Deng Hongyong, Xu Ji
Shanghai University of Traditional Chinese Medicine, No. 1200 Cailun Road, Pudong District, Shanghai, China, 201203.
Cochrane Database Syst Rev. 2017 Jun 28;6(6):CD012217. doi: 10.1002/14651858.CD012217.pub2.
Wendan decoction (WDD) is one of the classical Chinese herb formulas used for psychotic symptoms. It is thought to be safe, accessible and inexpensive.
To investigate the effects of WDD for treatment of people with schizophrenia or schizophrenia-like illness compared with placebo, antipsychotic drugs and other interventions for outcomes of clinical importance.
We searched the Cochrane Schizophrenia Group's Trials Register (February 2016), which is based on regular searches of CINAHL, BIOSIS, AMED, Embase, PubMed, MEDLINE, PsycINFO, China biomedical databases group (SinoMed, CNKI, VIP, Wanfang) and clinical trials registries. There are no language, date, document type, or publication status limitations for inclusion of records in the register. We also inspected references of identified studies and contacted relevant authors for additional information.
Randomised controlled trials with useable data comparing WDD with antipsychotics, placebo or other interventions for people with schizophrenia.
We extracted data independently. For binary outcomes, we calculated risk ratios (RR) and 95% confidence intervals (CIs), on an intention-to-treat basis. For continuous data, we estimated mean differences (MD) between groups and their 95% CIs. We employed a random-effect model for analyses. We assessed risk of bias for included studies and created 'Summary of findings' tables using GRADE.
We included 15 randomised trials (1437 participants) of WDD for schizophrenia. There was a high risk of performance bias within the trials but overall, risk for selection, attrition and reporting bias was low or unclear.Data showed WDD improved the short-term global state of participants compared with placebo or no treatment (1 RCT n = 72, RR 0.53, 95% CI 0.39 to 0.73, low-quality evidence).When WDD was compared with antipsychotic drugs, such as chlorpromazine or risperidone, no difference in short-term global state of participants was observed (2 RCTs n = 140, RR 1.18 95% CI 0.98 to 1.43, moderate-quality evidence) and mental state (total endpoint Positive and Negative Syndrome Scale (PANSS): 2 RCTs, n = 140, MD 0.84, 95% CI -4.17 to 5.84, low-quality evidence). However, WDD was associated with fewer people experiencing extrapyramidal effects (EPS) compared with other treatments (2 RCTs 0/70 versus 47/70, n = 140, RR 0.02, 95% CI 0.00 to 0.15, moderate-quality evidence).WDD is often used as an add-on intervention alongside antipsychotics. When WDD + antipsychotic was compared to antipsychotic alone, the combination group had better global state (short-term results, 6 RCTs, n = 684, RR 0.60, 95% CI 0.50 to 0.72, moderate-quality evidence) and mental state (short-term total endpoint PANSS: 5 RCTs, n = 580, MD -11.64, 95% CI -13.33 to - 9.94, low-quality evidence), fewer people with EPS (2 RCTs n = 308, RR 0.46, 95% CI 0.30 to 0.70, moderate-quality evidence) and reduction of the mean use of risperidone (1 RCT n = 107, MD -0.70, 95% CI -0.87 to -0.53, low-quality evidence). But, there was no effect on weight gain (1 RCT n = 108, RR 0.50, 95% CI 0.20 to 1.24, low-quality evidence).When WDD + low-dose antipsychotic was compared with normal-dose antipsychotic alone, the combination again showed benefits for short-term global state (7 RCTs n = 522, RR 0.69, 95% CI 0.51 to 0.93, moderate-quality evidence), mental state (total endpoint PANSS: 4 RCTs n = 250, MD -9.53, 95% CI -17.82 to -1.24, low-quality evidence), and fewer participants with EPS (3 RCTS n = 280, RR 0.29, 95% CI 0.16 to 0.51, moderate-quality evidence).Across all comparisons, we found no data on outcomes directly reporting quality of life, hospital service use and economics.
AUTHORS' CONCLUSIONS: Limited evidence suggests that WDD may have some positive short-term antipsychotic global effects compared to placebo or no treatment. However when WDD was compared with other antipsychotics there was no effect on global or mental state, but WDD was associated with fewer adverse effects. When WDD was combined with an antipsychotic, positive effects were found for global and mental state and the combination caused fewer adverse effects. The available evidence is not high quality. Better designed large studies are needed to fully and fairly test the effects of WDD for people with schizophrenia.
