“Your aunt Clara has long struggled with her weight. She has tried various diets in past but has always tended to regain the weight and is currently quite overweight. She has been looking online and has noticed that many products containing “Garcinia Cambogia” are promoted as weight loss aid. She has asked you weather it would be worth trying such a product. Given you are learning about the importance of using the evidence to inform practice, you want to know if there is any evidence for this.
Developing research question
Population- Clara, obese women
Intervention- intake of Garcinia cambogia
Comparative- when compared to those who does not take Garcinia cambogia
Outcome- decrease in weight
Research question in- In obese women can intake of Garcinia cambogia reduce weight?
Search histories for Medline
Medline search- both Boolean mode and smart text searching mode was used. Boolean operators used (AND)
obese women, Garcinia cambogia, hypolipemic effect, hypolipemic effect of Garcinia, obesity, weight loss, hypolipemia, clinical effectiveness Hypolipemic effect AND Gacinia cambogia, Garcinia cambogia AND obese women, Garcinia cambogia AND weight loss,
Limiters-= full text articles, English language, Published- 2014-2017
Expand- Apply to all words,
Search history for CINAHL
CINAHL search- both Boolean mode and smart text searching mode was used. Boolean operators used (AND)
Search terms- obese women, Garcinia cambogia, hypolipemic effect, hypolipemic effect of Garcinia, obesity, weight loss, hypolipemia, clinical effectiveness
Hypolipemic effect AND Gacinia cambogia, Garcinia cambogia AND obese women, Garcinia cambogia AND weight loss,
Truncation- Garcinia cambogia*, hypolipemic effect of Garciniaa#
Limiters-= full text articles, abstract available, reference available, English language, special interest was chosen as “evidence based practice”
Published- 2014-2017
Expand- Apply to all words,
In the article by Vasques et al., (2014) a double blinded randomised trial was conducted to evaluate the efficacy of Garcinia cambogia in obese women and on lipid profile . The aim of the paper is to determine if it has the hypolipemic effect and improves the lipid profile. The paper also evaluated the effect of G. Cambogia on the endocrine, anthropometric and the calorimetric parameters of obese women. The researcher has no stated any hypothesis that can be considered a minor drawback of the paper.
The article has clearly presented the aim and objective of the research in the abstract concisely. However, the title of the paper does not itself inform of the research methodology and was elucidated in the later sections of the paper. The abstract was interesting enough to grab the attention of the reader as it details the outcomes of the research (LoBiondo-Wood & Haber, 2017). The double blinded randomised study is considered to be the objective scientific methodology and is widely accepted by the medicine. The methodology is the strength of the paper as it is considered to produce results that are untainted by bias (Spieth et al., 2016).
For this study, the researcher has chosen a sample size of 60 and 43 participated in the trial between the age group 25-60. The treatment group comprised of 30 members and the control group comprised of 13 members. The sample size is appropriate as per the research design selected (Vasques et al., 2014).
All the participants were obese women with BMI above 25 kg/m2. The participants were selected with the inclusion criteria of stable body weight for last 3 months and eating habits, and not following the low calorie diet, no drug use for last eight weeks or before the start of the trail, stable physical activity for last six months. The inclusion criterion was justified as the drug use can hamper the appetite and consequently weight (Spieth et al., 2016). Further stable weight and level of physical activity are included in the criteria, as these parameters will effect on the blood glucose levels and lipid profile (Thornby & Cargill, 2016).
An additional criterion of excluding the participants was also justified. It includes the history of pathologies like pregnancy or lactation, kidney or liver disease, type 2 diabetes, active gastrointestinal dysfunction, any kind of cancer. These parameters if not exclude will create biasness in study and it cannot be deciphered if the weight loss has occurred due to the administration of G. Cambogia. It may happen so, that the weight loss has occurred due to the already present diseases and comorbidities (Thornby & Cargill, 2016). Each of the members in the treatment and the control group are administered with the G. Cambogia (800 mg) or placebo for 60 days.
One capsule was administered thrice a day before each main meal. To ensure correct outcomes all the participants were given the individualized diet plan during the treatment after the assessment of the daily caloric intake, resting energy expenditure, weight, circumference and height, estimation of the body composition and other blood test (glucose, insulin, cholesterol and others). The methods and the materials used in the study are appropriate as per the literature review of similar studies. Thus, the author has used evidenced based methodology (LoBiondo-Wood & Haber, 2017).
The findings of the trial showed a significant decrease in the triglycerides in the treated group. There was a difference in the post-treatment variation when compared to the placebo group. When other variables were evaluated, there was no significant response. These include calorimetric parameter and anthropometric parameters. After the treatment, there was no significant alteration in the Leptin and insulin levels. Since it was short-term treatment, hypotriglyceridemic effect was observed (Thornby & Cargill, 2016).
