Content of review 1, reviewed on April 16, 2020

Paper title: A randomized controlled clinical trial evaluating the effect of Trigonella foenum-graecum (fenugreek) versus glibenclamide in patients with diabetes.

DOI: 10.4314/ahs.v19i1.34

Abstract, title and references 1. Is the aim clear? The objective the article was stated clearly in this article 2. Is it clear what the study found and how they did it? What the study found had been informed in the abstract, however, it is not clear enough since the authors only stated whether it is increase or decrease and only presented the p value. The value of each variable reported (blood glucose, insulin, ratio of high- to low-density lipoprotein) was not stated. Regarding how the authors did the study, it was clearly stated. 3. Is the title informative and relevant? The title was relevant. However, the title was not informative enough. It would be better if the title reporting what the study found. 4. Are the references: a. Relevant? The references used in this article were relevant with the topic of this article b. Recent? The references used were up-to-date. Several references were more than 10 years, however the information were recently up-to-dated in those years. c. Referenced correctly? The format of the references were in correct manner d. Are appropriate key studies included? Yes, the key studies

Introduction/background 1. Is it clear what is already known about this topic? Yes. In the introduction, it was clearly stated the relevant and recent knowledge regarding the Trigonella foenum-graecum (fenugreek), management of diabetes, and relevant previous studies regarding fenugreek. 2. Is the research question clearly outlined? The research question was clearly stated in the end of the introduction section. 3. Is the research question justified given what is already known about the topic? Yes, the recent knowledge regarding the topic of this article was already outlined and the research question is in align with the known knowledge.

Methods 1. Is the process of subject selection clear? The subject selection was clear. The exclusion criteria were clearly outlined, the allocation was described adequately. 2. Are the variables defined and measured appropriately? Several variables relevant to this topic were defined and measured appropriately, which is HbA1C and blood glucose. However, the method of measurement for plasma lipid profiles were not stated clearly. 3. Are the study methods valid and reliable? The study methods were valid and reliable. The authors employed appropriate statistical analysis. The design of the study also appropriate to obtain the expected result. Either the radom allocation, concealment and randomization was employed appropriately. 4. Is there enough detail in order to replicate the study? Yes. The methods were described completely in order to replicate the study.

Results 1. Is the data presented in an appropriate way? • Tables and figures relevant and clearly presented? No figures presented in this article. However, the tables presented in this article were clearly presented. The information depicted in the tables were clearly delivered to the reader. • Appropriate units, rounding, and number of decimals? Yes, the units, rounding, and number of decimals were appropriate • Titles, columns, and rows labelled correctly and clearly? Yes, they were labelled correctly and clearly • Categories grouped appropriately? Yes, the samples in this study were divided into patients who received Fenugreek and patients who receive glibenclamide 2. Does the text in the results add to the data or is it repetitive? Some information still describing the same information with . For example, the information in paragraph 1 of the result section were the same with information in the table 1. 3. Are you clear about what is a statistically significant result? Yes, the p value already informed. 4. Are you clear about what is a practically meaningful result? Yes, the result of both the primary and secondary outcomes were already depicted

Discussion 1. Are the results discussed from multiple angles and placed into context without being overinterpreted? The topic has been discussed with multiple angles. The authors describe the previous study results which relevant to the current topic. The interpretation of this study is not overinterpreted, since the authors already compare the current study results with the previous studies. 2. Do the conclusions answer the aims of the study? Yes, the conclusion already answer the primary and secondary outcomes clearly. 3. Are the conclusions supported by references or results? Yes, the conclusion interpreted from the results of the study 4. Are the limitations of the study fatal or are they opportunities to inform future research? The limitation of the study already informed in the final section of this article. The limitation of the study could be used as the future research to improve.

Overall 1. Was the study design appropriate to answer the aim? This study used the interventional open-label randomized controlled allocation concealed trial to evaluate the efficacy of fenugreek versus glibenclamide in controlling blood glucose levels in patients with uncontrolled diabetes. In order to answer the research question, the authors already employed an appropriate study design. 2. What did this study add to what was already known on this topic? This study contribute to the the increment of knowledge regarding the use of fenugreek to improve blood glucose control, hypolipidemic impacts, and its effect to insulin level in uncontrolled diabetes. 3. What were the major flaws of this article? The major flaws were the total sample of the study. However, this flaw could be addressed for the future research. 4. Is the article consistent within itself? Yes, the article was consistent.

Overall statement or summary of the article and its findings in your own words The current study was aimed to determine whether fenugreek compared with glibenclamide had any impacts on controlling blood glucose in patients with uncontrolled type II DM on conventional therapy. The outcome of this study were primary outcome measures were FBG level, insulin level HbA1c, and homeostatic model assessment for insulin resistance (HOMA-IR), whereas secondary outcome measures were lipid profile (HDL, LDL, triglycerides, total cholesterol, and HDL/LDL ratio). In summary, this study evaluate the hypoglycemic and hypolipidemic effect of fenugreek. Fenugreek showed to decrease the fasting blood sugar, however it was not significant compared with glibenclamide. There was a significant increase in fasting insulin level as well as an increase in the HDL/LDL ratio after administration of fenugreek for three months. The study showed that fenugreek decreased the HOMA-IR, HbA1c, LDL, and triglyceride levels although not significant. In addition, its evaluation of adverse effect and safety parameters also informed by the authors.

Overall strengths of the article and what impact it might have in your field This study showed the opportunities for additional therapy of blood glucose control, along with lipid management for future approach in managing diabetic patients.

Specific comments on weaknesses of the article and what could be done to improve it Major points in the article which needs clarification, refinement, reanalysis, rewrites and/or additional information and suggestions for what could be done to improve the article. 1. There should be no repetitive information in the paragraph of the result section. The table itself already informed the reader in regards to the information. For example, in paragraph 1 of the results section, since the information is the same with what already written in paragraph 1. 2. The mechanism in which fenugreek affecting the insulin, blood glucose, and lipid profiles should be more elaborated. In the article, it already stated that the mechanism of fenugreek in lowering blood glucose could be related to the high fiber content of fenugreek, either the total or mucilaginous fibers. Another reason related to the delayed gastric emptying that inhibits glucose transport and inhibits its absorption. However, it should be more described by the authors.

Minor points like figures/tables not being mentioned in the text, a missing reference, typos, and other inconsistencies. 1. None. The relevant information that need to be reported regarding to safety parameters, which is the liver and renal function, were already described as the data provided in supplement.

Source

    © 2020 the Reviewer.