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Influence of weight reduction by sibutramine on female sexual function

Article  in  International Journal of Obesity · May 2006

DOI: 10.1038/sj.ijo.0803198 · Source: PubMed

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 International Journal of Obesity (2006) 30, 758–763
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ORIGINAL ARTICLE
Influence of weight reduction by sibutramine on
female sexual function
KK Kim, HC Kang, SS Kim and BB Youn

Department of Family Medicine, Yonsei University College of Medicine, Seoul, Korea

Background: It is well known that selective serotonin reuptake inhibitors (SSRIs) can cause sexual dysfunction, so it is possible
that sibutramine, a serotonin and norepinephrine reuptake inhibitor, could induce sexual dysfunction.
Design and subjects: The effect of sibutramine on sexual function was evaluated in 46 overweight and obese (body mass index
(BMI) X23 kg/m2) but otherwise healthy married women (28–44 years). Participants were randomly assigned at baseline to
either the sibutramine or control group. The Female Sexual Function Index (FSFI) questionnaire was used to assess sexual
function at baseline and after treatment with behavioral therapy plus sibutramine 10 mg once daily or behavioral therapy alone
(control) for 8 weeks.
Results: Mean weight loss from baseline to week 8 was
6.03% in sibutramine group and
0.38% in the control group. There
was significant improvement of FSFI total score, arousal domain score and lubrication domain score in the sibutramine group
(Po0.05), and significant differences in arousal, orgasm, satisfaction domain score and total score (Po0.05) in favor of
sibutramine. Decreases in body weight and BMI were correlated with the improvement of arousal (r ¼
0.44 and r ¼
0.48,
respectively) and orgasm (r ¼
0.45 and r ¼
0.46, respectively) domains.
Conclusion: Treatment with sibutramine plus behavioral therapy did not induce sexual dysfunction and sibutramine-induced
weight reduction appeared to have a positive impact on sexual function in this small group of overweight and moderately obese
women. The degree of improvement in sexual function was correlated with the degree of weight reduction.
International Journal of Obesity (2006) 30, 758–763. doi:10.1038/sj.ijo.0803198; published online 10 January 2006

Keywords: sibutramine; female sexual function; FSFI; weight reduction

Introduction dent sexual dysfunction is one of the most commonly

Female sexual dysfunction is identified by DSM-IV based on
the phases of human sexual response, namely, desire,
excitement, orgasm, resolution.1 These phases have been
used widely in studies investigating female sexual response.
The desire phase of sexual response is closely associated
with the balance between the dopamine-sensitive excitatory
center and the serotonin-sensitive inhibitory center.2 It is
thought that a drug that increases serotonin activity in the
brain may affect the patient’s sexual desire and change their
sexual function. Indeed, those who take selective serotonin
reuptake inhibitors (SSRIs), the drugs of which are most
commonly prescribed for depression, reported diminished
sexual desire, arousal, sensitivity and orgasm.3 Dose-depen-
Correspondence: Dr H-C Kang, Department of Family Medicine, Yonsei
University College of Medicine, 134, Shinchon-dong, Seodaemoon-gu, Seoul
120-752, Korea.
E-mail: kanghc@yumc.yonsei.ac.kr
Received 25 May 2005; revised 12 October 2005; accepted 18 November
2005; published online 10 January 2006
reported side effects of treatment with SSRI antidepres-
sants4,5 and has been reported with the use of SSRI,
fluoxetine (Prozacs). Although not approved for use as a
weight-loss agent, treatment with fluoxetine has also been
shown to result in weight loss over the short term.6
Sibutramine (Reductils) and orlistat (Xenicals) approved
in 1997 and 1999, respectively, by the FDA in the US for the
treatment of obesity are the only weight loss medications
approved for use beyond 3 months.7 Sibutramine is thought
to work by inhibiting the reuptake of both serotonin and
norepinephrine in the hypothalamus8 and it was originally
developed as an antidepressant9 rather than as a drug
designed to affect weight loss. Because of this mode of
action, hypothetically, the use of sibutramine might increase
the likelihood of eliciting sexual dysfunction similar to
that demonstrated by the use of fluoxetine. To date, we have
found no evidence of any study conducted with sibutramine
on sexual function. Therefore, authors decided to assess
the effects of sibutramine-induced weight loss on sexual
function in a group of overweight and obese women in
Korea.

