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1.
BMC Psychiatry ; 24(1): 366, 2024 May 15.
Article in English | MEDLINE | ID: mdl-38750535

ABSTRACT

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.


Subject(s)
Analgesics , Anxiety , Depression , Nonprescription Drugs , Humans , Male , Female , Adolescent , Nonprescription Drugs/therapeutic use , Analgesics/therapeutic use , Depression/epidemiology , Anxiety/epidemiology , Norway/epidemiology , Sex Factors , Surveys and Questionnaires
3.
Arch Dermatol Res ; 316(6): 230, 2024 May 24.
Article in English | MEDLINE | ID: mdl-38787441

ABSTRACT

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.


Subject(s)
Acne Vulgaris , Benzoyl Peroxide , Dermatologic Agents , Dicarboxylic Acids , Salicylic Acid , Humans , Acne Vulgaris/drug therapy , Benzoyl Peroxide/administration & dosage , Benzoyl Peroxide/adverse effects , Benzoyl Peroxide/therapeutic use , Adult , Male , Female , Salicylic Acid/administration & dosage , Salicylic Acid/adverse effects , Salicylic Acid/therapeutic use , Prospective Studies , Young Adult , Treatment Outcome , Double-Blind Method , Dicarboxylic Acids/adverse effects , Dicarboxylic Acids/administration & dosage , Dicarboxylic Acids/therapeutic use , Dermatologic Agents/adverse effects , Dermatologic Agents/administration & dosage , Dermatologic Agents/therapeutic use , Vitamin A/administration & dosage , Vitamin A/adverse effects , Vitamin A/therapeutic use , Administration, Cutaneous , Adolescent , Severity of Illness Index , Nonprescription Drugs/administration & dosage , Nonprescription Drugs/adverse effects , Nonprescription Drugs/therapeutic use , Drug Therapy, Combination/methods
4.
Adv Exp Med Biol ; 1447: 151-167, 2024.
Article in English | MEDLINE | ID: mdl-38724792

ABSTRACT

The pathogenesis of atopic dermatitis (AD) is complex and multifactorial. However, recent advancements in the genetics and pathophysiology of AD suggest that epidermal barrier dysfunction is paramount in the development and progression of the condition (Boguniewicz M, Leung DYM, Immunol Rev 242(1):233-246, 2011). In addition to standard therapy for AD, there are a plethora of nonprescription treatment modalities which may be employed. Over-the-counter treatments for atopic dermatitis can come in the form of topical corticosteroids, moisturizers/emollients, and oral antihistamines. Though these treatments are beneficial, prescription treatments may be quicker acting and more efficacious in patients with moderate to severe disease or during flares. OTC agents are best used for maintenance between flares and to prevent progression of mild disease. Alternative and complementary treatments lack strong efficacy evidence. However, wet wraps, bleach baths, and other treatments appear to be promising when used in conjunction with conventional treatments. With the financial burden of atopic dermatitis ranging from 364 million to 3.8 billion dollars each year in the United States, we suspect this topic will gain further research attention.


Subject(s)
Dermatitis, Atopic , Histamine Antagonists , Nonprescription Drugs , Humans , Adrenal Cortex Hormones/therapeutic use , Dermatitis, Atopic/drug therapy , Emollients/therapeutic use , Histamine Antagonists/therapeutic use , Nonprescription Drugs/therapeutic use
5.
Medicine (Baltimore) ; 103(19): e37881, 2024 May 10.
Article in English | MEDLINE | ID: mdl-38728461

ABSTRACT

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.


Subject(s)
Medicine, Chinese Traditional , Humans , Medicine, Chinese Traditional/methods , Administration, Oral , Nonprescription Drugs/therapeutic use , Drugs, Chinese Herbal/therapeutic use , Drugs, Chinese Herbal/administration & dosage
6.
J Am Coll Cardiol ; 83(21): 2080-2088, 2024 May 28.
Article in English | MEDLINE | ID: mdl-38599257

ABSTRACT

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).


