core Collection, Cochrane Library, ProQuest, China National Knowledge Infrastructure (CNKI), China Science Periodical Database (CSPD), Chinese Citation Database (CCD), Chinese Biomedical Literature Database (CBM), and ClinicalTrials.gov were comprehensively searched from their inception to 29 February 2024. The quality of the included RCTs was examined using the Cochrane Risk of Bias assessment tool, version 2.0 (RoB 2). Surface under the cumulative ranking curve (SUCRA) probability values were applied to rank the relative efficacy. Bayesian network meta-analysis was designed to assess the efficacy of different CPMs., Results: After applying the inclusion and exclusion criteria, a total of 77 eligible RCTs involving 6980 patients were enrolled. The outcomes assessed included clinical effectiveness rate (CER), left ventricular ejection fraction (LVEF), left ventricular end-diastolic dimension (LVEDD), 6-min walk test (6MWT), brain natriuretic peptide (BNP), and cardiac output (CO). The results of the NMA indicated that Qili Qiangxin capsule (QLQX), Wenxin granule (WX), Tongxinluo capsule (TXL), Qishen Yiqi dropping pill (QSYQ), Shexiang Baoxin pill (SXBX), Yangxinshi tablet (YXST), Yixinshu capsule (YXSC), and Getong Tongluo capsule (GTTL) combined with CAM significantly improved performance compared with CAM alone in treating DCM-HF. YXST + CAM (MD =  - 9.93, 95% CI - 12.83 to - 7.03) had the highest probability of being the best treatment on account of the enhancement of LVEF. WX + CAM had the highest likelihood of being the best treatment considering the improvement in LVEDD (MD =  - 11.7, 95% CI - 15.70 to - 7.79) and 6MWT (MD =  - 51.58, 95% CI - 73.40 to - 29.76). QLQX + CAM (MD =  - 158.59, 95% CI - 267.70 to - 49.49) had the highest likelihood of being the best intervention for the reduction in BNP. TXL + CAM (MD =  - 0.93, 95% CI - 1.46 to - 0.40) might be the optimal choice for increasing CO levels in DCM-HF patients. No serious treatment-emergent adverse events were observed., Conclusion: This NMA suggested that adding CPMs to the current CAM treatment exerted a more positive effect on DCM-HF. Thereinto, QLQX + CAM, TXL + CAM, WX + CAM, and YXST + CAM showed a preferable improvement in patients with DCM-HF when unified considering the clinical effectiveness rate and other outcomes. Furthermore, due to the lack of information on CPMs against DCM-HF and the uneven distribution of included studies among interventions, more high-quality studies are needed to provide more robust evidence to support our findings., Systematic Review Registration: PROSPERO (CRD42023482669)., (© 2024. The Author(s).)

Objectives: The aim of this study was to understand profiles of topical Voltaren gel diclofenac (VGD) 2.32 and 1.16% consumers through analyzing prescription patterns and to characterize treatment satisfaction, functional impairment, and pain relief after over-the-counter (OTC) VGD use in Sweden under real-world conditions., Methods: This observational, real-world study conducted in Sweden had retrospective and prospective segments. The retrospective secondary data segment utilized 12-month diclofenac gel prescription data from the Swedish eHealth Agency (E-hälsomyndigheten). The prospective segment included electronic surveys completed at baseline and weeks 4 and 12 by adult consumers who purchased OTC VGD to treat their pain., Results: Secondary data analyses ( n = 12,145) showed that 56.7% of patients receiving diclofenac gel were females ≥70 years old. Most patients did not switch pain treatments; the mean time between diclofenac gel refills was about 2.5 months. From the surveys ( n = 264), VGD provided pain relief, indicated by improvement in 11-point pain numeric rating scale scores. Average pain severity at baseline was 5.8 - improving by a mean of 1.3 and 1.9 points at weeks 4 and 12, respectively. The majority of consumers reported improvement in daily functioning (i.e., health-related quality of life [HRQoL]), and most were at least somewhat satisfied with VGD treatment results., Conclusions: This real-world study provides important insights into the prescription patterns of diclofenac gel and the consumer experience with OTC VGD in Sweden. Patients rarely switched to other topical nonsteroidal anti-inflammatory drugs, and VGD consumers reported pain relief and improved HRQoL compared to baseline - resulting in treatment satisfaction., (© 2024 the author(s), published by De Gruyter.)

Importance: Patients undergoing cancer treatment experience a multitude of skin, hair, and nail adverse events, prompting them to use non-evidence-based and often restrictive over-the-counter (OTC) recommendations to alleviate their symptoms. Comprehensively assessing evidence-based OTC modalities is crucial to enable cancer patients to comfortably resume their lives post-treatment and integrate clinically sound practices into their self-care routines., Objective: Perform a systematic review and assessment of evidence-based OTC skin, hair, and nail care recommendations for adult patients undergoing cancer treatment., Evidence Review: PubMed, Cochrane, Embase, and Medline databases were searched in March 2023 to identify English articles addressing OTC skin, hair, and nail care recommendations for adult patients before, during, and after cancer chemotherapy or radiation therapy (RT). Quality was assessed with Oxford Centre for Evidence Based Medicine criteria., Findings: 2192 unique articles were screened, of which 77 met inclusion criteria consisting of 54 randomized controlled trials (RCT), 8 non-randomized controlled cohorts, 1 non-randomized controlled clinical trial, 3 controlled prospective cohorts, 4 prospective cohorts, 2 controlled clinical trials, 1 prospective comparative study, 2 case reports, and 2 case series discussing 9322 patients. An additional article outside of our database search was included for a total of 78 articles. OTC skin care treatments with the best quality of evidence included moisturizing creams. Our review revealed a paucity of evidence-based hair and nail care practices., Conclusions and Relevance: This systematic review serves to highlight the efficacy of diverse OTC skin, hair, and nail care recommendations for adult cancer patients while encouraging further clinical trials to establish evidence-based management guidelines., (© 2024. The Author(s).)