Materials and methods
The study was conducted in married women who were obese
and still menstruating regularly but without any other
documented health problems. As it was important that the
subjects be comfortable talking about their personal sexual
habits, the study recruited married women. All subjects were
premenopausal. The body mass index (BMI) of individual
subjects was 23 kg/m2 or higher, which is used as a cutoff
point for overweight in the Asia–Pacific region.10,11 All
subjects met the requirement that they were having sexual
intercourse at least once a month.
Subjects were excluded who had a diagnosis of hyperten-
sion or were taking antihypertensive medicine or had known
cardiovascular disease. Also excluded were subjects who had
other chronic illness such as diabetes or neurological disease,
subjects with an abnormal hematological profile, abnormal
creatinine levels and/or thyroid function test, subjects
taking any type of medication or receiving any kind of
medical treatment during the previous 1 month prior to
enrolment into the study. Also contraindicated were
subjects with a history of psychiatric conditions, hysterectomy
or other procedures that might impact sexual function. As
the use of sibutramine in pregnant and breast-feeding
mothers is contraindicated and weight loss per se is not
recommended during pregnancy, pregnant women and
breast-feeding mothers were also excluded. It is also
known that both pregnancy and breast-feeding can impact
sexual function; therefore, subjects were encouraged
not to become pregnant during the study period and any
subject who became pregnant was withdrawn from study
medication.
All subjects were briefed on the research procedures, and a
written consent for participation was obtained from each
subject. The Severance Hospital Institutional Review Board
approved this study.
The treatment period was 8 weeks. Subjects were rando-
mized to treatment with behavioral therapy plus sibutra-
mine 10 mg once daily or behavioral therapy only (control
group) at baseline. All subjects were required to visit the
hospital every 2 weeks (five visits in total) to receive
behavioral therapy for obesity based on the LEARN program
developed by Brownell.12 Under the program, subjects were
counseled on how to modify their behavior and diet (based
on a 1500 kcal/day allowance) and how to increase their
overall exercise. Compliance with the guidelines was
assessed at each of these bi-weekly visits.
Body weight, height and waist circumference were deter-
mined before commencing study medication and at end
point. Height was measured to the nearest to 0.1 cm, and
weight to the nearest to 0.1 kg with the subjects wearing
light clothing and with an empty stomach. BMI was
calculated as weight in kilograms divided by the square of
the height in meters. Waist size was measured to the nearest
to 0.5 cm by the same person following the instructions
suggested by NIH.7
Effect of sibutramine on female sexual function
KK Kim et al
759
Bioelectrical impedance analysis was used to measure body
composition using an InBody 2.0 analyzer, manufactured by
Biospace Co. Subjects were to have an empty stomach and
stand relaxed for 5 min before measurement took place.
The subjects completed the self-report Female Sexual
Function Index (FSFI) questionnaire, published by Rosen
et al.,13 to rate their level of sexual function before starting
the study and after the 8-week treatment period. As the FSFI
questionnaire was designed to collect data over 1-month
periods, baseline FSFI was completed by the subjects prior to
starting study medication and the subsequent questionnaire
