A randomized controlled double-blinded split-face prospective clinical trial to assess the efficacy, safety, and tolerability of a novel 3-step routine compared to benzoyl peroxide for the treatment of mild to moderate acne vulgaris.

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.

[Network Meta-analysis of Chinese patent medicine in treatment of heart failure with preserved ejection fraction].

This study systematically evaluated the efficacy and safety of different Chinese patent medicines combined with conventional western medicine in the treatment of heart failure with preserved ejection fraction(HFpEF) and ranked for the drug selection. Randomized controlled trial(RCT) on Chinese patent medicines in treatment of HFpEF were obtained from the CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, EMbase, Web of Science, and other databases from the inception to October 9, 2022. The included RCT was quantitatively analyzed using gemtc and rjags packages of R software for the network Meta-analysis. 74 RCTs were included, with a total of 7 192 patients enrolled, involving 11 different Chinese patent medicines(Shenfu Injection, Shenmai Injection, Qili Qiangxin Capsules, Shexiang Baoxin Pills, Xuezhikang Capsules, Salvia Miltiorrhiza Polyphenols Injection, Tanshinone Ⅱ_A Sulfonate Injection, Xinmailong Injection, Yangxinshi Tablets, Qishen Yiqi Dripping Pills, and Yixinshu Capsules). The results of network Meta-analysis are shown as followed.(1)In terms of improving clinical effective rate, for injection preparations, Xinmailong Injection + conventional western medicine was recommended. while for oral preparations, Shexiang Baoxin Pills + conventional western medicine, Qishen Yiqi Dripping Pills + conventional western medicine, and Qili Qiangxin Capsules + conventional western medicine were preferred.(2)In terms of improving the mitral ratio of peak early to late diastolic filling velocity(E/A), for injection preparations, Shenmai Injection + Salvia Miltiorrhiza Polyphenols Injection + conventional western medicine, Shenmai Injection + conventional western medicine, Shenfu Injection + conventional western medicine were preferred. While for oral preparations, Yixinshu Capsules + conventional western medicine was preferred.(3)In terms of reducing the ratio of early diastolic mitral inflow to early diastolic mitral annular velocity(E/e'), Shenfu Injection + conventional western medicine could be used as injection preparation, and Qili Qiangxin Capsules + conventional western medicine, Qishen Yiqi Dripping Pills + conventional western medicine for oral preparations.(4)In terms of improving 6-minute walking trail(6MWT), the injection preparations such as Shenmai Injection + conventional western medicine, Xinmailong Injection + conventional western medicine were suitable, while oral preparations like Qishen Yiqi Dripping Pills + conventional western medicine, Qili Qiangxin Capsules + conventional western medicine were recommended.(5)In terms of reducing N-terminal pro B-type natriuretic peptide(NT-proBNP), Qili Qiangxin Capsules + conventional western medicine were preferred.(6)In terms of reducing B-type natriuretic peptide(BNP), Xinmailong Injection + conventional western medicine could be used for injection preparation and Qili Qiangxin Capsules + conventional western medicine can be used for oral preparation. In terms of adverse drug reactions, there was no significant difference between Chinese patent medicine combined with conventional western conventional and traditional western medicine alone. The results showe that Chinese patent medicine combined with conventional western medicine in treating HFpEF is superior to conventional western medicine alone in reducing clinical symptoms, improving cardiac function, and improving exercise tolerance, which also has good drug safety. However, the existing evidence is still limited by the quality and quantity of included studies, so the above conclusion requires further validation through more prospective RCT.

Drug stewardship in chronic kidney disease to achieve effective and safe medication use.

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.

A Case of Tinea Faciei due to Trichophyton indotineae with Steroid Rosacea Related to Topical Over-The-Counter Drugs Purchased Outside of Japan.

