Critical Appraisal Of LI85008F In Fostering Weight Loss Among Overweight Adults: A Randomized, Double-Blind, Placebo-Controlled Clinical Study

You will be provided with a choice of two scientific journal articles to critically appraise in the form of a short report. Using the skills acquired in module content 1, 2, 3 and 4 you are required to critique your choice of ONE of the articles. Copies of these articles, Dixit et al. (2018) and Franklin et al. (2018), are in the Assessment task 4 folder on MyLO. There is no prescribed format for your critique, but ideally you should include the following (which align with the first four criteria of the marking rubric):

• An introduction – briefly introduce the study by providing some relevant background information and explain how the study fits into this context. You should highlight the justification of the work – why the study was performed and why it was an important undertaking, as well as the specific aims of the study.
• An overview and assessment of the research methodology – describe the experimental approach and consider whether it was appropriate. We would like you to identify and discuss the strengths and/or weaknesses of the chosen experimental approach.
• An explanation and assessment of the study’s results – evaluate the quality of the data and whether the results have been correctly interpreted. Note that you are not expected to comment on statistical analyses not covered in CAM103.
• An assessment of the study’s Discussion/Conclusions. You should assess whether the overall conclusions made by the authors were valid, and whether their discussion section was appropriate in the context of other published literature.

Design and Participants

The number of obese and overweight individuals across the globe has seen a great increase. The world Health Organization (2014) explains that while the rates of prevalence of these conditions continue to increase across the globe, the population of obese and overweight people stands a 1 billion and 300 million respectively. To date, body mass index (BMI) is considered as one of the most effective techniques of detecting obesity and overweight among patients (Mistry and Puthussery, 2015). Kelishadi, Haghdoost, Sadeghirad and Khajehkazemi, (2014) reveal that the two conditions are closely associated with the prevalence of lifestyle diseases such as cancers, cardiovascular ailments and type 2 diabetes. While conventional strategies of managing weight are effective, the scholars explain that they are highly expensive and may lead to the advancement of detrimental effects on the side of the patient. As a consequence, Dixit, Kamath, Alluri and Davis (2018) advance a research aimed at undertaking a reevaluation of the effectiveness of LI85008F in fostering weight loss among overweight adults by adopting a 16-week randomized, double-blind, placebo-controlled clinical study.

According to Dixit et al. (2018) LI85008F is an herbal remedy advanced with the aim of fostering high quality body weight management through inclusion of clinically and botanically researched dietary ingredients. The scholars reveal that LI85008F works by provoking lipogenic factors such as PPAR? and fostering the inhibition of key processes such as lipogenesis in a simultaneous way. Ideally, the scholarly material under review proceeded with the primary objective of exploring the efficacy and levels of tolerability of LI85008F in fostering weight loss among healthy participants that are overweight. For effective comparison, the researchers adopted reductions in fat mass, BMI, hip and waist circumferences, serum lipid and ghrelin profiles. An analysis of the scholarly material reveals that it attained its desired objectives. For instance, the scholars take the option of adopting a larger population them administering the described treatment for a longer period. Such an approach does not only increase the levels of reliability of the study but also enhances its reliability and ease of making generalizations to other populations (McNeish and Stapleton, 2016).

Participants

The investigation was conducted between 1^st June and 15^th November 2015. The Krupa Centre for Diabetes and Obesity, Bengaluru and the Sudeep Diabetes Care Centre, Bengaluru were adopted as independent institutions to foster the process of recruiting voluntary participants visiting the outpatient wings. 157 participants were recruited and screened to verify their efficacy of taking part in the study. Of this population, only 140 were considered based on the set inclusion criteria.

