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      Current Characteristics of Herbal Medicine Interventions for Cancer on Clinical Databases: A Cross-Sectional Study

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          Abstract

          Background:

          The utilization of herbal medicine has been noteworthy for treating cancer; however, there is not enough information regarding the characteristics of clinical trials of herbal medicine interventions. This study aimed to evaluate the characteristic of registered trials using herbal medicine interventions for cancer.

          Methods:

          A cross-sectional study was performed via the website ClinicalTrials.gov, ISRCTN registry, Chinese clinical trial registry, and international clinical trials registry platform to gather associated registered clinical trials using an advanced search with the developed keyword strategy as of March 26, 2023. All obtainable information from the trials was collected without any restrictions to conduct a comprehensive review.

          Results:

          A total of 169 registered trials were included for evaluation. Of all trials, 102 trials were eligible for this study. Countries from Asia registered the most trials (62.75%), and hospitals sponsored most of the trials (42.16%). Randomized, Phase 2, interventional trials were dominant, and approximately 64.71% of the trials anticipated recruiting less than 100 participants. More than half of the trials were from 2016 to 2023 (53.92%). While 45 trials were completed, only 16 trials had results for further analysis. According to the completed results, the types of herbal medicines from the trials mainly focused on lung, breast, and colorectal cancer.

          Conclusion:

          This study is the first to explore the characteristics of clinical trials of herbal medicine for cancer registered in large clinical databases. The acquired trials had relatively informative data; however, better-designed trials may be needed for health professionals to consider herbal medicine as an option when treating cancer patients.

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          Most cited references56

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          Cancer statistics, 2022

          Each year, the American Cancer Society estimates the numbers of new cancer cases and deaths in the United States and compiles the most recent data on population-based cancer occurrence and outcomes. Incidence data (through 2018) were collected by the Surveillance, Epidemiology, and End Results program; the National Program of Cancer Registries; and the North American Association of Central Cancer Registries. Mortality data (through 2019) were collected by the National Center for Health Statistics. In 2022, 1,918,030 new cancer cases and 609,360 cancer deaths are projected to occur in the United States, including approximately 350 deaths per day from lung cancer, the leading cause of cancer death. Incidence during 2014 through 2018 continued a slow increase for female breast cancer (by 0.5% annually) and remained stable for prostate cancer, despite a 4% to 6% annual increase for advanced disease since 2011. Consequently, the proportion of prostate cancer diagnosed at a distant stage increased from 3.9% to 8.2% over the past decade. In contrast, lung cancer incidence continued to decline steeply for advanced disease while rates for localized-stage increased suddenly by 4.5% annually, contributing to gains both in the proportion of localized-stage diagnoses (from 17% in 2004 to 28% in 2018) and 3-year relative survival (from 21% to 31%). Mortality patterns reflect incidence trends, with declines accelerating for lung cancer, slowing for breast cancer, and stabilizing for prostate cancer. In summary, progress has stagnated for breast and prostate cancers but strengthened for lung cancer, coinciding with changes in medical practice related to cancer screening and/or treatment. More targeted cancer control interventions and investment in improved early detection and treatment would facilitate reductions in cancer mortality.
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            The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline: a systematic review.

