Are oral steroids as effective as NSAIDS in relieving patient

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Are oral steroids as effective as NSAIDS in relieving patient

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Philadelphia College of Osteopathic Medicine
[email protected]
PCOM Physician Assistant Studies Student Scholarship

Student Dissertations, Theses and Papers

2018
Are oral steroids as effective as NSAIDS in relieving patient pain from gout?
Haley T. Peeples
Philadelphia College of Osteopathic Medicine

Follow this and additional works at: https://digitalcommons.pcom.edu/pa_systematic_reviews Part of the Medicine and Health Sciences Commons
Recommended Citation
Peeples, Haley T., "Are oral steroids as effective as NSAIDS in relieving patient pain from gout?" (2018). PCOM Physician Assistant Studies Student Scholarship. 373. https://digitalcommons.pcom.edu/pa_systematic_reviews/373
This Selective Evidence-Based Medicine Review is brought to you for free and open access by the Student Dissertations, Theses and Papers at [email protected] It has been accepted for inclusion in PCOM Physician Assistant Studies Student Scholarship by an authorized administrator of [email protected] For more information, please contact [email protected]

Are oral steroids as effective as NSAIDS in relieving patient pain from gout?
Haley T. Peeples, PA-S A SELECTIVE EVIDENCE BASED MEDICAL REVIEW
In Partial Fulfillment of the Requirements For The Degree of Master of Science In
Health Sciences- Physician Assistant Department of Physician Assistant Studies Philadelphia College of Osteopathic Medicine
Atlanta, Georgia
December 15, 2018

ABSTRACT
OBJECTIVE: The objective of this selective EBM review is the determine whether or not, “oral steroids are as effective as NSAIDS in relieving patient pain from gout?”
STUDY DESIGN: Review of three English language primary studies, published between 2008 and 2016.
DATA SOURCES: Three randomized controlled trials (RCTs) were found using PubMed and Embase database. These studies analyzed the effectiveness of steroids in relieving patient pain from gout.
OUTCOMES MEASURED: The major outcomes measured were improvements in joint tenderness on palpation, joint erythema, joint swelling, and joint activity measured on a 5-point Likert scale. (0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain, 4=extreme pain). Analgesic effectiveness was measured as changes in pain on a 100-mm visual analogue scale. With 1 being the least pain the patient has ever experiences and 100 being the worst.
RESULTS: All three studies showed comparable efficacy between prednisolone and NSAIDS in treating gout. The Xu et al study concluded similar results between NSAIDS and Prednisolone in improving pain, tenderness, and joint activity. Furthermore, the study also stated Prednisolone may be more effective in reducing inflammation and was better tolerated. The Rainer et al and Janssen et al study found prednisolone and indomethacin have similar analgesic effectiveness, and prednisolone is a safe, and effective first line option for gout treatment.
CONCLUSION: The results of all three RCT’s which compared the efficacy between prednisolone and NSAIDS in the treatment of gout concluded similar results between the two groups. Therefore, proving steroids as an effective treatment option for patients diagnosed with gout.
KEY WORDS: Gout, Steroids, and NSAIDS.

Peeples, Gout and Prednisolone 1
INTRODUCTION Gout is a metabolic disease associated with abnormal amounts of urates which manifests
as recurrent acute arthritis. 5 The disease will most commonly present in the first metatarsal phalangeal joint of the great toe also known as “podagra”.5 Areas such as the feet, ankles, and knees, are also commonly affected.5 The attacks are characterized by intense pain with swollen, warm, and tender joints, dusky red skin overlying the joint space, and fever.5 In some cases tophi can be found on the feet, ears, and hands as a result of accumulation of uric acid crystallization years after the initial gout attack.5 Purine rich foods are proven to potentiate attacks such as alcohol, seafood, and thiazide diuretics.5 Patients may be asymptomatic for months or even years after their first attack. However, if left untreated patients can develop chronic gout.5 This paper discusses the results of three randomized control trials to determine if steroids are indeed as effective as NSAIDS in treating patients diagnosed with gout.
This topic is relevant to both patients and the PA practice because gout is the most common form of inflammatory arthritis.5 Gout most commonly effects men over the age of 30 years old.5 When gout manifests in women it most commonly appears after the woman is postmenopausal.5 It is crucial as medical professionals we accurately diagnose and treat gout, because if left untreated patients can develop chronic gout which can lead to deformation of the joint spaces mimicking the effects of rheumatoid arthritis.5 As a result, these patients are at an increased risk for joint replacements and corrective surgeries.1
Due to the rising frequency and widespread occurrence of gout there is an increased cost burden associated with the disease.1 For patients who suffer six or more gout flares per year, direct gout-related health care costs top $12,020.4 Furthermore, according to a 2016 study, gout hospitalization expenses have increased by 68% from 34,456 to 58,000.4 There is an increasing