However, this does not indicate the relation to the change in the leptinemia. It means in order to determine the efficacy of the G. cambogia extract, it is required to understand the pharmacodynamic and pharmacokinetic properties. The mechanism by which these extracts seem to work on the obese women is by inhibiting the lipid biosynthesis. This mechanism promoted the hypotriglyceridemic effect and is independent of the insulin and the serum Leptin levels (Campbell & Walters, 2014). Thus, the findings can be concluded to have partially helped the research question. The strength of the paper is the detail elucidation of the research methodology and the research findings. The statistical analysis adds to the strength of the paper, as readers can comprehend the data even with the little knowledge on the numerical part.
The use of lucid language and avoiding too many jargons allows the readers to be interested in reading till the end. In the given results the probability of achieving the flawed results were 0.0002 in the treated group and the probability in the placebo group was 0.04. Therefore, if we assume that that hypothesis was a positive effect of G. Cambogia on reducing the weight. Then, it can be interpreted that the results do not provide measure of support for alternate hypothesis (LoBiondo-Wood & Haber, 2017). Therefore, the findings can be used to advocate clara for taking the capsules of G cambogia however, she should not completely rely on it.
In the randomised control trail, the internal validity can be ensured by eliminating the possibility of bias in design and conduct. The threat may occur in this paper due to statistical analysis or if there is discrepancy in the data collection. A flaw in the interpretation of the study data can also create bias. Factors such as genetic predisposition that may seem to manifest suddenly can also alter the result that is the lipid biosynthesis.
The external valid can be ensured by obtaining the results that are useful. Further, the external validity can be endured if the results are relevant to the clinical setting patients (a definable group). In this paper it is doubtful that it can be generalised to other population in clinical setting. This may be the potential threat as the selection criteria eliminated many people (Porrittet al., 2014).
According to Spieth et al. (2016) the placebo control trial is capable of creating masking bias due to the concealment in this paper. Distinct outcomes can be obtained by the proper masking. As it includes investigator’s self-selection, there is the chance of bias. Other potential distortions can be the consent and preference, which makes the study objective in the disciplinary sense and not in realistic perspective. In the trial by Vasques et al. (2014) there is evidence of consent and preferences mentioned by the author.
In this study, all the patients who are eligible does receive placebo and many are excluded due to strict eligibility criteria. This was good to reduce external validity. However, the threat include that the results wail be misleading due to less number of eligible patients and they may differ from those who were excluded as a result of severity of disease or physical activity or diet. Due to good baseline prognosis the outcome due to these obese women, may be better than the those excluded. It may happen so that the clinicians may compare the outcomes with the patient and assess the external validity. These data may hide the real make up of the trial population (Davey et al., 2015).
In order to avoid the threats the randomised trail design can give adequate information in the publications and in clinical guidelines and in secondary reports. The methodology should be designed in a way that can allow generalisability by clinicians. There should be a defined priority for clinically relevant end points. There is a need of warranty for unbiased analysis and report of the study results. The researchers should publish both the nonsignificant and the significant results. To avoid threats to the internal validity, the study design should be as per “Consolidated Standards of Reporting Trials statement ”. Further, during an ongoing RCT, there is a need of conducting the preplanned interim analyses. It will help to assess harms and benefits creating clinical equipoise (Spieth et al., 2016).
References
Campbell, M. J., & Walters, S. J. (2014). How to design, analyse and report cluster randomised trials in medicine and health related research. John Wiley & Sons.
Davey, C., Hargreaves, J., Thompson, J. A., Copas, A. J., Beard, E., Lewis, J. J., & Fielding, K. L. (2015). Analysis and reporting of stepped wedge randomised controlled trials: synthesis and critical appraisal of published studies, 2010 to 2014. Trials, 16(1), 358.
LoBiondo-Wood, G., & Haber, J. (2017). Nursing Research-E-Book: Methods and Critical Appraisal for Evidence-Based Practice. Elsevier Health Sciences.
Porritt, K., Gomersall, J., & Lockwood, C. (2014). JBI’s systematic reviews: study selection and critical appraisal. AJN The American Journal of Nursing, 114(6), 47-52.
Spieth, P. M., Kubasch, A. S., Penzlin, A. I., Illigens, B. M. W., Barlinn, K., & Siepmann, T. (2016). Randomized controlled trials–a matter of design. Neuropsychiatric disease and treatment, 12, 1341.
Thornby, K. A., & Cargill, S. (2016). Garcinia cambogia: Evidence for weight loss, lipid-lowering effects. Pharmacy Today, 22(1), 15.
Vasques, C. A., Schneider, R., Klein?Júnior, L. C., Falavigna, A., Piazza, I., & Rossetto, S. (2014). Hypolipemic effect of Garcinia cambogia in obese women. Phytotherapy research, 28(6), 887-891.
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