Subject(s)
Hydroxymethylglutaryl-CoA Reductase Inhibitors , Internet , Humans , Female , Male , Middle Aged , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Aged , Prospective Studies , Nonprescription Drugs/therapeutic use , Cholesterol, LDL/blood
7.
Zhongguo Zhong Yao Za Zhi ; 49(3): 819-835, 2024 Feb.
Article in Chinese | MEDLINE | ID: mdl-38621886

ABSTRACT

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.


Subject(s)
Drugs, Chinese Herbal , Heart Failure , Humans , Heart Failure/drug therapy , Natriuretic Peptide, Brain , Nonprescription Drugs/therapeutic use , Network Meta-Analysis , Stroke Volume , Prospective Studies , Drugs, Chinese Herbal/therapeutic use , Capsules
8.
Zhongguo Zhong Yao Za Zhi ; 49(3): 836-841, 2024 Feb.
Article in Chinese | MEDLINE | ID: mdl-38621887

ABSTRACT

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.


Subject(s)
Drugs, Chinese Herbal , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Nonprescription Drugs/therapeutic use , Technology , Data Mining/methods
9.
Zhongguo Zhong Yao Za Zhi ; 49(3): 842-848, 2024 Feb.
Article in Chinese | MEDLINE | ID: mdl-38621888

ABSTRACT

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.


Subject(s)
Drugs, Chinese Herbal , Nonprescription Drugs , Humans , Nonprescription Drugs/therapeutic use , Medicine, Chinese Traditional , Evidence-Based Medicine , Treatment Outcome , China , Drugs, Chinese Herbal/therapeutic use
10.
Zhongguo Zhong Yao Za Zhi ; 49(6): 1673-1682, 2024 Mar.
Article in Chinese | MEDLINE | ID: mdl-38621951

ABSTRACT

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.


Subject(s)
Drugs, Chinese Herbal , Heart Failure , Medicine, East Asian Traditional , Myocardial Infarction , Humans , Nonprescription Drugs/therapeutic use , Drugs, Chinese Herbal/adverse effects , Myocardial Infarction/drug therapy , Network Meta-Analysis , Heart Failure/drug therapy , Medicine, Chinese Traditional , Randomized Controlled Trials as Topic
11.
Zhongguo Zhong Yao Za Zhi ; 49(5): 1397-1405, 2024 Mar.
Article in Chinese | MEDLINE | ID: mdl-38621988

ABSTRACT

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 ß-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.


Subject(s)
Drugs, Chinese Herbal , Medicine, East Asian Traditional , Ventricular Premature Complexes , Humans , Ventricular Premature Complexes/drug therapy , Nonprescription Drugs/therapeutic use , Reproducibility of Results , Drugs, Chinese Herbal/therapeutic use , Capsules
12.
Zhongguo Zhong Yao Za Zhi ; 49(4): 1113-1121, 2024 Feb.
Article in Chinese | MEDLINE | ID: mdl-38621918

ABSTRACT

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.


Subject(s)
Diabetes Mellitus , Diabetic Foot , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Humans , Diabetes Mellitus/drug therapy , Diabetic Foot/drug therapy , Drugs, Chinese Herbal/therapeutic use , Nonprescription Drugs/therapeutic use , Randomized Controlled Trials as Topic
13.
Zhongguo Zhong Yao Za Zhi ; 49(4): 1102-1112, 2024 Feb.
Article in Chinese | MEDLINE | ID: mdl-38621917

ABSTRACT

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.


Subject(s)
Diabetes Mellitus, Type 2 , Drugs, Chinese Herbal , Humans , Diabetes Mellitus, Type 2/drug therapy , Drugs, Chinese Herbal/adverse effects , Medicine, Chinese Traditional , Nonprescription Drugs/therapeutic use , Quality of Life , Randomized Controlled Trials as Topic
14.
J Dent ; 145: 104989, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38582435

ABSTRACT

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.


