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PloS One 2018For nearly a century, no generic form of insulin has been available in the United States. However, the first biosimilar insulin, Basaglar, was approved by the U.S. Food... (Meta-Analysis)
Meta-Analysis Review
IMPORTANCE
For nearly a century, no generic form of insulin has been available in the United States. However, the first biosimilar insulin, Basaglar, was approved by the U.S. Food and Drug Administration in 2015, and subsequently Admelog and Lusduna in 2017.
OBJECTIVE
To summarize the scientific evidence comparing the safety, efficacy, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin products.
DATA SOURCES
We conducted a systematic review using PubMed, Cochrane, Embase, Latin America and Caribbean Health Sciences, South Asian Database of Controlled Clinical Trials, and IndiaMED from their inception through January 14, 2018.
STUDY SELECTION
We included randomized controlled trials (RCTs) comparing safety, clinical efficacy, pharmacokinetics and pharmacodynamics of any biosimilar insulin with a reference product in adults regardless of sample size and location.
DATA EXTRACTION AND SYNTHESIS
Two researchers independently reviewed all titles, abstracts and text; extracted data; and performed quality assessments.
MAIN OUTCOMES AND MEASURES
Efficacy, safety, pharmacokinetics, and pharmacodynamics of biosimilar and reference insulin products.
RESULTS
Of 6945 articles screened, 11 studies were included in the data synthesis. LY2963016, Basalog, Basalin, and MK-1293 were compared to Lantus while SAR342434 was compared to Humalog. Three trials enrolled healthy volunteers, five enrolled type 1 diabetics, and two enrolled type 2 diabetics. One study enrolled both healthy and type 1 diabetics. Of the eleven studies, six examined pharmacokinetic and/or pharmacodynamic parameters and five examined clinical efficacy and immunogenicity. All studies included adverse events. All PK and/or PD studies showed that comparable parameters of biosimilar and reference products were within the pre-specified equivalence margins. Clinical studies suggested similar clinical efficacy and immunogenicity. Adverse events were similar between the groups across all studies.
CONCLUSIONS AND RELEVANCE
Few published studies have compared biosimilar and reference insulins, though those that did suggest that the biosimilars have comparable safety and clinical efficacy as its reference product.
Topics: Biosimilar Pharmaceuticals; Diabetes Mellitus; Humans; Hypoglycemic Agents; Insulins; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 29668697
DOI: 10.1371/journal.pone.0195012 -
Journal of Ethnopharmacology Jan 2022Isatidis Radix (called Banlangen, BLG in Chinese) and Isatidis Folium (called Daqingye, DQY in Chinese) are common traditional edible-medicinal herbs in detoxifying for...
ETHNOPHARMACOLOGICAL RELEVANCE
Isatidis Radix (called Banlangen, BLG in Chinese) and Isatidis Folium (called Daqingye, DQY in Chinese) are common traditional edible-medicinal herbs in detoxifying for thousands of years, have been traditionally applied in traditional Chinese medicine for centuries. Both of them are bitter in taste, coolness in nature, acting on the heart and stomach channels. They are often used to treat influenza and other viral infectious diseases in clinic, as well as could treat fever, dizziness, and cough and sore throat caused by lung heat.
AIMS OF THE REVIEW
This review aimed at summarizing the latest and comprehensive information of BLG and DQY on the ethnopharmacology, phytochemistry, pharmacology, toxicity and clinical application to explore the therapeutic potential of them. In addition, outlooks and perspective for possible future researches that related are also discussed.
MATERIALS AND METHODS
Related information concerning BLG and DQY were gathered from the internet database of Google Scholar, PubMed, Baidu Scholar, GeenMedical, CNKI and Web of Science, as well as other relevant textbooks, reviews, and documents (e.g., Chinese Pharmacopoeia, 2020 edition, Chinese herbal classic books and PhD and MSc thesis, etc.). Among of them with the keywords including "Isatis indigotica" "Isatidis Radix", "Isatidis Folium", "phytochemistry", "pharmacology", "toxicology", "clinical application" etc. and their combinations.
