Journal Club Presentation

Chaipat Siriwachirachai
ID 553150179-1 Thai regular section
Faculty of Pharmaceutical Sciences, Khon Kaen University
1
Outline
- Medication reviews
- Introduction
- Background
- Objective
- PICO analysis
- RCT evaluation

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Sulfasalazine

3
Prednisolone enema 20 mg/100 ml

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Sucralfate

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Introduction
- Curative radiation therapy administered for urinary or gynecologic
malignancies caused radiation-induced proctosigmoiditis
(commonest complication, 5%)
- Radiation results injury ---> ischemia + fibrosis (Vessel and CNT)
Clinical manifestations = bleeding, tenesmus*, and diarrhea
- Endoscopic founds ---> hyperemia** and telangiectasia*** to
ulceration and necrosis

* feeling of incomplete defecation ** increase in organ blood flow *** spider veins or angioectasias 6
Introduction (Cont.)

- Proctosigmoiditis was not been address, unfortunately

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Background and Signification of RCT
- Oral sulfasalazine therapy was tried
(limited success, small patients, uncontrolled manner)
- Steroid enemas have often been recommended
(lacking of data documenting efficacy)
- Previous pilot* study shown benefit of sucralfate enemas
(3 patients with bleeding changes in 7-16 days
with 2 g, twice a day)

*pre-study of your fuller study

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Objective
- Prospective, randomized, double-blind controlled trial
- Comparing the efficacy sucralfate retention enemas
and oral sulfasalazine combined with steroid retention
enemas in radiation proctosigmoiditis

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 PICO Analysis : P
- All patients with symptomatic radiation-induced proctosigmoiditis
(July 1988 - June 1989 : 1 year)
(Departments of Gastroenterology and Radiotherapy, Postgraduate
Institute of Medical Education and Research, Chandigarh, India)
(All patients had received radiotherapy at earlier)
- excluded if they had received sulfasalazine and/or steroids in
preceding two weeks.

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PICO Analysis : P (Cont.)

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PICO Analysis : I
- 3.0 g oral sulfasalazine + 20 mg twice daily rectal prednisolone enemas
- 2.0 g twice daily rectal sucralfate enemas plus oral placebo

PICO Analysis : C
- Clinical stagment before intervention

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PICO Analysis : O
- Clinically and endoscopically assessment (grading method)
- clinical assessment follows
1. diarrhea
1 point (1-3 stools/day)
2 points (4-6 stools/day)
3 points (more than 6)
2. bleeding per rectum
0 point (no bleeding)
1 points (mild bleeding)
2 points (bleeding requiring blood transfusion) 13
PICO Analysis : O (Cont.)
- clinical assessment follows (cont.)
3. tenesmus
0 point (absent)
1 points (not requiring any drug)
2 points (requiring analgesics/antispasmodics)
All scores above were classified in to 3 grades
I (2 points),
II (3-4 points)
III (5 points)
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PICO Analysis : O (Cont.)
- Endoscopic assessment follows
rectum and sigmoid colon after an oral laxative (bisacodyl,
Dulcolax, German Remedies, India)
within 24 hr of clinical assessment (criteria of Gilinsky et. al)
mild/grade I
(erythema telangiectasia, edema, thickening, pallor)
moderate/grade II
(grade1 plus friability)
severe/grade III
(ulceration necrosis).
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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Generals
1.

>> Digestive Diseases and Sciences, Vol. 36, No. 1 (January 1991),
pp. 103-107 () Impact factor 2.163
2.

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Generals
3.

4. :
17
Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Generals
5. : 1

6.

>>
Pre-study18
Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Abstracts
7. objective, study design, setting, patients,
intervention, main outcome measure, result, conclusion

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Introductions
8.

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Introductions
9.

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 Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Methodology
10. (study design)
>> Prospective, Randomized, Double-Blind Controlled Trial
>> 2 treatment
SE

11.
>>

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Methodology
12.
13.

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Methodology
14.
>> No control group
15.

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Methodology
16.

>> Observe as a short duration (4 weeks)

>>

17. (washing period)

>> parallel study washing period

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Methodology
18. ()

>> RCT excluded if they had received sulfasalazine
and/or steroids in preceding two weeks.

19. ( Single blind, Double blind )

>> Double blind

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Methodology
20.
(Blind technique)

21. (Efficacy)

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Methodology
22. Subjective Objective
>> 2 >>

23.

-
- 2 observers
-

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Methodology
24.

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Result
25.

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Result
26.
>> 2
()
27. (Dropout)

>>

*** / (Myalgia)
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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Result
28.

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Discussion and Conclusions
29.

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Result
30.
>>

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Discussion and Conclusions
31.
>>
32.

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Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Discussion and Conclusions
32.

>>

36
Liturature Evaluation (follow 33 items ofUniversity of Illinois)
Discussion and Conclusions
33.

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38
 Summary
1.

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