Abstract: Seasonal allergies have a negative impact on patients' quality of life. Nurses must be aware of the different treatment options and lifestyle modifications to help patients manage their symptoms. This article discusses the benefits and risks of over-the-counter medications for seasonal allergies and other implications for nurses., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Depression, anxiety, and insomnia are prevalent in older people and are associated with increased risk of mortality, dependency, falls and reduced quality of life. Prior to or whilst seeking treatment, older people often manage these symptoms or conditions using products purchased over the counter (OTC), such as medication or herbal products. This review aims to map the evidence available for OTC medications, herbal medicines and dietary supplements for depression, anxiety and insomnia in older adults., Methodology: We carried out a scoping review, including searches of five databases to identify relevant randomised controlled trials (inception-Dec 2022). We took an inclusive approach to products to represent the wide range that may be available online. Trials were summarised according to condition and product., Results: We included 47 trials and 10 ongoing trial protocols. Most targeted insomnia (n = 25), followed by depression (n = 20), and mixed conditions (n = 2). None evaluated products targeted at anxiety alone. Where reported, most products appeared to be safe for use, but studies rarely included people with multiple comorbidities or taking concomitant medication. Some types of melatonin for insomnia (n = 19) and omega-3 fatty acids for depression (n = 7) had more substantive evidence compared to the other products., Conclusion: There is a substantial gap in evidence for OTC products for anxiety in older people. This should be addressed in future trials. Research should also focus on products that are widely used, and these need to be tested in older populations that are similar to those who would use them in practice., (© 2024. The Author(s).)

Evidence mapping was performed to systematically search and review the clinical studies about the treatment of insomnia with Chinese patent medicines. The evidence distribution in this field was analyzed and the problems of the studies were summarized. Chinese-and English-language articles of the studies involving the Chinese patent medicines specified in three national drug catalogs for the treatment of insomnia were searched against the databases with the time interval from inception to August 2023. Figures and tables were established to present the results. Finally, 23 Chinese patent medicines were screened out, which were mentioned in 299 articles involving 236 randomized controlled trials(RCTs), 35 non-randomized controlled trials(non-RCTs), 7 retrospective studies, 17 systematic reviews/Meta-analysis, and 4 guidelines/expert recommendations or consensus. Bailemian Capsules, Wuling Capsules, and Yangxue Qingnao Granules were mentioned in a large proportion of articles. The outcome indicators included sleep rating scale, clinical response rate, safety indicators, and anxiety and depression scores. The results showed that the studies about the treatment of insomnia with Chinese patent medicines were growing. However, there was a scarcity of research evidence, and the available studies were single-center with small sample sizes and short periods. These studies spanned broad clinical scopes with inadequately emphasized advantages of TCM and insufficient outcome indicators about quality of life, follow-up, and recurrence rate. RCT exhibited a high risk of bias, and the systematic reviews/Meta-analysis demonstrated low overall quality. The retrospective studies received suboptimal scores, and the non-RCT failed to mention follow-up time, loss rate to follow-up, and sample size estimations, which compromised result reliability. It is recommended that the research protocol for Chinese patent medicines in treating insomnia should adhere to the clinical research standards of TCM. The TCM syndrome score can serves as a crucial outcome measure, and emphasis should be placed on patients' quality of life, follow-up, and recurrence prevention. Measures should be taken to enhance the accessibility and affordability of Chinese patent medicines and strengthen the connection between medical insurance policies and the policies pertaining to Chinese patent medicines. Furthermore, it is advisable to reasonably increase the inclusion of Chinese patent medicines with well-established efficacy and safety evidence in the category A list of medical insurance.

Introduction: Medication abortion is safe and effective, but restrictions still limit patients from accessing this method. Alternative models of medication abortion provision, namely advance provision, over-the-counter (OTC), and online, could help improve access to care for some, although there is limited evidence about abortion patients' interest in these models., Methods: Between 2017 and 2019, we administered a cross-sectional survey to abortion patients at 45 clinics across 15 U.S. states to explore their interest in and support for advance provision, OTC, and online abortion access. We assessed relationships between sociodemographic characteristics and interest in and support for each model using bivariate logistic regressions and present perceived advantages and disadvantages of each model, as described by a subset of participants., Results: Among 1,965 people enrolled, 1,759 (90%) initiated the survey. Interest in and support for advance provision was highest (72% and 82%, respectively), followed by OTC (63% and 72%) and online access (57% and 70%). In bivariate analyses, non-Hispanic Black and Asian/Pacific Islander respondents expressed lower interest and support for the online model and Alaska Native/Native American respondents expressed higher interest in an OTC model, as compared with white respondents. Among 439 participants naming advantages and disadvantages of each model, the most common advantages included convenience and having the abortion earlier. The most common disadvantages were not seeing a provider first and possibly taking pills incorrectly., Conclusions: Although most abortion patients expressed interest in and support for alternative models of medication abortion provision, variation in support across race/ethnicity highlights a need to ensure that abortion care service models meet the needs and preferences of all patients, particularly people from historically underserved populations., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Network Meta-analysis was performed to compare the efficacy and safety of Chinese patent medicines in treating chronic pulmonary heart disease. CNKI, VIP, Wanfang, SinoMed, PubMed, Web of Science, EMbase, and Cochrane Library were searched for randomized controlled trial(RCT) of treating chronic pulmonary heart disease with Chinese patent medicines with the time interval from inception to December 2023. The Cochrane risk-of-bias tool was used for quality assessment of the included articles. RevMan 5.4 and Stata 17.0 were employed to establish the risk of bias map and perform the network Meta-analysis, respectively. Ultimately, a total of 95 RCTs involving 8 787 cases and 11 different Chinese patent medicines were included. Network Meta-analysis yielded the following results based on the surface under the cumulative ranking curve(SUCRA).(1)In terms of cardiac function improves clinical total effective rate, SUCRA the top three were Wenxin Granules + conventional western medicine, Tongxinluo Capsules + conventional western medicine, and Qishen Yiqi Dropping Pills + conventional western medicine.(2)For improving forced expiratory volume in the first se-cond(FEV1), SUCRA the top three were Danting Feixin Granules + conventional western medicine, Tongxinluo Capsules + conventional western medicine, and Bufei Huoxue Capsules + conventional western medicine.(3)Regarding increasing the FEV1/forced vital capacity(FVC%) value, SUCRA the top three were Qili Qiangxin Capsules + conventional western medicine, Shexiang Baoxin Pills + conventional western medicine, and Qishen Yiqi Dropping Pills + conventional western medicine.(4)In terms of increasing the partial pressure of oxygen(PaO&#95;2), SUCRA the top three were Qili Qiangxin Capsules + conventional western medicine, Qishen Yiqi Dropping Pills + conventional western medicine, and Shexiang Baoxin Pills + conventional western medicine.(5)In terms of reducing the partial pressure of carbon dioxide(PaCO&#95;2), SUCRA the top three were Tongxinluo Capsules + conventional western medicine, Qishen Yiqi Dropping Pills + conventional western medicine, and Shexiang Baoxin Pills + conventional western medicine.(6)In terms of increasing left ventricular ejection fraction(LVEF), SUCRA the top three were Bufei Huoxue Capsules + conventional western medicine, Qishen Yiqi Dropping Pills + conventional western medicine, and Shexiang Baoxin Pills + conventional western medicine.(7)In terms of decreasing brain natriu-retic peptide(BNP), SUCRA the top three were Compound Danshen Dropping Pills + conventional western medicine, Qili Qiangxin Capsules + conventional western medicine, and Tongxinluo Capsules + conventional western medicine.(8)In terms of improving the hematocrit level, SUCRA the top three were Qishen Yiqi Dropping Pills + conventional western medicine, Compound Danshen Dropping Pills + conventional western medicine, and Tongxinluo Capsules + conventional western medicine. In terms of safety, 26 RCTs reported adverse reactions, which primarily involved the circulatory and digestive systems. The combination of Chinese patent medicines with conventional western medicine has demonstrated enhanced therapeutic effects on chronic pulmonary heart disease. However, due to the varying quality and sample sizes of included studies and the absence of direct comparisons between Chinese patent medicines, the conclusions should be further validated by multicenter studies with larger sample sizes and higher methodological rigor.