RESULTS
To date, 39 Chinese patent medicines containing BLG and/or DQY have been developed on basis of the data of NMPA. Besides, 304 and 142 compounds have been found in BLG and DQY, respectively. The main chemical differences between BLG and DQY were concentrated on alkaloids and lignans, such as indican, indirubin, (R, S)-epigoitrin, 4(3H)-quinazolinone, clemastanin B and isatindigotindolines A-D. In 2020 Edition ChP, (R, S)-goitrin and indirubin are now used as the official marker to monitor the quality of BLG and DQY, respectively. Modern pharmacology has mainly studied some monomer components such as 4(3H)-quinazolinone, clemastanin B, erucic acid and adenosine, etc., all of which have shown good effects. These active compounds can resist various viruses, such as influenza virus, respiratory syncytial virus, herpes simplex virus, etc.. By regulating the level of immunity and a variety of inflammatory factors, inhibit the growth and reproduction of the virus. At the same time, it is worth noting that different components of BLG and DQY lead to BLG is more powerful in antiviral and immunomodulatory activity than DQY, while DQY possesses a higher intensity than BLG in anti-oxidant activity.
CONCLUSION
By collecting and collating a large number of literature and various data websites, we concluded that the common compounds are mainly alkaloids. Recent findings regarding the phytochemical and pharmacological properties of BLG and DQY have confirmed their traditional uses in antiviral, antibacterial and treatment immune diseases. Without doubt, their significant differences on ethnopharmacology, phytochemistry and pharmacology can be used as evidence of separate list of BLG and DQY. For shortcomings, some comprehensive studies should be well designed for further utilization of BLG and DQY.
Topics: Animals; Drugs, Chinese Herbal; Ethnopharmacology; Humans; Isatis; Medicine, Chinese Traditional; Phytochemicals; Plant Leaves; Plant Roots
PubMed: 34543684
DOI: 10.1016/j.jep.2021.114648 -
BioMed Research International 2018Menstrual bleeding cessation is one of the most frequent gynecologic disorders among women in reproductive age. The treatment is based on hormone therapy. Due to the... (Review)
Review
INTRODUCTION
Menstrual bleeding cessation is one of the most frequent gynecologic disorders among women in reproductive age. The treatment is based on hormone therapy. Due to the increasing request for alternative medicine remedies in the field of women's diseases, in present study, it was tried to overview medicinal plants used to treat oligomenorrhea and amenorrhea according to the pharmaceutical textbooks of traditional Persian medicine (TPM) and review the evidence in the conventional medicine.
METHODS
This systematic review was designed and performed in 2017 in order to gather information regarding herbal medications of oligomenorrhea and amenorrhea in TPM and conventional medicine. This study had several steps as searching Iranian traditional medicine literature and extracting the emmenagogue plants, classifying the plants, searching the electronic databases, and finding evidences. To search traditional Persian medicine references, Noor digital library was used, which includes several ancient traditional medical references. The classification of plants was done based on the repetition and potency of the plants in the ancient literatures. The required data was gathered using databases such as PubMed, Scopus, Google Scholar, Cochrane Library, Science Direct, and web of knowledge.
RESULTS
In present study of all 198 emmenagogue medicinal plants found in TPM, 87 cases were specified to be more effective in treating oligomenorrhea and amenorrhea. In second part of present study, where a search of conventional medicine was performed, 12 studies were found, which had 8 plants investigated: and . Traditional Persian medicine has proposed many different medicinal plants for treatment of oligomenorrhea and amenorrhea. Although just few plants have been proven to be effective for treatment of menstrual irregularities, the results and the classification in present study can be used as an outline for future studies and treatment.