Peeples, Gout and Prednisolone 2
number of patients who visit their healthcare provider due to gout attacks each year.4 According to the “National Ambulatory Survey” between the years of 2008 and 2016, there were 7 million ambulatory visits due to gout.1 Therefore, there is an overwhelming need in the medical community to correctly diagnose, treat, and care for patients diagnosed with gout to decrease the economic burden surrounding the disease.4
Gout is widely understood throughout the medical community as uric acid deposition in the soft tissue as well as bone and joints.5 However, the amount of uric acid present in the serum does not depict the severity of the disease.5 Furthermore, the precise relationship between hyperuricemia and gouty arthritis is still unknown.5 This is because chronic hyperuricemia is found in those who have never before experienced a gout attack.5 Instead, medical professionals rely on arthrocentesis, as the test of choice when diagnosing patients with acute gout.5 The fluid will show negatively birefringent needle shaped crystals under a light microscopy which differentiate gout from pseudogout.5
Treatment of gout begins with lifestyle modifications such as a decrease in intake of purine rich food such as alcohol, seafood, and red meat.5 It is also crucial to consider medications such as loop and thiazide diuretics which can potentially increase serum uric acid levels and provoke gout attacks.5 NSAIDS such an Indomethacin are currently used as the drug of choice in acute gout attacks.5 Colchicine is considered 2nd line if the patient presents within 36 hours of onset or are refractory to the use of NSAIDS.5 Steroids are then considered if the patient is unresponsive to both NSAIDS and Colchicine.5 It is important to treat episodes of acute gout and chronic gout differently as medications to treat chronic gout can potentiate or worsen gout symptoms if given during an acute gouty episode.5 Drugs such as Allopurinol which reduces uric acid production or Probenecid which promote renal uric acid secretion are available

Peeples, Gout and Prednisolone 3
to treat patients with recurrent or chronic gout.5 Each treatment listed above has shown to be beneficial for patients suffering from gout. Treatment is based on patient presentation, timeperiod, and past medical history. In addition, based on the three articles, steroids are proven to be just as effective as NSAIDS as first line treatment for gouty arthritis. OBJECTIVE
The objective of this selective EBM review is the determine whether or not, “oral steroids are as effective as NSAIDS in relieving patient pain from gout?” METHODS
The population analyzed in this review includes patients diagnosed with gout. One group was given Prednisone in comparison to the other group which received a trial of NSAIDS. The outcome studied in these reviews is pain relief, and the patients rated their amount of pain through a Likert or visual analogue scale. All three studies are randomized controlled trials which studied the effectiveness of Prednisolone in comparison to NSAIDS.
All three studies were published in peer reviewed English articles. The key words used to locate the articles included “gout”, “steroids”, and “NSAIDS”, and were searched on the Pubmed and Embase databases. The articles were chosen based on relevance to the clinical question, and due to importance to the patient population in order to create a POEM. A POEM stands for patient-oriented evidence that matters. Inclusion criteria included all randomized controlled trials published after 2001. Exclusion criteria included patients who used NSAIDS or steroids 24-72 hours prior, had progressed to the chronic gouty arthritis stage, or had been diagnosed with gastrointestinal disease. The statistics reported in all three studies included confidence interval, p-value and mean change from baseline. Each of the three studies demographics and characteristics can be found on Table 1.

Peeples, Gout and Prednisolone 4

Results: Table of demographics and characteristics of included studies (Table 1)

Study Type # Pts Janssens, RCT 120 2008 (1)
Rainer, RCT 416 2016 (2)
Lingling RCT 132 Xu, 2015 (3)

Age

Inclusion

Exclusion

W/D

(yrs) Criteria

Criteria

All ages Pts with

Pts with

1

monoarticular comorbidities

gout

such as renal

confirmed by failure or heart

arthrocentesis. attack. Pts with

Pts were

history of GI

required to disease. Pts

give consent. were not

allowed to have

NSAIDs or

other pain meds

24 hours prior.

Pts aged Pts who

Pts were not

40

18 years presented to allowed to

or older the ER within receive steroids

3 days of

or NSAIDs

symptom

within 24 hours.

onset. Pts

Pts with hx of

were

comorbidities,

evaluated by a suspected septic

physician to arthritis or

be diagnosed history of

with gout.

bleeding

disorders.

Pts aged Pts who

Pts were

19

18 years presented

excluded if they

and

with gout

had chronic

older attacks within gouty arthritis,

72 hours of clinical

screening.

suspicion of

The degree of joint disease,

pain on the comorbidities,

Likert scale GI issues,

was at least NSAIDS or

moderate.

steroids within

72 hours.

