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Clinical Trail of Butea Superba
An alternative herbal treatment for Impotence
Erectile Dysfunction (ED) is physically and psychologically a key
sexual problem for all men. A Thai traditional medicine with Butea
superba as a major ingredient has long been accepted as an effective
treatment of ED. A randomised, double blind clinical trial with
the preparation of Butea superba to evaluate its effect on ED treatment.
Dr
W. Cherdshewasart1, Dr
N. Nimsakul2
Aim
To study the effect of Butea superba on erectile dysfunction (ED)
in men.
Methods
A 3-month randomised double-blind clinical trial was carried out
in volunteers with ED, aged 30 years ~ 70 years, to evaluate the
therapeutic effect of the preparation of Butea superba tubers on
ED.
Results
1) There was a significant upgrading in 4 of the 5 descriptive
evaluations of the IIEF-5 questionnaire.
2) Estimation of the sexual record indicated that 82.4%
of the patients exhibited significant improvement.
3) Haematology and blood chemistry analysis revealed no apparent
change.
Conclusion
The plant preparation improves the erectile function in ED patients
without apparent toxicity.
1Department of Biology, Faculty of Science,
Chulalongkorn University, Phyathai Road, Bangkok 10330, Thailand
2Deja General Hospital, Sriayudhya Road, Bangkok 10600,
Thailand
1
Introduction
White Kwao Krua (Pueraria mirifica) is a Thai phytoestrogen-rich
plant that has been used for a long time as a herbal medicine and
its chemical contents [1, 2], reproductive physiology [3, 4] and
clinical application [5] have been well studied.
The related plant, Red Kwao Krua (Butea superba), is abundantly
distributed in the Thai deciduous forest and has been popular among
Thai males for the purpose of rejuvenation and increasing sexual
vigour [6].
The tuberous roots of Thai Butea superba were found to contain flavonoid
and flavonoid glycoside with cAMP phosphodiesterase inhibitor activity
as well as sterol compounds, including b-sitosterol, campesterol
and stigmasterol [7].
However, the Indian Butea superba stem contains flavone glycoside
[8] and flavonol glycoside [9] with no reports on its use for male
sexual purposes. It was demonstrated that coumarins from Cnidium
monnieri exhibited a vasodilation effect on animal corpus cavernosum
[10], which opened the possibility to develop this plant into a
product for the treatment of impotence.
Butea superba exhibits a similar effect as it contains a high cAMP
phosphodiesterase inhibitor activity, which was directly related
to corpus cavernosal vasodilation.
Erectile Dysfunction (ED) is physically and psychologically a key
sexual problem for all men. A Thai traditional medicine with Butea
superba as a major ingredient has long been accepted as an effective
treatment of ED. A randomised, double blind clinical trial with
the preparation of Butea superba to evaluate its effect on ED treatment.
2 Materials and methods
2.1 Plant preparation
Fresh tubers of Butea superba were collected from Lampang Province,
cleaned, sliced into pieces, completely dried in a hot air oven,
ground into fine powder, passed through 100 mesh sieves and finally
filled into capsules with the net filling amount of 250 mg/capsule.
Tapioca starch of the same weight was filled into the same type
of capsule that served as the placebo.
2.2 Volunteers and treatment
Thirty-nine non-alcoholic males, aged 30~70 years, having a fixed
sexual partner and a history of ED for at least 6 months were recruited.
They were divided into a treated and a placebo group at random and
took no other ED treatment during the trial. The volunteers had
a completed blood cell count and a blood chemistry analysis before
and after the trial, including haemoglobin, haematocrit, white blood
cells, blood urea nitrogen, creatinine phosphate, calcium, SGOT,
SGPT, cholesterol, sugar and blood testosterone levels. They were
verbally informed about the details of the drug and the study, including
the consumption of 2 capsules per day of either the drug or the
placebo at a double-blind manner during the first 4 days and 4 capsules
per day afterwards for a total of 3 months. Written informed consent
was obtained. The volunteers had interview appointments every 2
weeks to fill out the IIEF-5 questionnaire and received the next
batch of capsules.
2.3 Statistical analysis
The results were expressed as mean±SD. Pair t-test was used
for analysis of the test results and P<0.05 was considered significant.
3
Results
3.1 Volunteers
Seventeen volunteers in the treated group completed the 3-month
trial period. Eight volunteers dropped out between week 2 and 4.
Nobody in the placebo group returned to fill out the IIEF-5 questionnaire
and receive the second batch placebo capsules since the beginning
of week 3.
The background data of the 17 volunteers completed the course is
shown in Table 1.
