Research topic
The research question developed for this evidence based paper is “In type two diabetes patients, the use of herbal medication in comparison with standard therapy improve the glycaemic management within the time frame of 6 months to a year?”
The clinical question has a significant value in the structure and nature of the evidence based literature and the outcome of the study as well. The PICOT framework provides the opportunity to develop clinical question in accordance with the various needs of evidence based practice (Kloda & Bartlett, 2013). This clinical question has also been developed taking the assistance of the PICOT framework. The population in this case had been patients with type 2 diabetes, the intervention chosen is herbal medicine, the comparison element will be patients with standard therapy, the outcome is better glycaemic control, and the time frame selected had been 6 to 12 months.
The research design selected for this research article by Lian et al. (2015) has been a double-Blind, randomized, placebo-controlled, multi-centre trial study. While critically evaluating the research design of the study, double blind and multicentre study is the fact that participants from different centres had been used which indicates that that any information that can influence the behaviour of the subjects is withheld so that there is chances of bias. Considering the process of the research, the HbA1c, FPG, 2h PG, body weight, BMI, HOMA insulin resistance (HOMA-IR) and β-cell function (HOMA- β) were evaluated. The data analysis procedure involved SPSS19.0 software for the statistical analysis of the collected data, t-test or Wilcoxon rank sum test for the between group comparative analysis, along with χ2 test or Fisher’s exact test to evaluate the incidence of adverse events between the two groups. Hence, the data collection, evaluation measurement and data analysis process has been elaborate and extensive which is commendable (Elliott et al., 2017). The ethics of human subject research was maintained by written informed consent and approval by Guanganmen Hospital Medical Ethics Commission in China. The data findings indicated strong evidence of better glycaemic control with Jilinda which enhanced the action of metformin as a potent conjunctive medication (Lian et al., 2015).
Diabetes is one of the most radically spreading epidemic of the 21st century in both developing and developed countries. Considering the example of Australia, 280 Australians have been noted to develop diabetes on a daily basis which round up to 1.7 million Australians to be living with diabetes (Davis et al., 2018). In the past year itself, 100000 Australians have developed diabetes and the numbers are rising every day. Hence, undoubtedly it is one of the most alarming chronic diseases present in Australia and there is need for advanced medication or treatment regimen to help these people manage the diabetes and prevent the onset of the co-morbidities such as cardiovascular diseases, obesity, foot ulcer, and many more. The available treatment regimen present in the health care industry presently is focussed on the symptom management and not on holistic management of the disease (Harding et al., 2014). Along with that, the standard treatment activities associated is also based on a variety of adverse effects without providing desirable glycaemic control. The traditional Chinese medication is based on holistic ideation of the functioning human body, based on the age-old phenomenon of yin and yang. There is mounting evidence that indicates at the effectiveness of the Chinese herbal medication to provide enhanced symptomatic management of diabetes, especially in glycaemic control. However, in order to integrate the Chinese herbal medication into the national strategic chronic disease management framework, it is very important to understand the applicative benefits and feasibility of the treatment intervention (Health.gov.au, 2018). This study hence, had chosen to explore the effects of Chinese herbal medication on diabetes patients as compared to traditional medicine only.
Review of literature
The first article chosen for the research study has been by Lian et al. (2015), a primary resource that has focussed entirely on the effectiveness of Chinese herbal medication Jilinda combined with metformin on the glycaemic control of the type 2 diabetes patents, with comparison to the standard treatment with metformin. The sample size for this research study had been 186 diabetes type 2 patients into two groups, intervention group and placebo groups. In this case, the sample size of the research study has to be criticized, the very small sample size selected for the assignment has to be taken into consideration which can limit the reliability of the data due to enhanced scope of biases (Palinkas et al., 2015). However, the data findings reveal the HbAc1 levels of the intervention group had been reduced by 0.92 ± 1.09% which is undoubtedly a significant reduction within just 12 weeks. Furthermore, the intervention group also showed improved β-cell function with a HOMA-β increase than the placebo group indicating at better glycaemic management facilitated by both Jilinda and metformin as compared to metformin monotherapy. However the only limitation in this case had been the very small sample size and limited time frame of just 12 weeks which restricted the authors to judge the long term impact of combined medication therapy involving both Jilinda and metformin (Lian et al., 2015).