Interventions Prednisolone
Prednisolone
Prednisolone

Peeples, Gout and Prednisolone 5
OUTCOMES MEASURED All three studies measured the outcome of pain relief through either a 5-point Likert scale
or visual analog scale. The Xu et al study primarily focused on the reduction of pain as experienced by the patient.7 The degree of joint pain was represented by a 5-point Likert scale (0=no pain, 2=moderate pain, 3=severe pain, 4=extreme pain).7 The number was then recorded by the patient on day 1 before the start of treatment and on day 2 and 4 approximately 4 hours after the dose of drug was administered.7 The physician also measured the patient’s overall response to treatment on a 5- point Likert scale (0=very good, 1=good, 2=fair, 3=poor, 4=very poor) at day 4 at the end of the study.7 Although the study also analyzed joint tenderness to palpation, joint erythema, joint swelling, and joint activity, for the purpose of study only pain scores were analyzed.7 The remaining two studies measured analgesic effectiveness as changes in pain on a visual analogue scale with 1 being the least amount of pain the patient has ever experienced to 100 being the worst. RESULTS
All three studies included in this paper are randomized control trials studying the effectiveness of Prednisolone in comparison to NSAIDS in the treatment of gout. Although each study implemented different participant age requirements, all patients were included if they were diagnosed with acute gouty arthritis. All studies presented data in continuous format and no dichotomous data was converted. Changes in mean score, confidence interval, and p-value with a significance of  0.05 was analyzed.
In the Xu et al study, 132 inpatients aged 18 or older with acute gouty arthritis within 72 hours of onset were randomly assigned to trial treatments.7 These patients were diagnosed with gout according to the clinical criteria of the 1977 American College of Rheumatology

Peeples, Gout and Prednisolone 6

classification.7 The participants were chosen based on the inclusion and exclusion criteria listed in Table 1. The patients were randomly assigned using computer-generated tables and prepared by an independent party.7 The participants received either Prednisolone 35 mg qd, Etoricoxib 120 mg qd, or Indomethacin 50 mg tid. 7 The patients were only studied for 4 days due to the self-limiting nature of acute gouty arthritis.7 The participants pain levels were measured using a 5-point Likert scale and the same physician observed and studied each patient throughout the 4 days.7 Of the 132 patients who were randomized, 113 participants were ultimately analyzed. Of the 113 studied, 33 were given Prednisolone, 44 were given Etoricoxib, and 36 were given Indomethacin.7 Adverse effects noted during the trial mainly included gastric or abdominal pain, dizziness, edema, fatigue, drowsiness, and dry mouth.7
The results demonstrate both Indomethacin and Prednisolone significantly decrease the severity and pain of acute gouty arthritis. The mean difference between the two groups is 0.11 with a p value of 0.416.7 The treatment effect is small. This is because the reduction in pain when comparing Prednisolone to Indomethacin is 0.11. The confidence interval is wide at 95% (0.16 to 0.39). 7 This is due to the small sample size.7 The p-value is 0.415.7 Therefore, because the p > 0.005 there is no significant difference between the groups. The efficacy of Prednisone in reducing pain was comparable to Indomethacin after 4 days. Furthermore, there is no significant difference between the groups and Prednisolone can be used just as effectively to treat gout. Results: Indomethacin vs Prednisolone (Table 2)

Group
Prednisolone vs
Indomethacin

Value Measured LS Mean Difference Confidence Interval

Pain

0.11 (.0138)

-0.16 to 0.39

P Value 0.415

Peeples, Gout and Prednisolone 7
In the Rainer et al double-blind randomized trial, 416 patients aged 18 years or older with a clinical diagnosis of acute gout were enrolled in the study.3 Of the 416 enrolled, 376 completed the study. 3 The patients were chosen based on the inclusion and exclusion criteria listed in table 1. Patients were randomly assigned using a 1:1 ratio to receive either Indomethacin or Prednisolone for 5 days.3 The physicians and patients were unaware of which drug they were to receive. In the Indomethacin group (n=208), patients initially received 50mg (two 25mg tablets) of oral Indomethacin 3 times daily. 3 Patients were also given 6 tablets of oral placebo Prednisolone to take once daily for 2 days. 3 This was followed by 25 mg of Indomethacin 3 times a day and the placebo Prednisolone to take once per day for 3 days.3 In the Prednisolone group (n=208), patients initially took 30 mg (three 10mg tablets) of oral Prednisolone once a day, and 2 tablets of placebo Indomethacin 3 times a day for 2 days.3 This was followed by 30mg (three 10 mg tablets) of Prednisolone once a day and 1 tablet of placebo Indomethacin 3 times a day for 3 days.3 Patients were required to take the first dose in the presence of one of the investigators and all patients were given the analgesic Acetaminophen to use as needed.3 The results were measured using a 100mm visual analogue scale.3
When comparing the effectiveness of Indomethacin to Prednisolone in this study, there was a small difference between the two groups. While measuring decrease in pain scores on days 1-14 while the patient was a rest, demonstrated a reduction of 1.67 mm for Indomethacin and 1.52 mm for Prednisolone.3 As a result, the difference in mean pain score between the two groups is 0.15 mm.3 Furthermore, the number of patients which demonstrated a significant change in their pain score was calculated.3 Among the patients who received Indomethacin, 111 patients illustrated a significant change, and in the Prednisolone group 101 patients demonstrated a change in pain score.3 Therefore, the average difference between the two
GoutPatientsPainNsaidsPrednisolone