Background: The escalating use of complementary and alternative medicine (CAM) raises concerns, particularly among geriatric patients taking multiple medications. Notably, the doubled chance of major drug interactions between prescription and over-the-counter (OTC) drugs in older adults underscores the need for further research. This study aimed to evaluate clinically significant CAM and prescription medication interactions in a geriatric clinic, emphasizing the growing importance of understanding CAM implications in health care., Methods: A 2-year cross-sectional study, approved by the Institutional Review Board, enrolled 420 participants aged 65 and older from a geriatric primary care clinic. Participants completed a survey, and pharmacy students conducted chart reviews to evaluate potential CAM products and prescription medication interactions., Results: Among the 420 participants-who were predominantly White females and who were taking supplements, OTC medications, or both-15.6% experienced potential drug interactions. Ginkgo biloba , garlic, and calcium were common contributors to major, moderate, and minor interactions, respectively, among supplements. Meanwhile, ibuprofen was among the contributors to major and moderate interactions among OTC medications. Most supplements and OTC medications were disclosed to health care professionals. However, there was a lack of investigation by health care professionals regarding CAM use, emphasizing a discrepancy between patient-reported and physician-inquired CAM usage., Conclusion: This study highlighted the significant use of CAM and/or OTC medications, particularly among vulnerable older adults, revealing a concerning 15.6% rate of potential drug interactions. The findings emphasized the need for awareness among health care practitioners and standardized CAM surveys to enhance accuracy and patient safety., Competing Interests: Conflicts of Interest None declared

On January 18, 2024, the US Centers for Disease Control and Prevention issued their most recent guidelines for over-the-counter drugs for coronavirus disease 2019 (COVID-19). Specifically, the organization stated that "Most people with COVID-19 have mild illness and can recover at home. You can treat symptoms with over-the-counter medicines, such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil), to help you feel better." In this review we consider the contributions of different types of evidence and conclude that healthcare providers should make individual clinical judgments for each of their patients in the selection of over-the-counter drugs to treat symptoms of COVID-19. This judgment should be based on the entire benefit to risk profile of the patient. It is our belief that the individual healthcare provider knows far more about each of his or her patients than anyone, including expert members of guideline committees. Their astute and judicious individual clinical decision-making for each individual patient based on all these considerations has the potential to do far more good than harm., (Copyright © 2024. Published by Elsevier Inc.)

Background: Vestibular migraine (VM) is a common cause of recurrent vertigo. Migraine headache preventative therapies are currently prescribed to control vertigo symptoms in VM. Clinical trials of nutraceuticals for migraine headache prevention have shown positive outcomes, but, to date, there have been no studies to assess their effectiveness in the management of VM., Aims: To report the effects of nonprescription therapy management on VM symptoms., Methods: We undertook a prospective, questionnaire-based assessment of patients diagnosed with VM between November 2019 and August 2021 at two Sydney tertiary referral clinics. Patients were advised on optimising sleep, hydration, exercise and nutrition and instructed to use an over-the-counter combination product containing riboflavin 200 mg, magnesium 150 mg, coenzyme Q10 75 mg and feverfew 200 mcg. Symptom severity and frequency were assessed using the Dizziness Handicap Inventory (DHI), the Vertigo Symptom Score short-form (VSS-sf) and two visual analogue scales for severity (VAS-s) and frequency (VAS-f) before and 3 months after commencing treatment., Result: In 82 participants (78% female; mean age, 44 ± 14 years) we recorded a decrease in DHI (mean, 16.8 [95% confidence interval (CI), 12.8-20.9], VSS-sf (9.3, 7.1-11.5), VAS-s (3.0, 2.2-3.8) and VAS-f (2.8, 2.1-3.4), equating to an improvement of 44.1%, 44.9%, 44.1% and 38.9% for each measure respectively. On the DHI and VSS-sf, 41 (50%) and 44 (53.7%) patients showed improvement in their symptoms; 39 (47.6%) and 36 (43.9%) patients noted no change and two patients reported worsening. The supplement was well-tolerated., Conclusions: The results provide preliminary evidence that VM symptom frequency and severity can be reduced by using nonprescription therapies., (© 2024 The Authors. Internal Medicine Journal published by John Wiley & Sons Australia, Ltd on behalf of Royal Australasian College of Physicians.)

Objective: To map and summarize the current scientific evidence concerning the active ingredients, effectiveness, and adverse effects of over-the-counter (OTC) bleaching products., Data and Source: This study was conducted according to the PRISMA-ScR guidelines for scoping reviews and registered on the Open Science Framework platform., Study Selection: Database searches were conducted in PubMed/MEDLINE, Embase, and Scopus up to January 2024. All in vitro, in situ, and clinical studies evaluating the effectiveness and adverse effects of OTC bleaching products were included. A descriptive analysis of the included studies was performed., Results: A total of 88 studies were included. Most of them were in vitro studies (n = 49), followed by randomized clinical trials (n = 28). The main OTC bleaching products identified were whitening or stain-removing toothpastes (n = 42), followed by whitening strips (n = 39). Most clinical studies indicate that whitening strips are effective in improving tooth color and providing whitening benefits. In contrast, the bleaching effectiveness of toothpastes, mouth rinses and whitening trays was mainly supported by in vitro studies. The main adverse effects associated with OTC bleaching agents were tooth sensitivity and gingival irritation., Conclusion: A wide variety of OTC bleaching products is available for consumer self-administered use. Clinical studies have mainly confirmed the bleaching effectiveness of whitening strips, while the validation for toothpastes, mouth rinses and whitening trays has mainly relied on in vitro studies. Nevertheless, the use of OTC bleaching products may result in adverse effects, including tooth sensitivity, gingival irritation, and enamel surface changes., Clinical Significance: Some over-the-counter bleaching products may have whitening properties supported by clinical studies, particularly those containing hydrogen or carbamide peroxide. Nonetheless, clinicians must be aware of the potential risks associated with excessive self-administration of these products, which may result in adverse effects., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

