BI proportion difference between the two groups in
month 1, 2, and 3 were not statistically significant.
Those suggested that Nigella sativa did not result in
different BI outcomes.
At baseline, there was significant difference of MI
proportion in both groups. However, after 1 month
therapy, the proportion comparison became not
statistically significant. This suggested that Nigella
sativa did not significantly decreased MI decline in
treatment group compared to MI decline in control
group.
Immunity mechanisms relied on Accessory
Immune System (AIS) reactivation which was
responsible for leprosy and stimulation of T or B
lymphocytes. T cells regulated T cytotoxic cells
induction, B lymphocyte function and macrophage
function by releasing cytokines. Th1 cells release
IFN- which would activate macrophages to kill
bacteria or to inhibit microbe growth and would
trigger T cytotoxic cell response resulting in self-
healing disease (Williams & Kupper, 2012). In
contrast, Th2 cells facilitated humoral immune
response and inhibited cellular immune response
which caused progressive infection. There were cross
regulatory cytokines. Th1 released IFN- which down
regulated Th2. Th2 released IL-4, IL-5, and IL-10
which inhibited and down regulated Th1 and
macrophages. (Williams et al., 2012; Abulafia &
Vignale, 2001).
Studies had demonstrated that Nigella sativa
extract had immune-modulator effect. Nigella sativa
had strong potentiation effect on cellular immunity
(mediated by T cell), as well as suppression effect on
humoral immunity which was mediated by B
lymphocytes. A study which was conducted more
than a decade ago, showed that Nigella sativa could
increase human immunity when was used regularly.
Most of subjects who administered Nigella sativa for
4 weeks showed increasing T CD4 to CD8 ratio by
55% and increasing natural killer cell function by
30% (Salem, 2005).
Boskabady et al. studied about Nigella sativa
immune-modulator effects in albumin desensitized
guinea pigs and observed the increase of IFN- and
the decrease of IL-10, suggested that Nigella sativa
had inhibition effect on Th2 cell and its cytokines and
stimulation effect on Th1 and its cytokines
(Boskabady, 2011). Study on cytomegalo-virus
infected murine showed that serum IFN- level was
associated with undetected virus on the 10
th
day
(Salem, 2000). Study on allergic rhinitis patients
showed that supplementation with Nigella sativa 2
gram daily for 30 days would increase PMN
fagocytosis activity and intracellular killing (Isik et
al., 2010).
In lepromatous leprosy, immune response against
M. leprae was dominated by T-suppressor cells
(CD8
+
, CD28
-
), with only small amount of CD4
+
.
Naive T cells commonly could not be activated
immediately. In this type of leprosy, high T2 activity
also observed, which should increase IL-4, IL-5, and
IL-10 productions. These cytokines would stimulate
B lymphocytes transformation into antibody-
secreting cells which produced antibody.(Bryceson et
al., 1990; Williams & Kupper, 2012; Abulafia &
Vignale, 2001) Therefore, Nigella sativa
supplementation to MB leprosy patients
administering MDT-WHO would improve patients’
prognosis.
It was possible to increase Nigella sativa clinical
efficacy and effect on lipid metabolism by means of
increasing the dose. However, it would increase the
gastrointestinal side effect. Daily 40 mg/kg Nigella
sativa administration was well tolerated by adults and
children. There was no side effect observed, except
for children who received 80 mg/kg dose (Kalus et
al., 2003) Other toxicity study demonstrated that 1
g/kg Nigella sativa supplementation for 28 days did
not elevate liver enzyme and did not cause toxicity
effect on the liver function (Dollah et al., 2013).
There were some limitations in this study. There
was inhomogeneity of MDT duration at baseline due
to the difficulty of finding new untreated cases as the
study subjects. In addition, in Donorojo Hospital,
Reitz serum examination were only performed on
serum from right and left ear lobules, whereas this
study only included patients from Donorejo Hospital.
The other limitation of this study was the study only
gave one supplementation dose to subjects.
5 CONCLUSIONS
This study had not proved Nigella sativa effect on
decreasing BI and MI of MB leprosy patients.
However, there was significant difference of average
MI and BI decline between treatment and control
group. Further studies should consider the subjects
homogeneity especially for MDT duration, enroll
new untreated cases only, use various Nigella sativa
doses, and be performed in larger field.
REFERENCES
Abulafia, J., & Vignale, R. A., 2001. Leprosy: accessory
immune system as effector of infectious, metabolic, and