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Alcohol & Alcoholism Vol. 42, No. 4, pp. 340–346, 2007
Advance Access publication 30 May 2007
doi:10.1093/alcalc/agm041
SILDENAFIL CITRATE IN THE TREATMENT OF SEXUAL DYSFUNCTION AND ITS EFFECT
ON QUALITY OF LIFE IN ALCOHOL DEPENDENT MEN: PRELIMINARY FINDINGS
ALEXANDER GRINSHPOON
1,2
, ANATOLY MARGOLIS
3
, ABRAHAM WEIZMAN
4
and ALEXANDER M. PONIZOVSKY
1∗
1
Mental Health Services, Ministry of Health, Jerusalem, Israel,
2
Tirat Carmel Mental Health Center, Ministry of Health, Tirat Carmel, Israel,
3
Department of Substance Dependence Treatment, Ministry of Health, Jerusalem, Israel and
4
Geha Mental Health Center and Felsenstein Medical Research Center, Rabin Medical Center, Beilinson Campus, Petakh Tikva,
Sackler Faculty of Medicine, Tel Aviv University, Israel
(Received 28 December 2006; first review notified 10 April 2007; in revised form 11 April 2007; accepted 12 April 2007;
advance access publication 30 May 2007)
Abstract — Background: Alcohol-dependent men commonly suffer from erectile dysfunction (ED) and men with ED are frequently
chronic alcohol addicts. Sildenafil is used for treatment of ED caused by diverse factors. The aim of this study was to examine
(i) the effect of sildenafil citrate (VIAGRA) on ED in alcohol dependent men, and (ii) whether the effective treatment of ED with
sildenafil improves the patient’s QoL and related emotional distress. Methods: Fifty-four men with an ICD-10 diagnosis of alcohol
dependence (AD) and concomitant ED agreed to enter an open-label trial, in which they were assigned to take 50 mg of sildenafil as
add-on to a standard treatment for AD for 12 weeks. Fifty patients (92.3%) completed all baseline and endpoint assessments. Efficacy
was evaluated using the International Index of Erectile Function (IIEF), Quality of Life Enjoyment and Satisfaction Questionnaire
and General Health Questionnaire. Results: At endpoint, total IIEF scores had improved significantly ( = 16.9), reflecting a 42%
improvement (P<0.0001). A significant increase in the mean scores of each sexual function domain was also noted among all
subjects. Sildenafil’s positive effect was accompanied by a significant improvement (P<0.001) in satisfaction with overall QoL
and specific life-domains, as well as a significant reduction in emotional distress scores (P<0.001). Conclusion: The sildenafil
add-on evaluated in this trial had a marked beneficial effect on ED and QoL, and was associated with a significant reduction in
emotional distress among men with AD. The information obtained is valuable for both clinicians and policymakers in developing
innovative therapeutic strategies for men with AD.
Alcohol dependence (AD) is defined as repeated alcohol-
related difficulties in at least three of seven areas of
functioning, clustered together over any 12-month period
(DSM-IV, American Psychiatric Association, 1994). The life-
time risk for male AD in most western countries is about
10–15%. Alcohol-dependent men commonly suffer from
erectile dysfunction (ED) (Fahrner, 1987; Van Steenbergen,
1993; O’Farrell et al ., 1998; Wetterling et al ., 1999) and
men with ED are frequently chronic alcohol addicts (Jeff-
coate, 1991; McCambridge et al ., 2006). Former addicts, after
forcible withdrawal from alcohol, particularly complain about
impotence and report it as a ‘cause’ for relapse. The find-
ings of previous studies show that modest ethanol doses (e.g.
at blood alcohol concentrations of 100 mg/dL) can both
increase sexual drive and decrease erectile capacity in men
(Caspari et al., 1999). In turn, the effect of ethanol in boost-
ing sexual desire may lead to greater alcohol consumption in
an attempt at ‘self-treatment’. In this way, a vicious circle of
ED and heavy alcohol consumption develops.
Sildenafil citrate (VIAGRA) is reportedly an effective and
safe medication indicated for the treatment of ED (Cheitlin
et al., 1999; Benchekroun et al., 2003). It is a compet-
itive inhibitor of cGMP-specfic phosphodiesterase type 5.
