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Chin J Integr Med 2007 Sep;13(3):185-189 • 185 •

ORIGINAL ARTICLE
Clinical Study on the Treatment of Premature Ejaculation by
Uighur Medicine Gu-jing-mai-si-ha Tablet (固精麦斯哈片)
SONG Guo-hong (宋国宏)1, Halmurat·Upur (哈木拉提·吾甫尔)2, GENG Jin-cheng (耿进成)1,
FENG Lian-cheng (冯连成)1, Yilihamujiang ·shabi (伊力哈木江·沙比提)2,
MA Chao (马 超)3, and LIU Jun (刘 军)1

ABSTRACT Objective: To observe the effect of Uighur medicine Gu-jing-mai-si-ha Tablet (固精麦
斯哈片, GJMSHT) for treatment of premature ejaculation (PE) and to explore part of its mechanism.
Methods: The condition of patients was scored by related questionnaire, and the intravaginal ejaculation
latency time (IELT) was observed before and after GJMSHT treatment, with the blood levels of nitric
oxide (NO) and prostaglandin F2α (PGF2α) detected in PE patients as well. The results were compared
with those in the control group. Results:After treatment, the scores of PE and IELT, as well as the
levels of NO and PGF2α, all increased significantly compared to those before treatment in the treated
group (P <0.01), while in the control group, all the parameters were insignificantly changed (P >0.05).
Therefore, the difference of these parameters between the two groups after treatment all showed
statistical significance (P <0.01). Conclusion: GJMSHT could treat PE effectively, its mechanism is
possibly by strengthening the coordination of the related smooth muscles through increasing the blood
levels of NO and PGF2α, and the endurance of patients to the cavitary effect of prostatico-urethral
pressure, thus postponing the arrival of urgent ejaculatory feeling.
KEY WORDS nitric oxide, prostaglandin F2α, premature ejaculation, intravaginal ejaculation latency
time

Premature ejaculation (PE) is one of the intravaginal ejaculation latency time (IELT) less
sexual disorders with the highest incidence, than 2 min; (2) The sexual partner's satisfaction
and, as a psycho-neuro-endocrine disease rate was below 50%; (3) Ejaculation happened
and also a urological disease, it could severely before his willingness; and (4) PE is not caused
affect the harmony of patients' family and by abstention from certain psychiatric active
create a high mental stress on the male. The substances, like narcotic drugs.
therapeutic effect of Uighur medicine Gu-jing-
mai-si-ha Tablet (固精麦斯哈片, GJMSHT) on Subjects Selection
PE was observed and part of its mechanism The criteria for inclusion were: (1) patients
was explored by the authors and reported in this with their condition matching the above-
paper. mentioned diagnostic standard, both the primary
(PE began at the first sex life) and the secondary
METHODS ones; (2) males have married or cohabited and
Diagnostic Standard went steady with regular sexual life; (3) with no
In reference to the standard issued by the severe disease of the heart, liver or kidney; (4)
American Urological Association (1) and that in patients agreed to be treated with the test drug
the "Handbook for Diagnosis and Statistical
Management of Mental Diseases" promulgated Supported by the Program of Developing Modern Uighur
by the American Psychiatric Association(2), the Medicine and Setting an Example Project of High-Tech
diagnostic standard for patients enrolled in Industries (No. 2002-422)
1. The 5th Affiliated Hospital of Xinjiang Medical University,
this study was formulated comprehensively as Urumuqi (830011); 2. Xinjiang Medical University; 3. The
follows: (1) Continual or repeated ejaculation Affiliated TCM Hospital, Xinjiang Medical University
occurred under very mild sexual stimulation Correspondence to: Dr. Halmurat·Upur, Tel: 0991-4362206,
E-mail: halmurat@263.com
before, during or soon after penetration, with DOI: 10.1007/s11655-007-0185-7
• 186 • Chin J Integr Med 2007 Sep;13(3):185-189

