From the CONSORT to the ConPhyMP statement and beyond—how to ascertain best practice

With the implementation of the ConPhyMP reporting tool as an element of peer review in Frontiers in Pharmacology, Section Ethnopharmacology and in other journals, this short perspective paper highlights the use of a new tool available via the website of the Society for Medicinal Plant and Natural Product Research (https://ga-online.org/best-practice/) and how to use it. The ConPhyMP guidelines and the tool cover the relevant aspects which need to be reported when studying a plant extract using pharmacological, toxicological microbiological, clinical and other approaches. In our vision, science will only remain impactful if it is based on a drive for best practice, i.e., on a sound conceptual and methodological basis

Reporting guidelines for medicinal plant extracts used in pharmacological and toxicological research: ConPhyMP

Every year, the number of studies that evaluate the pharmacological effects, (clinical) efficacy or the toxicity of medicinal plant extracts is constantly increasing, but the reporting quality remains unsatisfactory. One of the main reasons is that there is a lack of detailed reporting standards for guidance. In response to this long-standing challenge, a core group of nine experts with proficiency in phytochemical analysis, including editors-in-chief of leading specialist journals, and based in different research settings globally, developed the Consensus based reporting guidelines for Phytochemical Characterisation of Medicinal Plant extracts (ConPhyMP) through a multi-staged development process. This incorporated a) a global survey among medicinal plant researchers, b) a core group, who reviewed and developed the guidelines through a Delphi process, and c) an advisory group of 20 experts, including editors of leading journals and scientific societies in medicinal plants research, who provided feedback and sanctioned the final guidelines. The ConPhyMP guidelines comprise two tables with accompanying explanatory figures. The first table provides recommendations for reporting the starting material and its initial processing, and the second table presents recommendations for conducting and reporting the analytical methods for defining the chemical profile based on the type of extracts used in the research. The group hopes that the ConPhyMP will support authors as well as peer reviewers and editors assessing these studies for publication and assist the production of evidence-based guidance of studies utilising medicinal plant extracts

Best practice in the chemical characterisation of extracts used in pharmacological and toxicological researcht - the ConPhyMP-guidelines

BACKGROUND : Research on medicinal plants and extracts derived from them differs from studies performed with single compounds. Extracts obtained from plants, algae, fungi, lichens or animals pose some unique challenges: they are multicomponent mixtures of active, partially active and inactive substances, and the activity is often not exerted on a single target. Their composition varies depending on the method of preparation and the plant materials used. This complexity and variability impact the reproducibility and interpretation of pharmacological, toxicological and clinical research. OBJECTIVES : This project develops best practice guidelines to ensure reproducibility and accurate interpretations of studies using medicinal plant extracts. The focus is on herbal extracts used in pharmacological, toxicological, and clinical/intervention research. Specifically, the consensus-based statement focuses on defining requirements for: 1) Describing the plant material/herbal substances, herbal extracts and herbal medicinal products used in these studies, and 2) Conducting and reporting the phytochemical analysis of the plant extracts used in these studies in a reproducible and transparent way. THE PROCESS AND METHODS : We developed the guidelines through the following process: 1) The distinction between the three main types of extracts (extract types A, B, and C), initially conceptualised by the lead author (MH), led the development of the project as such; 2) A survey among researchers of medicinal plants to gather global perspectives, opportunities, and overarching challenges faced in characterising medicinal plant extracts under different laboratory infrastructures. The survey responses were central to developing the guidelines and were reviewed by the core group; 3) A core group of 9 experts met monthly to develop the guidelines through a Delphi process; and. 4) The final draft guidelines, endorsed by the core group, were also distributed for feedback and approval to an extended advisory group of 20 experts, including many journal editors. OUTCOME : The primary outcome is the “Consensus statement on the Phytochemical Characterisation of Medicinal Plant extracts“ (ConPhyMP) which defines the best practice for reporting the starting plant materials and the chemical methods recommended for defining the chemical compositions of the plant extracts used in such studies. The checklist is intended to be an orientation for authors in medicinal plant research as well as peer reviewers and editors assessing such research for publication.Willmar Schwabe GmbH & Co. KG, Germany.https://www.frontiersin.org/journals/pharmacologydm2022Paraclinical Science