The medication amplifies the effect of sexual stimulation by
retarding the degradation of this enzyme. Sildenafil has been
found effective in several subpopulations of men with ED,
including sufferers from diabetes (Basu and Ryder, 2004),
*Author to whom correspondence should be addressed at: Mental Health
Services, Ministry of Health, 2 Ben Tabai St., 93591 Jerusalem, Israel. Tel:
972 2 6727794; Fax: 972 2 6719007;
E-mail: alexander.ponizovsky@moh.health.gov.il
hypertension (Feldman et al ., 1999), spinal cord injuries
(Hultling et al ., 2000; Deforge et al ., 2006), multiple scle-
rosis (Fowler et al., 2005), depression (Seidman et al ., 2001;
Rosen et al., 2004; Tignol et al., 2004; Fava et al., 2006),
PTSD (Orr et al ., 2006), and schizophrenia (Aviv et al.,
2004; Gopalakrishnan et al., 2006), men after resection of
the prostate or radical prostatectomy (Nandipati et al., 2006),
after renal transplant (Sharma et al ., 2006), men on dialy-
sis (Dachille et al ., 2006), and men aged 65 years and older
(Wagner et al., 2001; Carson, 2004). To our knowledge, there
has been no investigation of the effects of sildenafil on ED in
men with AD.
The impact of disease on health-related quality of life
(QoL) is now accepted, as is the importance of health-related
QoL as a measure of treatment efficacy (NIH Consensus
Development Panel on Impotence, 1993; Donovan et al .,
2005). Health-related QoL is severely impaired in alcohol
dependants (Feeney et al ., 2004; Fisher et al., 2005), and
one of the causes is the distress associated with ED, since
sexual health is an important component of QoL (Donovan
et al., 2005). Newly introduced compounds, such as acam-
prosate, naltrexone and topiramate, used as an add-on treat-
ment for alcoholism, by promoting abstinence, have been
shown to improve QoL profiles to levels comparable to those
of healthy individuals (Johnson et al ., 2004; Morgan et al.,
2004; UKATT Research Team, 2005). An analogous effect
may be achieved with innovative social behavior and net-
work therapy for alcohol problems (UKATT Research Team,
2005), with a cognitive behaviour treatment program (Feeney
et al., 2004) and with medication compliance enhancement
treatment (Johnson et al ., 2004). Because sexual health is
an important component of QoL, ED that caused significant
The Author 2007. Published by Oxford University Press on behalf of the Medical Council on Alcohol. All rights reserved
SILDENAFIL AND QUALITY OF LIFE IN ALCOHOLISM 341
distress can diminish the QoL (NIH Consensus Development
Panel on Impotence, 1993).
The goal of the study reported here was to attempt to
break the vicious circle of ED and heavy alcohol consumption
by using VIAGRA to treat impotence in subjects with AD.
Specifically, we sought to examine (i) the effect of VIAGRA
on ED in alcohol-dependent men, (ii) whether the effective
treatment of ED with VIAGRA improves the patient’s QoL,
and (iii) reduced emotional distress.
METHODS
Study design
This paper reports preliminary results of a 12-week, open-
label trial was conducted from January 1, 2005 to June
31, 2006 simultaneously at 11 outpatient medical centres
for alcohol abuse across Israel. All the centres belong to
the Ministry of Health and are audited by its Department
for the Treatment of Addictions. The Ministry of Health’s
institutional review board approved the study protocol, and all
patients gave their written informed consent before enrollment
in the study.
The patients
Male patients were eligible if they met the following criteria:
(i) aged 18–50 years, (ii) had an ICD-10 diagnosis of AD
(F10.2), (iii) had sought treatment to stop alcohol consump-
tion, (iv) had completed a detoxification program not later
than 1 month before study enrolment, (v) had complained of
ED for at least the 12 weeks preceding the study, and (vi) had
a regular female partner during the research period.
