Selective serotonin re-uptake inhibitors (SSRIs) versus placebo for obsessive compulsive disorder (OCD)

 

Abstract

Background

Obsessive compulsive disorder is a common and disabling disorder. A significant proportion of patients manifest a chronic course. Individual randomised controlled trials (RCTs) have shown that selective serotonin re-uptake inhibitors (SSRIs) are effective in this condition. Previous systematic reviews or meta-analyses summarising the evidence are methodologically problematic or limited in the scope of their analysis.

Objectives

To examine the efficacy and adverse effects of serotonin re-uptake inhibitors (SSRIs) versus placebo for obsessive compulsive disorder (OCD) in adults.

Search methods

CCDANCTR-Studies and CCDANCTR-References were searched on 12/11/2007. Reference lists were checked. Experts in the field were contacted.

Selection criteria

All RCTs and quasi-RCTs examining the efficacy of SSRIs compared with placebo for OCD in adults were eligible for inclusion.

Data collection and analysis

Selection of studies and data extraction were carried out by two review authors independently, and quality assessment of studies was undertaken. Data analysis was conducted using Review Manager software. Summary measures were produced using the weighted mean difference (WMD) for continuous data and relative risk (RR) for dichotomous data, with 95% confidence intervals (CI). SSRIs were examined as an overall group of drugs, and as individual drugs.

Main results

Seventeen studies were included in the review, involving 3097 participants. Based on all 17 studies, SSRIs as a group were more effective than placebo in reducing the symptoms of OCD between 6 and 13 weeks post-treatment, measured using the Yale-Brown Obsessive Compulsive Scale (YBOCS) (WMD -3.21, 95% CI -3.84 to -2.57). The WMD for individual SSRI drugs were similar and not statistically different. Based on 13 studies (2697 participants), SSRIs were more effective than placebo in achieving clinical response at post-treatment (RR 1.84, 95% CI 1.56 to 2.17). The pooled RR was shown to be similar between individual SSRI drugs. Although reported adverse effects data were more limited, with few exceptions, the overall and individual adverse effects for the different SSRIs were always worse than for placebo and, in the majority of cases, the difference was statistically significant. Nausea, headache and insomnia were always reported amongst the most common adverse effects in trials of each of the drugs.

Authors' conclusions

SSRIs are more effective than placebo for OCD, at least in the short-term, although there are differences between the adverse effects of individual SSRI drugs. The longer term efficacy and tolerability of different SSRI drugs for OCD has yet to be established.

 

Plain language summary

Selective serotonin re-uptake inhibitors (SSRIs) versus placebo for obsessive compulsive disorder (OCD)

Obsessive compulsive disorder (OCD) is a common and disabling disorder, which frequently follows a chronic course. It is characterised by intrusive thoughts of imagined harm, which are difficult to dispel, and ritualistic behaviour such as repetitive washing of hands and repetitive checking for risk of harm. Individual randomised controlled trials have demonstrated that antidepressants are effective for OCD. This review summarises all the available evidence for one class of antidepressant drugs, the selective serotonin re-uptake inhibitors (SSRIs) (including citalopram, fluoxetine, fluvoxamine, paroxetine and sertraline) compared to placebo in the treatment of OCD in adults. The review included 17 studies (3097 participants), and showed that SSRIs were effective in reducing the symptoms of OCD. Based on 13 studies (2697 participants), the review showed that people receiving SSRIs were nearly twice as likely as those receiving placebo to achieve clinical response (defined as a 25% or more reduction in symptoms). Indirect comparisons of effectiveness suggested that although individual SSRI drugs were similar in their effectiveness, they differed in terms of their adverse effects. The most common adverse effect reported by participants was nausea. Further studies involving head to head comparisons between different SSRI drugs are required to obtain more reliable information on differences between SSRIs, both in terms of effectiveness and adverse effects.