collected data on sexual function between weeks 5 and 8.
The author and an English language expert translated the
FSFI questionnaire into the Korean language. This version
was back-translated into English by a second English
language expert who was not aware of the content of the
original questionnaire. The back-translated questionnaire
was verified and approved for use by Leiblum who developed
the original FSFI questionnaire.
The primary efficacy variable was the change in FSFI before
and after treatment; changes in weight, BMI, waist circum-
ference, fat body mass, fat-free mass, cholesterol, triglyce-
rides, HDL and LDL were assessed as secondary variables.
All statistical analyses used statistical analysis system (SAS)
for Window (version 8.01). t-Test was performed to test a
statistical significance of mean differences in the overall
group of subjects or those who completed the study. Where
the sample size was too small for normal distribution,
nonparametric methods were used. Wilcoxon’s rank sum
test was used to compare characteristics between subjects
who completed the study and those who did not. Wilcoxon’s
signed rank test was used to assess changes in variables in
subjects after treatment. A correlation analysis was per-
formed to identify health parameters related to changes in
FSFI total score and individual domain scores (D1, desire; D2,
arousal; D3, lubrication; D4, orgasm; D5, satisfaction; D6,
pain).
Results
A total of 46 subjects (age range 28–44 years) met the
inclusion criteria and were enrolled into the study; 24 were
randomized to the sibutramine 10 mg treatment group and
22 to the control group. At baseline, there was no significant
difference between the groups in terms of age, height, body
weight, BMI and FSFI; however, mean waist circumference in
the sibutramine group was smaller than that of the control
group (Table 1).
A total of 10 subjects prematurely withdrew from the
study: four in the sibutramine treatment group and six in the
control group. There was no statistically significant differ-
ence in terms of baseline characteristics between subjects
who withdrew prematurely and those who completed the
study. Data from two subjects in the control group relating to
the FSFI questionnaire were excluded from the analysis of
International Journal of Obesity
 Effect of sibutramine on female sexual function
KK Kim et al
760
Table 1 Baseline characteristics for participants in the sibutramine plus BT Table 2 Changes in the degree of obesity and serum after treatment
group and in the control (BT alone) group
Variable Sibutramine+BT a Control a (n ¼ 16) P-value b
Variable Sibutramine+BT a Control a (n ¼ 22) P-value b (n ¼ 20)
(n ¼ 24)
Anthropometric measurement
Age (years) 34.574.8 36.674.5 0.1341 Weight (kg)
3.9471.55*
0.3871.76 o0.0001
Height (cm) 156.9675.56 157.2775.36 0.8464 Weight (%)
6.0372.32*
0.3571.96 o0.0001
Weight (kg) 66.2677.00 69.41710.10 0.2226 BMI (kg/m2)
1.6670.65*
0.0970.68 o0.0001
BMI (kg/m2) 26.9072.56 27.9872.90 0.1888 Waist circumference (cm)
3.1773.98*
1.7873.80 0.0970c
Waist circumference (cm) 81.6377.49 87.4579.16 0.0223
Lipid values (mg/dl)
FSFI domainc Total cholesterol
9.30718.80*
5.21717.38 0.8472
D1 2.9870.91 2.7370.82 0.3397 Triglycerides
17.20741.46
13.86738.34 0.5518
D2 3.8970.88 3.7071.10 0.5165 HDL cholesterol
1.7574.56
0.2975.77 0.4610
D3 4.9670.86 4.7771.13 0.5223 LDL cholesterol
5.0079.55*
3.14718.79 0.4947
D4 4.6870.89 4.2770.94 0.1368
D5 4.6570.71 4.3571.13 0.2844 Body composition
D6 5.5070.63 5.2571.02 0.3375 Fat body mass (kg)
3.6673.12* 0.5773.89 0.0010
Total 26.6673.40 25.0774.41 0.1757 Fat-free mass (kg) 3.3476.76
1.0872.77 0.0625d

