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A. O. Akinsulie, E. O. Temiye, A. S. Akanmu, F. E. A. Lesi, C. O. Whyte, Clinical Evaluation of Extract of Cajanus cajan (Ciklavit®) in Sickle Cell Anaemia, Journal of Tropical Pediatrics, Volume 51, Issue 4, August 2005, Pages 200–205, https://doi.org/10.1093/tropej/fmh097
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Abstract
The major pathology in sickle cell anaemia (SCA) is sickling of red cells due to the precipitation of reduced haemoglobin. We report our experience with extract of Cajanus cajan as a possible antisickling agent by determining changes, if any, in clinical and laboratory features of the disease in patients given the extract in a single-blind placebo-controlled study. One hundred patients with steady-state SCA were randomized into treatment and placebo arms. The extract/placebo were administered twice daily to the subjects. Weight, hepatosplenomegaly, blood levels of biliurubin, urea, creatinine, and packed cell volume (PCV) were monitored over a 6-month period. Recall episodes of pain 6 months before enrolment were compared with episodes of pains recorded during the treatment period. Twenty-six cases (55.3 per cent) had hepatomegaly on enrolment. This significantly reduced to 33.3 per cent at 6 months (p = 0.03); but increased in the placebo arm (p>0.05). The total number of recall painful episodes in cases was 207 (mean 4.4 ± 10.3 (SD), range 0–60) and fell to 191 (mean 4.2 ± 4.4 (SD), range 0–16); p = 0.03. Episodes of pain increased from 109 in controls (mean 2.6 ± 5.0 (SD), range 0–26) to 164 (mean 3.9 ± 4.3 (SD), range 0–22); p = 0.01. Mean PCV in the cases showed no appreciable changes (p = 0.1) but there was a significant increase in the controls (p = 0.02). In conclusion, the extract may cause a reduction of painful crises and may ameliorate the adverse effects of sickle cell anaemia on the liver. The mechanism of action remains to be determined.
Author notes
1Department of Paediatrics, College of Medicine of University of Lagos (CMUL), Nigeria, 2Department of Haematology and Blood Transfusion, College of Medicine of University of Lagos (CMUL), Nigeria
Comments
Dear Sir,
Akinsulie et al (May 25 epub)(1)reported a randomized single-blind placebo controlled study which showed that the extract of Cajanus Cajan (Ciklavit) reduced the frequency of painful crises and possibly ameliorated the adverse effects of SCA on the Liver in children aged 1-15years.
The results of this study are encouraging when viewed in the light of increasing concern about the benefit of new therapies like Hydroxyurea in an African setting where limited resources make widespread use, monitoring of side effects, and toxicities virtually impossible. Considerable attention has thus been paid, particularly in Africa, to naturally occurring anti-sickling agents which offer the potential of being relatively safer, easily administered and potentially less costly than Hydroxyurea. (2,3)
The encouraging results of this study need to be balanced by concerns over uncertainties of the effect of this product with long term use and the fact that the results of this study have not been confirmed by multicentre studies. The authors rightly stress the need to determine the mechanism of action of this extract, and further clinical studies with this product need to identify the predictive factors for response and non response to therapy among SCA patients because this will influence how to optimize therapy with this product.
Secondly, the effect of the product in pregnancy and on adults with SCA needs to be studied. Thirdly, it is unclear at this stage, what the effect of this product is with long term therapy even though it showed promising results at six months follow-up.
A longer period of follow-up may reveal an uncommon effect or increases in an adverse outcome, and will provide the benefit of observing the effect of the product on the frequency of painful crises over a minimum of 12 months which will cover the entire duration of the rainy season which has been associated with an increase in the frequency of painful crises in individuals with SCA.(4-7) Lastly, future studies will also need to examine how efficacy of this product compares with effectiveness in the general population of SCA patients.
In summary, evidence from this study shows that the extract of Cajanus Cajan appears to be safe, easily administered and efficacious in reducing painful crises and may offer increased benefit to patients with SCA in future. Its effect on ameliorating Liver pathology needs to be further evaluated with studies which use ultrasonography to objectively assess hepatic changes.
A.T. ABEGUNDE.MBBS, DTM&H, MSc 40 Hutchins Road Thamesmead central SE 28 8SA London U.K. Email: abegs@mailcity.com
REFERENCES
1.Akinsulie AO, Temiye EO, Akanmu AS, Lesi FE, Whyte CO.
Clinical Evaluation of Extract of Cajanus cajan (Ciklavit(R)) in Sickle Cell Anaemia.
J Trop Pediatr. 2005 May 25; [Epub ahead of print]
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4.Ibrahim AS. Relationship between meteorological changes and occurrence of painful sickle cell crises in Kuwait.Trans R Soc Trop Med Hyg. 1980;74(2):159-61
5.Mohan J, Marshall JM, Reid HL,Thomas PW, Hambleton I, Serjeant GR.Peripheral vascular response to mild indirect cooling in patients with homozygous sickle cell (SS) disease and the frequency of painful crisis. Clin Sci (Lond). 1998 Feb;94(2):111-20.
6.Mohanty D, Mukherjee MB. Sicklecell disease in India.
Curr Opin Hematol. 2002 Mar;9(2):117-22. Review.
7.Stevens MC, Padwick M, Serjeant GR. Observations on the natural history of dactylitis in homozygous sickle cell Disease. Clin Pediatr (Phila). 1981 May;20(5):311-7.
Conflict of Interest:
None declared