 

摘要

背景

選擇性血清素回收抑制劑(SSRI)及安慰劑在強迫症(OCD)之比較

強迫症是常見且會導致失能的疾病，很大比例的患者呈現出慢性化的病程。個別隨機對照試驗(RCTs)顯示在這種情況下選擇性血清素回收抑製劑(SSRIs)是有效的。之前的系統性文獻回顧或統合分析的總結證據有其方法學問題或有其分析範疇上的限制

目標

檢驗相較於安慰劑，選擇性血清素回收抑制劑(SSRI)在成人強迫症(OCD)患者的效果及副作用

搜尋策略

在2007年12月11日搜尋CCDANCTRStudies及CCDANCTRReferences，並且核對其參考文獻並諮詢本領域之專家

選擇標準

所有比較選擇性血清素回收抑制劑及安慰劑在成人強迫症(OCD)患者效果的隨機臨床試驗及半隨機臨床試驗均納入

資料收集與分析

研究選擇及資料萃取由2位回顧作者各自完成，並且評估研究的品質，資料分析是使用Review Manager軟體，彙總測量是在95%信賴區間(confidence intervals, CI)使用加權平均差異(Weighted Mean Difference, WMD)來看連續資料，使用相對風險(Relative Risk, RR)來看二分法的資料。選擇性血清素回收抑制劑藥物在當中有視為同一類群的藥物分析，也有視為個別的藥物分析

主要結論

17個試驗被納入此篇回顧，包括了3097位參與者。以這17個全部的試驗來看，將選擇性血清素回收抑制劑藥物視為同一組，比安慰劑組在治療後6週及13週強迫症的症狀減少效果較佳，評估後使用YaleBrown Obsessive Compulsive Scale(YBOCS)量測(WMD −3.21, 95% CI −3.84 到 −2.57)。個別選擇性血清素回收抑制劑間的加權平均差異(WMD)相似且無統計上的差異。以13個試驗來看(2697位參與者)，選擇性血清素回收抑制劑藥物(SSRIs)比安慰劑在更能有效達治療後之臨床反應(RR 1.84, 95% CI 1.56 to 2.17)，個別的選擇性血清素回收抑制劑藥物之加總相對危險則相似，僅管副作用的報告有限，除少數例外，總體或個別的選擇性血清素回收抑制劑藥物副作用都比安慰劑嚴重，大部分的個案，其差異是有統計意義的。噁心、頭痛和失眠是這些藥物試驗最常報告的副作用

作者結論

雖然不一樣的選擇性血清素回收抑制劑藥物之間在副作用上有差異，至少在短期內以選擇性血清素回收抑制劑藥物(SSRIs)在強迫症比安慰劑有效，至於不一樣的選擇性血清素回收抑制劑藥物對強迫症的長期效用及耐受性尚待建立

翻譯人

本摘要由彰化基督教醫院許文郁翻譯

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

總結

選擇性血清素回收抑制劑及安慰劑在強迫症之比較。強迫症是常見的失能性疾病，並常有慢性化的病程，它的特點是插入性想像的傷害的思考，很難去除這些想法，而且有儀式化行為，如重複洗手和重複檢查的傷害危險。個別隨機對照試驗顯示服用抗憂鬱藥物在強迫症是有效的。這篇回顧總結所有針對成人強迫症可得的證據，此一類抗憂鬱藥為選擇性血清素回收抑制劑(包括citalopram，fluoxetine，fluvoxamine，paroxetine，和sertraline)，並和安慰劑作比較。這個回顧包括17個試驗(3097參與者)，顯示選擇性血清素回收抑制劑對減少強迫症症狀是有效的。以13個試驗來看(2697位參與者)，此回顧顯示約2倍的個案接受選擇性血清素回收抑制劑，比安慰劑達至臨床反應(臨床反應定義為25%以上症狀的改善)。間接的效益比較認為雖然個別選擇性血清素回收抑制劑有相似的效力，但它們副作用不一。參與者最常見的副作用是噁心，進一步個別選擇性血清素回收抑制劑間的一對一比較研究是必要的，以獲得更可信的資料，如其效果及副作用等