Subject(s)
Nonprescription Drugs , Tooth Bleaching Agents , Tooth Bleaching , Toothpastes , Tooth Bleaching/adverse effects , Tooth Bleaching/methods , Humans , Tooth Bleaching Agents/therapeutic use , Tooth Bleaching Agents/adverse effects , Nonprescription Drugs/therapeutic use , Nonprescription Drugs/adverse effects , Toothpastes/therapeutic use , Toothpastes/adverse effects , Mouthwashes/therapeutic use , Mouthwashes/adverse effects , Dentin Sensitivity/chemically induced , Tooth Discoloration/chemically induced , Tooth Discoloration/drug therapy , Hydrogen Peroxide/therapeutic use , Hydrogen Peroxide/adverse effects , Carbamide Peroxide/therapeutic use
15.
BMJ Open ; 14(4): e074188, 2024 Apr 29.
Article in English | MEDLINE | ID: mdl-38684278

ABSTRACT

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 (HPER), 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 HPER, 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.


Subject(s)
Anti-Bacterial Agents , Drug Therapy, Combination , Drugs, Chinese Herbal , Helicobacter Infections , Helicobacter pylori , Network Meta-Analysis , Peptic Ulcer , Humans , Helicobacter Infections/drug therapy , Drugs, Chinese Herbal/therapeutic use , Drugs, Chinese Herbal/adverse effects , Peptic Ulcer/drug therapy , Peptic Ulcer/microbiology , Anti-Bacterial Agents/therapeutic use , Anti-Bacterial Agents/adverse effects , Anti-Bacterial Agents/administration & dosage , Randomized Controlled Trials as Topic , Proton Pump Inhibitors/therapeutic use , Proton Pump Inhibitors/administration & dosage , Proton Pump Inhibitors/adverse effects , Anti-Ulcer Agents/therapeutic use , Anti-Ulcer Agents/administration & dosage , Anti-Ulcer Agents/adverse effects , Treatment Outcome , Nonprescription Drugs/therapeutic use , Nonprescription Drugs/adverse effects
16.
J Infect Public Health ; 17(5): 767-773, 2024 May.
Article in English | MEDLINE | ID: mdl-38518682

ABSTRACT

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.


Subject(s)
COVID-19 , Common Cold , Pharyngitis , Humans , Acetaminophen/therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Aspirin/therapeutic use , Common Cold/drug therapy , Common Cold/chemically induced , Cough , Expectorants/therapeutic use , Headache/chemically induced , Headache/drug therapy , Nonprescription Drugs/therapeutic use , Pandemics , Pharmacists , Pharyngitis/chemically induced , Pharyngitis/drug therapy , Rhinorrhea
18.
Nat Rev Nephrol ; 20(6): 386-401, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38491222

ABSTRACT

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.


Subject(s)
Renal Insufficiency, Chronic , Humans , Renal Insufficiency, Chronic/drug therapy , Pregnancy , Medication Reconciliation , Female , Polypharmacy , Neoplasms/drug therapy , Lactation , Nonprescription Drugs/therapeutic use , Deprescriptions
19.
J Am Pharm Assoc (2003) ; 64(3): 102062, 2024.
Article in English | MEDLINE | ID: mdl-38432479

ABSTRACT

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.


Subject(s)
Analgesics, Opioid , Chronic Pain , Naloxone , Humans , Cross-Sectional Studies , Female , Male , Chronic Pain/drug therapy , Chronic Pain/economics , United States , Adult , Analgesics, Opioid/economics , Analgesics, Opioid/therapeutic use , Middle Aged , Naloxone/economics , Naloxone/therapeutic use , Naloxone/administration & dosage , Surveys and Questionnaires , Narcotic Antagonists/economics , Narcotic Antagonists/therapeutic use , Opioid-Related Disorders/drug therapy , Opioid-Related Disorders/economics , Drug Overdose , Nonprescription Drugs/economics , Nonprescription Drugs/therapeutic use , Young Adult
20.
Am J Med ; 137(6): 490-493, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38490308

ABSTRACT

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.


Subject(s)
COVID-19 Drug Treatment , Nonprescription Drugs , Practice Guidelines as Topic , Humans , Nonprescription Drugs/therapeutic use , COVID-19 , United States , SARS-CoV-2 , Health Personnel , Severity of Illness Index
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