Evaluation of the efficacy and safety of the combined therapy with diclofenac sodium slow release capsule and suppository in the treatment of rheumatoid arthritis

—Including the assessment of quality of life measures—

Abstract

In the current treatment of rheumatoid arthritis (RA), to achieve the high quality of life (QOL) of patients became important. Therefore, we assessed QOL as well a the efficacy and safety in the combined therapy of diclofenac sodium slow release capsule (Voltaren SR capsule) and suppository (Voltaren SUPPO) .
To 70 RA patients, slaw release capsule 37.5 mg was given orally twice daily I capsule each after breakfast and dinner, and 25 mg p.r. of suppository before sleep for 8 weeks, respectively.
Among the inflammatory findings, significant improvement was seen in the number of painful joints and painful/swollen joints after week 4 and 8 of the treatment.
There was no change in QOL evaluated using modified health assessment questionnaire (HAQ), quality of well-being score face scale and analogue scale evaluation method developed by us The results of HAQ stratified by the various factors showed improvement in the groups of“No treatment history with NSAIDs”in week 4 and more serious cases of“Stage”and“Pre-administration MHAQ value”.
The final general improvement rate was 20.8% (10/48) for“moderate improvement”or better, and 60.4% (29/48) for“slight improvement”or better.
Adverse effects were seen in 7 patients among 61 (11, 5%) . Symptoms were mild except for moderate epigastric pain.
From the above, the usefulness of the present therapy was confirmed as high as that of the double blind test of slow release capsule. The short-term efficacy of the present therapy was also suggested by some QOL measures, especially in serious RA patients. However, we think that further studies using controlled test with sufficient number of natients are necessary to confirm these findings.