A Filipino woman in her forties had facial erythema that was being self-treated with over-the-counter (OTC) drugs purchased outside of Japan. The drugs included clobetasol propionate, antibiotic, and antifungal components. Her facial erythema symptoms were worse during summertime. KOH direct examination of annular erythema was positive for fungal hyphae and negative for Demodex folliculorum. Fungal culture revealed Trichophyton indotineae based on internal transcribed spacer sequence analysis. Minimal inhibitory concentration for terbinafine was 0.06 µg/mL. We made a diagnosis of tinea faciei with steroid rosacea. We treated the patient with oral itraconazole. Physicians should be aware of increasing T. indotineae infections and increasing self-medication using topical OTC steroids combined with antifungals and antibiotics not only in India but also among foreign people living in other countries such as Japan.

Silica-based microencapsulation used in topical dermatologic applications.

Microencapsulation has received extensive attention because of its various applications. Since its inception in the 1940s, this technology has been used across several areas, including the chemical, food, and pharmaceutical industries. Over-the-counter skin products often contain ingredients that readily and unevenly degrade upon contact with the skin. Enclosing these substances within a silica shell can enhance their stability and better regulate their delivery onto and into the skin. Silica microencapsulation uses silica as the matrix material into which ingredients can be embedded to form microcapsules. The FDA recognizes amorphous silica as a safe inorganic excipient and recently approved two new topical therapies for the treatment of rosacea and acne. The first approved formulation uses a novel silica-based controlled vehicle delivery technology to improve the stability of two active ingredients that are normally not able to be used in the same formulation due to potential instability and drug degradation. The formulation contains 3.0% benzoyl peroxide (BPO) and 0.1% tretinoin topical cream to treat acne vulgaris in adults and pediatric patients. The second formulation contains silica microencapsulated 5.0% BPO topical cream to treat inflammatory rosacea lesions in adults. Both formulations use the same amorphous silica sol-gel microencapsulation technology to improve formulation stability and skin compatibility parameters.

Are unknown co-medications, over-the-counter and off-label drug use still problems among people living with HIV? Results from a transversal survey in 23 centres in France.

INTRODUCTION: Polypharmacy can lead to drug-drug interactions (DDIs), especially with ART. The burden of co-medications, including over-the-counter (OTC) drugs and self-medications, could be underestimated. We aimed to investigate the proportion of people living with HIV (PLHIV) with declared and undeclared co-medications, as well as their potential burden. METHODS: We conducted a national, multicentre, 1 week cross-sectional study between 10 December and 16 December 2019 in 23 French hospitals amongst consecutive adult PLHIV presenting for a routine outpatient visit. A standardized questionnaire filled in by the physicians assessed all medications and other active chemical substances taken by the PLHIV. RESULTS: Overall we enrolled 496 participants from 23 centres. Median age was 50.6 years; ART regimens included an integrase inhibitor in 61% (n = 302), an NNRTI in 34% (n = 169) and a PI in 14% (n = 70) of the cases. Co-medications involved 392 (79%) PLHIV, among which 85 (17%) received polypharmacy (≥5 medications). Previously unknown co-medications or other active substances were found for 32% (n = 159) of the participants. Corticosteroids (9%, n = 46) and proton pump inhibitors (10%, n = 50) were frequently administered. These co-medications did not differ according to age range. Illegal drug use was declared by 11% (n = 54) and OTC drugs by 23% (n = 113) of PLHIV. Potential DDIs were discovered for 11% (n = 53), leading to treatment modifications in 47% (25/53) of cases. CONCLUSIONS: Potential DDIs that lead to therapeutic modifications remain significant whatever the age of PLHIV. More devoted time to identify co-medications and OTC treatment is needed in all PLHIV.

Chinese patent medicine Kanglaite injection for non-small-cell lung cancer: An overview of systematic reviews.