Best Practice in the chemical characterisation of extracts used in pharmacological and toxicological research—The ConPhyMP—Guidelines

The Advisory group on Consensus statement on the Phytochemical Characterisation of Medicinal Plant extracts (ConPhyMP) is a consortium of experts on Pharmacognosy and Phytochemistry open access articleBackground: Research onmedicinal plants and extracts derived fromthem differs from studies performed with single compounds. Extracts obtained from plants, algae, fungi, lichens or animals pose some unique challenges: they are multicomponent mixtures of active, partially active and inactive substances, and the activity is often not exerted on a single target. Their composition varies depending on the method of preparation and the plant materials used. This complexity and variability impact the reproducibility and interpretation of pharmacological, toxicological and clinical research. Objectives: This project develops best practice guidelines to ensure reproducibility and accurate interpretations of studies using medicinal plant extracts. The focus is on herbal extracts used in pharmacological, toxicological, and clinical/intervention research. Specifically, the consensus-based statement focuses on defining requirements for: 1) Describing the plant material/herbal substances, herbal extracts and herbal medicinal products used in these studies, and 2) Conducting and reporting the phytochemical analysis of the plant extracts used in these studies in a reproducible and transparent way. The process and methods: We developed the guidelines through the following process: 1) The distinction between the three main types of extracts (extract types A, B, and C), initially conceptualised by the lead author (MH), led the development of the project as such; 2) A survey among researchers of medicinal plants to gather global perspectives, opportunities, and overarching challenges faced in characterising medicinal plant extracts under different laboratory infrastructures. The survey responses were central to developing the guidelines and were reviewed by the core group; 3) A core group of 9 experts met monthly to develop the guidelines through a Delphi process; and. 4) The final draft guidelines, endorsed by the core group, were also distributed for feedback and approval to an extended advisory group of 20 experts, including many journal editors. Outcome: The primary outcome is the “Consensus statement on the Phytochemical Characterisation of Medicinal Plant extracts“ (ConPhyMP) which defines the best practice for reporting the starting plant materials and the chemical methods recommended for defining the chemical compositions of the plant extracts used in such studies. The checklist is intended to be an orientation for authors in medicinal plant research as well as peer reviewers and editors assessing such research for publicatio

Herbal Supplements In The Middle East (Iraq And Jordan): Regulation, Quality And Safety Of And Development Of A Method To Detect Common Adulterants

Herbal supplements are important and widely used health care choices but also pose a global challenge in quality and safety. The lack of regulations and less stringent supply chains, for example, result in adulterations with undeclared synthetic substances. The extent and nature of this issue are unknown in the Middle East. Pharmacists manage these products, and their role is critical to educate and advise the public on the risks and benefits associated with these products. Besides, analytical methods for easy implementation in laboratories without sophisticated instrumentations and limited resources are always in demand, particularly in developing countries. This research project’s objective was to determine the extent and nature of low-quality herbal supplements and explore pharmacists' perceptions and views towards herbal supplements, focusing on two Middle Eastern countries (i.e., Iraq and Jordan). Two questionnaires were used to explore Iraqi and Jordanian pharmacists' perception of herbal supplements. Of 74 participants included in the Iraqi pharmacists' pilot survey, 97% reported the availability of these products in their pharmacies; slimming aids followed by sexual enhancements were the most requested products by Iraqi consumers. The Jordanian pharmacists' survey included 401 participants; 98% reported the availability of these products in their pharmacies; supplements for slimming followed by sexual enhancements were the most requested by the Jordanian consumers. 56% of Jordanian pharmacists reported good knowledge about regulations, adverse reactions, and interactions of herbal medicines. The nature of low-quality herbal supplements was determined using 40 samples promoted as slimming aids and sexual enhancers. This study used HPTLC and packaging analysis. The HPTLC identified that 47.5% of slimming and sexual enhancer samples contain at least one adulterant, i.e., a substance not declared on the packaging and leaflet. The packaging and leaflet analysis showed that 73% contained no safety information. The results of this multi-disciplinary PhD project could provide a unique contribution to the evolving discipline of pharmacy research, education, and quality assurance of herbal supplements

