Oral prednisolone is as effective as indomethacin for relieving pain in acute gout and should be considered a first-line treatment option, according to a report published online Feb. 22 in Annals of Internal Medicine.
Colchicine and nonsteroidal anti-inflammatory drugs have been considered the first-line treatment for acute gout for many years. “However, their use is limited in elderly adults and in patients with comorbid conditions (such as renal insufficiency or gastrointestinal disease) because of their potential adverse effects and drug interactions,” said Dr. Timothy Hudson Rainer of the emergency medicine academic unit, Cardiff (Wales) University, and his associates.
They performed a double-blind, randomized trial comparing oral indomethacin against oral prednisolone in 416 patients who presented during a 2-year period to the emergency departments of four Hong Kong hospitals, where acute gout typically is treated in the ED. Those who were randomized to indomethacin initially received 50 mg (two 25-mg tablets) of the drug three times a day and six tablets of oral placebo prednisolone once a day for 2 days, followed by 25 mg of indomethacin three times a day and six tablets of placebo prednisolone once a day for 3 days. Prednisolone-treated patients initially received 30 mg (three 10-mg tablets) of the drug once a day and two tablets of placebo indomethacin three times a day for 2 days, followed by 30 mg (three 10-mg tablets) of prednisolone once a day and one tablet of placebo indomethacin three times a day for 3 days. All the patients received 1 g oral paracetamol to be taken every 6 hours as needed. The mean patient age was 65 years, and most (74%) of the study participants had a history of recurrent gout. The patients were followed for 2 weeks.
Scores on several measures of joint pain, redness, and tenderness were equivalent between the two treatment groups throughout the study period. During a 2-hour period at the emergency department, 100-mm visual analog scale (VAS) pain scores at rest declined by 6.54 mm/hour with indomethacin and by 5.05 mm/hour with prednisolone, and with activity, the declines were 11.69 mm/hour and 11.38 mm/hour, respectively. VAS scores declined during days 1-14 of treatment by similar mean amounts both at rest (1.80 mm/day for indomethacin and 1.68 mm/day for prednisolone) and with activity (2.96 mm/day vs. 3.19 mm/day, respectively). All VAS pain score improvements except for the one at rest in the ED exceeded 13 mm, meeting the definition for clinically meaningful improvement. The number of patients who showed clinically meaningful declines in pain scores also was equivalent between the two groups in both the intention-to-treat and the per-protocol analyses, the investigators said (Ann Intern Med. 2016 Feb 23. doi: 10.7326/M14-2070).
Both groups also showed similar responses in secondary endpoints of improvement in redness and tenderness of the affected joints, need for additional paracetamol, and patient satisfaction with analgesia.
There were no serious adverse events, but seven patients in the indomethacin group and one in the prednisolone group discontinued treatment because of adverse signs or symptoms. This included abdominal pain, dizziness, and lethargy among patients taking indomethacin and mild hyperkalemia in the patient taking prednisolone. The rate of minor adverse events was significantly higher with indomethacin (19%) than with prednisolone (6%).
“Our study provides robust evidence that oral corticosteroids are as effective at treating pain and as acceptable to patients as NSAIDs,” Dr. Rainer and his associates noted.
This trial was supported by the Hong Kong government’s Health and Health Services Research Grant Committee. Dr. Rainer and his associates reported having no relevant financial disclosures.