criticism and appraisal of journal article

1. Critical Appraisal of Journel Article
By Dr Ketan Asawalle

2. Efficacy and safety of add on therapy
of bromocriptine with metformin in
Indian patients with type 2 diabetes
mellitus: A randomized open labeled
phase IV clinical trial
Sengupta1, Pranab Sahana1, Debasis Giri1, Parama Indian Journal of Pharmacology | February 2014 | Vol 46 | Issue 1

3. Introduction
Type 2 Diabetes Mellitus is caused mainly due to insensitivity of Metformin is the 1st agent added to diet modification and exercise Due to need of regular dosage ORAL therapy is most convenient for But due to safety issues, tolerability and weight change of patient, Bromocriptine got FDA approval in 2009 as an adjuvant for treatment

4. DOPAMINE AGONIST acting centrally on D2 receptors to reduce blood Site of Action HYPOTHALLAMUS

5. OBJECTIVE
effectiveness and safety of add on therapy of bromocriptine

6. METHODOLOGY
TYPE OF STUDY
PROSPECTIVE
RANDOMISED
OPEN LABLED
PHASE IV
CLINICAL TRIAL
Ethics committee approval taken and trial registered in Clinical Trials

7. SAMPLE SIZE CALCULATION
Based on an effect size of one, standard deviation of

8. INCLUSION CRITERIA
Newly Diagnosed
18 TO 60 years
Type 2 DM
HbA1c >/= 6.5 </=10

9. EXCLUSION CRITERIA
Pregnanat/Lactating women
FPG>250mg/dl
PPPG>350mg/dl
comorbid cardiac renal conditions
allergy to drug

10. on selection criteria the patients were divided into 3 groups randomly
GROUP A - Metformin 500mg BD
GROUP B - Metformin 500mg BD + Bromocriptine 0.8mg
GROUP C - Metformin 500mg BD + Bromocriptine 1.6mg
Compliance assessed on basis of pill count method at every visit

11. 0) and at subsequent follow-up visits on weeks

12. advised to stop smoking and consumption of alcohol during

14. DATA ANALYSIS
Subjects reporting for at least one post- baseline follow-up visit Data were analyzed by repeated measures analysis of variance P value < 0.05 was considered to be statistically significant.

15. RESULTS
SCREENED = 80
ENROLLED = 74
GROUP A = 23
GROUP B = 25
GROUP C = 26
AE. Three patients (12%) in group B reported

16. No statistically significant difference in base line levels of HbA1c values significantly reduced in all 3 groups from Intergroup analysis of data show at every interval (weeks cont…

17. Intergroup analysis did not show any statistically significant

18. Changes in glycosylated hemoglobin (HbA1C) level (%) in groups A, B, and

19. DISCUSSION
type 2 DM is far from satisfactory. Hence, there type 2 (D2)-receptor agonist that has been approved

20. trials evaluated efficacy and safety of bromocriptine

21. bromocriptine (1.6 mg/day for 2 weeks) reduced the fasting

22. in which bromocriptine was added to therapy

23. the placebo-subtracted decrease in HbA

24. CONCLUSION
bromocriptine with metformin is more effective

25. Acknowledgment
Care Ltd, Mumbai, Maharashtra, India

26. EVALUATION

27. QUESTIONS TO ASK WHEN CRITICALLY APPRAISING A RESEARCH 1. Is the study question relevant?
2. Does the study add anything new?
3. What type of research question is being asked?
4. Was the study design appropriate for the research question?
5. Did the study design address the most important potential source 6. Was the study performed according to original protocol?
7. Does the study test the stated hypothesis?
8. Were the statistical analysis performed correctly?
9. Do the data justify the conclusions?
10.Are there any conflicts of interest?

28. 1. Are the objectives clearly and precisely stated
Yes
2. Does the design meets the objectives?
Yes, to some extent.
3. Is the study based on a sample? Is it representative sample from the target population?
yes yes
4. If the study is an experiment, is there randomization and is the randomization procedure
explained?
yes

29. 5. Does the sample size provide for possible non-response and, if it is follow-up study, drops out?
yes
6. Is the overall methodology adequate for achieving the objectives of the study?
Yes, but they have not mentioned about phase I to IV
7. Is the methodology ethically sound?
yes
8. Are the findings stated clearly and concisely, yet in sufficient detail for the readers to make their own judgment?
partial, weight information not mentioned

30. 9. Are the conclusions based on facts, with the opinions clearly indicated as such?
yes, to some extent
10. Is the analysis focused on the objectives initially set out? Are coincidental findings specified?
yes
11. Are the results consequent to the analysis presented?
yes, but not for all
12. Is a proper explanation given for the results obtained?
Yes, but not for all.

31. 13. Do these conclusions really answer the questions posed in the objectives?
14. Is it clearly stated how the results of the investigation advance the current knowledge on the topic?
no