Simultaneous identification of common synthetic adulterants in slimming aids and sexual enhancers herbal supplements by High-performance Thin Layer Chromatography

Introduction Herbal supplements are important and widely used health care choices but also pose a global challenge in quality and safety. The lack of regulations and less stringent value chains, for example, result in adulterations with undeclared synthetic substances. The extent and nature of this issue has been unknown in the Middle East. Besides, analytical methods for easy implementation in laboratories without sophisticated instrumentations and limited resources are always in demand, particularly in developing countries. To the best of our knowledge, all proposed methodologies to date focused on identifying one class of synthetic adulterants, such as erectile dysfunction drugs [1] and anti-obesity drugs [2]. This project aimed to develop and validate a simple, rapid, robust, specific, reliable and cost-effective qualitative and quantitative HPTLC method. Materials and Methods 40 samples were collected from pharmacies and herbal shops in Iraq, including those promoted for slimming and sexual enhancements. During method development, several steps were optimised, including the choice of stationary phase, mobile phase, samples extraction, injection volumes, detection and derivatisation. Ethanol solvent system with silica gel as stationary phase was selected. It enabled a good separation of all reference standards (i.e., R F value ranged from 0.10 to 0.76, and injection volumes varied from 2 to 20 μl). Results and Discussions The developed method was validated for specificity, precision, repeatability, and linearity. The limit of detection (148-1378μg), the limit of quantification (450-4176μg), and the regression coefficient was calculated. Out of the samples analysed, 48% (n=19) contained one adulterant; among these, 15% (n=6) contained two adulterants. [Figure 1] shows the percentage of adulterants identified in herbal supplements promoted for slimming and sexual enhancements (n=40). Conclusions The use of supplements promoted for slimming and sexual enhancement could impose a health risk to the consumers due to common adulterations in such products. The method developed enables a efficient one-step detection of common adulterants

Herbal supplements in Jordan: a cross-sectional survey of pharmacists’ perspectives and knowledge

Objectives Pharmacists are ideal partners for engaging with the needs and expectations of patients. They can play a vital role by providing information and supplying herbal medicines. In some community settings, pharmacists are also the main first point of care. This study explored Jordanian community pharmacists’ perspectives and knowledge of herbal medicines available in pharmacies.Design A cross-sectional study using an online survey was developed, and it was distributed via social media platforms. The one-way analysis of variance (ANOVA) test was used to compare the mean knowledge scores between different demographic groups. Multiple linear regression analysis was used to identify predictors of herbal medicines knowledge.Setting Jordanian community pharmacies.Participants 401 Jordanian community pharmacists.Results Herbal supplements are sold in practically all pharmacies (98.5%). Slimming aids (14.7%), followed by sexual and sports enhancements (14%) and maintaining general health (12.1%) were most requested by Jordanian customers. While supplements for maintaining general health (12%), followed by slimming aids (11.4%) and skin conditions (9.3%) were most recommended by Jordanian pharmacists. 63.1% were not aware of potential herb–drug interactions, 95.6% did not receive complaints from customers about herbal medicines and 41.2% would not report adverse reactions to the national pharmacovigilance services. The mean knowledge score for knowledge of use, regulation, adverse reactions, and drug interactions was 3.7 (SD: 0.7), 3.5 (SD: 0.8), 3.6 (SD: 0.8), and 3.6 (SD: 0.8) (out of 5), respectively. ANOVA test showed that total pharmacists’ knowledge scores significantly differed based on the length of time practising pharmacy (p<0.05).Conclusion This study highlights some key concerns relating to recommendations, awareness and reporting of herbal medicines among Jordanian community pharmacists. Pharmacists need enhanced education to provide objective and evidence-based information on the benefits–risks of herbal medicines. Future studies need to be carried out to confirm whether our findings are transferable to other Middle Eastern countries

Global variation in postoperative mortality and complications after cancer surgery: a multicentre, prospective cohort study in 82 countries