The second primary resource article chosen for this research study had been a large scale, randomized, double?blind, placebo?controlled clinical trial conducted by Tong et al. (2013). This research study however focused on TM81 or Tang-Min-Ling-Wan, a potent Chinese herbal medication which had been used in treating type 2 diabetes. The primary aim and objective of the research article had been to judge the safety and efficiency of administering this particular medication in actual treatment trails on a large scale (Nelson, Macnaughton & Goering, 2015). The sampling had been done for 480 overweight patients with type 2 early stage diabetes and the sampling had been done randomly in a 3:1 ratio of intervention and placebo group. The intervention strength had been 6 g TM81 administered daily for 12 weeks. The data findings indicate the level of HbA1c levels to decrease 1.02% in the intervention group whereas the placebo group had a decrease of only 0.47%. Along with that, the plasma glucose levels of the patients also reduced 0.8 ± 0.1 mM in the intervention group, along with that, β?cell function and homeostatic model assessment (HOMA)? β was also found to be affective with the TM81 intervention group. Hence, from the data findings it can be stated that this Chinese medication also provided better glycaemic control (Tong et al., 2013).
The third article chosen for this review had been by Lian et al. (2014), the purpose of the study had been to explore whether the Chinese herbal medication, Tianqi, for the type 2 diabetes patients. This primary resource had been a double-blind, randomized, placebo-controlled, multi-centre Trial. The research design for the study mimics the previous research studies chosen for the literature article enhancing the reliability and authenticity of the data findings and reducing the possibility of biases. The sample size in this case had been higher with 420 subjects with impaired glucose tolerance who had been enrolled equally yet randomly in intervention and placebo group. The data findings indicated that the Chinese medication Tianqi reduced the risk of type two diabetes by 32.1% without any possible adverse effects as well. Hence, from the data findings of this article, it can be mentioned that the chinese herbal medicines do not only provide better glycaemic control and can be easily integrated into the standard treatment regimen; if used adequately for the at risk target population of the diabetes type two, it can also reduce the chances and probability of acquiring the diseases by a 32%. Hence, undoubtedly the Chinese herbal medication have a strong and significant impact on improving the quality of life among the diabetic patients and can even reduce the risk of acquiring diabetes by a considerable amount. However, it has to be mentioned that there is need for more research to explore the effectiveness of this medication on a large scale basis so that can be easily implemented in clinical practice.
Chinese herbal medication has a strong impact on improving the glycaemic management and improving the overall health of the type 2 diabetics (Lian et al., 2016). The three primary source articles reviewed for this study even though utilized three different Chinese herbal medication but had consistent findings. Whereas the first article by Lian et al., (2015) how effectively the medicine Jilinda can be integrated with metformin to provide higher glycaemic management to the patient. On the other hand, the second article revealed the effectiveness of the TM81 to improve the glycaemic control in the patients (Tong et al., 2013). The third article by Lian et al. (2014) on the other hand provided a completely novel information that Tianqi can even provide preventative control to at risk population with ineffective glycaemic control against acquiring the disease altogether. However, both the sample size and time frame chosen for both the studies had been very limited for it to provide data on large scale and long term applicability. The recommendation will be to explore the effectiveness and efficiency of the Chinese herbal medication involving a larger sample size and for longer time frame, preferably in a multicentre double blind double dummy randomized control trial study design to provide authentic and reliable data devoid of bias.
Lian, F., Tian, J., Chen, X., Li, Z., Piao, C., Guo, J., … & Yuan, C. S. (2015). The efficacy and safety of Chinese herbal medicine Jinlida as add-on medication in type 2 diabetes patients ineffectively managed by metformin monotherapy: a double-blind, randomized, placebo-controlled, multicenter trial. PLoS One, 10(6), e0130550. Retrieved from https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0130550
This double-Blind, randomized, placebo-controlled, multicenter trial study explored the effectiveness of Jilinda when combined with metformin on glycaemic management when compared to metformin monotherapy. The result revealed much better glycaemic management for the combined therapy.
Tong, X. L., Wu, S. T., Lian, F. M., Zhao, M., Zhou, S. P., Chen, X. Y., … & Wang, C. Z. (2013). The safety and effectiveness of TM81, a Chinese herbal medicine, in the treatment of type 2 diabetes: a randomized double?blind placebo?controlled trial. Diabetes, Obesity and Metabolism, 15(5), 448-454. Retrieved from https://onlinelibrary.wiley.com/doi/abs/10.1111/dom.12051
This randomized double?blind placebo?controlled trial study explored the effectiveness of TM81 as compared to placebo to provide better glycaemic control in patients with type 2 diabetes. The data findings revealed the TM81 to provide a drastic improvement in blood glucose level management than standard placebo group.