BMI, body mass index; FSFI, Female Sexual Function Index; BT, behavior *Significant change after treatment within the group by Wilcoxon’s signed
therapy. aValues are mean7s.d. bBy t-test. cDomains of FSFI: D1, desire; D2, rank test (Po0.05). BT: behavior therapy. aValues are mean7s.d. Control: BT
arousal; D3, lubrication; D4, orgasm; D5, satisfaction; D6, pain. alone. bBy Wilcoxon’s rank sum test (two-tailed test). cP ¼ 0.0485 by one-
tailed test. dP ¼ 0.0355 by one-tailed test.

change in sexual function, as the subjects did not have Table 3 Change of FSFI after treatment
sexual intercourse during the final month of the study before
FSFI domaina Sibutramine+BT b Control b (n ¼ 14c) P-value d
completing the questionnaire. (n ¼ 20)
At week 8, there was a statistically significantly greater
mean reduction in both body weight and BMI in sibutra- D1 0.2171.00 (0.2549) 0.1370.89 (0.7031) 0.6893
D2 0.2770.54 (0.0179)
0.3670.76 (0.1978) 0.0194
mine-treated subjects who completed the study compared to
D3 0.2770.50 (0.0313) 0.0270.79 (1.0000) 0.1525
subjects in the control group (Po0.0001). Waist circumfer- D4 0.1870.60 (0.2598)
0.6370.86 (0.0110) 0.0026
ence was reduced in both treatment groups but the fact that D5 0.2670.70 (0.0612)
0.3171.09 (0.2188) 0.0354
no statistically significant difference based on a two-tailed D6 0.1870.53 (0.1641) 0.2370.70 (0.2500) 0.7726
Total 1.3772.59 (0.0132)
0.9373.67 (0.4973) 0.0219
test (P ¼ 0.097) was found between the groups is probably
related to the smaller mean waist circumference of the a
Domains of FSFI: D1, desire; D2, arousal; D3, lubrication; D4, orgasm; D5,
sibutramine treatment group at baseline. Significance in satisfaction; D6, pain. bValues are mean7s.d. (P-value for the change after
favor of sibutramine was seen based on a one-tailed test treatment within the group by Wilcoxon’s signed rank test). Control: behavior
therapy (BT) alone. cTwo of 16 control group completion participants
(Po0.05) (Table 2). answered that they had had no sexual activity during the past 1 month at
There was no statistically significant difference between the end of the study. Their FSFI scores were considered outliers, so they were
groups in triglycerides, total cholesterol, LDL cholesterol or removed from FSFI analysis. dFor differences between the groups by
Wilcoxon’s rank sum test (two-tailed test).
HDL cholesterol. The mean absolute changes in LDL and
total cholesterol from baseline to end point in the sibutra-
mine treatment group were, however, significantly different To determine which variables may have had a positive
from zero (Po0.05) (Table 2). Bioimpedance analysis re- impact on FSFI, a correlation analysis was performed based
vealed a statistically significant reduction of fat body mass in on the data from both treatment groups combined to
the sibutramine treatment group compared to the control determine the relationship between changes in FSFI total,
group (P ¼ 0.001) (Table 2). and individual domain scores and health parameters,
Changes in FSFI are presented in Table 3. There was no including body weight, BMI, waist circumference, fat body
significant change from baseline to week 8 in the control mass and fat-free mass (Table 4).
group in FSFI total score and individual domain scores No correlation was seen between any variable and
except for orgasm domain score (D4), which fell after improvement in desire, lubrication, satisfaction domains
treatment (P ¼ 0.011). Subjects in the sibutramine group and FSFI total score. Decrease in body weight and BMI had a
exhibited significant improvement from baseline in FSFI positive impact on arousal (r ¼
0.44 and r ¼
0.48, respec-
total score (P ¼ 0.0132) and the domain scores relating to tively) and orgasm (r ¼
0.45 and r ¼
0.46, respectively).
arousal (D2) (P ¼ 0.0179) and lubrication (D3) (P ¼ 0.0313). The results also revealed a tendency for lower pain domain
There was a statistically significant difference (Po0.05) scores to be positively correlated with decrease in body
between the groups in favor of sibutramine for FSFI total weight, BMI and body fat mass; body fat mass and changes in
score and in the domain scores relating to arousal (D2), the pain domain score showed a particularly significant
orgasm (D4) and satisfaction (D5). correlation (r ¼ 0.48).

