Oniyangi Oluseyi, Cohall Damian H
Paediatrics Department, National Hospital, Plot 132 Central District (Phase II), PMB 425 Garki, Abuja, Nigeria.
Cochrane Database Syst Rev. 2010 Oct 6(10):CD004448. doi: 10.1002/14651858.CD004448.pub3.
Sickle cell disease (SCD), a common recessively inherited haemoglobin disorder, affects people from sub-Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbeans and South America. It is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass many of the plant remedies from traditional healers which the populations most affected would encounter. There has been little systematic appraisal of their benefits.
To assess the benefits and risks of phytomedicines in people with SCD of all types, of any age, in any setting.
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register and the ISRCTN Register for all publication years; AMED was searched by the previous authors for an earlier version of this review for the period 1985 to August 2003.Dates of most recent searches:Haemoglobinopathies Trials Register: 07 July 2010;ISRCTN: 28 December 2009;AMED: August 2003.
Randomised or quasi-randomised trials with participants of all ages with SCD, in all settings, comparing the administration of phytomedicines, by any mode to placebo or conventional treatment, including blood transfusion and hydroxyurea.
Both authors independently assessed trial quality and extracted data.
Two trials (182 participants) and two phytomedicines Niprisan(®) (also known as Nicosan(®)) and Ciklavit(®)) were included. The Phase IIB (pivotal) trial suggests that Niprisan(®) was effective in reducing episodes of severe painful SCD crisis over a six-month period. It did not affect the risk of severe complications or the level of anaemia. No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit(®)) reported a possible benefit to individuals with painful crises, and a possible adverse effect (non-significant) on the level of anaemia.
AUTHORS' CONCLUSIONS: While Niprisan(®) appeared to be safe and effective in reducing severe painful crises over a six-month follow-up period, further trials are required to assess its role in the management of people with SCD and the results of its multicentre trials are awaited. Currently no conclusions can be made regarding the efficacy of Ciklavit(®). Based on the published results for Niprisan(®) and in view of the limitations in data collection and analysis of both trials, phytomedicines may have a potential beneficial effect in reducing painful crises in SCD. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines in managing SCD.
镰状细胞病（SCD）是一种常见的隐性遗传性血红蛋白疾病，影响撒哈拉以南非洲、中东、地中海盆地、印度次大陆、加勒比地区和南美洲的人群。它与并发症相关且预期寿命缩短。植物药（源自原始状态植物的药物）包含了许多传统治疗师使用的植物疗法，而受影响最严重的人群会接触到这些疗法。目前对其益处的系统评估很少。
评估植物药对所有类型、任何年龄、任何环境下的镰状细胞病患者的益处和风险。
我们检索了考克兰囊性纤维化和遗传疾病组血红蛋白病试验注册库以及ISRCTN注册库的所有出版年份资料；AME数据库由之前的作者检索，用于该综述1985年至2003年8月的早期版本。最近的检索日期：血红蛋白病试验注册库：2010年7月7日；ISRCTN：2009年12月28日；AME：2003年8月。
随机或半随机试验，参与者为所有年龄的镰状细胞病患者，在任何环境下，比较以任何方式给予植物药与安慰剂或传统治疗（包括输血和羟基脲）。
两位作者独立评估试验质量并提取数据。
纳入了两项试验（182名参与者）和两种植物药（Niprisan®（也称为Nicosan®）和Ciklavit®）。IIB期（关键）试验表明，Niprisan®在六个月期间有效减少了严重疼痛性镰状细胞病危机的发作次数。它没有影响严重并发症的风险或贫血水平。未报告严重不良反应。关于木豆（Ciklavit®）的单项试验报告了对疼痛性危机患者可能有益，以及对贫血水平可能有不良影响（无统计学意义）。
虽然Niprisan®在六个月的随访期内似乎安全有效，可减少严重疼痛性危机，但需要进一步试验来评估其在镰状细胞病患者管理中的作用，且正在等待其多中心试验的结果。目前关于Ciklavit®的疗效无法得出结论。基于已发表的Niprisan®结果，并鉴于两项试验在数据收集和分析方面的局限性，植物药在减少镰状细胞病疼痛性危机方面可能具有潜在益处。这需要在未来试验中进一步验证。需要更多关于植物药治疗镰状细胞病安全性和有效性的试验。