Table 1. Background data of 17 tested volunteers.
| Age (years) |
Number of patients |
Status |
Circumcision |
Additional diseases |
| Single |
Married |
| 30-39 |
2 (12 %) |
9 (53 %) |
8 (47 %) |
10 (59 %) |
3 diabetes mellitus, 2 hypertension, 1 heart disease, 1 hyperthyroidism |
| 40-49 |
5 (29 %) |
|
|
|
|
| 50-59 |
6 (35 %) |
|
|
|
|
| 60-69 |
4 (24 %) |
|
|
|
|
3.2 Haematology, blood chemistry and testosterone
In the 17 volunteers, there were no significant change between
the pre- and post-trial data of all analysed parameters (Table 2
& Table 3).
Table 2. Haematology data of 17 tested volunteers.
| |
Haematology |
Differential count (%) |
| Haemoglobin (g) |
Haematocrit (%) |
Neutrophil |
Lymphocyte |
Monocyte |
Eosinophil |
| Pre-treatment |
14.35±1.37 |
45.12±7.06 |
52.12±5.78 |
2.53±2.55 |
40.82±8.20 |
0.59±0.87 |
| Post-treatment |
13.88±1.36 |
42.12±4.33 |
54.24±12.18 |
3.41±2.21 |
42.24±11.71 |
0.58±0.24 |
Table 3. Blood chemistry and testosterone of 17 tested
volunteers.
| |
Pre-treatment |
Post-treatment |
| BUN (mg %) |
12.53±3.71 |
11.00±3.14 |
| Creatinine (mg %) |
0.86±0.13 |
0.88±0.16 |
| Calcium (mg %) |
10.00±0.71 |
10.07±0.70 |
| SGOT (U/L) |
29.06±12.68 |
24.53±9.36 |
| SGPT (U/L) |
34.41±14.33 |
28.35±15.90 |
| Cholesterol (mg %) |
254.1±38.7 |
237.4±38.1 |
| Sugar (mg %) |
116.5±78.2 |
118.5±50.2 |
| Testosterone (ng/mg) |
2.75±1.40 |
3.06±1.37 |
3.3
IIEF-5 questionnaire and sexual record
Favourable responses were obtained with the IIEF-5 questionnaire
and the sexual function record. There was a significant upgrading
(P<0.05, P<0.01) in 4 of the 5 descriptive evaluations of
the IIEF-5 questionnaire (Table 4). The sexual record showed that
14 (82.4 %) patients showed fair to excellent improvement (Table
5).
Table 4. IIEF-5 questionnaire in 17 tested volunteers.
bP<0.05, cP<0.01, compared with pre-treatment value.
| Q |
% Pre-treatment |
% Post-treatment |
Description |
| 1 |
52.90 |
82.40 |
Enjoys sexual intercourse |
| 2 |
17.50 |
76.50 |
High confidence for erection |
| 3 |
58.80 |
82.40 |
Has erections with sexual stimulation hard
enough for penetration |
| 4 |
35.20 |
70.50 |
Can maintain erection to completion of intercourse |
Table 5. Sexual function record in 17 tested volunteers.
| Score |
Reaction |
Evaluation |
Number of patients (%) |
| 0 |
- |
No improvement |
3 (17.6) |
| 2 |
++ |
Noticeable improvement |
6 (35.3) |
| 4 |
++++ |
Excellent improvement |
8 (47.1) |
There were 3 volunteers with diabetes mellitus, 2 with hypertension,
1 with heart disease and 1 with hyperthyroidism (Table 1). They
were among the volunteers with ED improvements.
4
Discussion
The complete loss (100 %) of the placebo volunteers should be the
consequence of total uselessness of the tapioca starch and may imply
that there is no psychological effect that could possibly created
by the use of the placebo. This then further implies that the patient
response to the Butea superba capsule should be derived from its
pharmacological rather than psychological influence.
Haematology and blood chemistry analyses showed no significant
change. It meant that all relevant functions were not disturbed
by 3 months consumption of 1000 mg/day Butea superba.
The IIEF-5 questionnaire and sexual record indicated a significant
improvement in ED patients taking the drug. The authors believe
that Butea superba may act primarily by increasing the relaxation
capacity of the corpus cavernosum smooth muscles via cAMP phosphodiesterase
inhibition [7] and may also affect the brain, triggering the improvement
of the emotional sexual response. It is interesting to note that
patients with additional health problems, such as diabetes mellitus,
hyper-tension, heart disease and hyperthyroidism, responded satisfactorily
to Butea superba.
Acknowledgements
The authors wish to thank the Department of Biology, Faculty of
Science, Chulalongkorn University and Deja General Hospital, Bangkok
for support to the research.
References
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