Chinese Herbal Medicine for the Treatment of Cough Variant Asthma: A Study Protocol for a Double-Blind, Randomized Controlled Trial

Global technological advances have increased the production of artificial medication to treat various infections. However, many herbal medicines are still used in this era due to their consistent positive outcomes. According to Xu et al., china has developed various herbal medication that acts as traditional healing methods that society has embraced due to their efficiency in treating several health conditions, including cough variant asthma (CVA). (1) In the article “Chinese herbal medicine for the treatment of cough variant asthma: a study protocol for a double-blind, randomized controlled trial,” Fan et al. aim to investigate the efficiency of Chinese herbal medicine in the treatment of CVA. (2) Although the study predicts producing significant results demonstrating the efficiency of the medicine in treating CVA, the study findings shall not be considered significant as the study shall be limited by the small sample size and the data collection method to be employed.

The researchers plan to conduct a randomized-control double-blind trial, approved by the Institutional Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine. The participants will be drawn from the respiratory outpatient department, Guangdong Provincial Hospital of Chinese Medicine, registered in the Chinese Clinical Trial Registry, and approved by The study duration is expected to comprise a three-month intervention phase a follow-up phase for six months. The participants’ recruiting procedure will involve advertisements through newspapers, posters, and various social media platforms. The inclusion criteria will consider subjects with active cough variant asthma, aged between 18 and 70 years, and those whose CVAS will be at least two. On the other hand, the exclusion criteria will consist of participants under bronchodilator, CHM, or systematic corticosteroid treatment in the past four months, pregnant and breastfeeding women, those who react negatively to interventional drugs, patients with severe acute or chronic organic disease or mental disorder, and those currently involved in other similar studies. Overall, the research aim at recruiting 60 participants and categorizing them into two groups; the experimental group consuming CHM granules and the control group consuming placebo granules. The primary outcomes will be the changes in CVAS, while the primary outcomes will involve lung functions, blood tests, quality of life, among other secondary outcomes. Next, data analysis will be conducted using the PASW statistic 18.0, chi-square, and fisher’s exact analyses.

Nevertheless, this study’s outcomes are likely to have notable shortcomings in the sample and data collection tools. Firstly, Fan et al. target to sample 60 participants. According to the general scope of the study, this sample size is too small to generalize the results for the entire world population. Small sample size may lead to a higher level of marginal error, thus interfering with the overall conclusion. According to Taherdoost, the sample size is an essential factor to consider in research. The author suggests that, for the generalization of results, the sample size should not be too small as this would ignore the errors and should not be extreme as the results shall be exaggerated. (3) As such, Fan et al. shall not detect the medication side effects due to the small sample size proposed. Larger sample size could have provided better variations in side effects among respondents as the respondents may have varying immune systems. This could have provided a better interpretation of the results. Second, the researchers aim to employ the pill counting method. The participants shall be required to fill a daily medication diary, and the follow-up conducted via phone interviews. A suitable method of data collection should provide room for information validation. Although interviews have been termed effective in providing reliable data in some instances, to some research, it has produced errors, thus affecting the general reliability of the findings. According to Kvale, interviews’ effectiveness depends on the investigators’ ability to ask questions and the integrity of the respondents. The author highlights the possibility of the investigator asking probing questions. (4) This shall affect the overall study findings, and, as such, the results cannot be reliable. Apart from that, the respondent’s integrity to fill the daily medical diaries is questionable. Thus, the results regarding the efficacy of Chinese Herbal medicine shall not be reliable. As expected, some of the respondents shall demonstrate inconsistency, a possible way to fill the data inaccurately. As argued by Rowley, a questionnaire is a limited tool for data collection as the information provided can be erroneous. (5)

In conclusion, this article aims to evaluate a significant subject regarding the efficiency of Chinese Herbal medicine in treating CVA. While the study predicts to produce convincing results, the study is likely to be undermined by the small sample size and poor data collection method proposed, which shall provide unreliable results. The proposed 60 participants cannot fully represent all the required variables for the desired outcomes. Besides, the sample size will have minimal generalization power. In addition, the daily examination diaries may be underreported or exaggerated, hence likely to provide inaccurate reports on the medication outcomes and side effects. As such, Fan et al. should consider increasing their targeted sample size and adopt better data collection tools for accurate and reliable findings.

References

1. Xu HY, Zhang YQ, Liu ZM, Chen T, Lv CY, Tang SH, Zhang XB, Zhang W, Li ZY, Zhou RR, Yang HJ. ETCM: an encyclopedia of traditional Chinese medicine. Nucleic acids research. 2019 Jan 8;47(D1): D976-82. Available at: https://academic.oup.com/nar/article-abstract/47/D1/D976/5144966
2. Fan RR, Wen ZH, Wang DW, Yang RY, Ou AH, Jin LS, Liu YT. Chinese herbal medicine for the treatment of cough variant asthma: a study protocol for a double-blind, randomized controlled trial. Trials. 2019 Dec;20(1):1-8. Available at: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3073-x
3. Taherdoost H. Determining sample size; how to calculate the survey sample size. International Journal of Economics and Management Systems. 2017;2. Available at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3224205
4. Kvale S. Doing interviews. Sage; 2012 Aug 14. Available at: https://books.google.com/books?hl=en&lr=&id=gkBdBAAAQBAJ&oi=fnd&pg=PR5&dq=interviews&ots=bgzgCPaG2-&sig=vK8ivjNwmhmtx_OlJnp-dptmW24
5. Rowley J. Designing and using research questionnaires. Management research review. 2014 Mar 11. Available at: https://www.emerald.com/insight/content/doi/10.1108/MRR-02-2013-0027/full/