Carrizales_N_Assignment5
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School
University of Texas, Rio Grande Valley *
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Course
6310
Subject
Medicine
Date
Feb 20, 2024
Type
docx
Pages
3
Uploaded by KOUNOMI
Assignment 5 Template
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Questions
Answers
Points
1.
Title of article, Journal name, and your name
Comparative Effects of Low-Dose Rosuvastatin, Placebo, and Dietary
Supplements on Lipids and Inflammatory Biomarkers, Journal of the American College of Cardiology, Nancy Carrizales
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2.
What is the research question addressed in this study?
The research question addressed in the study would be if a low-dose statin (rosuvastatin 5 mg daily) is more efficient than a placebo and 6 common supplements (fish oil, cinnamon, garlic, turmeric, plant sterols,
or red yeast rice) in impacting lipid and inflammatory biomarkers.
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3.
Identify the dependent variable(s)
Lipids and inflammatory biomarkers
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4.
Identify the independent variable(s)
Low-dose rosuvastatin, placebo, and dietary supplements
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5.
What is the research design used?
The research design used for SPORT (Supplements, Placebo, or Rosuvastatin Study) was a single-center, prospective, randomized, single-blind clinical trial.
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6.
What type of sampling design was used?
The sampling design used for this study was a simple random sample. From May 2021 through July 2022, a total of 203 participants consented, and 199 underwent randomization. Of those randomized, 190 completed baseline and follow-up laboratory assessments.
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7.
Describe the intervention. Was it adequately described?
The intervention consisted of 8 groups of 25 participants taking daily doses of either rosuvastatin 5 mg, classified as a moderate-intensity statin, placebo (similar in appearance to rosuvastatin), Nature Made fish oil 2,400 mg, NutriFlair brand cinnamon 2,400 mg, Garlique brand garlic with 5,000 mg of allicin, Bio-Schwartz brand turmeric curcumin with B
ioperine
4,500 mg, Nature Made – CholestOff Plus with 1,600 mg
of plant sterols, or Arazo Nutrition brand of red yeast rice 2,400 mg and
patients were instructed to take the recommended dose. Participants had a fasting lipid panel, complete metabolic panel, and high-sensitivity
C-reactive protein (hsCRP) measured at day 0 and day 28 of the trial at a Cleveland Clinic laboratory. LDL-C was calculated using the Friedewald equation. Study regimen adherence was measured using pill counts from returned bottles. The intervention was adequately described.
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8.
Describe the control or comparison
condition. Was it adequately described?
The comparison condition was the primary and secondary endpoints. The primary endpoint was the percent change in LDL-C for rosuvastatin 5 mg daily compared with the following regimens tested in
a hierarchical order: placebo, fish oil, cinnamon, garlic, turmeric, plant sterols, and red yeast rice. Secondary endpoints included the percent change in hsCRP, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and serum triglycerides for each study group compared with rosuvastatin. Additional secondary endpoints were the percent 8
change in lipid and inflammatory biomarkers of each supplement compared with the placebo. All details for the intervention were adequately and clearly described.
9.
Were the participants fully informed about the nature of the research?
Yes, the Institutional Review Board approved the trial, and all the patients provided written informed consent before participating. Since medical products were used in this trial, the FDA needed to approve the Investigational New Drug Application (IND).
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10.
Was ethical permission granted for the study?
Ethical permission was granted for this study because the IRB in Cleveland Clinic approved the trial.
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11.
Were randomization procedures adequately explained? Describe them.
Yes, participants were randomly assigned to one of eight study groups in a 1:1:1:1:1:1:1:1 ratio via the REDCap Cloud electronic data capture tools hosted at the Cleveland Clinic Foundation. Simple randomization was used to place participants into treatment groups consisting of Rosuvastatin, Placebo, Fish Oil, Cinnamon, Garlic, Turmeric, Plant sterols, and red yeast rice.
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12.
Does the article provide evidence that randomization was
successful - that is, it resulted in groups that were comparable prior to the intervention? Elaborate.
Yes, the randomization was successful since the covariance analysis was performed to compare the percent change from the baseline of LDL-C between rosuvastatin and each of the other study groups. The differences in the percent change between rosuvastatin and each
study groups were calculated by subtracting the least square means of each comparison. Similar analyses were performed to assess percent changes in hsCRP, HDL-C, total cholesterol, and triglycerides
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13.
Was the study longitudinal? How many data collection points were there?
No, this study was not longitudinal. The study collected data using primary and secondary endpoints. 5
14.
Was blinding used? If yes, who was blinded - and was this adequate? If not, is there an adequate rationale for failure to blind/mask?
Yes. Observers have been blinded to rosuvastatin 5mg, supplements, and placebo recipients. This was adequate to show the results of the study in a randomized, placebo-controlled, parallel-arm trial in finding evidence of the effectiveness it has in lowering low-density lipoprotein cholesterol (LDL-C).
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15.
What are the results of the study? Did the results answer the research question(s)?
A total of 190 participants completed the study. The percent LDL-C reduction with rosuvastatin was greater than all supplements and placebo (P < 0.001). The difference in LDL-C reduction with rosuvastatin compared with placebo was 35.2% (95% CI: 41.3% to 29.1%; P < 0.001). None of the dietary supplements demonstrated a significant decrease in LDL-C compared with t
he placebo.
Yes, the research question was answered. The low-dose statin was more effective than the placebo or supplements used for comparison.
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16.
Was outcome data reported even for treatment group members who did not complete the program (intention-to-
treat analysis)? If not, what was the rationale? If not applicable, indicate that in your answer.
1,003 participants were screened, 203 consented, 199 of those underwent randomization, and only 190 completed the baseline and follow-up laboratory assessments. Outcome data was reported on the randomized participants of the study based on the intention-to-treat 5
principle. There were several individuals who were lost to follow-up, withdrew consent, or lost due to protocol deviation.
17.
What were the study limitations?
-The study was relatively short and did not fully capture the effect on lipid biomarkers of supplements with a longer duration of use.
-The small sample size cannot rule out a small benefit from 1 or more of the supplements.
-Small sample size does not allow subgroup analysis.
-The small sample size and low dose used in SPORT showed that there was a
lack of effect of rosuvastatin on hsCRP with inconsistent data.
-Limitations on other races since the study was mainly non-Hispanic White (89%).
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18.
Do you consider the outcomes measured to be important policy or practical outcomes? Were they measured over a
long enough period?
Yes, it was important to assess the efficacy of low-dose statin with a placebo to compare common supplements to show the effectiveness in
lowering lipoprotein cholesterol (LDL-C). It is also a major public health
concern since most U.S. consumers believe cholesterol health supplements are safer than prescription medications, and a majority of the public also believes supplements are as effective, or more effective
than statins. As previously noted, they weren’t measured over a long enough period since it was a 28-day trial duration was chosen based on the 2018 blood cholesterol guidelines recommendation to assess adherence and percentage response to LDL-C lowering medications and lifestyle changes with repeat measurement in 4 to 12 weeks.
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