Experimental Approach

Inclusion criteria

For inclusion, the respondents adopted for this study needed to be healthy based on their medical records, aged between 21 and 50 years and free from diabetes mellitus intestinal illnesses and metabolic bone disease. Further, the participants were required to reveal a BMI ranging between 27 and 29.9kgm^-2. Similarly, the voluntary contributors needed to show that they were medically fit to undertake the research based on their medical records. Additionally, the partakers were verified to ensure that they were not affected with conditions such as renal and cardiovascular diseases as well as abnormal functioning of the liver (Dixit et al., 2018).

The participants were excluded from the study if they revealed the presence of inflammatory disorders, HIV and inexplicable loss of gain of weight three months before the commencement of the study.  Similarly, patients exposed to alcohol smoking and weight loss drugs were excluded from the study (Dixit et al., 2018).

Experimental approach

The scholars adopted a 16-week randomized, double-blind, placebo-controlled clinical study. Two groups of the participants (n = 70 per group) were adopted and divided into two groups in a 1:1 ratio. The groups were randomized to obtain an LI85008F and placebo sets each comprising of 70 participants. The respondents were exposed to two identical placebo capsules or divided doses of LI85008F at a rate of 900mg/d. similarly a dietitian was adopted to advise the participants on the importance of following the ~1800 kcal/d meal adopted for the study as well as the inclusion of a physical exercise program that involved walking for thirty minutes, five days per week within the investigation period.

In my opinion, the experimental approach adopted for this study was highly effective. According to Hopkins (2017), the sample size put into consideration by a researcher plays a crucial role in determining its levels of reliability. Overall, the scholars adopted a larger sample size (n = 140); an aspect that increases the effectiveness of method in fostering generalizations. Similarly, the move to adopt an exclusion criterion that eliminated participants exposed to other weight management medications, alcohol and smoking played a significant role in eliminating the experimental errors associated with reactions between the research treatment considered and these drugs.

According to Simonsohn (2015), a randomized, double-blind, placebo-controlled clinical research design is highly effective in allowing researchers to draw experimental inferences concerning the perceived effects of a treatment on the entire population as represented by the participants. Consequently, the design implemented by the scholars is fit to the intended analysis. Similarly, Orne (2017) reveal that an active control group can be used to represent the interests of the placebo group. However, the researchers divide the placebo and LI85008F groups in a 1:1 ratio as a way of initiating active control. Lastly, the blinding effect used on the scholars played a significant role in minimizing personal biases.

Results and Analysis

  Based on the experimental analysis adopted by the scholars, there was a significant reduction in body weight among the participants adopted for the study upon uptake of the prescribed LI85008F treatment in comparison to the placebo group. Similarly, the treatment group revealed a reduction in the BMI, hip and waist circumferences. On the other hand, great improvements in lipid profiles, low density lipoproteins. Further the participants did not reveal issues of adversity related to the treatment they were exposed to.

There were significant reductions in the levels of adiponectin and ghrelin serum among the participants that were adopted as the LI85008F treatment group. The researchers found out a reduction of 20.17% in the levels of ghrelin in the LI85008F team compared to 15.05% reduction in the placebo group. Similarly, the assessment of the participants’ overall mood revealed great improvements in the group exposed to the LI85008F treatments.

Minimal adverse events were realized in the processes of implementing the research. For instance, Dixit et al. (2018) reveal that the minor events recorded among the participants included headaches, fever, loose stool and an increase in the levels of dehydration and appetite. However, the fact that these minor adverse events were effectively distributed limited their effects on the results obtained. Similarly, issues of absenteeism among the respondents led to the exclusion of about ten of the people adopted to participate in the investigation. Based on the researchers’ viewpoints, such reductions altered the population of participants adopted go represent each of the two groups adopted for this study. Despite the minor irregularities, none of the subjects was excluded from the study as a result of adverse events.

