Volume 5, No. 6 June, 2024
p ISSN 2723-6927-e ISSN 2723-4339
Adjuvant Therapy
Effect of Curcuma Longa Rhizome Extract On TGF-
Serum Levels in Leprosy Ulcer Patients
Rizki Alfarizi1*,
Renni Yuniati2, Farmaditya Eka Putra Mundhofir3, Noor
Wijayahadi4, Yora Nindita5
1,2,3,4,5Diponegoro
University, Semarang, Indonesia
Email:
rizkialfarizi33@gmail.com
ABSTRACT
Leprosy ulcer is one of the worsening manifestations of leprosy that
often causes disability if not appropriately handled. Healing of ulcers
requires a long enough duration so that a good immunological response is needed
to encourage the wound healing process, one of which is transforming growth
factor- 
(TGF-), which is
necessary of the plants that plays a role in the expression of TGF- to spur wound healing is Curcuma longa rhizome
or turmeric rhizome. This study is expected to prove that administering Curcuma
longa rhizome extract can increase serum TGF-β levels in leprosy ulcer
patients. This study is an experimental study with a pre and post-randomised
single-blind controlled trial design involving 22 subjects with leprosy ulcers.
The control group obtained standard therapy for leprosy ulcers, and the
treatment group received standard therapy and adjuvant Curcuma longa rhizome
extract at a dose of 1 g per day for 30 days. TGF-β levels were measured by
the ELISA method. Data analysis used the Wilcoxon test and the Mann-Whitney
test. The results showed no significant difference in TGF-β levels after and
before the intervention in the control group (p=0.79) and the treatment group
(p=0.14). However, there was a significant difference in TGF-β levels after the
intervention in the control group and treatment (p=0.01). Curcuma longa rhizome
extract did not show an important role in changes in serum TGF-β levels in
leprosy ulcer patients. This study showed that administering Curcuma longa rhizome
extract for 1 month did not show a potential role as an adjuvant therapy.
Keywords: Curcuma longa rhizome extract, transforming growth factor-, wound healing, leprosy ulcer
INTRODUCTION
Leprosy is a chronic infection caused by
the bacteria Mycobacterium leprae. This disease is also known as leprosy
or Morbus Hansen. This condition generally often raises problems not
only in the health sector also in various developing countries due to the
limited comprehensive services that can be provided to people infected with
leprosy. The recapitulation of leprosy patients in Indonesia as of January
2022, based on data from the Ministry of Health of the Republic of Indonesia,
amounted to 12,288 people. Leprosy ulcer is one of the worsening manifestations
of leprosy, which often causes disability in leprosy patients, which if not
handled properly, will cause further effects in the form of deformity and even
amputation 
(TGF-) that are
needed in the process.
Transforming growth factor- has various roles in the wound healing
process. Several studies have stated that one of the plants that play a role in
wound healing and is expected to increase TGF- expressions.
Immobilization and proper wound care are
the basic principles of leprosy ulcer management. A wide selection of wound
care modalities, such as Platelet Rich Plasma, Low-Level Laser Therapy, and so
on, have proven to have quite good results, it is just that these various
modalities often require high maintenance costs, and the distribution of these
facilities is not evenly distributed, so a more affordable option is needed.
RESEARCH
METHODS
This study is an experimental study with
a pre and post-randomized single-blinded controlled trial design. The subject
of the study involved 22 leprosy ulcer patients undergoing treatment at Kelet
Jepara Hospital in the January-April 2024 period. All subjects were divided
into two research groups: the control group and the treatment group. The
control group subjects received standard therapeutic interventions in the form
of Multi Drug Therapy (MDT) for leprosy, NaCl dressings for ulcers, and placebo
capsules, while the treatment group subjects received standard therapeutic
interventions and 2 x 5 capsules of Curcuma longa rhizome extract
with a dose of 100 mg per capsule (total: 1000 mg/day). The intervention was
carried out for 1 month. Curcuma longa rhizome extract capsules were
obtained from one of the herbal medicine and pharmaceutical industry companies
in Central Java. This research has obtained permission from the Research Ethics
Commission of the Faculty of Medicine, Diponegoro University.
All subjects were given a complete
explanation of research techniques. The subjects involved in the study have
also signed an informed consent sheet. The inclusion criteria in this study
were leprosy ulcer patients aged 20-60 years, receiving standard therapy in the
form of MDT and NaCl dressing for ulcers, and agreeing and signing
informed consent. The exclusion criteria in this study were subjects who were
pregnant or breastfeeding and obtained other treatments other than standard
therapy. The dropout criteria are subjects which apply to stop taking
medication and develop an allergic or more severe reaction. The measurement
of TGF-β levels using subjects' blood
samples was obtained from the mediana cubitii vein as much as 3 ccs each
before and after the intervention for 1 month. The measurement of TGF-β levels
used the Enzyme-linked immunosorbent assay (ELISA) method with the Human
TGF-β ELISA Kit E3051hu at the GAKI Laboratory, Faculty of Medicine, Diponegoro
University. Data analysis used the Wilcoxon test to determine the
difference in TGF-β levels before and after the intervention in each group.
