Diacerein for osteoarthritis

Fidelix TSA, Soares BGDO, Trevisani VF M

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Summary

Diacerein for osteoarthritis

Does diacerein work to treat osteoarthritis and is it safe?
Seven studies of moderate to high quality were reviewed and provide the best evidence we have today. The studies tested over 2000 people with osteoarthritis of the hip or knee. The studies compared people who took 100 mg of diacerein to people who took a placebo (fake pill), or non-steroidal anti-inflammatory drugs (NSAIDs) or other slow acting arthritis drugs. The studies lasted 2 months to 3 years.

What is osteoarthritis and could diacerein work?

Osteoarthritis (OA) is the most common form of arthritis that can affect the hands, hips, shoulders and knees. In OA, the cartilage that protects the ends of the bones breaks down and causes pain and swelling. Drug and non-drug treatments are used to relieve pain and/or swelling. Diacerein is a slow-acting drug taken as a pill that may slow down the breakdown of cartilage and relieve pain and swelling. It may also be safe on the stomach. It is not clear whether diacerein works and whether it is safer than other drugs used to treat OA.

What did the studies show?

Pain improved about the same whether people took diacerein, a placebo, NSAIDs or other slow acting drugs. But, pain does seem to improve a bit more in people who take diacerein.

Pain decreased by about 5 more points on a 0-100 scale for people who took diacerein than a placebo.

One study shows that pain, stiffness, and physical function overall improved more in people who took diacerein than a placebo.

Two long term studies which lasted 1 year and 3 years measured the progress of the disease on x-rays. The studies found that diacerein slowed the progress in OA of the hip more than a placebo but did not slow the progress in OA of the knee.

How safe is diacerein?
Side effects such as diarrhoea, heartburn, soft stools, stomach pain and frequent bowel movements. Diarrhoea was the most common side effect and usually occurred during the first two weeks of starting diacerein.

42 out of 100 people who took diacerein had diarrhoea.
18 out of 100 people who took diacerein withdrew from the studies due to side effects compared with 13 out of 100 people in the placebo group.

What is the bottom line?

The level of quality of the evidence is 'gold'. It appears that diacerein has a small effect in improving pain and slowing the progress of osteoarthritis (in the hip). Diarrhoea is a common side effect of diacerein.

Longer studies need to be done to determine the long term benefits and harms of diacerein.

This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2008 Issue 3, Copyright © 2008 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).
This record should be cited as: Fidelix TSA, Soares BGDO, Trevisani VF M. Diacerein for osteoarthritis. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD005117. DOI: 10.1002/14651858.CD005117.pub2

This version first published online: January 25. 2006

Abstract

Background

Osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases. Diacerein acts differently from traditional non-steroidal anti-inflammatory drugs (NSAIDs) which inhibit prostaglandin synthesis, leading to adverse gastrointestinal effects. It has been proposed that diacerein acts as a slow-acting, symptom-modifying and perhaps disease-structure modifying drug for OA.

Objectives

To assess the effectiveness and safety of diacerein for treatment of OA in adults with peripheral or axial osteoarthritis according the American College of Rheumatology and/or EULAR diagnostic criteria.

Search strategy

We searched MEDLINE (1966-2004), EMBASE (1980-2004), Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, Issue 3, 2004, and LILACS(1982-2004) and hand searched reference lists of published articles. Pharmaceutical companies and authors of published articles were contacted. There was no language restriction.

Selection criteria

Randomized controlled trials (RCT) or quasi-RCTs of placebo-controlled and comparative studies of diacerein in adults with primary or secondary OA fulfilling the American College of Rheumatology (ACR) criteria were eligible for inclusion. The main criteria for exclusion was evidence of secondary disease.

Data collection and analysis

Data abstraction and quality assessment was performed independently by three investigators according to predetermined criteria and the results were compared to determine the degree of agreement. Quality evaluation was done using Cochrane Handbook Criteria, Jadad and Schultz scores. Continuous outcome measures were pooled using weighted mean differences (WMD). Dichotomous outcome measures were pooled using random effects model and results were expressed as relative risks (RR).

Main results

Collectively, the seven identified studies including 2069 participants demonstrated a small, consistent, beneficial effect of diacerein in the treatment of OA. When compared to placebo, pain on a visual analog scale (0-100 mm) was evaluated in 1228 participants and showed a statistically significant difference in favour of diacerein WMD -5.16 (95%CI -9.75, -0.57) with an absolute change of 5 points on the scale; but the heterogeneity analysis result was important (P=0.04). When analysed separately by hip OA and knee OA, no difference was detected.
According to the Lequesne Impairment Index for function, 1006 participants evaluated did not have improvement in the whole group or in the subgroup analysis with homogeneity in all results (P>0.10). For hip OA, three studies showed a WMD -0.21 (95%CI -0.82, 0.40). For knee OA, two studies showed WMD -0.95 (95%CI -2.64, 0.74). The summary WMD was -0.29 (95%CI -0.87, 0.28).
Two long-term studies, one evaluating hip OA and another evaluating knee OA, analysed structural progression with radiographic measurements of joint space. In hip OA, there was statistical significant slowing of progression in contrast with knee OA that did not demonstrate this reduction. However, the overall effect was very different between studies (P=0.04 for hip OA and P= 0.85 for knee OA).
The most frequent adverse event was diarrhea. 459 participants among 1083 participants that received diacerein (42%) were affected. 18% in the treatment group compared with 13% in the placebo group withdrew due to adverse events.

Authors' conclusions

There is 'gold' level evidence that diacerein has a small, consistent benefit in improvement in pain. Further research is necessary to confirm the short and long-term effectiveness and toxicity of diacerein therapy in OA.

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