People living with chronic kidney disease (CKD) often experience multimorbidity and require polypharmacy. Kidney dysfunction can also alter the pharmacokinetics and pharmacodynamics of medications, which can modify their risks and benefits; the extent of these changes is not well understood for all situations or medications. The principle of drug stewardship is aimed at maximizing medication safety and effectiveness in a population of patients through a variety of processes including medication reconciliation, medication selection, dose adjustment, monitoring for effectiveness and safety, and discontinuation (deprescribing) when no longer necessary. This Review is aimed at serving as a resource for achieving optimal drug stewardship for patients with CKD. We describe special considerations for medication use during pregnancy and lactation, during acute illness and in patients with cancer, as well as guidance for the responsible use of over-the-counter drugs, herbal remedies, supplements and sick-day rules. We also highlight inequities in medication access worldwide and suggest policies to improve access to quality and essential medications for all persons with CKD. Further strategies to promote drug stewardship include patient education and engagement, the use of digital health tools, shared decision-making and collaboration within interdisciplinary teams. Throughout, we position the person with CKD at the centre of all drug stewardship efforts., (© 2024. Springer Nature Limited.)

Background: Although statins reduce adverse cardiovascular outcomes, less than one-half of eligible patients receive treatment. A nonprescription statin has the potential to improve access to statins., Objectives: This study sought to assess concordance between clinician and consumer assessment of eligibility for nonprescription statin treatment using a technology assisted self-selection Web application (Web App) and evaluate effect on low-density lipoprotein cholesterol (LDL-C) levels., Methods: This study was a prospective actual use 6-month study to evaluate use of a Web App to qualify participants without a medical background for a moderate-intensity statin based on current guidelines. Participants entered demographic information, cholesterol values, blood pressure, and concomitant medications into the Web App, resulting in 3 possible outcomes: "do not use," "ask a doctor," and "OK to use.", Results: The study included 1,196 participants, with a median age of 63 years (Q1-Q3: 57-68 years); 39.6% were women, 79.3% were White, 11.7% were Black, and 4.1% had limited literacy. Mean LDL-C was 139.6 ± 28.3 mg/dL and the median calculated 10-year risk of atherosclerotic cardiovascular disease was 10.1% (Q1-Q3: 7.3%-14.0%). Initial Web App self-selection resulted in an outcome concordant with clinician assessment in 90.7% (95% CI: 88.9%-92.3%) of participants, and 98.1% (95% CI: 97.1%-98.8%) had a concordant final use outcome during treatment. Mean percent change in LDL-C was -35.5% (95% CI: -36.6% to -34.3%). Serious adverse events occurred in 27 (2.3%) participants, none related to the study drug., Conclusions: In this actual use study, a technology-assisted Web App allowed >90% of consumers to correctly self-select for statin use and achieve clinically important LDL-C reductions. (Technology-Assisted Cholesterol Trial in Consumers [TACTiC]; NCT04964544)., Competing Interests: Funding Support and Author Disclosures The trial was funded by AstraZeneca and coordinated by AstraZeneca, Concentrics Research (a contract research organization) and the Cleveland Clinic Coordinating Center for Clinical Research (C5Research). Ms Wolski, Dr Watson, Dr Martin, Dr Michos, Dr Weintraub, Dr Cho, Dr Laffin, Dr Jacoby, Dr Ballantyne, Dr Menon, Ms Strzelecki, and Dr Ridker have received support from AstraZeneca to conduct this study. Dr Hutchinson, Mr Ekelund, Mr Birve, and Ms Morris are employees of AstraZeneca., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Adult acne vulgaris affects up to 43-51% of individuals. While there are numerous treatment options for acne including topical, oral, and energy-based approaches, benzoyl peroxide (BPO) is a popular over the counter (OTC) treatment. Although BPO monotherapy has a long history of efficacy and safety, it suffers from several disadvantages, most notably, skin irritation, particularly for treatment naïve patients. In this prospective, randomized, controlled, split-face study, we evaluated the comparative efficacy, safety, and tolerability of a novel 3-step azelaic acid, salicylic acid, and graduated retinol regimen versus a common OTC BPO-based regimen over 12 weeks. A total of 37 adult subjects with self-reported mild to moderate acne vulgaris were recruited. A total of 21 subjects underwent a 2-week washout period and completed the full study with 3 dropping out due to product irritation from the BPO routine, and 13 being lost to follow-up. Detailed tolerability surveys were conducted at Week 4. Additional surveys on tolerability and product preferences were collected monthly, at Week 4, Week 8, and Week 12. A blinded board-certified dermatologist objectively scored the presence and type of acne lesions (open or closed comedones, papules, pustules, nodules, and cysts) at baseline, Week 4, Week 8, and Week 12. Patients photographed themselves and uploaded the images using personal mobile phones. Detailed Week 4 survey results showed across 25 domains of user-assessed product performance, the novel routine outperformed the BPO routine in 19 (76%) which included domains in preference (e.g. "I would use this in the future) and performance ("my skin improved" and "helped my acne clear up faster"). Users of the novel routine reported less facial redness, itching, and burning, though differences did not reach statistical significance. In terms of efficacy, both products performed similarly, reducing total acne lesions by 36% (novel routine) and 40% (BPO routine) by Week 12. Overall, accounting for user preferences and tolerability the novel routine was more preferred than the BPO routine in 79% of domains (22/28). Differences in objective acne lesion reduction were not statistically significant (p = 0.97). In a randomized split-face study, a 3-step azelaic acid, salicylic acid, and graduated retinol regimen delivered similar acne lesion reduction, fewer user dropouts, greater user tolerability, and higher use preference compared to a 3-step BPO routine based in a cohort of participants with mild-to-moderate acne vulgaris., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: The use of over-the-counter analgesics (OTCA) is common among adolescents and has been linked with increased symptoms of anxiety and depression. However, little is known about which specific symptoms are most strongly connected to OTCA usage. The current study assessed which anxiety and depression symptoms were most closely associated with OTCA usage in a large sample of adolescents and examined whether this differed across genders., Method: The present study was based on data from 626,581 participants from the Ungdata survey in Norway. Associations between OTCA and anxiety and depression symptoms were examined using network analysis. Non-regularized partial-correlation networks were constructed to estimate the conditional dependent relations between the use of OTCA and symptoms while controlling for pain. Gender-specific networks were created for comparison., Results: OTCA usage was associated with most symptoms, even after controlling for pain, with the strongest associations with "sleep problems", "stiff or tense", "everything is a struggle" and "suddenly scared". There were some gender differences, showing that "sleep problems" and "hopeless" were more strongly related to OTCA usage in females, whereas "stiff or tense" was more strongly related to OTCA usage in males., Conclusion: Overall, the somatic symptoms of anxiety and depression displayed the strongest associations with OTCA usage. When examining the gender-specific networks, both showed similar trends, although males exhibited slightly stronger associations between OTCA usage and somatic symptoms., (© 2024. The Author(s).)