Topics: Amenorrhea; Female; Herbal Medicine; Humans; Iran; Medicine, Traditional; Oligomenorrhea; Phytotherapy; Plants, Medicinal; Sesamum
PubMed: 29744355
DOI: 10.1155/2018/3052768 -
Molecules (Basel, Switzerland) Jul 2023The use of medicinal plants to treat inflammatory conditions and painful processes has attracted the attention of scientists and health professionals due to the evidence... (Review)
Review
The use of medicinal plants to treat inflammatory conditions and painful processes has attracted the attention of scientists and health professionals due to the evidence that natural products can promote significant therapeutic benefits associated with fewer adverse effects compared to conventional anti-inflammatory drugs. The genus is composed of various plants with pharmacological potential, which are used to treat various diseases in traditional communities worldwide. The present study systematically reviewed species with anti-inflammatory and analgesic potential. To this end, a systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol. The search was conducted on the following databases: PubMed, ScienceDirect, SciVerse Scopus, and Web of Science. Different combinations of search terms were used to ensure more excellent article coverage. After the selection, a total of 45 articles were included in this review. This study identified twelve species indicated for the treatment of different inflammatory conditions, such as wounds, fever, bronchitis, abscess, asthma, hepatitis, labyrinthitis, tonsillitis, and uterine inflammation. The indications for pain conditions included headache, sore throat, heartburn, menstrual cramp, colic, toothache, stomachache, migraine, chest pain, abdominal pain, local pain, labor pain, and recurring pain. Among the listed species, ten plants were found to be used according to traditional knowledge, although only four of them have been experimentally studied. When assessing the methodological quality of preclinical in vivo assays, most items presented a risk of bias. The SR results revealed the existence of different species used to treat inflammation and pain. The results of this systematic review indicate that species have the potential to be used in the treatment of diseases with an inflammatory component, as well as in the management of pain. However, given the risk of biases, the experimental analysis of these species through preclinical testing is crucial for their safe and effective use.
Topics: Female; Pregnancy; Humans; Ethnopharmacology; Phytotherapy; Plectranthus; Abdominal Pain; Analgesics; Anti-Inflammatory Agents; Inflammation; Phytochemicals
PubMed: 37570622
DOI: 10.3390/molecules28155653 -
Fitoterapia Oct 2022In Africa, herbalism supplements allopathic medicine's efforts to ensure Universal Health Coverage attainment. This review was conducted to identify and to summarise... (Review)
Review
BACKGROUND
In Africa, herbalism supplements allopathic medicine's efforts to ensure Universal Health Coverage attainment. This review was conducted to identify and to summarise current literature on methodological approaches used for quality control of herbal medicines in Africa, to evaluate the gaps associated with existing strategies within context of best practices, and make recommendations for future improvements.
METHODS
A systematic search was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Articles were screened and assessed for eligibility.
RESULTS
118 articles were included into the study. There was a high preference for impurity profiling tests (77%) indicating the prioritization for tests that guarantee safety despite the limited analytical resources available. Other classes of tests reported included identification tests (29%), physicochemical tests (18%), and content assays (12%). Although standard methods exist in preparing samples for impurity tests, different techniques were observed in different studies, and this could lead to differences in analytical outcomes. Content assays focused on single marker assessments, which may be inadequate to comprehensively assess the quality of products.
CONCLUSION
This review provides knowledge of existing strengths and challenges for herbal medicine quality assessments in Africa. For future it is recommended to implement more studies on contaminants (e.g. mycotoxins) and pharmaceutical adulterants. The use of chemometrics to develop analytical methods should be promoted. Also, stakeholders in the medicine quality industry in Africa need to effectively collaborate to establish a well co-ordinated and harmonized system to provide a sustainable framework for the GACP and GMP guided production and quality assurance of herbal medicines.