ETHNOPHARMACOLOGICAL RELEVANCE: Kanglaite injection (KLTi), a Chinese herbal medicine, is used as an adjuvant treatment for non-small-cell lung cancer (NSCLC). AIMS OF THE STUDY: To provide an evidence-based endorsement for the clinical application and selection of KLTi by evaluating the reporting quality, methodological quality, risk of bias, and evidence quality of systemic reviews (SRs). MATERIALS AND METHODS: SRs of KLTi adjuvant therapy of NSCLC were searched by using 12 databases, consulting experts, and retrieving relevant conference papers until 2022.03.24. The treatment group received KLTi in combination with other therapies, regardless of dosage, duration, or the therapy combined. Network meta-analyses and SRs using repeated data were excluded. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines 2009, A MeaSurement Tool to Assess systematic Reviews, Risk of Bias in Systematic Review, and the Grading of Recommendations Assessment, Development and Evaluation were used to assess the quality of reports, methodological quality, risk of bias, and level of evidence; R was used for visual analysis of the relevant contents. RESULTS: Twenty SRs (13 Chinese and 7 English articles), all authored by Chinese authors as the first author, were included. The reporting information of most included studies was relatively complete (21-27 points), accounting for three-fourths of the total literature. The quality of the methods used in all studies was critically low. The risk of bias was mostly high. Results of the evidence summary showed that among the "moderate" evidence, KLTi combined with chemotherapy had benefits of 9.7-16.4% for objective response rate (ORR) (11 SRs), 8.1-14% for disease control rate (four SRs), and 20.1-28.6% for quality of life (12 SRs) compared with those of chemotherapy alone. The incidence of gastrointestinal symptoms (five SRs) was reduced by 11.5%-23.2%, while that of leukopenia (four SRs) improved by 19.5-29.2%. Combined radiotherapy and targeted therapy had benefits of 25.9% and 16.8%, respectively, in ORR and 31.3% and 22.8%, respectively, in quality of life (the quality of evidence was "low"). The results depicted that treatment with two courses of KLTi produce the best results. CONCLUSION: Our results suggest that KLTi, whether combined with chemotherapy, radiotherapy, or targeted therapy, has an effect on ORR and quality of life and induces adverse reactions, such as leukopenia, nausea, and vomiting. It may improve patient survival; however, the impact of its low-grade quality on the immune function remains undetermined. Owing to the low reporting quality and methodological quality and high risk of bias of the SRs and the included studies, clinical application of KLTi remains unelucidated; higher-quality SRs and randomized controlled trials are necessary in the future.

[Clinical comprehensive evaluation of Jinsang Sanjie Pills/Capsules in treatment of vocal nodule/polyp of vocal cord].

This study used health technology assessment methods and multi-criteria decision analysis(MCDA) model, according to the guideline for clinical comprehensive evaluation of Chinese patent medicine, we developed this assessment tool. The comprehensive evaluation score of Jinsang Sanjie Pills/Capsules is calculated based on the additive model. This score is calculated by "quantitative evaluation software v1.0 for clinical comprehensive evaluation of Chinese patent medicines" which developed by the project team. The evaluation yielded the following results.(1)Effectiveness: compared with the control group, Jinsang Sanjie Pills/Capsules can improve the total effectiveness rate of vocal nodule/polyp of vocal cord, and improve the symptoms and signs.(2)Safety: Jinsang Sanjie Pills/Capsules did not show acute toxicity and long-term toxicity. The most common adverse reaction was gastrointestinal system damage, all of the adverse reactions were either improved or cured.(3)Economy: from the perspective of the health system, evaluating the single use or combination of Jinsang Sanjie Pills/Capsules with conventional medication in the treatment of vocal nodule/polyp of vocal cord is relatively effective and cost-effective compared to conventional medication, with a stable cost-effectiveness advantage.(4) Innovation: Jinsang Sanjie Pills/Capsules are used for the treatment of slow throat paralysis(vocal nodules, polyp of vocal cord, thickening of vocal mucosa) caused by heat toxin accumulation, Qi stagnation and blood stasis, and the resulting hoarseness. Jinsang Sanjie Pills/Capsules have good innovation and targeted indications.(5) Suitability: the investigated doctors, pharmacists and patients all believed that Jinsang Sanjie Pills/Capsules have good suitability.(6)Accessibility: Jinsang Sanjie Pills/Capsules are included in the category B of the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalogue(2021 edition), which have good cost-effectiveness and affordability for medical insurance and self-paid patients. Jinsang Sanjie Pills/Capsules do not contain endangered animals and plants. The supply of raw materials can meet the demand of production at present. The comprehensive evaluation score is 76.06 points. Based on all dimensions of evidence, 71.4% experts consensus on Jinsang Sanjie Pills/Capsules is class A, which can be directly converted into decision making. This study comprehensively evaluated the clinical application value of Jinsang Sanjie Pills/Capsules in the treatment of vocal nodule/polyp of vocal cord, so as to provide evidence for their rational clinical use and regulatory decision-making.