Differences in TGF- levels before and after treatment between
groups were observed using the Mann-Whitney test. The data in this study is
considered significant if a variable is obtained with a p-value < 0.05.
Statistical analysis in this study uses a data analysis application.
RESULT
AND DISCUSSION
Table 1 shows the characteristics of the
research subjects, including gender, age, and duration of leprosy.
Table 1. Characteristics
of the Research Subject
|
Characteristic |
Control (n=11) |
Treatment (n=11) |
|
Gender,
n(%) |
|
|
|
Male |
5(45,5) |
8(72,2) |
|
Female |
6(54,5) |
3(27,3) |
|
Age,
n(%) |
|
|
|
21-30
years old |
2(18,2) |
0 |
|
31-40
years old |
1(9,1) |
6(54,5) |
|
41-50
years old |
3(27,3) |
1(9,1) |
|
51-60
years old |
5(45,5) |
4(36,4) |
|
Duration
of Leprosy (months), median (min-max) |
60(24-120) |
60(12-300) |
There were more male subjects than female
subjects, with 13 people, while female subjects amounted to 9. The
characteristics of the study subjects were reviewed, and the age tendency was
to be more in the age range of 51-60 years, with a total of 9 people, namely 5
people in the control group and 4 people in the treatment group. The duration
of leprosy in the control and treatment groups showed the same duration,
namely, having suffered from leprosy for 60 months.
Gender distribution in this study is in
line with previous studies related to the epidemiology of leprosy in Indonesia
which male patients dominate. Various factors, such as differences in habits,
lifestyle, and concern for hygiene, also affect why leprosy tends to occur more
in men. Male mobility tends to be higher, resulting in men being more
susceptible to contact with lepers. The age characteristics of the subjects in
this study were dominated by the age range of 51-60. This data differs from a
report by the Ministry of Health of the Republic of Indonesia in 2019, which
stated that the incidence of leprosy in Indonesia is highest at a young and
productive age.
The average result of pre-intervention serum
TGF-β levels in the control group was 516.37 pg/ml, while the post-intervention
was 444.18 pg/ml. The average TGF-β of pre-intervention serum in the treatment
group was 525.83 pg/ml, while the post-intervention group was 385.12 pg/ml.
Graphic 1.
Average of
TGF-β serum levels pre and post-intervention:
control (left) and treatment (right)
The analysis of the difference in TGF-
serum levels pre-intervention and
post-intervention in each group did not show significantly different results as
shown in the table below.
Table 2.Results of
Different Test Results of TGF- Serum Pre-Intervention and Post-Intervention
Levels of Each Group
|
Group |
Median (min-maks) |
p |
|
|
Control |
Pre |
346,90 (232,40-1483,60) |
0,79 |
|
Post |
323,00 (294,40-979,40) |
||
|
Treatment |
Pre |
253,50 (214,50-1917,50) |
0,14 |
|
Post |
251,40 (95,90-1125,50) |
||
Description:
significant p<0.05
Differential testing of serum TGF- levels was also carried out between the two
groups which showed significant differences in post-intervention between the
control group and treatment while in pre-intervention there was no significant
difference.
Table 3. Results of
the level difference test TGF- Pre and
Post Intervention Between Groups
|
|
p |
|
|
Pre-Intervention (Mann-Whitney) |
Treatment |
0,178 |
|
Control |
||
|
Post-Intervention (Mann-Whitney) |
Treatment |
0,011* |
|
Control |
||
Description:
Significant p<0.05
A number of literature states that Curcuma
longa rhizome (turmeric rhizome) with the active content of
curcumin, has a fairly wide pharmacological effect. Previous studies have shown
that turmeric rhizomes have a number of effects, such as anti-inflammatory,
antioxidant, anti-cancer, anti diabetic, and promote the wound healing process good upregulation and downregulation which was more significant
than in the control group. 1 and its receptors and induced angiogenesis after the intervention for
19 days
This study is not in line with a number
of literature above, where in this study, there was no
significant change in serum TGF- serum levels between control up and the
treatment. Some previous studies related to the role of curcumin in wound
healing were in vitro and in vivo studies the topical administration of
extracts, while this study was a clinical study with the administration of
extracts orally. Curcumin has the characteristics of rapid absorption and
metabolism in the human body, so it tends to be easily eliminated and its
bioavailability is very limited. This condition results in a significantly
reduced therapeutic role levels and TGF- levels obtained from local lesions. An
increase in TGF- expression is not necessarily followed by an
increase in serum TGF- levels. These results indicate that the
systemic immune response does not necessarily describe what occurs in local
lesions and vice versa.
CONCLUSION
There was no significant difference in
serum TGF- levels before and after adjuvant therapy of Curcuma
longa rhizome extract at a dose of 1 gram per day for 1 month, as well as
in the control group that only received standard therapy. This study generally
shows that the administration of 1 gram of turmeric rhizome extract per day for
1 month has no potential role as an adjuvant therapy for leprosy ulcers
REFERENCES