Topics: Herbal Medicine; Molecular Structure; Mycotoxins; Phytotherapy; Plants, Medicinal
PubMed: 36031027
DOI: 10.1016/j.fitote.2022.105287 -
Journal of Ethnopharmacology Jan 2024Infertility is a global public health issue related to gynecological diseases and psychological disorders such as stress, depression, and fatigue. Prescriptions of... (Meta-Analysis)
Meta-Analysis Review
ETHNOPHARMACOLOGICAL RELEVANCE
Infertility is a global public health issue related to gynecological diseases and psychological disorders such as stress, depression, and fatigue. Prescriptions of various herbs in traditional East Asian medicine (TEAM) have recently gained attention among patients as a complementary alternative therapy for female infertility. However, studies on systemic analysis of the use of herbal medicines according to TEAM patterns or the therapeutic effects of herbal medicines on female infertility are limited.
AIM OF THE STUDY
We aimed to systematically investigate the single herb and TEAM patterns that are commonly used for treating female infertility using network analysis. Additionally, we performed a meta-analysis to assess the effect of herbal medicine on the pregnancy rate in women with infertility.
MATERIALS AND METHODS
PubMed, EMBASE, Korean Studies Information Service System, Science ON, Research Information Sharing Service, and Oriental Medicine Advanced Searching Integrated System were searched for randomized controlled trials (RCTs) reporting the pregnancy rate of herbal medicine for infertility until July 2021. Following identifying the top three herbs used in treating female infertility, a network analysis was performed to reveal the TEAM pattern relationships between each herb. A meta-analysis was performed to evaluate the therapeutic effect of herbal medicine on pregnancy rate. Moreover, the methodological quality of RCTs was analyzed using Consolidated Standards of Reporting Trials (CONSORT) extension guidelines and the Risk of bias (RoB) tool.
RESULTS
Eighteen RCTs with 2,662 participants were included. Cuscuta chinensis Lam. (Tusizi) is the most commonly used herb for treating female infertility, followed by Angelica gigas Nakai (Danggui) and Cyperus rotundus L. (Xiangfuzi). These herbs were mainly used to treat patients with kidney deficiency or kidney deficiency combined with blood stasis or Phlegm-dampness on the TEAM pattern. The meta-analysis revealed that the effect of herbal medicine led to a significant increase in pregnancy rates compared to the placebo treatment. Adverse events in the included studies were generally mild and infrequent. The methodological quality of RCTs using CONSORT extension was poor, while the RoB of the included RCTs was generally low.
CONCLUSIONS
The findings of this review suggest that herbal medicine will be beneficial for treating female infertility by improving pregnancy rates. However, more carefully designed studies on herbal medicines are encouraged to improve the quality of herbal medicine research in the future.
Topics: Pregnancy; Female; Humans; Infertility, Female; Drugs, Chinese Herbal; Phytotherapy; Herbal Medicine; Plants, Medicinal
PubMed: 37778518
DOI: 10.1016/j.jep.2023.117258 -
British Journal of Clinical Pharmacology Nov 2012The rate of medication errors is high, and these errors can cause adverse drug reactions. Elderly individuals are most vulnerable to adverse drug reactions. One cause of... (Review)
Review
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
The rate of medication errors is high, and these errors can cause adverse drug reactions. Elderly individuals are most vulnerable to adverse drug reactions. One cause of medication errors is the lack of drug knowledge on the part of different health professionals. Medical curricula have changed in recent years, resulting in less education in the basic sciences, such as pharmacology.
WHAT THIS STUDY ADDS
Our study shows that little curricular time is devoted to geriatric pharmacology and that educational programmes in geriatric pharmacology have not been thoroughly evaluated. While interest in pharmacology education has increased recently, this is not the case for geriatric pharmacology education. Education on geriatric pharmacology should have more attention in the curricula of health professionals, given the often complex pharmacotherapy in elderly patients. Educational topics should be related to the known risk factors of medication errors, such as polypharmacy, dose adjustments in organ dysfunction and psychopharmacotherapeutics.
AIMS
Given the reported high rates of medication errors, especially in elderly patients, we hypothesized that current curricula do not devote enough time to the teaching of geriatric pharmacology. This review explores the quantity and nature of geriatric pharmacology education in undergraduate and postgraduate curricula for health professionals.