Recent advances in Chinese patent medicines entering the international market.

As an indispensable part of Traditional Chinese medicine (TCM), Chinese patent medicines have played an important role in preventing and treating diseases in China. Since they are easy to use, easy to store, and cost-effective, Chinese patent medicines have been generally accepted and widely used in Chinese clinical practice as a vital medical resource. In recent years, as TCM has developed and it has been accepted around the world, many Chinese patent medicine companies have gained international market access and successfully registered several Chinese patent medicines as over-the-counter (OTC) or prescription drugs in regions and countries that primarily use Western medicine such as the EU, Russia, Canada, Singapore, and Vietnam. Moreover, several Chinese patent medicines have been obtained the US Food and Drug Administration (FDA) approval conducting phase II or III clinical trials in the US. The current work has focused on several Chinese patent medicines that have been successfully registered or that have been submitted for registration abroad. Summarized here are recent advances in the efficacy and molecular mechanisms of these Chinese patent medicines to treat respiratory infectious diseases (Lianhua Qingwen capsules, Jinhua Qinggan granules, and Shufeng Jiedu Capsules), cardiovascular and cerebrovascular diseases (Compound Danshen Dripping Pills, Huatuo Zaizao pills, and Tongxinluo Capsules), cancers (a Kanglaite injection and a Shenqi Fuzheng Injection), and gynecological diseases (Guizhi Fuling Capsules). The hope is that this review will contribute to a better understanding of Chinese patent medicines by people around the world.

Medication burden in young adults with juvenile idiopathic arthritis: data from a multicentre observational study.

OBJECTIVE: To assess the medication and disease burden of young adults with juvenile idiopathic arthritis (JIA). METHODS: Young adults with JIA prospectively followed in the Juvenile Arthritis Methotrexate/Biologics long-term Observation reported on their health status and medication use. All medications taken (disease-modifying antirheumatic drugs (DMARDs)/prescription/over-the-counter drugs, but excluding most local therapies) classified according to the Anatomical Therapeutic Chemical Classification System were included in this analysis. Medication use at last follow-up was evaluated by sex, JIA category and time from symptom onset to the first biological DMARD (bDMARD) start. RESULTS: A total of 1306 young adults (68% female) with JIA and a mean disease duration of 13.6±6 years were included in the study. Patients reported using on average 2.4±2.1 medicines and 1.5±1.7 non-DMARD medicines, respectively, at the last follow-up. Almost a quarter of the patients reported polypharmacy. The higher the number of medications used was, the higher the disease activity, pain and fatigue, and the lower the quality of life of patients. Medication usage differed significantly between sexes and JIA categories, being highest in patients with rheumatoid factor-positive polyarthritis and systemic JIA. The number of medications used was significantly associated with the time from symptom onset to bDMARD start. Patients taking opioids or antidepressants had a particularly high disease burden and had received bDMARDs an average of 2 years later than patients not taking these medications. CONCLUSION: Medication use in adults with JIA varies depending on sex, JIA category, and the time between symptom onset and initiation of treatment with bDMARD.

Clinical application of oral Chinese Patent Medicines in ophthalmology: a scoping review protocol.