© 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 licenseBackground: 80% of individuals with cancer will require a surgical procedure, yet little comparative data exist on early outcomes in low-income and middle-income countries (LMICs). We compared postoperative outcomes in breast, colorectal, and gastric cancer surgery in hospitals worldwide, focusing on the effect of disease stage and complications on postoperative mortality. Methods: This was a multicentre, international prospective cohort study of consecutive adult patients undergoing surgery for primary breast, colorectal, or gastric cancer requiring a skin incision done under general or neuraxial anaesthesia. The primary outcome was death or major complication within 30 days of surgery. Multilevel logistic regression determined relationships within three-level nested models of patients within hospitals and countries. Hospital-level infrastructure effects were explored with three-way mediation analyses. This study was registered with ClinicalTrials.gov, NCT03471494. Findings: Between April 1, 2018, and Jan 31, 2019, we enrolled 15 958 patients from 428 hospitals in 82 countries (high income 9106 patients, 31 countries; upper-middle income 2721 patients, 23 countries; or lower-middle income 4131 patients, 28 countries). Patients in LMICs presented with more advanced disease compared with patients in high-income countries. 30-day mortality was higher for gastric cancer in low-income or lower-middle-income countries (adjusted odds ratio 3·72, 95% CI 1·70–8·16) and for colorectal cancer in low-income or lower-middle-income countries (4·59, 2·39–8·80) and upper-middle-income countries (2·06, 1·11–3·83). No difference in 30-day mortality was seen in breast cancer. The proportion of patients who died after a major complication was greatest in low-income or lower-middle-income countries (6·15, 3·26–11·59) and upper-middle-income countries (3·89, 2·08–7·29). Postoperative death after complications was partly explained by patient factors (60%) and partly by hospital or country (40%). The absence of consistently available postoperative care facilities was associated with seven to 10 more deaths per 100 major complications in LMICs. Cancer stage alone explained little of the early variation in mortality or postoperative complications. Interpretation: Higher levels of mortality after cancer surgery in LMICs was not fully explained by later presentation of disease. The capacity to rescue patients from surgical complications is a tangible opportunity for meaningful intervention. Early death after cancer surgery might be reduced by policies focusing on strengthening perioperative care systems to detect and intervene in common complications. Funding: National Institute for Health Research Global Health Research Unit

Effects of hospital facilities on patient outcomes after cancer surgery: an international, prospective, observational study

© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 licenseBackground: Early death after cancer surgery is higher in low-income and middle-income countries (LMICs) compared with in high-income countries, yet the impact of facility characteristics on early postoperative outcomes is unknown. The aim of this study was to examine the association between hospital infrastructure, resource availability, and processes on early outcomes after cancer surgery worldwide. Methods: A multimethods analysis was performed as part of the GlobalSurg 3 study—a multicentre, international, prospective cohort study of patients who had surgery for breast, colorectal, or gastric cancer. The primary outcomes were 30-day mortality and 30-day major complication rates. Potentially beneficial hospital facilities were identified by variable selection to select those associated with 30-day mortality. Adjusted outcomes were determined using generalised estimating equations to account for patient characteristics and country-income group, with population stratification by hospital. Findings: Between April 1, 2018, and April 23, 2019, facility-level data were collected for 9685 patients across 238 hospitals in 66 countries (91 hospitals in 20 high-income countries; 57 hospitals in 19 upper-middle-income countries; and 90 hospitals in 27 low-income to lower-middle-income countries). The availability of five hospital facilities was inversely associated with mortality: ultrasound, CT scanner, critical care unit, opioid analgesia, and oncologist. After adjustment for case-mix and country income group, hospitals with three or fewer of these facilities (62 hospitals, 1294 patients) had higher mortality compared with those with four or five (adjusted odds ratio [OR] 3·85 [95% CI 2·58–5·75]; p<0·0001), with excess mortality predominantly explained by a limited capacity to rescue following the development of major complications (63·0% vs 82·7%; OR 0·35 [0·23–0·53]; p<0·0001). Across LMICs, improvements in hospital facilities would prevent one to three deaths for every 100 patients undergoing surgery for cancer. Interpretation: Hospitals with higher levels of infrastructure and resources have better outcomes after cancer surgery, independent of country income. Without urgent strengthening of hospital infrastructure and resources, the reductions in cancer-associated mortality associated with improved access will not be realised. Funding: National Institute for Health and Care Research