We reviewed the evidence about the effect and safety of phytomedicines in people with sickle cell disease of all types, of any age, in any setting.
Sickle cell disease is an inherited blood condition caused by defects in the production of haemoglobin. Haemoglobin is the part of the red blood cell that carries oxygen across the body. Sickle cell disease occurs when people inherit faulty genes responsible for producing haemoglobin from both parents. A variety of complications and a reduced life expectancy are linked with sickle cell disease. Phytomedicines are medicines derived from plants in their original state. People with sickle cell disease may come across them in terms of plant-remedies from traditional healers. Their benefits have not been evaluated systematically. Laboratory work has long suggested that these medicines may help to ease the symptoms of sickle cell disease.
The evidence is current to: 24 August 2017.
Two trials (182 participants) and two phytomedicines Niprisan® (also known as Nicosan®) and Ciklavit® were included.
This review found that Niprisan® may help to reduce episodes of sickle cell disease crises associated with severe pain. Ciklavit®, which has been reported to reduce painful crises in people with sickle cell disease, deserves further study before recommendations can be made regarding its use. The trial of Ciklavit® also reported a possible adverse effect on the level of anaemia. Both formulations reported no serious adverse symptoms or derangement of liver or kidney function in the participants. More detailed and larger trials of these medicines will need to be carried out before we can make any recommendations about their use. Further research should also assess long-term outcome measures.
Quality of the evidence
We judged the quality of the evidence from this review to be of low to very low quality, depending on the outcome measured.
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 sickle cell disease 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 sickle cell disease. This needs to be further validated in future trials. More trials are required on the safety and efficacy of phytomedicines used in managing sickle cell disease.
Sickle cell disease, 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. Laboratory research and limited clinical trials have suggested positive effects of phytomedicines both in vivo and in vitro. However, there has been little systematic appraisal of their benefits. This is an update of a Cochrane Review first published in 2004, and updated in 2010, 2013, and 2015.
To assess the benefits and risks of phytomedicines in people with sickle cell disease of all types, of any age, in any setting.
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Haemoglobinopathies Trials Register, the International Standard Randomised Controlled Trial Number Register (ISRCTN), the Allied and Complimentary Medicine Database (AMED), ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP).
Dates of most recent searches: Cochrane Cystic Fibrosis and Genetic Disorders Haemoglobinopathies Trials Register: 10 April 2017; ISRCTN: 26 July 2017; AMED: 24 August 2017; ClinicalTrials.gov: 02 August 2017; and the WHO ICTRP: 27 July 2017.
Randomised or quasi-randomised trials with participants of all ages with sickle cell disease, 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 sickle cell disease crisis over a six-month period (low-quality evidence). It did not affect the risk of severe complications or the level of anaemia (low-quality evidence). No serious adverse effects were reported. The single trial of Cajanus cajan (Ciklavit®) reported a possible benefit to individuals with painful crises (low-quality evidence), and a possible adverse effect (non-significant) on the level of anaemia (low-quality evidence).