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Intervention Review

Diacerein for osteoarthritis

  1. Tania S.A. Fidelix1,*,
  2. Bernardo Soares2,
  3. Virginia Fernandes Moça Trevisani3

Editorial Group: Cochrane Musculoskeletal Group

Published Online: 25 JAN 2006

Assessed as up-to-date: 15 NOV 2005

DOI: 10.1002/14651858.CD005117.pub2


How to Cite

Fidelix TS, Soares B, Fernandes Moça Trevisani V. Diacerein for osteoarthritis. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD005117. DOI: 10.1002/14651858.CD005117.pub2.

Author Information

  1. 1

    UNIFESP (ESCOLA PAULISTA DE MEDICINA), Internal Medicine and Therapeutic, São Bernardo, São Paulo, Brazil

  2. 2

    Brazilian Cochrane Centre, São Paulo, SP, Brazil

  3. 3

    UNISA (Santo Amaro University)/UNIFESP (Paulista Medicine School), Rheumatology/Internal Medicine and Therapeutics, Jardim Marajoara, Sao Paulo, Brazil

*Tania S.A. Fidelix, Internal Medicine and Therapeutic, UNIFESP (ESCOLA PAULISTA DE MEDICINA), Rua Mediterraneo 290 sl 13, São Bernardo, São Paulo, 09750 420, Brazil. tsafidelix@uol.com.br.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 25 JAN 2006

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

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 methods

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.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

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.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

Diacerein治療退化性關節炎

退化性關節炎是常見骨骼肌肉疾病。Diacerein作用與傳統經由抑制前列腺素生成而往往造成腸胃道副作用的非類固醇消炎劑(NSAID)不同,曾被當為具有緩慢作用、症狀調節及疾病構造調節的治療退化性關節炎藥物。

目標

根據美國風濕病學會及或歐洲診斷條件,評估Diacerein治療成人中軸或周邊退化性關節炎之效果及安全性。

搜尋策略

搜尋包括MEDLINE (1966 – 2004), EMBASE (1980 – 2004), Cochrane Central Register of Controlled Trials (CENTRAL) he Cochrane Library, Issue 3, 2004, and LILACS(1982 – 2004)。同時手動搜尋所選文章之參考文獻、及聯絡藥廠及發表文章之作者。無語言限制。

選擇標準

Diacerein治療符合美國風濕病學會之原發及續發退化性關節炎之相關隨機及準隨機研究。排除其他疾病引起之退化性關節炎。

資料收集與分析

三位作者獨立進行預定條件之資料摘錄,並對每篇試驗研究的品質進行評估 (品質評估用Cochrane Handbook Criteria, Jadad and Schultz scores)。連續性資料使用加權平均差異(WMD)分析,二分法類別資料使用相對風險(RR)來表示,並使用隨機效應模型(random effects model)分析。

主要結論

總共7個研究包含2069例病患。Diacerein治療退化性關節炎有小但持續的益處。在一項1228位參與者的研究中,Diacerein比安慰劑其疼痛減少加權平均差異WMD −5.16 (95% CI −9.75, −0.57),絕對值減少 oints (0 – 100 mm視覺類比量表VAS),但有異質性(P = 0.04)。當髖與膝退化性關節炎分開分析時,並無顯著差異。根據Lequesne Impairment Index功能分析,1006位參與者其整體及同質性次群分析並無顯著差異 (P>0.10)。針對髖退化性關節炎3篇研究顯示加權平均差異WMD −0.21 (95% CI −0.82, 0.40)。針對膝退化性關節炎,兩篇顯示加權平均差異WMD −0.95 (95% CI −2.64, 0.74)。整體綜合加權平均差異WMD為 −0.29 (95% CI −0.87, 0.28)。2篇長期研究﹝髖與膝關節各一篇﹞關節腔空隙X光影像變化,其中髖關節腔空隙較少變窄惡化,但膝關節則無顯著差異。但不同研究之整體效果差異大(髖關節P = 0.04,膝關節P = 0.85)。最常見副作用為腹瀉(42%, 1083人使用Diacerein有459人腹瀉情況)。因副作用退出在治療組與安慰劑組分別為18% 與13% 。

作者結論

有金級的證據顯示Diacerein治療退化性關節炎疼痛有小但持續的益處。對於Diacerein治療退化性關節炎之短期與長期效果及副作用需進一步研究。

翻譯人

本摘要由林口長庚醫院余光輝翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

是否diacerein可治療退化性關節炎和其是安全嗎? 7項中到高品質的研究進行了回顧,並提供今日我們擁有最好的證據。該研究測試了超過 2000個髖關節或膝關節退化性關節炎患者。該研究比較了服用100毫克diacerein與服用安慰劑(假丸),或者非類固醇抗炎藥(NSAIDs)或其他緩慢作用的關節炎藥物。該研究歷時 2個月至3年。 什麼是退化性關節炎,diacerein有效嘛? 退化性關節炎(OA)是關節炎最常見的形式,會影響手,髖部,肩膀和膝蓋。在退化性關節炎OA,保護兩端骨頭的軟骨損壞,導致疼痛和腫脹。藥物和非藥物治療可以緩解疼痛和/或腫脹。diacerein是一種緩慢作用的藥物,作為一種藥丸,可減緩軟骨破裂,減輕疼痛和腫脹。對於胃,它也可能是安全的。目前尚不清楚是否diacerein治療退化性關節炎OA的效用,且是否有比其他藥物更安全。 研究表明什麼?不論使用服用diacerein或服用安慰劑,非類固醇抗炎藥(NSAIDs)或其他緩慢作用的關節炎藥物其疼痛改善都相同。但是,比起使用安慰劑,使用diacerein的患者疼痛減少了約 5分(0 – 100分量表)。一項研究表明,比起使用安慰劑,使用diacerein組在疼痛,僵硬和身體功能更全面改善。2個長期研究,歷時 1年和3年測量了疾病在X光下的進展。研究發現,比起使用安慰劑,diacerein可使髖關節退化性關節炎OA的進展較緩慢但在膝關節退化性關節炎OA則沒有減緩進展。 diacerein安全性如何?副作用,如腹瀉,胃灼熱,軟便,胃痛,頻繁排便。腹瀉是最常見的副作用,通常發生在使用diacerein頭兩個星期開始。每100個使用diacerein患者會有42個出現腹瀉症狀。比起安慰劑是每100個有13個退出計畫,每100個使用diacerein患者會有18個由於副作用而退出計畫。 什麼是底線?證據品質等級是‘金’級。Diacerein似乎對於改善疼痛有一個小的效果,並且可改善延緩退化性關節炎的進展(在髖關節)。腹瀉是使用diacerein一種常見的副作用。還需要長期的研究以確定diacerein的長期好處與壞處。