METHODS
Pubmed, Embase and PsycINFO databases were searched (from 1 January 2000 to 11 January 2011), using the terms 'pharmacology' and 'education' in combination. Articles describing content or evaluation of pharmacology education for health professionals were included. Education in general and geriatric pharmacology was compared.
RESULTS
Articles on general pharmacology education (252) and geriatric pharmacology education (39) were included. The number of publications on education in general pharmacology, but not geriatric pharmacology, has increased over the last 10 years. Articles on undergraduate and postgraduate education for 12 different health disciplines were identified. A median of 24 h (from 15 min to 4956 h) devoted to pharmacology education and 2 h (1-935 h) devoted to geriatric pharmacology were reported. Of the articles on education in geriatric pharmacology, 61.5% evaluated the teaching provided, mostly student satisfaction with the course. The strength of findings was low. Similar educational interventions were not identified, and evaluation studies were not replicated.
CONCLUSIONS
Recently, interest in pharmacology education has increased, possibly because of the high rate of medication errors and the recognized importance of evidence-based medical education. Nevertheless, courses on geriatric pharmacology have not been evaluated thoroughly and none can be recommended for use in training programmes. Suggestions for improvements in education in general and geriatric pharmacology are given.
Topics: Curriculum; Drug-Related Side Effects and Adverse Reactions; Education, Graduate; Education, Professional; Geriatrics; Health Personnel; Humans; Medication Errors; Pharmaceutical Preparations; Pharmacology; Risk Factors
PubMed: 22416832
DOI: 10.1111/j.1365-2125.2012.04268.x -
Phytotherapy Research : PTR Aug 2017Searching for new natural drugs that are capable of targeting Th1 and Th17 may lead to development of more effective treatments for inflammatory and autoimmune diseases.... (Review)
Review
Searching for new natural drugs that are capable of targeting Th1 and Th17 may lead to development of more effective treatments for inflammatory and autoimmune diseases. Most of the natural drugs can be derived from plants that are used in traditional medicine and folk medicine. The aim of this systematic review is to identify and introduce plants or plant derivatives that are effective on inflammatory diseases by inhibiting Th1 and Th17 responses. To achieve this purpose, the search terms herb, herbal medicine, herbal drug, medicinal plant, phytochemical, traditional Chinese medicine, Ayurvedic medicine, natural compound, inflammation, inflammatory diseases, Th1, Th17, T helper 1 or T helper 17 were used separately in Title/Keywords/Abstract in Web of Science and PubMed databases. In articles investigating the effect of the medicinal plants and their derivatives in inhibiting Th1 and Th17 cells, the effects of eight extracts of the medicinal plants, 21 plant-based compounds and some of their derivatives, and eight drugs derived from the medicinal plants' compounds in inhibiting Th1 and Th17 cells were reviewed. The results showed that medicinal plants and their derivates are able to suppress Th17 and Th1 T cell functions as well as cytokine secretion and differentiation. The results can be used to produce herbal drugs that suppress Th, especially Th17, responses. Copyright © 2017 John Wiley & Sons, Ltd.