and had signed the informed consent. had to be suspended when any patient caught a
cold.
The criteria for exclusion were: (1) patients
with hot constitution; (2) with the IELT longer For the 33 patients in the control group,
than 2 min (determined by clock for 1-2 times); no drug for treatment was given during the
(3) age below 20 or over 60; (4) administration of observation period (the first 15 days after
non-steroid drugs like indomethacin and aspirin; enrollment). However, a course of GJMSHT
(5) simultaneous administration of other drugs medication same as that for the treated group
for PE; (6) with primary diseases of the heart, was offered to these patients at no cost after
liver, kidney, and nervous system; (7) alcoholics; the observation for humanistic care, since the
and (8) patients who did not take the test drug test drug was formally approved by the State
on time, quit in the course, or were irregular in Administration for Drugs and Foods Supervision,
sexual life. and had already entered the market as a over-
the counter drug.
General Materials
All the subjects were selected from PE Items and Methods of Observation
patients of the Fifth Affiliated Hospital or the Blood levels of prostaglandin F2α (PGF2α)
Affiliated TCM Hospital of Xinjiang Medical and nitric oxide (NO) were determined at the
University in the period from March 2006 to beginning (just after enrollment) and by the end
August 2006, who participated in the study of the treatment course (in the treated group) or
voluntarily and all matched the criteria of the observation period by collecting fasting blood
subjects selection. They were assigned to in the morning. The sample was preserved in a
two groups according to the randomized and refrigerator under -70 ℃ immediately after being
controlled principle, in their visiting order by centrifuged for testing. The test was conducted
randomizing number table. Patients in the with the test kits for PGF 2α (batch number:
treated group were aged 31.54±7.92 years, ADL10-9031) and NO (batch number: 0602205)
with the course of disease as 4.53±3.54 years, produced by Adlitteram Diagnostic Laboratories
33 of Han nationality and 2 of Uighur nationality; and purchased from Shanghai Xitang Bio-tech
while patients in the control group were 33.88 Co.
±9.52 years old, 4.71±4.36 years in course of
disease, 32 Hans and 1 Uighur. By statistical PGF2α was determined by double-antibody
analysis, the two groups were comparable ELISA. It was carried out at room temperature
in the aspects of age, course of disease and (22 ℃) in the following procedure: the standard
nationality (P >0.05). sample, blood plasma, and enzyme binding
material were added into a 96-well reaction plate
Treatment in that order, washed with diluted washing fluid 5
For the 35 patients in the treated group, times; a color developer and then the terminating
GJMSHT (consisting of Radix anacycli pyrethri, solution were added in sequence; the OD
Mastiche, Fructus Cardamomi, Rhizoma value was read using an enzyme immunoassay
Cyperi, Stigma Croci, Semen Myristicae, Radix instrument at 450 nm; then the standard curve
Curcumae, Folium Syringae oblatae, Radix was drawn with the OD value as longitudinal
et Rhizoma Nardostachyos, Fructus Tsaoko, coordinate, and the concentration of standard as
and Flos Rosae rugosae ), a Uighur medical horizontal coordinate. The OD value of the blood
drug prepared by Kanghabo Co., Ltd. of Uighur sample from patients was determined in the
Medicine, Xinjiang, with the production batch same way, and the level of PGF2α was checked
number of 060206, was orally given 4 tablets finally depending on the OD value in reference to
each time, twice a day, with 15 days as one the standard curve.
therapeutic course. Pungent and stimulating
foods as well as other pertinent drugs were not NO in the blood sample was tested by
allowed in the treatment period. The medication determining the total NO with nitrate reductase
Chin J Integr Med 2007 Sep;13(3):185-189 • 187 •

method strictly according to the instruction, difference.