AD was diagnosed according to International Classifica-
tion of Diseases, Tenth Edition (ICD-10) criteria (World
Health Organization, 1993). The subjects’ alcohol history
was described by the following parameters: (i) age at first
alcohol consumption, (2) age at first binge, (3) duration of
harmful alcohol consumption, (4) number of inpatient or
outpatient detoxifications, (5) average alcohol intake in last
6 months (grams alcohol/drinking day), and (6) number of
drinking days during last month. AD severity was rated
on ICD-10 criteria into one of three categories, according
to frequency of drinking (during the previous 6 months)
and amount of alcohol intake. The three categories were:
(1) continuous drinkers = (almost) daily alcohol consump-
tion without binges, (2) frequent heavy drinkers = frequent
alcohol consumption (more than 3 days/week) with fre-
quent intoxication (more than one/week), and (3) episodic
drinkers = less frequent, irregular alcohol consumption with
longer (>5 days) sober periods, and some binges (less than
one/week).
Alcohol-associated sexual dysfunction (AASD) was defined
by DSM-IV criteria for substance-induced sexual dysfunc-
tion (American Psychiatric Association, 1994). The criteria
include impaired desire, arousal (ED), orgasm, and sexual
pain. Trial subjects had to have substantially impaired sexual
function, as defined by at least one of the following criteria,
and which was causing significant distress: ED, defined as
persistent or recurrent inability to retain an adequate erection
until completion of sexual activity; inability to reach orgasm;
ejaculatory delay of at least 10 min in masturbation or inter-
course.
Patients were not enrolled if they had anatomical penile
deformities (e.g. Peyronie’s disease), a primary or prior diag-
nosis of a sexual disorder other than AASD, or had serious
co-morbid medical illnesses (hepatic, renal, neurological, car-
diovascular, hematological, diabetes mellitus); if they were
evaluated as a suicide risk; if they suffered from acute psy-
chosis, severe depression, or organic brain syndromes; or if
they were currently using psychoactive substances, drugs or
therapies other than alcohol, such as benzodiazipines, seda-
tives, antidepressants, barbiturates, and antipsychotics.
Study protocol
Patients were recruited from outpatient settings and referrals.
All patients were evaluated for eligibility at screening and
all consenting patients (N = 54) completed the International
Index of Erectile Function (IIEF) (Rosen et al., 2002) to
establish their ability to self-evaluate sexual dysfunction.
All patients received a physical examination covering blood
pressure, electrocardiogram, and standard biochemistry and
hematological laboratory tests.
A total of 54 patients were assigned to VIAGRA as an
add-on to a standard outpatient program for AD treatment.
This program consisted of education and therapy, address-
ing problems contributing to or resulting from alcoholism,
and learning skills to manage alcoholism over time. At the
baseline, eligible patients assigned to receive sildenafil were
instructed to take 1 tablet approximately 1 h before antici-
pated sexual activity but not more than once a day. They also
were instructed to make at least two attempts at sexual activity
each week. The dose of the drug could be adjusted from 1 to
2 tablets (VIAGRA, was provided by Pfizer Pharmaceuticals
Israel Ltd, Herzliya Pituakh, Israel).
Drug accountability, and self-rated and physician-rated
assessment were performed at baseline and after 12 weeks.
Throughout the study, the investigators monitored for spon-
taneous reports of adverse events and evaluated their severity
and relationship to the study medication.
Outcome measures
Efficacy was evaluated using a battery of validated measure-
ments. The primary outcome measure was the IIEF (Rosen
et al., 2002), supplemented by two global efficacy questions:
(a) Did treatment improve your erections? and (b) Did treat-
ment improve your ability to perform sexual intercourse? The
questions were asked at baseline and at weeks 4, 8, and
12. Secondary outcome measures used were the Quality of
Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
(Endicott et al ., 1993) and the General Health Questionnaire
(GHQ) (Goldberg and Williams, 1988). Time frame for the
measures was the 10 days preceding the assessment.
The IIEF is a self-rated 15-item instrument for assess-
ing sexual function across five functional domains: erection,
orgasm, desire, intercourse satisfaction and overall satis-
faction. Questions are answered on a 6-point scale, where
1 = ‘almost never/never’ and 5 = ‘almost always/always’.
