Finasteride 5 mg and Sexual Side Effects: How Many of these are Related to a Nocebo Phenomenon?
UO Urology, S Maria Annunziata Hospital, University of Florence, Florence, Italy. Journal of Sexual Medicine
(Impact Factor: 3.15).
11/2007; 4(6):1708-12. DOI: 10.1111/j.1743-6109.2007.00563.x
Sexual adverse experiences such as erectile dysfunction (ED), loss of libido, and ejaculation disorders have been consistent side effects of finasteride in a maximum percentage of 15% after 1 year of therapy. Such data could be seen as far from reality, if compared to a higher percentage that may be found in any common clinical practice.
This study aims to explain the dichotomy between literature's data and clinical practice data.
One hundred twenty patients with a clinical diagnosis of benign prostatic hyperplasia (BPH), sexually active and with an International Index of Erectile Function-erectile function (IIEF-EF) domain >/=25 were randomized to receive finasteride 5 mg concealed as an "X compound of proven efficacy for the treatment of BPH" for 1 year with (group 2) or without (group 1) counseling on the drug sexual side effect. The phrase used to inform group 2 patients was ". . . it may cause erectile dysfunction, decreased libido, problems of ejaculation but these are uncommon".
The estimation of side effect was conducted at 6 and 12 months using the male sexual function-4 (MSF-4 item) questionnaire and a self-administered questionnaire.
One hundred seven patients completed the study. Group 2 patients (N = 55) reported a significant higher proportion of one or more sexual side effects as compared to group 1 (N = 52) (43.6% vs. 15.3%) (P = 0.03). The incidence of ED, decreased libido, and ejaculation disorders were 9.6, 7.7, and 5.7% for group 1, and 30.9, 23.6, and 16.3% for group 2, respectively (P = 0.02, P = 0.04, and P = 0.06).
In the current study, blinded administration of finasteride was associated with a significantly higher proportion of sexual dysfunction in patients informed on sexual side effects (group 2) as compared to those in which the same information was omitted (group 1) (P = 0.03). A scenario similar to group 2 of the current study is likely to occur in clinical practice, where the patient is counseled by the physician and has access to the drug information sheet. The burden of this nocebo effect (an adverse side effect that is not a direct result of the specific pharmacological action of the drug) has to be taken into account when managing finasteride sexual side effects.
Available from: Winfried Rief
- "Thus, expectations are associated with brain processes that increase the likelihood of experiencing the expected perception. Not surprisingly, expectations can contribute to the development of negative treatment effects, side effects , and the nocebo phenomenon [Barsky et al., 2002; Bohman et al., 2012; Mondaini et al., 2007; Rief et al., 2011]. Patients' treatment and outcome expectations are also crucial for psychotherapy (see Lambert in this issue; [Greenberg et al., 2006; Lewin et al., 2011; Wampold et al., 2005]), although the placebo concept is difficult to apply to psychological interventions. "
Available from: Kate Faasse
- "and ejaculation disorder if they were randomly assigned to the group that had been described Finasteride's possible side effects, compared to those who were not informed. (Mondaini et al., 2007), Similarly, in a study looking at complaints of erectile dysfunction after therapy with the beta-blocker metoprolol, those who were fully informed of the possible side effects reported double the rates of erectile dysfunction compared with those who were not told about this potential side effect (Cocco, 2008). Thus, pretreatment expectations of sensitivity to medicines may play an important role in side effect experiences. "
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ABSTRACT: Objectives. We report on the development and psychometric properties of a scale to measure perceived sensitivity to medicines (PSM).
Design. The internal consistency, test–retest reliability, criterion-related, and predictive validity of the PSM Scale were evaluated using data collected as part of four previously published studies and one unpublished data set.
Methods. Participants (n= 1,166) included patients receiving treatment for HIV infection and hypertension, individuals receiving a travel vaccination, and undergraduate students. Criterion-related validity was assessed by examining associations between the PSM and beliefs about medicines (Beliefs about Medicines Questionnaire), anxiety and depression (Hospital Anxiety and Depression Scale). Predictive validity was assessed by examining associations between the PSM and medication adherence and with symptom reports following vaccination. Test–retest reliability was assessed in an undergraduate sample who completed the PSM on two occasions, 2 weeks apart.
Results. Test–retest reliability was high (r= .89, p < .001). Cronbach's alpha ranged from 0.79–0.94. Consistent with expectations, high PSM scores were associated with negative beliefs about medicines in general, strong concerns about potential adverse effects of prescribed medicines, and doubts about the necessity for treatment. High PSM scores predicted non-adherence to anti-retroviral therapy and a higher incidence of symptoms following vaccination.
Conclusion. The findings present preliminary evidence that the PSM is a valid and reliable measure of perceived sensitivity to medication. While further work is needed to develop and evaluate the scale, the findings support its use as a research tool in studies of the use and effects of medicines.
What is already known on this subject? It is now well understood that beliefs about medicines have an important influence on whether patients start and continue with treatment. Research spanning a range of long-term conditions and across different countries has shown that treatment uptake and adherence are consistently related to specific beliefs about prescribed medicines, such as how patients judge their personal need relative to concerns about potential adverse effects as well as more general beliefs about medicines as a class of treatment.
What does this study add? The paper reports on the development and psychometric properties of a new scale to measure patients' perceptions of their sensitivity to medicines. In five studies involving different groups of individuals we found the Perceived Sensitivity to Medicines (PSM) Scale to be a reliable and valid measure. The PSM may be useful for researchers and clinicians in explaining treatment decisions, adherence and reported side-effects.
Available from: PubMed Central
- "A report demonstrated that 5ARIs caused reduction in NOS activity in the corpus cavernosum and reduction of the erectile response to electrical stimulation . However, Mondaini et al suggested a noxious effect on the basis of the observation that blind administration of finasteride was associated with a significantly higher proportion of sexual dysfunction in patients counseled about potential sexual AEs than in those from whom the same information was withheld . "
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ABSTRACT: Sexual adverse events (AEs), a major cause for discontinuing 5α-reductase inhibitor (5ARI) therapy for benign prostatic hyperplasia (BPH), are known to occur most frequently early in therapy and appear to decline over time. The aim of this study was to investigate the changes in sexual function occurring with dutasteride treatment during a 1-year follow-up period in Korean men.
Using the International Index of Erectile Function, we prospectively evaluated, after 1, 3, 6, 9, and 12 months of treatment, the changes in sexual function of 55 outpatients (mean age 62.3±7.2 years) with BPH (mean volume 48.9±16.0 g) who had relatively good erectile function (EF) and were treated with dutasteride for at least 1 year.
EF scores showed the most significant decrease at 1 month (p<0.01). Function gradually recovered thereafter but was still significantly decreased after 12 months of treatment (p<0.05). The scores for orgasmic function and sexual desire also showed the most significant reduction at 1 month but were restored to the baseline level at 6 months. No significant correlation was observed between changes in sexual function and prostate-specific antigen level, prostate volume, or International Prostate Symptom Scores.
After 1 month of treatment, dutasteride therapy resulted in a significant reduction in all investigated sexual functions. Overall, recovery in sexual function was noted at 3 months, and orgasmic function and sexual desire were restored to baseline levels at 6 months. However, EF was still significantly reduced at 12 months.
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