INTRODUCTION: The prevalence of eye diseases has been increasing worldwide. In China, in addition to conventional medicine, Traditional Chinese Medicine (TCM) plays an important role in maintaining people's vision health. Although less flexible and targeted than TCM decoction, Chinese Patent Medicines (CPMs) are stable and well used. In recent years, CPMs have been increasingly used in ophthalmology clinics by TCM practitioners and by Western doctors in general hospitals. However, comprehensive evidence for using CPMs in ophthalmology is lacking. AIM: We will apply the methodology of scoping review to systematically search and sort out the available evidence on oral CPMs for the treatment of eye diseases, identify the distribution of evidence in this field and provide a basis for clinical practice and medical decisions. METHODS: The scoping review will be implemented in the following seven steps: (1) defining the research question; (2) searching National Essential Medicines List (2018 edition), National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2020 edition) and Chinese Pharmacopoeia (2020 edition) for oral CPMs for the treatment of eye diseases; (3) searching Embase, Web of Science, PubMed, Cochrane Library, Chongqing VIP Chinese Scientific Journals Database, Chinese National Knowledge Infrastructure, Chinese Biomedical Literature Database and Wanfang Database for relevant literature published from inception to December 2021; (4) developing eligibility criteria; (5) screening the studies based on inclusion criteria; (6) extracting relevant data and lastly, (7) collating, summarising and reporting the results. ETHICS AND DISSEMINATION: Since the scoping review aims at collecting data from publicly available publications, this study does not require ethical approval. The results will be published in a peer-reviewed journal and presented at scientific conferences.

[Network Meta-analysis of peroral Chinese patent medicines for activating blood and resolving stasis in treatment of endometriosis].

Network Meta-analysis was performed to systematically compare the efficacy of different Chinese patent medicines for activating blood and resolving stasis in the treatment of endometriosis and to provide evidence-based references for clinical medication regimens. The relevant randomized controlled trials(RCTs) involving Chinese patent medicines combined with conventional treatment(experimental group) vs conventional treatment(control group) were retrieved from Chinese and English literature databases. The bias risk assessment tool recommended in Cochrane handbook 5.3 was used to evaluate the quality of the included studies. The result data of each outcome index was extracted for network Meta-analysis in Stata 15.0. A total of 44 RCTs were included in this study, involving 4 345 patients and 9 Chinese patent medicines. The network Meta-analysis revealed the following trends.(1)In terms of reducing the visual analogue scale(VAS) scores, Dan'e Fukang Plaster+conventional treatment>Xuefu Zhuyu Capsules+conventional treatment>Gongliuxiao Capsules+conventional treatment.(2)In terms of reducing cancer antigen CA125, Xiaojin Capsules+conventional treatment>Shaofu Zhuyu Granules+conventional treatment>Dan'e Fukang Plaster+conventional treatment.(3)In terms of reducing estradiol(E_2), Gongliuxiao Capsules+conventional treatment>Xiaojin Capsules+conventional treatment>Sanjie Zhentong Capsules+conventional treatment.(4) In terms of reducing recurrence rate, Guizhi Fuling Capsules+conventional treatment>Xuefu Zhuyu Capsules+conventional treatment>Dan'e Fukang Plaster+conventional treatment. The peroral Chinese patent medicines for activating blood and resolving stasis combined with conventional treatment have better efficacy in the treatment of endometriosis than conventional treatment. However, considering the low quality of the included literature, large-scale high-quality clinical trials are needed in the future research.

[Exploration and practice of post-marketing survival benefit evaluation of Chinese patent medicine for cancer].

Traditional Chinese medicine(TCM) is an important feature of cancer treatment in China. The methods to tap the advantages of TCM, reasonably evaluate and accurately apply Chinese patent medicines have become current research hotspots and difficulties. TCM takes syndrome differentiation and treatment as the core, with the characteristics of overall regulation and multi-targets efficacy. Therefore, the post-marketing survival benefit evaluation of Chinese patent medicines for cancer is different from that in modern medicine. The primary treatment goals in cancer patients include to improve the disease control rate and prolong their survival time. At present, Chinese patent medicines for cancer patients are lacking indepth studies on survival benefit at the post-marketing stage. In addition, the characteristics of individualized treatment with TCM have also increased the complexity of clinical research on TCM. Therefore, it is of certain practical significance and necessity to evaluate the survival benefit of Chinese patent medicines for cancer after marketing. Based on this, in this paper, we first summarized the technical methodological means of survival benefit evaluation at this stage, and then explored the post-marketing survival benefit evaluation of Chinese patent medicines for cancer from three aspects: the evaluation of cancer treatment effect based on survival time and quality of life, treatment-related toxicity and the auxiliary effect of TCM, and the improvement effect for tumor-related symptoms. Based on the practices of early clinical researches, and according to the insufficient efficacy evaluation of current clinical research on Chinese patent medicines, this paper proposed to improve the evaluation system for clinical researches on Chinese patent medicines, establish the evaluation method with TCM characteristics, clarify the dominant population, lay a theoretical foundation for the evaluation of post-marketing survival benefits of Chinese patent medicines for cancer in the future, and promote the modernization process of TCM.

