BACKGROUND: Sickle cell disease (SCD), a common recessively inherited haemoglobin disorder, affects people from sub-Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean 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. OBJECTIVES: To assess the benefits and risks of phytomedicines in people with SCD of all types, of any age, in any setting. SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN) and the Allied and Complimentary Medicine Database (AMED).Dates of most recent searches:Haemoglobinopathies Trials Register: 05 July 2012;ISRCTN: 28 December 2009;AMED: August 2003. SELECTION CRITERIA: 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. DATA COLLECTION AND ANALYSIS: Both authors independently assessed trial quality and extracted data. MAIN RESULTS: 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 used in managing SCD.
BACKGROUND:Sickle cell disease (SCD), a common recessively inherited haemoglobin disorder, affects people from sub-Saharan Africa, the Middle East, Mediterranean basin, Indian subcontinent, Caribbean 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. OBJECTIVES: To assess the benefits and risks of phytomedicines in people with SCD of all types, of any age, in any setting. SEARCH METHODS: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN) and the Allied and Complimentary Medicine Database (AMED).Dates of most recent searches:Haemoglobinopathies Trials Register: 05 July 2012;ISRCTN: 28 December 2009;AMED: August 2003. SELECTION CRITERIA: 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. DATA COLLECTION AND ANALYSIS: Both authors independently assessed trial quality and extracted data. MAIN RESULTS: 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 used in managing SCD.