Risperidone versus typical antipsychotic medication for schizophrenia

 

Abstract

Background

Risperidone is one of the 'new generation' antipsychotics. As well as its reputed tendency to cause fewer movement disorders than the older drugs such as chlorpromazine and haloperidol, it is claimed that risperidone may improve negative symptoms.

Objectives

To evaluate the effects of risperidone for schizophrenia in comparison to 'conventional' neuroleptic drugs.

Search methods

The original electronic searches of Biological Abstracts (1980-1997), Cochrane Schizophrenia Group's Register (1997), The Cochrane Library (1997, Issue 1), EMBASE (1980-1997), MEDLINE (1966-1997), PsycLIT (1974-1997), and SCISEARCH (1997) were updated with a new electronic search of the same databases in 2002. The search term used in the update was identical to that used in 1997. Any new studies or relevant references were added to the review. In addition, references of all identified studies were searched for further trial citations. Pharmaceutical companies and authors of trials were also contacted.

Selection criteria

All randomised trials comparing risperidone to any 'conventional' neuroleptic treatment for people with schizophrenia or other similar serious mental illnesses.

Data collection and analysis

Citations and, where possible, abstracts were independently inspected by reviewers, papers ordered, re-inspected and quality assessed. Data were also independently extracted. Where possible, sensitivity analyses on dose of risperidone, haloperidol and duration of illness were undertaken for the primary outcomes of clinical improvement, side effects (movement disorders) and acceptability of treatment. For homogeneous dichotomous data the Relative Risk (RR), 95% confidence interval (CI) and, where appropriate, the number needed to treat/harm (NNT/H) were calculated on an intention-to-treat basis.

Main results

In the short-term, risperidone was more likely to produce an improvement in the Positive and Negative Syndrome Scale (PANSS) when compared with haloperidol (n=2368, 9 RCTs, RR not 20% improved 0.72 CI 0.59 to 0.88 NNT 8). A similar, favourable outcome for risperidone was found in long-term studies (n=859, 2RCTs RR not 20% improved 0.51 CI 0.38 to 0.67 NNT 4;n=675 1RCT, RR not improved 40% 0.75 CI 0.66 to 0.84 NNT 5; n=675, 1 RCT, RR not 60% improved 0.90 CI 0.84 to 0.96, NNT 11). Risperidone was also more likely to reduce relapse at one year follow up, compared with haloperidol (n=367, 1 RCT, RR 0.64 CI 0.41 to 0.99, NNT 7). Less people allocated risperidone left studies before completion, both for short-term (n=3066, 16 RCTs, RR 0.76 CI 0.63 to 0.92, NNT 6) and long-term trials (n=1270, 4RCTs, RR 0.55 CI 0.42 to 0.73 NNT 4). For general movement disorders results favoured risperidone. People given risperidone had significantly fewer general movement disorders (including extrapyramidal side effects) than those receiving older typical antipsychotics (n=2702, 10 RCTs, RR 0.63 CI 0.56 to 0.71, NNT 3). Significantly fewer people given risperidone used antiparkinsonian drugs (n=2524, 11 RCTs, RR 0.66 CI 0.58 to 0.74, NNT 4). As regards body weight, however, four studies (n=1708) found people were more likely to gain weight if allocated risperidone compared to typical antipsychotics (RR 1.55 CI 1.25 to 1.93, NNH 3). Risperidone was no more or less likely than haloperidol to cause sexual problems such as erectile dysfunction (n=106, 2 RCTs, RR 1.55 CI 0.58 to 4.20). Finally, some results found risperidone was more likely to cause rhinitis than conventional antipsychotics (n=656, 3 RCTs, RR1.99 CI 1.24 to 3.19, NNH 3).

Authors' conclusions

Risperidone may be more acceptable to those with schizophrenia than older antipsychotics and have marginal benefits in terms of limited clinical improvement. Its adverse effect profile may be better than haloperidol. With the addition of more studies to this review, the publication bias evident in previous versions is no longer a significant issue. Any marginal benefits this drug may have have to be balanced against its greater cost and increased tendency to cause side effects such as weight gain.

Recent important longer term data favouring risperidone's effect on relapse needs to be replicated by researchers independently of the manufacturers of the drug.

 

Plain language summary

Risperidone versus typical antipsychotic medication for schizophrenia

Risperidone is one of the most widely used new generation of antipsychotic drugs. This review summarises its effects compared with the older antipsychotics. In essence, risperidone may be equally clinically effective to relatively high doses of haloperidol, for an outcome that is difficult to interpret as clinically meaningful. Risperidone causes less adverse effects than the side-effect prone haloperidol.