342 A. GRINSHPOON et al .
A score of 0 means ‘no attempt at sexual intercourse’. The
possible total score ranges from a minimum of 5 to a max-
imum of 75. The changes in the IIEF scores quantified the
magnitude of the response to the treatment. A score of 21
is the cut-off point to roughly distinguish respondents with a
degree of ED (score = 21 or less) from those who have no
ED (score >21).
The Q-LES-Q is a valid, reliable, time-sensitive self-
report instrument for assessing satisfaction with QoL and
five specific life-domains (physical health, subjective feel-
ings, leisure-time activities, social relationships and general
activities). Each domain score and an average of the subscale
scores (QoL Index) was calculated. Responses were scored
on a 5-point scale (from ‘not at all/never’ to ‘frequently/all
the time’), with higher scores indicating more enjoyment and
satisfaction with particular life-domains and QoL as a whole.
The GHQ-12 has been used extensively worldwide as
a valid and reliable measure of non-specific psychological
distress or demoralisation (Ustun and Sartorius, 1993). The
questionnaire asks whether the respondent has experienced
a particular symptom or behavior recently. Responses are
rated on a 4-point Likert frequency scale, ranging from ‘much
less than usual’ (weighted as 0) to ‘much more than usual’
(weighted as 3). Total scores range from 0–36. Though scores
vary by study population, scores of about 11–12 are typical,
and a score higher than 20 suggests severe problems and
psychological distress.
Internal consistency reliability, as measured by Cronbach’s
α coefficient, was satisfactory for all instruments used,
specifically: 0.96 for the QoL Index (from 0.91 for physical
health to 0.94 for the general activities domain) and 0.71 for
the GHQ.
Statistical analysis
We computed frequency distribution and mean scores for the
subjects’ sociodemographic characteristics and mean scores
and standard deviations (SDs) were computed for the out-
come measures. Pearson product moment correlations were
calculated to measure relationships between sexual function,
QoL, and emotional distress. The statistical significance of
the change from baseline to week 12 () was calculated
by paired two-tailed t -tests. All the men who completed
two treatment efficacy assessments were classified as either
responsive or non-responsive to the treatment. For all analy-
ses, the level of statistical significance was set at P<0.05.
Analyses were performed with SAS version 9.1 (SAS Insti-
tute Inc, Cary, NC).
RESULTS
Patients’ characteristics
Of the 54 men who consented to participate in the study,
50 (94.4%) completed all baseline and endpoint (week 12)
assessments. The four subjects who withdrew did not show
significantly different baseline demographic and clinical char-
acteristics compared to those who completed the study.
Table 1 presents demographic and selected clinical charac-
teristics for the completers. Sixty two percent of the sample
Table 1. Sociodemographic and clinical characteristics (N = 50)
Characteristic N Percentage
Marital status
Single 6 12.0
Married 31 62.0
Divorced/separated/widowed 13 26.0
Employment
Employed 16 32.0
Unemployed 34 68.0
Religious affiliation
Jewish 31 62.0
Non-Jewish 19 38.0
Immigration status
Immigrant 27 54.0
Non-immigrant 23 46.0
Number of prior inpatient detoxifications
03060.0
11326.0
2+ 714.0
Mean SD
Length of immigration (in yrs.) 16.4 13.3
Schooling (in yrs.) 11.1 4.5
Mean age (in yrs.) 44.0 8.7
Age at first alcohol consumption (in yrs.) 17.2 3.4
Age at first binge (in yrs.) 20.5 6.4
Duration of harmful alcohol consumption (yrs.) 14.8 9.7
Average alcohol intake in last 6 months (g
alcohol/drinking day)
700 648.8
Number of drinking days in last month 8.6 10.8
were Jews; mean age was 44 years (SD = 8.7); most patients
were married (62%), 26% were divorced, separated or wid-
owed and 12% were single. Mean length of schooling was
11.1 years (SD = 4.5); 68% were unemployed and 54% had
immigrated to Israel from the former Soviet Union, with a
mean time since immigration of 16.4 years (SD = 13.3).