Lessons learned: Chronic idiopathic constipation patient experiences with over-the-counter medications.

INTRODUCTION: Chronic idiopathic constipation (CIC) is a prevalent functional gastrointestinal disorder diagnosed based on patient-reported symptoms and the absence of structural gastrointestinal abnormalities. Individuals with CIC typically institute dietary changes and use stool softeners or over-the-counter (OTC) laxatives, possibly at the direction of a healthcare provider, before prescription medications for CIC are initiated. Although highly prevalent, there is limited information regarding CIC patient experiences with OTC medications. METHODS: This post-hoc analysis used patient-reported data from a questionnaire administered during patient screening for a prospective linaclotide Phase 3b clinical trial in patients with CIC (N = 1482 screened). The questionnaire asked patients to report their experiences with OTC CIC medications over the preceding 6 months. RESULTS: Among patients with screening responses (N = 1423), most were female (85%) and white (66%), with a mean age of 48.9 years. A high proportion of patients had used one or more OTC medications (70% had ≥1 OTC; 19% had ≥3 OTCs), with the majority being bisacodyl (33%) and polyethylene glycol (30%). The most commonly cited reason for stopping an OTC medication was insufficient symptom relief (17-40%). The majority of patients taking OTC medications reported no or little satisfaction with the medication's effect on their constipation (62%) and CIC-specific abdominal symptoms (78%). Many patients had little to no confidence in bowel movement (BM) frequency after taking OTC medications and their confidence in their ability to predict BM timing was also low (49-81% not at all confident). CONCLUSIONS: Treatment effects on individual CIC symptoms, predictability of bowel habits, and satisfaction with treatment are all important factors for healthcare providers and patients to consider when establishing an effective treatment regimen for CIC. TRIAL REGISTRATION NUMBER: NCT01642914.

Add-on effect of Qiming granule, a Chinese patent medicine, in treating diabetic macular edema: A systematic review and meta-analysis.

This study aims to evaluate the efficacy and safety of Qiming granule (QG) on diabetic macular edema (DME). PubMed, Embase, the Cochrane Library, CNKI, Wanfang, qvip and China Biology Medicine Disc were searched. Randomized controlled trials (RCTs) about participants with a diagnosis of DME were included. Risk of bias assessment was conducted by Cochrane risk-of-bias tool for RCT. Random-effects model was implemented to pool results. Among 16 included studies, QG combined with conventional treatment was administered 13.5 g daily for a period ranging from 2 to 6 months. Results showed combination therapy was more effective than conventional treatment alone in central macular thickness (weighted mean difference (WMD) = -29.43, 95% confidence interval (CI) (-39.56 to -19.29), p = .0001), optimum corrected vision (pooled standardized mean difference (SMD) = -0.962, 95%CI (-1.35 to -0.57), p = .0001) and overall effective rate (RR = 1.25, 95%CI = [1.13 to 1.35], p < .0001). Only three studies reported adverse effects. The quality of evidence is low. Due to a lack of placebo control, the net efficacy of QG is still uncertain. More high-quality RCTs are needed to confirm the efficacy and safety of QG in DME.

Topical Over-the-Counter Antiaging Agents: An Update and Systematic Review.

Over-the-counter antiaging formulations aim to prevent or minimize the signs of aging skin, and to maintain the benefits obtained from different cosmetic procedures. Even though a huge selection of such products is available on the market, evidence and good clinical practice of the data supporting their use are oftentimes lacking. In this systematic review, the authors reviewed scientific data available in the published literature on the most common ingredients used in antiaging cosmetics, with a particular focus on in vivo studies.