with color matching at 550 nm, and then the
concentration of NO was calculated by a RESULTS
formula. Changes of PGF2α and NO Levels
As shown in Table 1, after treatment, the
Evaluation of PE condition was carried out levels of PGF2α and NO increased significantly in
by scoring method according to a questionnaire the treated group, showing significant difference
(IELT) established specially for this study in to those before treatment (P <0.01); while in the
order to make the evaluation more objective control group, both were changed insignificantly,
and concrete on the relationship of PE with the that is, the levels of PGF2α and NO in the control
levels of NO and PGF2α, which could quantify group after treatment were significantly lower as
all the conditions to facilitate clinical analysis. compared with those in the treated group at the
For the sake of fortifying the comparability of the corresponding time points (P <0.01).
results, both the scoring using the Chinese index
Table 1. Changes of PGF2α and NO Levels ( ±s )
of sexual function for premature ejaculation
Group Case Time PGF2α (pmol/L) NO (μmol/L)
(CIPE10) and the scale for five PE related items
Treated 35 BT 9.11±2.33 73.37±9.49
(CIPE5) were performed simultaneously. These
questionnaires were filled in at the beginning and AT 10.84±3.55 △ 101.50±24.80 △

the end of the treatment/observation period to Control 33 BT 9.17±3.13 75.10±12.63

evaluate the effect of treatment and its influence AT 9.30±3.04 74.17±11.73


on the levels of NO and PGF2α. Notes: P <0.01, compared with before
treatment in the same group; △P <0.01, compared
with the control group; BT: before treatment; AT:
The scale for PE grading was listed in detail
after treatment; the same tables below
as follows: (1) Lantency time (LT) of ejaculation
(the time from the insertion of the penis into Changes of IELT and PE Related Scores
the vagina to ejaculation in sexual intercourse) As shown in Table 2, IELT, SPSR and WFR
is scaled to (in minutes) 0.5, 1.0, 1.5, 2.0, 2.5, were all improved in the treated group after
3.0, 3.5, 4.0, 4.5, 5.0, 10.0, 15.0, 20.0, 25.0, treatment, showing significant difference to those
and 30.0. (2) Sexual partner's satisfaction rate before treatment (P <0.01), and also to those in
(SPSR) is scored from 0 (totally dissatisfactory) the control group (P <0.01).
to 10 (fully satisfactory). (3) Wish fulfillment rate
Table 2. Changes of IELT and
(WFR) is scored from 0 (unable to control) to 10
PE Related Scores ( ±s )
(fully controlled).
Group Time Case IELT (min) SPSR (Score) WFR (Score)
Treated BT 35 1.27±0.61 2.37±2.0 3.11±1.90
Quality Controlling △ △
AT 2.73±1.25 5.11±2.11 5.60±2.13 △
Personnel who took part in the study
Control BT 33 1.25±0.61 2.88±1.72 3.73±1.64
were all trained to master the program of the
trial; sample collection and preservation were AT 1.16±0.58 2.94±1.63 3.82±1.38

strictly controlled. Related knowledge was also


conveyed to all the patients enrolled to obtain Changes of CIPE10 and CIPE5 Scores
their cooperation and increase their compliance, Results of scoring by CIPE10 and CIPE5
and humanistic care was offered to patients scales are listed in Table 3. It is shown that
in the control group to further increase their Table 3. Changes of CIPE10 and
compliance.
CIPE5 Scores (Score, ±s )
Group Time Case CIPE10 CIPE5
Statistical Management
Treated BT 35 22.26±6.08 9.91±2.82
Data were managed with SPSS 12.0
AT 30.89±6.66 △ 15.80±3.60 △
s o f t w a r e , a n d e x p r e s s e d b y ±s . T h e
Control BT 33 23.36±6.60 11.03±3.06
measurement data were tested statistically by
t -test, with P < 0.05 regarded as having significant AT 23.21±6.84 10.85±3.18
• 188 • Chin J Integr Med 2007 Sep;13(3):185-189