温胆汤是用于治疗精神症状的经典中药方剂之一。人们认为它安全、易得且价格低廉。
与安慰剂、抗精神病药物及其他干预措施相比，研究温胆汤治疗精神分裂症或精神分裂症样疾病患者的效果，观察对具有临床重要性的结局指标的影响。
我们检索了Cochrane精神分裂症研究组试验注册库（2016年2月），该注册库基于定期检索CINAHL、BIOSIS、AMED、Embase、PubMed、MEDLINE、PsycINFO、中国生物医学数据库组（中国生物医学文献数据库、中国知网、维普、万方）及临床试验注册库。纳入注册库记录时无语言、日期、文献类型或发表状态限制。我们还检查了已识别研究的参考文献，并联系相关作者获取更多信息。
将温胆汤与抗精神病药物、安慰剂或其他干预措施用于精神分裂症患者进行比较且有可用数据的随机对照试验。
我们独立提取数据。对于二分类结局，我们基于意向性分析计算风险比（RR）和95%置信区间（CI）。对于连续性数据，我们估计组间平均差（MD）及其95%CI。我们采用随机效应模型进行分析。我们评估纳入研究的偏倚风险，并使用GRADE创建“结果总结”表。
我们纳入了15项关于温胆汤治疗精神分裂症的随机试验（1437名参与者）。试验中存在较高的实施偏倚风险，但总体而言，选择、失访和报告偏倚风险较低或不明确。数据显示，与安慰剂或未治疗相比，温胆汤改善了参与者的短期整体状况（1项随机对照试验，n = 72，RR 0.53, 95%CI 0.39至0.73，低质量证据）。当温胆汤与抗精神病药物如氯丙嗪或利培酮比较时，未观察到参与者短期整体状况有差异（2项随机对照试验，n = 140，RR 1.18，95%CI 0.98至1.43，中等质量证据），且精神状态（总终点阳性和阴性症状量表（PANSS）：2项随机对照试验，n = 140，MD 0.84，95%CI -4.17至5.84，低质量证据）也无差异。然而，与其他治疗相比，温胆汤导致锥体外系反应（EPS）的人数较少（2项随机对照试验，0/70对47/70，n = 140，RR 0.02，95%CI 0.00至0.15，中等质量证据）。温胆汤常与抗精神病药物联合使用。当温胆汤 + 抗精神病药物与单独使用抗精神病药物比较时，联合组的整体状况更好（短期结果，6项随机对照试验，n = 684，RR 0.60，95%CI 0.50至0.72，中等质量证据）和精神状态（短期总终点PANSS：5项随机对照试验，n = 580，MD -11.64，95%CI -13.33至 -9.94，低质量证据），发生EPS的人数较少（2项随机对照试验，n = 308，RR 0.46，95%CI 0.30至0.70，中等质量证据），且利培酮的平均使用量减少（1项随机对照试验，n = 107，MD -0.70，95%CI -0.87至 -0.53，低质量证据）。但是，对体重增加无影响（1项随机对照试验，n = 108，RR 0.50，95%CI 0.20至1.24，低质量证据）。当温胆汤 + 低剂量抗精神病药物与单独使用常规剂量抗精神病药物比较时，联合组在短期整体状况（7项随机对照试验，n = 522，RR 0.69，95%CI 0.51至0.93,中等质量证据）、精神状态（总终点PANSS：4项随机对照试验，n = 250，MD -9.53，95%CI -17.82至 -1.24，低质量证据）方面再次显示出优势，且发生EPS的参与者较少（3项随机对照试验，n = 280，RR 0.29，95%CI 0.16至0.51，中等质量证据）。在所有比较中，我们未发现直接报告生活质量、医院服务利用和经济学结局的数据。
有限的证据表明，与安慰剂或未治疗相比，温胆汤可能具有一些积极的短期抗精神病整体效果。然而，当温胆汤与其他抗精神病药物比较时，对整体或精神状态无影响，但温胆汤的不良反应较少。当温胆汤与抗精神病药物联合使用时，对整体和精神状态有积极作用，且联合用药引起的不良反应较少。现有证据质量不高。需要设计更好的大型研究来全面、公正地检验温胆汤对精神分裂症患者的疗效。