Background: Pyritum, a mineral drug, has been used primarily orally in traditional medicine to treat traumatic injuries, broken tendons, and fractures. Due to growing concerns about the accumulation of heavy metals in the body, this systematic review aims to evaluate the efficacy and safety of Chinese patent medicine containing pyritum for external use (CPMPE) to determine the effectiveness of external use of pyritum., Methods: A literature search was performed through China National Knowledge Infrastructure, Wanfang, EMBASE, Cochrane Library, and PubMed from inception to February 2023. "Pyrite," "pyritum," "zirantong," "traditional medicine," "oriental medicine," etc, were the keywords from the database. In this systematic review, RCTs and case reports were referred to analyze the efficacy rate and clinical status of CPMPE., Results: About 36 studies were reviewed. Of 36 studies, 23 were RCTs and 13 were case reports. The total effective rate in 34 studies was used to evaluate the efficacy of CPMPE for various disease classifications. The effectiveness of CPMPE was confirmed in case reports, and RCTs showed that using CPMPE as a single or combined treatment had a more significant effect than not using CPMPE in anorectal diseases, orthopedic diseases, obstetrics and gynecology diseases, and skin diseases., Conclusions: This review concluded that CPMPE might be a safe and effective alternative treatment method for various diseases and has potential benefits in preventing postoperative complications, reducing pain, relieving symptoms, and accelerating healing compared to the control group, which employs unused CPMPE., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2024 the Author(s). Published by Wolters Kluwer Health, Inc.)

Background: The application of wastewater-based epidemiology to track the outbreak and prevalence of coronavirus disease (COVID-19) in communities has been tested and validated by several researchers across the globe. However, the RNA-based surveillance has its inherent limitations and uncertainties., Objective: This study aims to complement the ongoing wastewater surveillance efforts by analyzing other chemical biomarkers in wastewater to help assess community response (hospitalization and treatment) during the pandemic (2020-2021)., Methods: Wastewater samples (n = 183) were collected from the largest wastewater treatment facility in Suffolk County, NY, USA and analyzed for COVID-19 treatment drugs (remdesivir, chloroquine, and hydroxychloroquine (HCQ)) and their human metabolites. We additionally monitored 26 pharmaceuticals including common over-the-counter (OTC) drugs. Lastly, we developed a Bayesian model that uses viral RNA, COVID-19 treatment drugs, and pharmaceuticals data to predict the confirmed COVID-19 cases within the catchment area., Results: The viral RNA levels in wastewater tracked the actual COVID-19 case numbers well as expected. COVID-19 treatment drugs were detected with varying frequency (9-100%) partly due to their instability in wastewater. We observed a significant correlation (R = 0.30, p < 0.01) between the SARS-CoV-2 genes and desethylhydroxychloroquine (DHCQ, metabolite of HCQ). Remdesivir levels peaked immediately after the Emergency Use Authorization approved by the FDA. Although, 13 out of 26 pharmaceuticals assessed were consistently detected (DF = 100%, n = 111), only acetaminophen was significantly correlated with viral loads, especially when the Omicron variant was dominant. The Bayesian models were capable of reproducing the temporal trend of the confirmed cases., Impact: In this study, for the first time, we measured COVID-19 treatment and pharmaceutical drugs and their metabolites in wastewater to complement ongoing COVID-19 viral RNA surveillance efforts. Our results highlighted that, although the COVID-19 treatment drugs were not very stable in wastewater, their detection matched with usage trends in the community. Acetaminophen, an OTC drug, was significantly correlated with viral loads and confirmed cases, especially when the Omicron variant was dominant. A Bayesian model was developed which could predict COVID-19 cases more accurately when incorporating other drugs data along with viral RNA levels in wastewater., (© 2023. The Author(s).)