            To systematically review the methodological assessment tools for pre-clinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline. We searched PubMed, the Cochrane Handbook for Systematic Reviews of Interventions, Joanna Briggs Institute (JBI) Reviewers Manual, Centre for Reviews and Dissemination, Critical Appraisal Skills Programme (CASP), Scottish Intercollegiate Guidelines Network (SIGN), and the National Institute for Clinical Excellence (NICE) up to May 20th, 2014. Two authors selected studies and extracted data; quantitative analysis was performed to summarize the characteristics of included tools. We included a total of 21 assessment tools for analysis. A number of tools were developed by academic organizations, and some were developed by only a small group of researchers. The JBI developed the highest number of methodological assessment tools, with CASP coming second. Tools for assessing the methodological quality of randomized controlled studies were most abundant. The Cochrane Collaboration's tool for assessing risk of bias is the best available tool for assessing RCTs. For cohort and case-control studies, we recommend the use of the Newcastle-Ottawa Scale. The Methodological Index for Non-Randomized Studies (MINORS) is an excellent tool for assessing non-randomized interventional studies, and the Agency for Healthcare Research and Quality (ARHQ) methodology checklist is applicable for cross-sectional studies. For diagnostic accuracy test studies, the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool is recommended; the SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool is available for assessing animal studies; Assessment of Multiple Systematic Reviews (AMSTAR) is a measurement tool for systematic reviews/meta-analyses; an 18-item tool has been developed for appraising case series studies, and the Appraisal of Guidelines, Research and Evaluation (AGREE)-II instrument is widely used to evaluate clinical practice guidelines. We have successfully identified a variety of methodological assessment tools for different types of study design. However, further efforts in the development of critical appraisal tools are warranted since there is currently a lack of such tools for other fields, e.g. genetic studies, and some existing tools (nested case-control studies and case reports, for example) are in need of updating to be in line with current research practice and rigor. In addition, it is very important that all critical appraisal tools remain subjective and performance bias is effectively avoided. © 2015 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd.
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              Phytochemicals in Cancer Treatment: From Preclinical Studies to Clinical Practice

              Cancer is a severe health problem that continues to be a leading cause of death worldwide. Increasing knowledge of the molecular mechanisms underlying cancer progression has led to the development of a vast number of anticancer drugs. However, the use of chemically synthesized drugs has not significantly improved the overall survival rate over the past few decades. As a result, new strategies and novel chemoprevention agents are needed to complement current cancer therapies to improve efficiency. Naturally occurring compounds from plants known as phytochemicals, serve as vital resources for novel drugs and are also sources for cancer therapy. Some typical examples include taxol analogs, vinca alkaloids such as vincristine, vinblastine, and podophyllotoxin analogs. These phytochemicals often act via regulating molecular pathways which are implicated in growth and progression of cancer. The specific mechanisms include increasing antioxidant status, carcinogen inactivation, inhibiting proliferation, induction of cell cycle arrest and apoptosis; and regulation of the immune system. The primary objective of this review is to describe what we know to date of the active compounds in the natural products, along with their pharmacologic action and molecular or specific targets. Recent trends and gaps in phytochemical based anticancer drug discovery are also explored. The authors wish to expand the phytochemical research area not only for their scientific soundness but also for their potential druggability. Hence, the emphasis is given to information about anticancer phytochemicals which are evaluated at preclinical and clinical level.
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                Author and article information

                Journal
                Integr Cancer Ther
                Integr Cancer Ther
                ICT
                spict
                Integrative Cancer Therapies
                SAGE Publications (Sage CA: Los Angeles, CA )
                1534-7354
                1552-695X
                15 December 2023
                2023
                : 22
                : 15347354231218255
                Affiliations
                [1 ]Hwasung Medi-Science University, Hwaseong-si, Gyeonggi-do, South Korea
                [2 ]Kyung Hee University, Seoul, Republic of Korea
                Author notes
                [*]Seong-Gyu Ko, Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Seoul, 02447, Republic of Korea. Email: epiko@ 123456khu.ac.kr
                Author information
                https://orcid.org/0000-0002-2345-430X
                Article
                10.1177_15347354231218255
                10.1177/15347354231218255
                10725141
                38099482
                8a2b9f0b-6a51-4176-a98a-3824f5c23e36
                © The Author(s) 2023

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                : 12 February 2023
                : 9 September 2023
                : 13 November 2023
                Funding
                Funded by: National Research Foundation of Korea, FundRef https://doi.org/10.13039/501100003725;
                Award ID: 2020R1A5A2019413
                Categories
                Review Article
                Custom metadata
                January-December 2023
                ts1

                herbal medicine,integrative medicine,cancer patients,herbal drug,clinical trials

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