The subjects’ alcohol history was characterized by an early
age of onset. Mean age at first-in-life alcohol consumption
was 17.2 years (SD = 3.4) and age at first alcohol binge was
20.5 years (SD = 6.4). The mean duration of harmful alcohol
consumption was 14.8 years (SD = 9.7). Most patients (60%)
had no prior inpatient detoxification, 26% had one and 14%,
more than two. Average alcohol intake in the last 6 months
was 700 g per drinking day (SD = 648.8), and the mean
number of drinking days in the last month was 8.6 (SD =
10.8).
Correlation between measures
Table 2 presents the correlations between baseline scores
for sexual function, quality of life domains, and emotional
distress. As can be seen, the IIEF total score is moderately
and positively associated with the Q-LES-Q Index score
and moderately but negatively with the GHQ total score
(P<0.001). Significant correlations similar in magnitude
and direction were also found between sexual function and
QoL specific life-domain scores and emotional distress scores.
The results suggest that sexual function, quality of life, and
emotional distress are distinctly separate constructs.
SILDENAFIL AND QUALITY OF LIFE IN ALCOHOLISM 343
Table 2. Baseline Correlations between Sexual Function (IIEF), Quality of Life (Q-LES-Q) and Psychological Distress (GHQ)
Sexual Q-LES-Q domain
function
domain Physical health Subjective feelings Leisure-time activities Social relationships General activities QoL Index GHQ
Erectile function 0.39 0.45 0.44 0.29 0.56 0.48 −0.39
Orgasmic function 0.38 0.45 0.47 0.26 0.55 0.47 −0.33
Sexual desire 0.23 0.25 0.38 0.20 0.33 0.32 −0.22
Intercourse satisfaction 0.33 0.40 0.34 0.27 0.50 0.43 −0.40
Overall satisfaction 0.35 0.36 0.49 0.26 0.52 0.44 −0.42
Total score 0.40 0.46 0.50 0.30 0.58 0.50 −0.41
GHQ −0.52 −0.49 −0.34 −0.45 −0.53 −0.54 —
Note: Correlations over 0.20 are significant at P<0.01.
Q-LES-Q, Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q; Endicott et al ., 1993); IIEF, International Index of Erectile Function (IIEF;
Rosen et al ., 1997); GHQ, General Health Questionnaire (GHQ-12, Goldberg, 1988).
Table 3. Mean (±SD) scores on the International Index of Erectile
Function at Baseline and End of the Sildenafil Trial (by paired
two-tailed t-test)
Sexual function
domain Baseline Week 12 t-value P -value
Erectile function 15.9 (7.6) 23.2 (5.6) 6.79 <0.0001
Orgasmic function 6.1 (3.1) 8.2 (2.1) 5.64 <0.0001
Sexual desire 6.0 (2.2) 7.3 (1.4) 5.11 <0.0001
Intercourse satisfaction 7.1 (3.7) 10.3 (2.8) 5.51 <0.0001
Overall satisfaction 4.7 (2.5) 7.6 (2.3) 8.35 <0.0001
Total score 39.9 (16.9) 56.7 (12.9) 7.23 <0.0001
Sexual function
At baseline, patients reported the following extensive sexual
dysfunction symptoms: 85.5% erectile dysfunction, 70.3%
libido problem, 61.3% premature ejaculation or delay in
ejaculation, 25% weak or absent orgasm, and 5.5% lack of
pleasure or pain. Table 3 presents changes in the IIEF total
score and five domain scores over 12 weeks of treatment.
At the endpoint, total IIEF scores had significantly improved
( = 16.8), reflecting 42% improvement in the scores (P<
0.0001). A statistically significant increase was noted also in
the mean scores for each sexual function domain. The largest
improvement (61.7%) came in the overall satisfaction domain
score, followed by, in descending order: Erectile Function
(45.9%), Intercourse Satisfaction (45.1%), Orgasmic Function
(34.4%), and Sexual Desire (21.7%). In addition, at the end of
week 4 and at week 12, 94 and 98% of patients, respectively,
gave affirmative responses to the global efficacy questions on
treatment-related improvement in (a) erectile function, and
(b) ability to perform sexual intercourse. Using the IIEF cut-
off score of 21, 37 patients (74%) responded positively to
the 12-week sildenafil treatment, and 13 (26%) were non-
responders.