Lian, F., Li, G., Chen, X., Wang, X., Piao, C., Wang, J., … & Lang, J. (2014). Chinese herbal medicine Tianqi reduces progression from impaired glucose tolerance to diabetes: a double-blind, randomized, placebo-controlled, multicenter trial. The Journal of Clinical Endocrinology & Metabolism, 99(2), 648-655.v. Retrieved from https://academic.oup.com/jcem/article/99/2/648/2537050
This double-blind, randomized, placebo-controlled, multicenter trial explored the effective of Tianqi on patient group having high levels of impaired glucose control. The data findings revealed that the medication can provide 32.1% reduction in risk of acquiring type 2 diabetes.
Chronic disease Overview – Australian Institute of Health and Welfare. (2018). Retrieved from-https://www.aihw.gov.au/reports-statistics/health-conditions-disability-deaths/chronic-disease/overview
Davis, W. A., Peters, K. E., Makepeace, A., Griffiths, S., Bundell, C., Grant, S. F., … & Davis, T. M. (2018). Prevalence of diabetes in Australia: insights from the Fremantle Diabetes Study Phase II. Internal medicine journal, 48(7), 803-809. Retrieved from https://onlinelibrary.wiley.com/doi/abs/10.1111/imj.13792
Elliott, D., Husbands, S., Hamdy, F. C., Holmberg, L., & Donovan, J. L. (2017). Understanding and improving recruitment to randomised controlled trials: qualitative research approaches. European urology. Retrieved rfom https://www.sciencedirect.com/science/article/pii/S0302283817303469
Harding, J. L., Shaw, J. E., Peeters, A., Guiver, T., Davidson, S., & Magliano, D. J. (2014). Mortality trends among people with type 1 and type 2 diabetes in Australia: 1997–2010. Diabetes Care, DC_140096. Retrieved from https://care.diabetesjournals.org/content/early/2014/06/14/dc14-0096.short
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Kloda, L. A., & Bartlett, J. C. (2013). Formulating answerable questions: question negotiation in evidence-based practice. Journal of the Canadian Health Libraries Association, 34(2), 55-60. Retrieved from https://eprints.rclis.org/22563/
Lian, F. M., Pang, B., Zhang, Y., Liu, J., He, L. S., Bai, Y. J., & Tong, X. L. (2016). Prevention of type 2 diabetes with the Chinese herbal medicine Tianqi capsule: a systematic review and meta-analysis. The Lancet Diabetes & Endocrinology, 4, S23. Retrieved from https://www.thelancet.com/journals/landia/article/PIIS2213-8587(16)30378-3/fulltext
Lian, F., Li, G., Chen, X., Wang, X., Piao, C., Wang, J., … & Lang, J. (2014). Chinese herbal medicine Tianqi reduces progression from impaired glucose tolerance to diabetes: a double-blind, randomized, placebo-controlled, multicenter trial. The Journal of Clinical Endocrinology & Metabolism, 99(2), 648-655.v. Retrieved from https://academic.oup.com/jcem/article/99/2/648/2537050
Lian, F., Tian, J., Chen, X., Li, Z., Piao, C., Guo, J., … & Yuan, C. S. (2015). The efficacy and safety of Chinese herbal medicine Jinlida as add-on medication in type 2 diabetes patients ineffectively managed by metformin monotherapy: a double-blind, randomized, placebo-controlled, multicenter trial. PLoS One, 10(6), e0130550. Retrieved from https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0130550
Nelson, G., Macnaughton, E., & Goering, P. (2015). What qualitative research can contribute to a randomized controlled trial of a complex community intervention. Contemporary clinical trials, 45, 377-384. Retrieved from https://www.sciencedirect.com/science/article/pii/S1551714415301075
Palinkas, L. A., Horwitz, S. M., Green, C. A., Wisdom, J. P., Duan, N., & Hoagwood, K. (2015). Purposeful sampling for qualitative data collection and analysis in mixed method implementation research. Administration and Policy in Mental Health and Mental Health Services Research, 42(5), 533-544. Retrieved from https://link.springer.com/article/10.1007/s10488-013-0528-y
Tong, X. L., Wu, S. T., Lian, F. M., Zhao, M., Zhou, S. P., Chen, X. Y., … & Wang, C. Z. (2013). The safety and effectiveness of TM81, a Chinese herbal medicine, in the treatment of type 2 diabetes: a randomized double?blind placebo?controlled trial. Diabetes, Obesity and Metabolism, 15(5), 448-454. Retrieved from https://onlinelibrary.wiley.com/doi/abs/10.1111/dom.12051
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