High quality data was adopted by the scholars. According to Hazen, Boone, Ezell and Jones-Farmer (2014), the quality of data and instruments of analysis adopted by a researcher play a significant role in determining the levels of validity and reliability of the results obtained. On the other hand, Sadiq and Indulska (2017) and Barnaghi, Bermudez-Edo and Tönjes, (2015) reveal that the uniformity of the results obtained upon application of multiple tools of analysis are of great essence in determining the study’s levels of efficacy in fostering generalizations. Therefore, the scholars adopted multiple tools of analyzing the data collected as a way of fostering validity and reliability. For instance, the researchers adopted standard deviation and ANCOVA to enhance the levels of reliability in the statistical analyses adopted.

Quality of Data and Analysis Tools

  Overweight and obesity have a great negative impact on the state of healthcare across the world. While these conditions call for inclusion of dire measures aimed at including friendly botanical remedies that enjoy scientific backing, here is need for adoption of weight management initiatives that are both friendly to the consumer and avail the expected results with a very short timeframe. Based on the results obtained by the study, proper exposure of patients to a supplementation of LI85008F as an herbal remedy leads to a significant reduction in the levels of BMI, body weight, hip and waist circumferences. As a consequence, the scholarly work revealed the levels of clinical efficacy of LI85008F as a safe herbal portion of managing weight among overweight and obese patients who are healthy.

Similarly, the research revealed that the LI85008F herbal formula acted as a useful supplementation in the processes of instilling alterations in the baseline anthropometric aspects of the respondents included by the researchers. While conventional researchers consider BMI as he most effective instrument of determining he levels of adiposity among clients, the scholars concurred that was circumference is equally important in assessing the advancement of metabolic syndrome. In my opinion, the discussion and conclusions availed by Dixit et al (2018) is highly relevant to the research question that was initially posed, the design implemented and the results arrived at. Similarly, the discussion is in line with other scholarly works published in this area.

References

Barnaghi, P., Bermudez-Edo, M., & Tönjes, R. (2015). Challenges for quality of data in smart cities. Journal of Data and Information Quality (JDIQ), 6(2-3), 6.

 Dixit, K., Kamath, D. V., Alluri, K. V., & Davis, B. A. (2018). Efficacy of a novel herbal formulation for weight loss demonstrated in a 16?week randomized, double?blind, placebo?controlled clinical trial with healthy overweight adults. Diabetes, Obesity and Metabolism.

Hazen, B. T., Boone, C. A., Ezell, J. D., & Jones-Farmer, L. A. (2014). Data quality for data science, predictive analytics, and big data in supply chain management: An introduction to the problem and suggestions for research and applications. International Journal of Production Economics, 154, 72-80.

 Hopkins, W. G. (2017). Estimating Sample Size for Magnitude-Based Inferences. Sportscience, 21.

 Kelishadi, R., Haghdoost, A. A., Sadeghirad, B., & Khajehkazemi, R. (2014). Trend in the prevalence of obesity and overweight among Iranian children and adolescents: a systematic review and meta-analysis. Nutrition, 30(4), 393-400.

Liu, C., Newell, G., & White, M. (2018). The effect of sample size on the accuracy of species distribution models: considering both presences and pseudo?absences or background sites. Ecography.

McNeish, D. M., & Stapleton, L. M. (2016). The effect of small sample size on two-level model estimates: A review and illustration. Educational Psychology Review, 28(2), 295-314.

Mistry, S. K., & Puthussery, S. (2015). Risk factors of overweight and obesity in childhood and adolescence in South Asian countries: a systematic review of the evidence. Public Health, 129(3), 200-209.

Orne, M. T. (2017). On the simulating subject as a quasi-control group in hypnosis research: What, why, and how. In Hypnosis (pp. 399-444). Routledge.

Sadiq, S., & Indulska, M. (2017). Open data: Quality over quantity. International Journal of Information Management, 37(3), 150-154.

Simonsohn, U. (2015). Small telescopes: Detectability and the evaluation of replication results. Psychological science, 26(5), 559-569.

World Health Organization (2014). Obesity and Overweight. Geneva, Switzerland. Available at:  https://www.who.int/mediacentre/factsheets/fs311/en/. Accessed 10/10/