Evidence-based Nursing

Submitted by:
De Guzman, Tammy S.
De Leon, Jenalyn C.
BSN113
I. Clinical Question

In patients with rheumatoid arthritis (RA), is celecoxib as efficacious (in anti-inflammatory and
analgesic effects) and safe (in avoiding endoscopic upper gastrointestinal [GI] ulcers) as
naproxen?

II. Citation:

Celecoxib was similar to naproxen for rheumatoid arthritis with fewer endoscopic ulcers
(1999) JAMA 282, 1921. Simon LS, Weaver AL, Graham DY, et al.. Anti-inflammatory and
upper gastrointestinal effects of celecoxib in rheumatoid arthritis. A randomized
controlled trial.. Nov 24;. :. –8.

II. Study Characteristics

a. Patients
1149 patients (mean age 54 y, 73% women) who had RA (American College of
Rheumatology criteria) for >3 months. Inclusion criteria were age ≥18 years and receipt
of stable medications; oral steroids and disease modifying antirheumatic drugs were
allowed.

b. Interventions
Symptomatic RA was confirmed after non-steroidal anti-inflammatory drugs (NSAIDs)
and analgesics were stopped for 2 to 7 days. Patients were then allocated to celecoxib,
100 mg twice/d (n=240), 200 mg twice/day (n=235), or 400 mg twice/day (n=218);
naproxen, 500 mg twice/day (n=225); or placebo (n=231). NSAIDs, injectable
corticosteroids, anticoagulants, and antiulcer drugs were prohibited.

c. Outcomes Monitored
Patients in the celecoxib and naproxen groups had similar outcomes, with more
improvements at 12 weeks in signs and symptoms of RA than with placebo (5 of 8
measures for the celecoxib, 100 mg group; 7 of 8 measures for the celecoxib, 200 mg
and 400 mg groups; and 4 of 8 measures for the naproxen group). Similar patterns were
shown at 2 and 6 weeks. Patients in the placebo group withdrew from the study more
often because of treatment failure than did patients in the celecoxib or naproxen groups
(p<0.001 for all comparisons). The placebo and celecoxib groups did not differ for
endoscopic GI ulcers; more patients in the naproxen group had ulcers than did those in
the other 4 groups (p<0.001), although endoscopy was done in only 57% of patients.
The rate of total adverse effects was 19% for placebo; 28%, 25%, and 26% for the 100
mg, 200 mg, and 400 mg celecoxib groups, respectively; and 31% for naproxen.
 d. Does the study focus on a significant problem in clinical practice?
The problem stated above which is “Is celecoxib as efficacious (in anti-inflammatory and
analgesic effects) and safe (in avoiding endoscopic upper gastrointestinal [GI] ulcers) as
naproxen?” is a significant problem in the clinical practice. In this study it will help patients with
Rheumatic arthritis in choosing a drug which will help in preventing certain effect such as
endoscopic gastrointestinal ulcers and other related effects.

IV. Methodology/Design
Randomized (allocation concealed*), blinded (patients, clinicians, and outcome
assessors),*placebo controlled, 12 week trial.

a. Inclusion Criteria are as follows:

• were age ≥18 years and receipt of stable medications; oral steroids and disease
modifying antirheumatic drugs were allowed
b. Exclusion Criteria are as follows:
• With active GI tract, renal, hepatic, or coagulation disorders
• history of cancer or gastric or duodenal surgery
• recent or current esophageal or gastroduodenal ulcers or ≥10 erosions

c. Has the original study been replicated?

The clinical problem stated above has no replicated studies.
d. What were the risks and benefits of the nursing action/intervention tested in the
study?

Risks were as follows:

• instances of serious GI complications, such as bleeding or perforation

Benefits were as follows:

Celecoxib was associated with fewer endoscopic gastrointestinal ulcers.
V. Results of the Study
Patients in the celecoxib and naproxen groups had similar outcomes, with more improvements
at 12 weeks in signs and symptoms of RA than with placebo (5 of 8 measures for the celecoxib,
100 mg group; 7 of 8 measures for the celecoxib, 200 mg and 400 mg groups; and 4 of 8
measures for the naproxen group). Similar patterns were shown at 2 and 6 weeks. Patients in
the placebo group withdrew from the study more often because of treatment failure than did
patients in the celecoxib or naproxen groups (p<0.001 for all comparisons). The placebo and
celecoxib groups did not differ for endoscopic GI ulcers; more patients in the naproxen group
had ulcers than did those in the other 4 groups (p<0.001), although endoscopy was done in only
57% of patients. The rate of total adverse effects was 19% for placebo; 28%, 25%, and 26% for
the 100 mg, 200 mg, and 400 mg celecoxib groups, respectively; and 31% for naproxen.

VI. Author’s Conclusions / Recommendations

a) What contribution to the client health status do the nursing action / intervention
make?
Celecoxib was as effective as naproxen for improving signs and symptoms of rheumatoid
arthritis with similar rates of adverse effects and withdrawals. Celecoxib was associated with
fewer endoscopic gastrointestinal ulcers

VII. Applicability

The study was able to answer the clinical question that has been stated. The said intervention is
feasible to carry out in the nursing practice, and could help in choosing a better replacement of
the said drug.

VII. Reviewer’s Conclusion/Commentary

We therefore conclude that the intervention presented in this study is a great help especially to
patients who are not aware on the effects of both non-steroidal anti-inflammatory drug. As it is
said celecoxib was as effective as naproxen for improving signs and symptoms of rheumatoid
arthritis with similar rates of adverse effects and withdrawals. Celecoxib was associated with
fewer endoscopic gastrointestinal ulcers.
IX. Evaluating Nursing Care Practice

a.Safety – The interventions mentioned is safe although it has risks such as

instances of serious GI complications, such as bleeding or perforation due to effects
of the drugs.
b.Competence of the care provider- the researchers and care provider in the study
are competent in conducting the research. They considered a lot of factors which are
critical in the study like the inclusion and exclusion criteria of the study.

c. Acceptability- The study is acceptable because it is very practical and is feasible

to carry out in the real clinical setting.

d. Effectiveness- It is effective as seen by the study that celecoxib has fewer

endoscopic gastrointestinal ulcers.

e. Appropriateness- The research is timely and appropriate. Its methodology and

choice of subjects will be a big help for the patients as well as to the health care
provider in the hospital setting.

SOURCES:

• Langman MJ, Jensen DM, Watson DJ et al. Adverse upper gastrointestinal effects of
rofecoxib compared with NSAIDs. JAMA 1999;282:1929–33.
• Emery P, Zeidler H, Kvien TK, et al. Celecoxib versus diclofenac in long-term
management of rheumatoid arthritis: randomised double-blind
comparison. Lancet1999;354:2106–11.
• Beejay U, Wolfe MM. Cyclooxygenase 2 selective inhibitors: panacea or flash in the
pan? Gastroenterology 1999;117:1002–14.
• Peterson WL, Cryer B. COX-1-sparing NSAIDs—is the enthusiasm
justified? JAMA1999;282:1961–3.