Background: Millions of U.S. people have been heavily affected by opioids. In March 2023, the Food and Drug Administration approved naloxone as an over-the-counter medication. This has allowed more access to patients at high risk of opioid overdose. However, the patient's willingness to pay for naloxone at the pharmacy counter has not been assessed., Objectives: This study aimed to characterize factors associated with the willingness to pay for naloxone among the patient group., Methods: A cross-sectional Qualtrics online panel survey instrument was developed. This survey was distributed to patients in the United States, aged ≥ 18 years, with any chronic pain and taking opioids. The survey included demographics, and clinical characteristics (pain assessment, opioid use, and knowledge of naloxone). In addition, willingness to pay was assessed using a 7-point Likert scale ranging from strongly disagree to strongly agree. An ordinal logistic regression model was used to examine demographic and clinical characteristics., Results: A total of 549 subjects completed the survey (women [53.01%], white or Caucasian (83.61%), age mean [SD] 44 [13]). Women were associated with less willingness to pay (adjusted odds ratio [aOR] 0.685 [95% CI 0.478-0.983], P = 0.0403). Compared with the high household income group (≥ $150,000), low household income ≤ $25,000 (aOR 0.326 [95% CI 0.160-0.662], P = 0.0020) or income between $25,000 and 74,999 (aOR 0.369 [95% CI 0.207-0.657], P = 0.0007) was associated with less likelihood of willing to pay. Patients with a previous diagnosis of obstructive sleep apnea were associated with a higher likelihood of willingness to pay (aOR 1.685 [95% CI 1.138-2.496], P = 0.0092). Each unit increase in pain was also associated with a higher likelihood of willingness to pay (aOR 1.247 [95% CI 1.139-1.365], P < 0.0001)., Conclusions: Demographics and clinical factors were associated with willingness to pay for naloxone. This study's findings are useful in the development of interventions to address pharmacy-based naloxone distribution programs., Competing Interests: Disclosure The authors declare no relevant conflicts of interest or financial relationships., (Copyright © 2024 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Background: The common cold is one of the most frequently occurring illnesses worldwide. The aim of this study was to determine which OTC anti-common cold medications were most often recommended by pharmacists and if the COVID-19 pandemic affected such recommendations., Methods: Non-interventional, observational research trial using a self-developed questionnaire to collect data on pharmacists' recommendations for anti-common cold OTC treatment. The data were collected during the COVID-19 pandemic (December 2021-February 2022) in four large community network pharmacies in Lodz (Poland) and then compared with an analogue period of time before the pandemic (December 2019-February 2020)., Results: During COVID-19 pandemic there was a significant (p < 0.05) reduction in paracetamol, acetylsalicylic acid, metamizole magnesium, inosines, alpha-mimetics, mucolytics, homeopathics, and sore throat products and an increase in other tablets/capsules and add-on product recommendations. There was a significant relationship (p < 0.05, OR > 1) between the recommended frequency of paracetamol, inosines, sore throat products (each symptom), metamizole magnesium (headache, fever), acetylsalicylic acid (headache, fever, fatigue), NSAIDs, alpha-mimetics (headache, rhinorrhea), pseudoephedrine (rhinorrhea), homeopathics (headache), herbal products (fatigue), antihistamines (rhinorrhea, cough), and mucolytics (headache, fever, cough)., Conclusions: Favorable prices (before COVID-19 pandemic) and reports on common NSAIDs side effects (beginning of the pandemic) led to high sale of paracetamol. Increased awareness of clinical effectiveness of some medications or their reduced availability influenced their limited recommendations., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests This work was supported by the Medical University of Lodz under Grant 503/0-149-03/503-01-001-19-00., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Objectives: To compare the efficacy and safety of seven Chinese patent medicines (CPMs) combined with conventional triple/quadruple therapy (T/Q) for Helicobacter pylori -positive peptic ulcers., Design: A systematic review and network meta-analysis., Data Sources: China National Knowledge Infrastructure, VIP database, Wanfang database, ScienceDirect, EBSCO, EMBASE, Web of Science, Cochrane Library and PubMed were searched through 1 June 2022., Eligibility Criteria: Randomised controlled trials (RCTs) testing CPMs combined with T/Q for H. pylori -positive peptic ulcers were included. The CPMs included Anweiyang capsule, Jianweiyuyang tablets/capsule/granule, Jinghuaweikang capsule, Kangfuxin liquid, Puyuanhewei capsule, Weifuchun tablets/capsule and Weisu granule. At least one of the following outcome indicators was recorded: complete ulcer healing rate (CUHR), effective rate (ER), H. pylori eradication rate ( HP ER), rate of peptic ulcer recurrence (RPUR) and incidence of adverse reactions (IAR)., Data Extraction and Synthesis: Two researchers independently conducted the study selection and extracted data for included studies. The risk of bias was assessed using the Cochrane risk of bias tool. A pairwise meta-analysis was performed using RevMan V.5.3. Network meta-analysis was performed using STATA/MP V.15.0. Confidence in the evidence was assessed using Grading of Recommendations, Assessment, Development and Evaluation., Results: A total of 36 RCTs involving 3620 patients were included. Compared with T/Q alone, Weisu+T/Q, Weifuchun+T/Q and Puyuanhewei+T/Q had the highest CUHR, ER and HP ER, respectively. Weisu+T/Q and Jianweiyuyang+T/Q had the lowest RPUR and IAR, respectively. The cluster analysis results showed Jianweiyuyang+T/Q might be the best choice concerning efficacy and safety simultaneously, followed by Kangfuxin+T/Q., Conclusion: Among the combination therapies with the CPMs, Jianweiyuyang+T/Q might be the most favourable option for H. pylori -positive peptic ulcers, followed by Kangfuxin+T/Q. Considering the limited quantity and quality of the included RCTs, the results should be interpreted with caution., Prospero Registration Number: CRD42022327687., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: There is a need for reproducible methods to measure over-the-counter (OTC) medication possession and use. This is because OTC medications are self-managed, variably monitored by healthcare professionals, and in certain populations such as older adults some OTC medications may introduce risk and cause more harm than benefit., Objective: (s): To develop and assess the feasibility of the Home Medication Inventory Method (HMIM), a novel method to measure possession and use of OTC medications., Methods: We benchmarked, adapted, and standardized prior approaches to medication inventory to develop a method capable of addressing the limitations of existing methods. We then conducted a pilot study of the HMIM among older adults. Eligible participants were aged ≥60 years, reported purchasing or considering purchasing OTC medication, and screened for normal cognition. Interviews were conducted both in person and remotely. When possible, photographs of all OTC medications were obtained with participant consent and completion times were recorded for both in-person and remote modalities., Results: In total 51 participants completed the pilot study. Home medication inventories were conducted in-person (n = 15) and remotely (n = 36). Inventories were completed in a mean (SD) of 20.2 min (12.7), and 96 % of inventories completed within 45 min. A total of 390 OTC medications were possessed by participants, for a mean (SD) of 7.6 (6.3) per participant. No differences in duration of interviews or number of medications reported were identified between in-person and remote modalities. Anticholinergic medications, a class targeted in the pilot as potentially harmful to older adults, were possessed by 31 % of participants, and 14 % of all participants reported use of such a medication within the previous 2 weeks., Conclusions: Implementing the HMIM using in-person and remote modalities is a feasible and ostensibly reproducible method for collecting OTC medication possession and use information. Larger studies are necessary to further generalize HMIM feasibility and reliability in diverse populations., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: This scoping review aims to document Chinese Patent Medicines (CPMs) for Type 2 Diabetes Mellitus, explore whether CPMs can improve patients' health outcomes, and set priorities in addressing research gaps in this area., Methods: Following the framework of PRISMA-SCr, we proposed the research questions based on PICOS principle, and searched the CPMs for T2DM from three drug lists, followed by a systematic search of the literature in eight databases from their inception to June 22, 2023. Then, we developed the eligibility criteria and systematically reviewed the relevant studies, retained the studies about CPMs for T2DM, extracted the related data, and identified the differences across studies in structured charts., Results: A total of 25 types of CPMs were extracted from the three drug lists. Radix astragali appeared most frequently (19 times) among the herbal medicinal ingredients of CPMs. A total of 449 articles were included in the full-paper analysis ultimately, all of which were about 20 types of CPMs, and there were no related reports on the remaining five CPMs. Except about a quarter (25.39 %, 114/449) using CPMs alone, the remaining studies all involved the combination with oral hypoglycemics for T2DM. Biguanides are the most common drugs used in combination with CPMs (50.14 %, 168/335). Fasting plasma glucose (FPG) is the most frequently reported outcomes in efficacy evaluation (82.41 %, 370/449)., Conclusion: There are a total of 25 types of CPMs currently available for T2DM patients. However, the volume of related evidence on these CPMs varies. It is necessary to standardize the combined use of CPMs and conventional medicine and select appropriate outcomes in future studies., Competing Interests: Declaration of Competing Interest All authors declare that they have no conflict of interests., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