Contemporary Role and Regulation of Over-the-Counter Sinonasal Medications.

OBJECTIVE: Numerous pharmaceutical options are available over-the-counter (OTC) for the relief of sinonasal symptoms. Patients typically utilize these drugs in an unsupervised manner, without appreciation of their relative efficacy or potential for adverse effects. This review covers the scope and regulation of the OTC drug market, the pros and cons of OTC availability, and specific concerns that surround the most common classes of OTC sinonasal drugs. Suggestions are provided for the improvement of patient care and public health. DATA SOURCES: MEDLINE publications and market reports. REVIEW METHODS: Literature review. CONCLUSIONS: Some of the most commonly used OTC sinonasal remedies, including decongestants and first-generation antihistamines, are less effective than alternative drugs and pose potential safety concerns. IMPLICATIONS FOR PRACTICE: Clinicians should advocate to their patients for the appropriate use of alternative agents, such as intranasal corticosteroids and newer-generation antihistamines, and discourage the unsupervised use of oral and topical decongestants. Furthermore, health care practitioners should encourage dialogue with their patients about the use of OTC sinonasal remedies, with the goals of optimizing individual health and health care delivery.

Prescribing over-the-counter medication in an OMFS department: a service review.

In 2018, NHS England released guidelines restricting the prescription of over-the-counter medicines (OTC). This was a project initially targeted at primary care, but we felt that it could also be used to improve services in secondary or tertiary care. We were interested to investigate our OTC prescribing pattern within a busy maxillofacial department and therefore carried out a service review. All outpatient prescriptions were reviewed between October 2017 and October 2018. The review was then repeated between October 2018 and October 2019. All OTC medications prescribed during these periods and their costs to the Trust were highlighted. Our aim was to improve prescribing patterns based on current guidelines and reduce the departmental spend in this area. The first year of data revealed that a total sum of £2742.75 was spent on OTC medications. Those most frequently prescribed were Difflam™ (Mylan) mouthwash and spray; chlorhexidine mouthwash, and miconazole oral gel. The findings of the service review indicated deficiencies in knowledge with regards to prescribing appropriately. Following departmental training the amount spent reduced from £2742.75 to £1312. There is a need to educate nationally to reduce spending on OTC medications, which would help to relieve financial pressures on other NHS services. As a department, we can also hope for further improvement.

Menstrual Dysfunction and Treatment Among Adolescents With Congenital Heart Disease.

STUDY OBJECTIVE: This study describes menstrual dysfunction and treatment among adolescent and young adult (AYA) females with congenital heart disease (CHD). DESIGN: Data collected from a 1-time survey completed by AYA females (and mothers if AYA unable). SETTING: Participants were recruited from pediatric cardiology clinics. PARTICIPANTS: Female AYA with CHD, aged 14-21 years (N = 114). INTERVENTIONS: None. MAIN OUTCOME MEASURES: The questionnaire assessed sexual and reproductive health (SRH) concerns, behaviors, and management. Outcome measures were self-reported menstrual complaints, use of over-the-counter (OTC) pain relief medications for dysmenorrhea, reported visits with a clinician for a menstrual problem, and reported use of hormones for menstrual problems or birth control. RESULTS: Mean age was 17.0 years (SD = 2.2). The majority of participants (83%) reported 1 or more menstrual complaints (67.5% cramping, 42.1% irregular menses, 46.5% heavy periods), and 88% reported any history of taking OTC medications for pain relief. Increased menstrual complaints were not associated with level of cardiac complexity, reported transplantation, or reported use of hormonal contraception. However, 32% of participants reported use of hormonal contraception for menstrual dysfunction. Combined oral contraceptive pills (COCs) were the most common; 2 of these women carried contraindications to estrogen. CONCLUSIONS: A large majority of AYA females with CHD reported menstrual dysfunction. Use of OTC medication for menstrual pain and inappropriate use of estrogen creates concerns that menstrual disorders may be unaddressed or addressed inappropriately. Thus, gynecological needs of adolescents with CHD may need to be specifically targeted by providers who feel comfortable with this population and their complex needs.