Why was this study undertaken?
The study “A systematic review of combinatorial treatment with warming and invigorating drugs and levothyroxine for hypothyroidism caused by Hashimoto disease” by Cheng et al. was undertaken to evaluate combinatorial treatment’s safety and clinical efficacy with invigorating drugs and warming and levothyroxine on hypothyroidism arising from Hashimoto’s thyroiditis (Cheng et al., 2016).
What were the aims or hypotheses?
The review’s objective was to evaluate previous evidence-based studies to establish the safety and validity of combining warming and invigorating drugs with levothyroxine in treating hypothyroidism arising from Hashimoto’s thyroiditis (Cheng et al., 2016).
Who were the study participants, and do they match the population?
The study focused on Hashimoto’s thyroiditis patients who also had subclinical hypothyroidism or hypothyroidism complications. However, these complications had to be minor. This led to 472 participants, wherein 231 were in the control group while 241 were in the experimental group (Cheng et al., 2016). The selected participants had symptoms matching the population of interest of the study: individuals having a combination of the two conditions.
What was the study design?
The study was a systematic review to evaluate the safety and clinical efficiency of the combinatorial treatment. Therefore, it involved a search in the Index Medicus, Cochrane Library, Wanfang Data databases for randomized clinical trials (RCTs), the Chinese Biomedical Literature Database, and the China National Knowledge Infrastructure (Cheng et al., 2016). The search retrieved 94 articles, but only seven were included after review because they were the only RCTs.
What were the overall outcomes?
The results established that combining levothyroxine and invigorating drugs and warming increased free thyroxine (FT4) and free triiodothyronine (FT3) levels in the given patients. However, it increased thyroglobulin (TGAb), thyroid peroxidase antibody (TPOAb), and thyroid-stimulating hormone (TSH) levels compared to when levothyroxine alone was administered. Nonetheless, the data obtained for FT4 was relatively unstable (Cheng et al., 2016). Additionally, significant statistical differences were not obtained between the control and experimental groups regarding total therapeutic effects and traditional Chinese medicine (TCM) (Cheng et al., 2016). Similarly, evidence was insufficient to conclude recurrence rate, TCM syndromes scores, adverse reactions, and goiter reduction.
Were sufficient implications for clinical practice discussed?
The authors discussed sufficient implications for clinical practice. They recommended prescriptions for levothyroxine and warming and invigorating drugs to treat hypothyroidism resulting from Hashimoto’s thyroiditis. However, they encouraged a stricter study design, including an unbiased randomization method and a large sample for better clinical curative effects (Hemmati et al., 2019). This increases clinical involvement, reduces practical barriers, and promotes self-management.
What ethical considerations were addressed, and/or not addressed, in the article?
The study addressed multiple ethical considerations. The articles chosen were those that had informed consent from the participants. Additionally, the trials conducted on the participants ensured there was no very actual harm. The preliminary studies also addressed objectivity, respect, and confidentiality in the prior studies, which the authors discussed highly (Artal & Rubenfeld, 2017). The authors also respected intellectual property as they credited the studies they reviewed, which was implicit in their responsible publication act (Artal & Rubenfeld, 2017). The researchers were also honest as they reported data, procedures, and methods as provided in the reviewed articles. Furthermore, the researchers did not use any deception to acquire the information as they searched for information through credible databases.
Where does this study sit on a hierarchy of evidence?
The study sits at level one on a hierarchy of evidence. This is because it is a systematic review, and it offers the best evidence type for the given research gap since data is obtained from multiple comprehensive literature searches (Caldwell & Bennett, 2020; Herner, 2019). Moreover, the studies reviewed are based on RCTs, which also offer quality evidence.
Artal, R., & Rubenfeld, S. (2017). Ethical issues in research. Best Practice & Research Clinical Obstetrics & Gynecology, 43(3), 107-114. Web.
Caldwell, P., & Bennett, T. (2020). Easy guide to conducting a systematic review. Journal of Pediatrics and Child Health, 56(6), 853-856. Web.
Cheng, X., Wei, Z., Zhang, G., Shao, X., Li, B., & Gao, R. (2016). A systematic review of combinatorial treatment with warming and invigorating drugs and levothyroxine for hypothyroidism caused by Hashimoto disease. Annals of Translational Medicine, 4(23), 459-460. Web.
Hemmati, F., Moghtaderi, M., & Hasanshahi, P. (2019). Congenital hypothyroidism in preterm newborns: A retrospective study arising from a screening program in Fars Province, Southwestern Iran. Oman Medical Journal, 34(3), 262-265. Web.
Herner, M. (2019). Perfect top of the evidence hierarchy pyramid, maybe not so perfect: Lessons learned by a novice researcher engaging in a meta-analysis project. BMJ Evidence-Based Medicine, 24(4), 130-132. Web.