This study employed evidence mapping to systematically sort out the clinical studies about the treatment of premature ventricular contractions with Chinese patent medicines and to reveal the distribution of evidence in this field. The articles about the treatment of premature ventricular contractions with Chinese patent medicines were searched against PubMed, Cochrane Library, Web of Science, CNKI, Wanfang, and VIP with the time interval from January 2016 to December 2022. Evidence was analyzed and presented by charts and graphs combined with text. According to the inclusion and exclusion criteria, 164 papers were included, including 147 interventional studies, 4 observational studies, and 13 systematic reviews. A total of 27 Chinese patent medicines were involved, in which Shensong Yangxin Capsules and Wenxin Granules had high frequency. There were off-label uses in clinical practice. In recent years, the number of articles published in this field showed a decreasing trend. Eight types of outcome indicators were used in interventional studies. Ambulatory electrocardiography, clinical response rate, safety, and echocardiography had high frequency, while the rate of β-blocker decompensation, major cardiovascular events, and pharmaceutical economic indicators were rarely reported. The evaluation was one-sided. The low quality of the included articles reduced the reliability of the findings. In the future, the clinical use of medicines should be standardized, and the quality of clinical studies should be improved. Comprehensive clinical evaluation should be carried out to provide a sound scientific basis for the treatment of premature ventricular contractions with Chinese patent medicines.

An evidence map was established to comprehensively sort out the clinical research in the treatment of post-acute myocardial infarction heart failure(P-AMI-HF) with Chinese patent medicines, so as to reveal the distribution of evidence in this field. CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, and EMbase were searched for the randomized controlled trial(RCT), systematic reviews/Meta-analysis, and guidelines/consensus in this field. The evidence was analyzed and displayed in the form of a combination of text, charts, bubble charts, and bar charts, and the quality of RCT, systematic reviews/Meta-analysis, and guidelines/consensus were evaluated by RoB 1.0, AMSTAR2, and AGREE Ⅱ, respectively. A total of 163 RCTs, 4 systematic reviews/Meta-analysis, 1 network Meta-analysis, 2 observational studies, and 5 guidelines/consensus were included. In recent years, the total number of publications in this field has shown an upward trend. There were a variety of Chinese patent medicines in the treatment of P-AMI-HF, among which Shenfu Injection received the most attention. The clinical RCT and systematic reviews/Meta-analysis generally had poor quality, and the RCT mostly had a small size, a single center, and a short cycle. The outcome indicators mainly included cardiac function indicators, myocardial injury markers, total response rate, hemodynamic indicators, and safety indicators, while the characteristic efficacy indicators of TCM received insufficient attention. The development processes of some guidelines/consensus lack standardization, which compromised their authority and rationality. Chinese patent medicines have advantages in the treatment of P-AMI-HF, while there are also problems, which remain to be solved by more high-quality evidence. That is, more large-sample and multi-center clinical studies should be carried out in the future, and the formulation process of relevant systematic reviews/Meta-analysis and guideline/consensus should be standardized and the quality of evidence should be improved. In this way, the effectiveness and safety of Chinese patent medicines in the treatment of P-AMI-HF can be explored.

Studies show that over-the-counter drugs are widely used by consumers. Moreover, there is a huge selection available and they are prominently featured in advertising. To date, there exist only a few studies that shed light on the attitudes, attributions, and usage patterns of patients with regard to use of over-the-counter drugs. An anonymized explorative waiting room survey was conducted among 900 patients in 60 GP practices in the German states of North Rhine-Westphalia, Hesse, and Rhineland-Palatinate. As well as the descriptive analysis, a t test was applied to independent random samples, in order to identify significant differences between two groups. 65% of respondents reported using over-the-counter drugs frequently or occasionally. With regard to effects, risks, and side effects, 54% state that they usually take advice from their GP and/or pharmacist before purchasing or taking over-the-counter preparations. For 56%, the package information leaflet is a frequent source of information about the over-the-counter drugs used. The respondents consider over-the-counter preparations to be particularly suitable for (preventive) treatment of colds, flu symptoms, and pain management. The widespread perception of over-the-counter drugs as simple to use (62%), low-dose (69%), and low-efficacy (73%) products does not always correspond to the actual capabilities and risks of over-the-counter self-medication. Given the easy availability of over-the-counter drugs and their strong presence in advertising, it is important that patients have a realistic idea of the capabilities and risks of over-the-counter products. In addition to the advice provided by pharmacists, the trusting, long-standing support provided by GPs and their ongoing information and advice services play a central role in this. It would be advisable to give more attention to this public health concern and to promote initiatives to make patients more aware of the risks regarding consumption of drugs without medical consultation., (© 2022. The Author(s).)

Due to the lack of specialized guidance, the post-marketing research on clinical effectiveness of Chinese patent medicines demonstrates varied quality and lacks high-quality evidence, failing to meet the demands of policy-making, clinical decision-making, and industrial decision-making. To address this issue, this project gathered experts in clinical medicine, clinical pharmacy, evidence-based medicine, drug epidemiology, medical ethics, and policy and regulation in China. They referred to the model of international post-marketing research on medicines and developed Guidelines for post-marketing research on clinical effectiveness of Chinese patent medicines under the framework of relevant laws and regulations and technical guidance documents in China. The guidelines were developed with consideration to the characteristics of Chinese patent medicines, China's national conditions, and all the stakeholders including marketing authorization holders, clinical researchers, drug administration, and users. The development of the guidelines followed the requirements for developing group standards set by the China Association of Chinese Medicine. The guidelines fully implement the concept of full life-cycle research, emphasizing the combination of traditional Chinese medicine(TCM) theory, human use experience, and clinical trials and pay attention to the compliance, scientificity, and ethics of research. The guidelines clarify the topic selection and decision-making path of the post-marketing research on effectiveness of Chinese patent medicines through six steps: determining research purpose, analyzing drug characteristics, evaluating research basis, proposing clinical orientation, clarifying research purpose, and implementing classified research. The general principles of research design and implementation were clarified from eight aspects: research type, research objects, sample size, efficacy indicators, bias, missing data, evidence level, and practicality. It focuses on the research on the TCM syndrome-based efficacy evaluation, clinical value-oriented mechanism of action, and the effectiveness of Chinese patent medicines with different routes of administration. The guidelines provide a universal methodological basis for the post-marketing research on clinical effectiveness of Chinese patent medicines.