Quality of life
Table 4 presents changes in the Q-LES-Q Index and specific
life-domain mean scores over the trial. A significant improve-
ment in satisfaction with overall QoL and all specific life-
domains was found (P<0.0001). The improvements ranged
from 10.3% for the Social Relationships domain to 17.2% for
the Physical Health domain. QoL measures improved par-
ticularly among the sildenafil-responsive patients (N = 37),
compared to those whose ED did not respond to this treat-
ment (N = 13): at endpoint, the responders scored signifi-
cantly higher than the non-responders on the Q-LES-Q Index
(3.5 ± 0.5vs2.9 ± 0.4, t = 3.84,P < 0.001).
Emotional distress
Baseline levels of emotional distress were generally unrelated
to efficacy or treatment satisfaction. Over the course of the
trial the subjects demonstrated a statistically significant reduc-
tion in GHQ distress scores (P<0.0001). From baseline to
the week 12 endpoint, the percentage of distressed persons,
defined as those with a GHQ score higher than 20, decreased
from 68 to 22%.
Side effects
Sildenafil was well tolerated. The most common side effect
was headache, reported by 32% of sildenafil-treated patients
(N = 16). Only one patient reported dyspepsia (2%). All
these adverse effects were transient and mild in nature. No
serious adverse events related to the study drug were reported.
DISCUSSION
This is the first study showing the effects of sildenafil on
men with both ED and AD and to measure the effect of
their consequent improved erectile function on QoL and
related emotional distress. Our results indicate that sildenafil,
as an adjunct drug to a standard treatment for men with
alcoholism, significantly improved erectile function and other
components of sexual function and also significantly raised
satisfaction with QoL and all specific life-domains. Finally,
this intervention markedly reduced psychological distress.
The improvements observed in this study were comparable
to those observed in other clinical trials of sildenafil for
ED in depressive disorder (Fava et al ., 2006), schizophrenia
(Gopalakrishnan et al ., 2006), PTSD (Orr et al ., 2006),
as well as in medical diseases and treatments such as
diabetes (Basu and Ryder, 2004), hypertension (Hultling
344 A. GRINSHPOON et al .
Table 4. Mean (±SD) scores on the Q-LES-Q Domains at Baseline and End of the Sildenafil
Trial (by paired two-tailed t -tests)
Q-LES-Q domain Baseline Changes from baseline to week 12 t-Value (df = 49) P -Value
Physical health 2.9 (0.7) 0.5 (0.8) 5.13 <0.0001
Subjective feelings 3.2 (0.8) 0.5 (0.7) 5.49 <0.0001
Social relationships 2.9 (0.7) 0.3 (0.6) 2.82 0.007
Leisure-time activities 2.6 (0.8) 0.4 (0.6) 4.55 <0.0001
General activities 2.7 (0.7) 0.4 (0.5) 6.02 <0.0001
Index score 2.9 (0.6) 0.4 (0.5) 5.57 <.0001
et al., 2000), heart failure (Freitas et al., 2006), spinal cord
injuries (Deforge et al., 2006), renal transplant (Sharma et al.,
2006), dialytic treatment (Dachille et al., 2006), and radical
prostatectomy (Nandipati et al., 2006). The study treatment
entailed little risk, as adverse effects were limited to headache
(N = 16) and dyspepsia (N = 1). Given that discontinuation
rates are a powerful indicator of medication effectiveness, the
low dropout rate (6%) in this study may be considered as
additional evidence of the intervention’s clinical benefit.
ED is a complex condition, deriving from many phys-
ical, emotional, societal, and relationship factors (Althof
et al., 2006; O’Leary et al., 2006), and which has a seri-
ous impact on the satisfaction with QoL of an affected
male and his partner (Benchekroun et al ., 2003; Dono-
van et al., 2005). In their recent qualitative study, Tom-
linson and Wright (2004) described the impact of ED on
the subjective feelings of 40 men, their expectations of
sildenafil, and the self-reported impact of the treatment
on the subjects and their relationships. ED caused serious
distress and sildenafil, when it worked, brought about a
great improvement in well-being. However, when the treat-
ment was ineffective, the distress worsened. In line with
these findings and those from a few other earlier studies
(Althof et al., 2006; Montorsi et al ., 2006; Steidle et al .,
2006; Cappelleri et al., 2006), we found that sildenafil treat-
ment meaningfully reduced the symptoms of emotional dis-
tress.