there was a significant increase of the two in the portion, PGF2α could increase its compliance to
treated group after treatment (P <0.01), while they augment the functional volume of the urethra to
were unchanged in the control group. Therefore, alleviate the rapid increase of pressure, so as to
the scores in the treated group after treatment enhance the ability of controlling ejaculation; it
were significantly higher than those in the control could also promote the release of endogenous
group after treatment (P <0.01). prostaglandins (15), and showed a regulation in
multiple ways.
DISCUSSION
PE is a kind of ejaculation function In the ingredients of GJMSHT, Radix
disorder, its incidence, according to a study in anacycli pyrethri could clean the abnormal
Europe, is 21% (3). The process of ejaculation mucous to open up stagnancy to alleviate pain;
is accomplished by the coordination of smooth Folium Syringae oblatae could tonify viscera,
muscles together with the participation of central fortify nerve and remove phlegm; amonum fruit
and peripheral nerves (4,5). Since the cavitary could strengthen Wei (胃) to help digestion;
pressure of the urinary tract takes part in the Semen Myristicae enforces brain and Gan (肝),
regulation of ejaculation, it is considered to be a dry up dampness to strengthen Wei, dispel
notable cause for PE. cold-qi to enrich sperm and invigorate yang;
Stigma Croci purges the abnormal mucous fluid,
It has been found by Chamness et al(6) that dispels phlegm to induce defecation, regulate
nitric oxide synthase (NOS) is distributed widely menstruation to enhance yang; Mastiche
in the tissues of male rats innervated by the removes dirty elements in the body, supplements
pelvic nerve ganglion, such as the epithelium brain, nourishes Xin (心), benefits Gan and Shen
of the urinary bladder membrane, tissues that (肾)(16). When they act altogether in the human
could irritate erection of penis, as well as the body, they could improve mucous in patients
vascular epithelia, endothelial cells, epithelium both in quality and quantity, improve and promote
and basal membrane of epididymis head, the production of heat-energy, stimulate the
body and tail, smooth muscles of spermaduct, substantial metabolic activity, remove dampness,
spermatophore and ejaculatory duct. It could nourish sexual gland and excretory system,
also be found in the human penis and prostate enhance the pinching power of the sexual organ
gland. NO could inhibit the secretion of sperm to realize the effects in curing emission, enuresis,
to prevent spermatorrhea by depressing the PE, weakness, early poliosis, listlessness, and
tonicity of the sympathetic nervous system fatigue.
in adult male rats, and could favorably delay
ejaculation (7) . Experimental study in vitro In this study, after the patients were
showed that the NO-cGMP pathway plays a treated with GJMSHT, significant changes were
role in regulating the contractile response of found in aspects of levels of PGF 2α and NO
spermatophore (8-11) , and NO could regulate and in the scores of the scale for PE grading
the activity of smooth muscles concerning CIPE5, CIPE10 and IELT. The mechanism
ejaculation. Thus, NO may be one of the is possibly due to the loosening of urethral
regulatory factors of PE. smooth muscles induced by the comprehensive
effect of prostaglandins (while endogenous
A study showed that PGF2α has an obvious PGF 2α increases, other prostaglandins may
effect in promoting the contraction of smooth also increase concomitantly), which could
muscles, and a gynecological study found that enhance the energy of the external sphincter
PGF2α could induce loosening of collagenous to strengthen the controlling of ejaculation and
fibers in the early and late stage of pregnant prolong the latency time. GJMSHT could also,
cervix by activating collagenolytic enzyme through raising the NO level in the body, reduce
and inhibiting the synthesis of collagen (12,13), the tonicity of the sympathetic nerve system to
which could reduce the tension of the cervix by inhibit sperm excretion, retard its process, and
50%(14). When acting on the prostatico-urethral to augment the cavitary functional volume of the
Chin J Integr Med 2007 Sep;13(3):185-189 • 189 •

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of ejaculation. nitric oxide-donating drugs on adrenergic tension of human
seminal vesicles in vitro . Urology 2003;61: 479-483.
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