This study systematically combed the randomized controlled trial(RCT) of Chinese patent medicines in treatment of type 2 diabetes mellitus(T2DM) in recent five years by using the method of evidence map. It understood the distribution and quality of evidence in this field and found the existing Chinese patent medicines in treatment of T2DM and the problems in its research. The study collected the commonly used Chinese patent medicines for the treatment of T2DM from three drug catalogs, retrieved Chinese and English databases to obtain RCT literature related to Chinese patent medicines in recent five years, and extracted information such as sample size, study drug, combination medication, course of treatment, and outcome indicators from the literature. It also conducted quality evaluation based on the Cochrane collaborative network bias risk assessment tool and used charts to display the analysis results. A total of 19 kinds of Chinese patent medicines are collected, of which 13 kinds of Chinese patent medicines are mentioned in 131 articles related to RCT. The literature concerning Shenqi Jiangtang Capsules/Granules, Jinlida Granules, and Xiaoke Pills accounts for a large proportion. Outcome indicators include blood glucose, blood lipids, pancreatic islet cell function, and clinical symptoms. In terms of literature quality, 75 articles have correct random methods, and 1 article performs allocation hiding and blind methods. Therefore, the clinical orientation of Chinese patent medicines for the treatment of T2DM is broad, failing to reflect their own characteristics and lacking safety information. Insufficient attention has been paid to TCM syndrome scores, quality of life, and blood lipid outcome indicators that reflect the characteristics of traditional Chinese medicine(TCM). The number of studies on the treatment of T2DM by Chinese patent medicines varies greatly among varieties, and the quality of the studies is low. It is suggested that the holders of the marketing license of T2DM Chinese patent medicines should carry out a post-marketing re-evaluation of the varieties of traditional Chinese patent medicines for treating T2DM according to the relevant requirements of the State Food and Drug Administration, standardize the clinical positioning, and revise and improve the safety information in the instructions. It is recommended that researchers construct a core indicator dataset for Chinese patent medicine treatment of T2DM, improve the efficacy evaluation system, and develop an experimental plan based on CONSORT before conducting RCT.

This study aims to construct the element relationship and extension path of clinical evidence knowledge map with Chinese patent medicine, providing basic technical support for the formation and transformation of the evidence chain of Chinese patent medicine and providing collection, induction, and summary schemes for massive and disorganized clinical data. Based on the elements of evidence-based PICOS, the conventional construction methods of knowledge graph were collected and summarized. Firstly, the data entities related to Chinese patent medicine were classified, and entity linking was performed(disambiguation). Secondly, the study associated and classified the attribute information of the data entity. Finally, the logical relationship between entities was constructed, and then the element relationship and extension path of the knowledge map conforming to the characteristics of clinical evidence of Chinese patent medicine were summarized. The construction of the clinical evidence knowledge map of Chinese patent medicine was mainly based on process design and logical structure, and the element relationship of the knowledge map was expressed according to the PICOS principle and evidence level. The extension path crossed three levels(model layer, data layer application, and new evidence application), and the study gradually explored the path from disease, core evaluation indicators, Chinese patent medicine, core prescriptions, syndrome and treatment rules, and medical case comparison(evolution law) to new drug research and development. In this study, the top-level design of the construction of the clinical evidence knowledge map of Chinese patent medicine has been clarified, but it still needs the joint efforts of interdisciplinary disciplines. With the continuous improvement of the map construction technology in line with the characteristics of TCM, the study can provide necessary basic technical support and reference for the development of the TCM discipline.

This study systematically collected, analyzed, and evaluated randomized controlled trial(RCT) in the treatment of diabetic foot ulcer(DFU). The aim as provide references for future studies and to enhance the application of clinical evidence. The RCT of DFU treated with Chinese Patent Medicine was obtained and analyzed using the AI-Clinical Evidence Database of Chinese Patent Medicine(AICED-CPM). The analysis was supplemented with data from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science. A total of 275 RCTs meeting the requirements were retrieved, with only 7 of them having a sample size of 200 or more. These trials involved 66 different Chinese patent medicine including 25 oral medications, 24 Chinese herbal injections, and 17 external drugs. Among the 33 different intervention/control designs identified, the most common design was Chinese patent medicine + conventional treatment vs conventional treatment(86 cases, 31.27%). Out of the 275 articles included in the literature, 50 did not provide information on the specific course of treatment(18.18%). A total of 10 counting indicators(with a frequency of 426) and 36 measuring indicators(with a frequency of 962) were utilized. The methodological quality of the RCT for the treatment of DFU with Chinese patent medicine was found to be low, with deficiencies in blind methods, other bias factors, study registration, and sample size estimation. There were noticeable shortcomings in the reporting of allocation hiding and implementation bias(blind method application). More studies should prioritize trial registration, program design, and strict quality control during implementation to provide valuable data for clinical practice and serve as a reference for future investigations.

Certain transgender women who seek gender-affirming hormone treatment (GAHT) face economic and social barriers that limit or prevent access to medically supervised GAHT. Transgender women facing such barriers might acquire GAHT without prescription, potentially without proper dosage, administration, and health monitoring in the absence of medical supervision. For this report, survey data were analyzed from 1,165 transgender women in seven urban areas in the United States to examine associations between self-reported use of nonprescription GAHT and known correlates of nonprescription GAHT, including cost, insurance coverage for GAHT, homelessness, receiving money or drugs in exchange for sex during the past 12 months (exchange sex), lack of comfort discussing gender with provider, and lack of health care use. After controlling for complex sampling design, transgender women who reported recent health care use or insurance coverage for GAHT were less likely to report nonprescription GAHT, and those reporting recent exchange sex or recent homelessness were more likely to report nonprescription GAHT. Findings suggest that transgender women were more likely to use GAHT without a prescription in situations of economic and social marginalization (e.g., disengagement from health care, lack of insurance or trans-specific health care, homelessness, or engagement in sex work). Public health professionals can use these results to design effective interventions to facilitate prescribed hormone use among transgender women in the United States, although access to housing, trans-affirming health care, and insurance coverage might be needed to prevent nonprescription use., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. No conflicts of interest were reported.