 

摘要

背景

比較Risperidone與典型抗精神病藥物在精神分裂症的治療

Risperidone是一種‘新世代’抗精神病藥物。如同相較於早期的藥物如chlorpromazine和 haloperidol，它著名在較少產生運動障礙，有人聲稱Risperidone可以改善負性症狀

目標

用‘傳統的’精神病藥物來比較，進一步評估risperidone在治療精神分裂症上的效果

搜尋策略

Biological Abstracts (1980 – 1997), Cochrane Schizophrenia Group's Register (1997), The Cochrane Library (1997, Issue 1), EMBASE (1980 – 1997), MEDLINE (1966 – 1997), PsycLIT (1974 – 1997), and SCISEARCH (1997)的原電子搜索於2002年，在同一數據庫更新了新的電子搜索。更新的搜索字詞與在1997年使用的完全相同。任何新的研究或有關參考文獻也被含括在這篇回顧。此外為了找到更多的引用試驗，搜尋所有辨識出研究的參考文獻。還接觸製藥公司和試驗的作家

選擇標準

所有比較Risperidone對任何‘傳統’抗精神病藥物在治療精神分裂症患者或其他類似的嚴重的精神疾病的隨機試驗

資料收集與分析

在可能情況下，引文和摘要由審查者獨立審視，排序文章，重新檢視和品質評估。數據也獨立提取。如有可能，Risperidone，haloperidol的劑量敏感性分析和疾病期長短被取用為臨床改善，副作用(運動障礙)和治療接受度的主要成果。對於同質二分項數據的Relative Risk (RR)，95% confidence interval (CI)，並在適當情況下the number needed to treat/harm (NNT/H)以意向治療(intentiontotreat)的基礎作計算

主要結論

在短期內，Risperidone比haloperidol在正性和負性症狀量表(PANSS)上改善更多(n = 2368，9個隨機對照試驗，RR不到20％的改善0.72, CI 0.59 to 0.88, NNT 8)。類似有利於Risperidone的結果被發現在長期的研究(n = 859，2個隨機對照實驗 RR不到20％的改善0.51, CI 0.38 to 0.67 NNT 4; n = 675 1個隨機對照實驗，RR 40％沒有改善0.75, CI 0.66 to 0.84, NNT 5; n = 675，1個隨機對照試驗，RR不到60％改善 0.90, CI 0.84 to 0.96，NNT 11)。Risperidone較haloperidol也更有可能減少追蹤一年後的復發(n = 367，1個隨機對照試驗，RR 0.64, CI 0.41 to 0.99，NNT 7)。不管在短期的(n = 3066，16隨機對照實驗，RR 0.76, CI 0.63 to 0.92，NNT6)和長期試驗(n = 1270，4RCTs，RR 0.55, CI 0.42 to 0.73, NNT 4，分配至Risperidone的人較少在研究完成之前離開。對於一般運動失調的結果，Risperidone表現較佳。被給予Risperidone的患者比那些接受早期的典型抗精神病藥物的患者明顯減少了一般的運動障礙(包括錐體外徑副作用)(n = 2702，10個隨機對照實驗，RR 0.63, CI 0.56 to 0.71，NNT 3)。給予Risperidone的人 大大減少使用於抗帕金森藥物(antiparkinsonian drugs)(n = 2524，11隨機對照實驗，RR 0.66 CI 0.58 to 0.74，NNT 4)。至於體重，四份研究報告(n = 1708)發現，分配到Risperidone的人較典型的抗精神病藥物的人更容易發胖(RR 1.55 CI 1.25 to 1.93，NNH 3)。Risperidone沒有比haloperidol引起更多或更少的性方面問題，如勃起功能障礙(n = 106，2個隨機對照實驗，RR 1.55, CI 0.58 to 4.20)。最後，一些結果發現Risperidone，比傳統抗精神病藥物更有可能導致過敏性鼻炎(n = 656，3個隨機對照實驗，RR 1.99, CI 1.24 to 3.19，NNH 3)

作者結論

Risperidone在精神分裂症可能比早期的抗精神病藥物更能被接受，並在有限的臨床改善下具備邊際收益。其副作用可能比haloperidol少。此外隨著更多的研究，在過去版本顯著存在的發表偏差(publication bias)，現在顯然已不再是一個重要的問題。這一藥物的任何邊際效益可能必需權衡其更高的成本和增加副作的趨勢，如體重增加。近來Risperidone在復發方面有較佳療效的重要長期數據需要被研究人員在獨立於藥廠外複製其研究

翻譯人

本摘要由彰化基督教醫院廖慈凰翻譯

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

總結

Risperidone是一種廣泛使用的新一代抗精神病藥物。這篇回顧總結其與早期抗精神病藥的效果比較。從本質上講，Risperidone，可能與相對高劑量的haloperidol有同樣臨床效果，這是一個難以解釋的臨床意義的結果。Risperidone比容易引起副作用的haloperidol較少有副作用。