We agree with Rosen et al.’s conclusion (Rosen et al.,
2006) that the changes in QoL associated with ED ther-
apy may be mediated by changes in sexual function, mood,
and family relationships and/or, as we observed, by a reduc-
tion in psychological distress. Stopping alcohol consumption
while undergoing treatment may also be a reason for an
improved QoL, although abstinence that is only temporary
may not be able to change behaviour and underlying psy-
chosocial features. One can suggest that the well studied
stress reduction effect of alcohol that is a major motiva-
tion for drinking (Hall, 1995) may be replaced here by the
analogous tension-reduction effect of sildenafil. Whatever, the
precise mechanisms by which the beneficial effects of silde-
nafil on ED translate into a positive QoL response require
further research.
The obvious limitation of our study is the lack of a con-
trol group without additional or with alternative treatment for
ED or with a placebo. Thus, a non-specific, placebo effect
on ED cannot be ruled out. This effect, however, is unlikely,
given the significant improvements not only in sexual function
but also in QoL and distress scores achieved over a relatively
short trial. The positive effects of sildenafil on emotional well-
being, self-esteem, confidence and relationship satisfaction of
men with ED revealed in several recent double-blind, placebo
controlled studies, support our findings (Cappelleri et al.,
2006; O’Leary et al ., 2006; Steidle et al., 2006). Unlike a
double blind clinical trial, an open label design is susceptible
to the clinician’s subjective bias during data collection and the
evaluation of study parameters, usually in favor of the efficacy
of the experimental compound over a comparative compound,
or vice versa. However, this bias would mostly show itself on
the clinician’s clinical impressions and symptom assessment.
On self-administered questionnaires the clinician’s impact on
outcomes is practically excluded. A potential bias deriving
from the participating physicians’ differential levels of exper-
tise is also precluded because, to our knowledge, the clinicians
in all participating centres were equivalently trained and expe-
rienced.
Another potential limitation is not the diagnosis specific
nature of the tool we used to assess QoL in patients with
AD. Although the Q-LES-Q was initially developed to assess
QoL in depressed patients, it has been used for evaluating
health-related QoL outcomes in various clinical populations
(Schwartz et al., 1998; Phillips et al ., 2005; Grant et al.,
2006). Its key virtue for us is that it contains only items
on satisfaction with sexual drive and interest included in
the general activities domain. This means that the significant
correlation between improvements in sexual functioning and
satisfaction with specific life domains which we found in this
study is a genuine outcome and not an artifact of convergent
validity between the IIEF and the Q-LES-Q, that is, it does
not derive from overlap between the underlying constructs.
This is also true for the psychological distress measure we
used.
Finally, the relatively short trial period meant that we were
not able to examine the effects of sildenafil on drinking
patterns. This issue should be addressed in further longitudinal
studies with a longer follow-up time.
In sum, the preliminary findings show that augmenting a
standard alcoholism treatment with sildenafil had a marked
beneficial effect on both ED and QoL, and was associated
with a significant reduction in emotional distress. Moreover,
the treatment entails little risk: adverse effects were few
and minor. The implications of these findings in relation to
the treatment intervention appropriate to this patient group
are important. The information obtained in the study (it
will be controlled in further controlled trial) is valuable for
both clinicians and policy makers in developing innovative
therapeutic strategies for men with alcohol dependence.
SILDENAFIL AND QUALITY OF LIFE IN ALCOHOLISM 345
Acknowledgements — This study was supported in part by independent
research grant from Pfizer Pharmaceuticals Israel Ltd., and the Israeli
Ministry of Immigrant Absorption (Dr A. Ponizovsky). We wish to
thank Drs L. Averbuch, S. Marshansky, M. Dakhis, T. Azarch, M. Khinich,
M. Lerman, L. Komarovsky, M. Patachov, S. Sonkin, S. Yavilevich,
M. Bard, S. Epstein, and M. Rubinstein for their part in collecting the data.
We also are grateful to our research assistant S. Rozen, to I. Radomislansky
for her statistical assistance and to N. Steigman for his editing.
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