Topics: Animals; Cell Differentiation; Herbal Medicine; Humans; Inflammation; Medicine, Traditional; Phytotherapy; Plant Extracts; Plants, Medicinal; Th1 Cells; Th17 Cells
PubMed: 28568565
DOI: 10.1002/ptr.5837 -
Pharmacology Research & Perspectives Dec 2023Pharmacogenomics remains underutilized in clinical practice, despite the existence of internationally recognized, evidence-based guidelines. This systematic review aims... (Review)
Review
Pharmacogenomics remains underutilized in clinical practice, despite the existence of internationally recognized, evidence-based guidelines. This systematic review aims to understand enablers and barriers to pharmacogenomics implementation in pediatric oncology by assessing the knowledge, attitudes, and practice of healthcare professionals and consumers. Medline, Embase, Emcare, and PsycINFO database searches identified 146 relevant studies of which only three met the inclusion criteria. These studies reveal that consumers were concerned with pharmacogenomic test costs, insurance discrimination, data sharing, and privacy. Healthcare professionals possessed mostly positive attitudes toward pharmacogenomic testing yet identified lack of experience and training as barriers to implementation. Education emerged as the key enabler, reported in all three studies and both healthcare professionals and consumer groups. However, despite the need for education, no studies utilizing a pediatric oncology consumer or healthcare professional group have reported on the implementation or analysis of a pharmacogenomic education program in pediatric oncology. Increased access to guidelines, expert collaborations and additional guidance interpreting results were further enablers established by healthcare professionals. The themes identified mirror those reported in broader pediatric genetic testing literature. As only a small number of studies met inclusion criteria for this review, further research is warranted to elicit implementation determinants and advance pediatric pharmacogenomics.
Topics: Humans; Child; Pharmacogenetics; Health Knowledge, Attitudes, Practice; Health Personnel; Medical Oncology; Neoplasms
PubMed: 38013228
DOI: 10.1002/prp2.1150 -
Pain Medicine (Malden, Mass.) Jan 2014This study was conducted to compare safety and efficacy outcomes between opioids formulated with technologies designed to deter or resist tampering (i.e.,... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
This study was conducted to compare safety and efficacy outcomes between opioids formulated with technologies designed to deter or resist tampering (i.e., abuse-deterrent formulations [ADFs]) and non-ADFs for commonly prescribed opioids for treatment of non-cancer pain in adults.
METHODS
PubMed and Cochrane Library databases were searched for opioid publications between September 1, 2001 and August 31, 2011, and pivotal clinical trials from all years; abstracts from key pain conferences (2010-2011) were also reviewed. One hundred and ninety-one publications were initially identified, 68 of which met eligibility criteria and were systematically reviewed; a subset of 16 involved a placebo group (13 non-ADFs vs placebo, 3 ADFs vs placebo) and reported both efficacy and safety outcomes, and were included for a meta-analysis. Summary estimates of standardized difference in mean change of pain intensity (DMCPI), standardized difference in sum of pain intensity difference (DSPID), and odds ratios (ORs) of each adverse event (AE) were computed through random-effects estimates for ADFs (and non-ADFs) vs placebo. Indirect treatment comparisons were conducted to compare ADFs and non-ADFs.
RESULTS
Summary estimates for standardized DMCPI and for standardized DSPID indicated that ADFs and non-ADFs showed significantly greater efficacy than placebo in reducing pain intensity. Indirect analyses assessing the efficacy outcomes between ADFs and non-ADFs indicated that they were not significantly different (standardized DMCPI [0.39 {95% confidence interval (CI) 0.00-0.76}]; standardized DSPID [-0.22 {95% CI -0.74 to 0.30}]). ADFs and non-ADFs both were associated with higher odds of AEs than placebo. Odds ratios from indirect analyses comparing AEs for ADFs vs non-ADFs were not significant (nausea, 0.87 [0.24-3.12]; vomiting, 1.54 [0.40-5.97]; dizziness/vertigo, 0.61 [0.21-1.76]; headache, 1.42 [0.57-3.53]; somnolence/drowsiness, 0.47 [0.09-2.58]; constipation, 0.64 [0.28-1.49]; pruritus 0.41 [0.05-3.51]).
CONCLUSION
ADFs and non-ADFs had comparable efficacy and safety profiles, while both were more efficacious than placebo in reducing pain intensity.
Topics: Adult; Chemistry, Pharmaceutical; Clinical Trials as Topic; Constipation; Delayed-Action Preparations; Headache Disorders, Secondary; Humans; Narcotics; Nausea; Opioid-Related Disorders; Pain Management; Pain, Postoperative; Substance-Related Disorders; Treatment Outcome
PubMed: 24112715
DOI: 10.1111/pme.12233