International Journal of Obesity


Table 4 Pearson correlation coefficients between the amount of FSFI change and the amount of anthropometric measurements, body composition change in
completion participants
FSFI domaina
Weight BMI
D1
0.1586
0.1832
D2
0.4371*
0.4762*
D3
0.2934
0.2702
D4
0.4501*
0.4567*
D5
0.1969
0.2296
D6 0.3370** 0.2975
Total
0.3063
0.3355***
FSFI, Female Sexual Function Index; BMI: body mass index. Completion participants: sibutramine group and control group altogether as one group. aDomains of
FSFI: D1, desire; D2, arousal; D3, lubrication; D4, orgasm; D5, satisfaction; D6, pain. *Po0.05. **P ¼ 0.0513. ***P ¼ 0.0524.
Discussion
The purpose of this study was to assess the impact of the
weight-loss drug, sibutramine, on sexual function. Given
differences in physiology of sexual response and assessment
criteria for sexual performance between men and women,
the study focused on female sexual function only. Female
sexual function can be evaluated from physiological mea-
surements, such as the amount of blood flow in the vagina,
but a self-reporting questionnaire, such as the FSFI used in
this study, is considered the most appropriate measurement
method. The FSFI questionnaire is simple, economical and
effective, reflecting actual sexual function in the normal
environment. This questionnaire requires less explicit sexual
descriptions than other questionnaires and helps subjects
reveal their sex life without being provoked.14,15 In addition,
the FSFI has a verified numeric rating scale system, enabling
investigators to easily determine any improvement in sexual
function.
With the exception of polycystic ovary syndrome (PCOS),
there is limited information available on the relationship
between obesity, weight reduction and female sexual func-
tion. The conclusions from studies in subjects with PCOS
cannot be applied to the overall obese female population, as
PCOS exhibits several specific endocrine features.16 It is also
important to recognize that the majority of studies that have
examined the effects of weight reduction on female sexual
function have used unvalidated tools to measure sexual
function.
It is unclear whether obese women have sexual dysfunc-
tion more often than non-obese women. In young women,
clinical trial data suggest an ambiguous association between
obesity and sexual satisfaction.17–19 However, weight reduc-
tion seems to improve sexual function in obese women.20,21
Of several mechanisms that could contribute to an overall
change in sexual function after weight reduction in obese
young women, alteration of the sex hormones estrogen and
androgen and improvement in body image are the most
important. Whether a change in sex hormone status is an
appropriate explanation for an improvement in sexual
Effect of sibutramine on female sexual function
KK Kim et al
761
Correlation coefficients (r)
Waist circumference Fat body mass Fat-free mass

0.0487 0.0246 0.1814
0.1546
0.2859 0.2570
0.0112 0.0219 0.2216

0.0744
0.3003 0.1314
0.1776
0.0122 0.1532
0.2149 0.4817* 0.2187
0.0911
0.0415 0.2689
function is difficult to determine because estrogen and
androgen levels either do not change significantly or, in
fact, are reduced after weight loss.
Estrogen is produced from cholesterol in the ovaries or by
aromatization of steroids in the adipose tissue. A reduction
in fatty tissue, therefore, can result in decreased levels of
blood cholesterol, aromatization and estrogen. However,
among premenopausal women, the far greater effect of
ovarian estrogen secretion would exceed any decreased
estrogen levels that occur through weight reduction.22
Estrogen levels tend to decrease after weight loss, which
could directly influence the FSFI questionnaire domains of
both lubrication and pain resulting in an increase in sexual
pain. In this study, however, the results for the sexual pain
domain showed no treatment change and no between-group
difference. The lubrication domain showed no correlation
to changes in fat body mass but did show an increase for
sibutramine-treated subjects who lost the most weight
(especially in terms of body fat). The small sample size may
have affected the sensitivity of the instruments to detect
treatment differences.
Several studies have reported that in regularly menstruat-
ing obese women, changes in androgen levels after weight
reduction indicate that sex hormone-binding globulin
consistently increases after weight loss and, in turn, free
testosterone seems to decrease.23–25 Androgen insufficiency
is related to hypoactive sexual desire disorder14,26 and
androgen, in contrast, can increase sexual desire, arousal,
orgasm and satisfaction.27,28 Weight reduction, therefore,
can reduce the score in each of these domains.
The sibutramine group in this study exhibited improve-
ment in not only FSFI total score, but also in a number of
individual domain scores, displaying statistically meaningful
results in arousal and lubrication domains and FSFI total
score. However, the control group, which showed no
significant weight change, also showed no significant
change in FSFI total score or other individual domain scores,
except the orgasm domain. When comparing the two
groups, the sibutramine group had greater improvement
than the control group in the domains of arousal, orgasm
International Journal of Obesity
 Effect of sibutramine on female sexual function
KK Kim et al
762
and satisfaction and FSFI total score. Data from two control
subjects were excluded from this analysis, as the subjects had
no sexual activity during the assessment period; if, however,
these data had been included in the analysis, the improve-
ment in sexual function achieved by the sibutramine group
would be more favorable.
Some weight-loss trials report simultaneous improvement
in both body image and sexual function in women.20,29 To
test whether the positive impact of sibutramine-induced
weight loss on sexual function is likely to be associated
with the amount of weight loss and improved body shape, a
correlation analysis was performed to estimate this relation-
ship. As presented in Table 4, a decrease in weight and
BMI had a positive impact on sexual function, especially in
arousal and orgasm domains, but there was no correlation
between loss in body fat and improvement of sexual
function. Therefore, it is weight loss itself rather than
improvement of body shape that is considered to play a
greater role in improving sexual function.
Arousal disorder (the female equivalent of impotence) can
be measured by the FSFI questionnaire’s arousal and lubrica-
tion domains. This study revealed that following treatment
with sibutramine plus behavioral therapy, the arousal
domain score increased, exceeding that of the control group,
and that the lubrication domain score also rose but without a
significant difference from the control group. The satisfac-
tion domain score, although only slightly improved in the
sibutramine group, showed a meaningful difference between
the two treatment groups, indicating that neither sibutra-
mine nor weight loss is likely to decrease blood flow to the
vagina or to decrease lubrication, but appears to improve
arousal and satisfaction in combination with other factors,
among which is the degree of weight loss. Unlike other SSRIs,
treatment with sibutramine plus behavioral therapy did not
cause arousal disorders in this study.
The FSFI orgasm domain score decreased in the control
group after treatment, whereas almost no change was
observed in the sibutramine group. The correlation analysis
showed a tendency of higher orgasm domain scores in
participants whose weight decreased.
Mean weight reduction in the sibutramine treatment
group in this study was almost 4 kg, equivalent to an
approximate fall of 6% from baseline. This is in contrast
to other published data with sibutramine where a weight
reduction of approximately 4% was achieved during the first
8 weeks of administration.30,31 The minimal weight loss
(o0.5 kg) achieved by the control group, which was less than
that reported previously using a similar behavioral modifica-
tion program (3.8–4.2 kg),32 could be related to the slightly
longer time interval (2 weeks) between clinic visits and to the
lower BMI inclusion criteria (X23 kg/m2).
Treatment with sibutramine plus behavioral therapy
improved body composition by decreasing body fat and
increasing fat-free mass. At the same time, changes in lipid
profile were characterized by a clinically relevant decrease in
total cholesterol and LDL cholesterol. A number of studies
International Journal of Obesity
state that sibutramine treatment decreased triglyceride and
increased HDL but did not show clinically relevant changes
in LDL cholesterol level.33–35 The decrease in LDL cholesterol
level achieved in this study may be attributable to the
combined behavioral therapy, which includes increased
exercise.
According to the data from a study of female sexual
function treatment, we cannot neglect the placebo effect on
sexual function.36 The fact that this was not a placebo-
controlled study is a limitation. However, this study tried to
avoid any possibility of affecting how participants answered
the questionnaire by not discussing sexual issues throughout
the treatment period, and by emphasizing weight reduction.
Depression has been related to the alteration of sexual
function,37 and can be related to female sexual dysfunc-
tion.38 Therefore, we tried to exclude from the study all
persons who had any medical history of psychiatric treat-
ment and asked participants whether they had symptoms of
a major depressive episode at screening. However, we did not
use a validated method to detect the presence or change of
mood in this study, which may constitute a bias.
In conclusion, weight reduction induced by sibutramine
plus behavioral therapy enhanced overall sexual function
in overweight and moderately obese women, and showed
statistically significant results in arousal, orgasm and
satisfaction domains. This result is more likely related to
the degree of weight loss, regardless of the use of sibutra-
mine. It is possible that the strong effect of ‘self body image
after weight reduction’ on sexual pleasure obscured a smaller
effect of sexual function impairment by sibutramine. But
sexual arousal and satisfaction, which have been thought to
be unfavorably influenced by sibutramine, showed improve-
ment after treatment with sibutramine plus behavioral
therapy, and the orgasm domain showed no change after
treatment with sibutramine plus behavioral therapy. These
results suggest that the beneficial effects resulting from
weight loss far exceed any deterioration of sexual function
that might be caused by sibutramine.
In this study, we concluded that treatment with sibutra-
mine plus behavior therapy for women who are overweight
or moderately obese was not associated with deterioration in
sexual function. Instead, weight loss induced by sibutramine
plus behavioral therapy enhanced sexual function, indica-
ting that improvement in sexual function was closely linked
to the degree of weight loss.
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