Should Sexual Desire and Arousal Disorders in Women Be Merged?
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- DeRogatis, L.R., Clayton, A.H., Rosen, R.C. et al. Arch Sex Behav (2011) 40: 217. doi:10.1007/s10508-010-9677-1
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Proposed criteria for Sexual Interest/Arousal Disorder (or Sexual Arousability Disorder) (Brotto, 2010)
A. Lack of sexual interest/arousal of ≥6 months’ duration as manifested by ≥4 of the following indicators:
1. Absent/reduced interest in sexual activity
2. Absent/reduced sexual/erotic thoughts or fantasies
3. No initiation of sexual activity and is not receptive to a partner’s attempts to initiate
4. Absent/reduced sexual excitement/pleasure during sexual activity (≥75% of sexual encounters)
5. Desire is not triggered by any sexual/erotic stimulus
6. Absent/reduced genital and/or non-genital physical changes during sexual activity (≥75% of sexual encounters)
B. The disturbance causes clinically significant distress or impairment
To gain further insights, we analyzed baseline data from three North American Phase III randomized controlled trials of flibanserin (a 5HT1a agonist/5HT2a antagonist in clinical development as a treatment for HSDD) (Jolly et al., 2009). These trials involved 2,573 premenopausal women who were seeking treatment for decreased sexual desire and whom a clinician had found (via a structured diagnostic interview) met DSM-IV-TR criteria for HSDD without concomitant FSAD. Mean (SE) baseline FSFI and FSDS-R total scores in these women were 20.7 (.15) and 30.1 (.23), respectively, indicating that these women had a sexual dysfunction that caused them distress. Analysis of the baseline data strongly suggests that the majority of these premenopausal women with HSDD would not meet the proposed criteria for Sexual Interest/Arousal Disorder (Clayton et al., 2010). All women met proposed criteria A1–A3, which were assessed through a structured diagnostic interview. Criterion A3 was also assessed using the receptivity item (Item 2) of the Sexual Interest and Desire Inventory-Female (Lewis-D’Agostino et al., 2007). For inclusion in the trials, women had to have a rating of 0 or 1 on this item, indicating little or no receptivity to their partner’s approaches for sex.
The trial participants reported that 68% of their sexual encounters during the 4-week baseline period were satisfying. Hence, they were unlikely to meet criterion A4 (absent/reduced sexual excitement/pleasure during sexual activity on ≥75% of sexual encounters). The participants had mean (SE) FSFI arousal and lubrication scores of 2.96 (.03) and 4.15 (.04), respectively, which indicates that their arousal response was “moderate” and that their lubrication response was adequate “most times.” Thus, these women were unlikely to meet criterion A6 (absent/reduced genital and/or non-genital physical changes during sexual activity on ≥75% of sexual encounters). No data were collected that would allow criterion A5 (absent/reduced desire triggered by any sexual/erotic stimulus) to be assessed; indeed, this criterion would be almost impossible to operationalize in clinical practice.
These data were analyzed specifically in response to Brotto’s (2010) proposal that women who met ≥4 of the Point A criteria listed in Table 1, accompanied by clinically significant distress or impairment, should receive a diagnosis of Sexual Interest/Arousal Disorder. Of course, reducing the number of criteria required for a diagnosis to be given would increase the number of women who received the diagnosis; however, liberalizing the definition in this way would also reduce the clinical meaningfulness of the combined definition. Indeed, if only three criteria need to be met for a diagnosis of Sexual Interest/Arousal Disorder to be given, women who had symptoms of low desire (A1–A3) but no arousal problems would qualify for a diagnosis of the combined condition.
These results do not invalidate the abundant epidemiologic evidence that deficiencies in sexual desire and arousal may coexist: 25.7% of the women in the North American Phase III randomized controlled trials of flibanserin met DSM-IV-TR criteria for both HSDD and FSAD. However, these data do raise significant validity and utility concerns for the proposed new diagnostic classification. Although the phases of the female sexual response and their dysfunctions are not always discrete, the majority of women in this trial population (and other samples) have a monophasic dysfunction. If women with HSDD according to DSM-IV-TR criteria would not qualify for a diagnosis of Sexual Interest/Arousal Disorder according to the proposed new classification, it raises the question of whether these women would receive any diagnosis at all, and thus whether they would be excluded from consideration for treatment.
There are significant ambiguities in the proposed new criteria. For example, are sexual excitement and pleasure interchangeable in criterion A4? How could criterion A5 be operationalized for evaluation in clinical practice given the number of sexual/erotic stimuli that may trigger sexual desire? What does “distress or impairment” mean in Criterion B? It is not clear whether impairment of a woman’s relationship would fulfil this distress criterion or whether the functioning of the woman herself must be in some way impaired. At present, no validated methods are available for assessing these criteria.
Caution should always be exercised when considering fundamental changes to medical or psychiatric nomenclatures. Any such changes should be based on confirmed data—preferably from multiple clinical trials or observational studies—rather than on theoretical speculation or expert opinion, as in the current proposal. In the absence of clear-cut evidence that they should be changed, preserving nosologic definitions is preferable to maintain continuity in research and clinical practice. Given the dearth of knowledge among clinicians generally regarding female sexual health, and the consistent under-recognition and lack of attention to sexual problems in women, the proposed modifications are likely to increase confusion about the diagnosis and management of female sexual dysfunction. Testing of proposed new criteria should be performed by general psychiatrists, gynecologists, and primary care practitioners, as well as sexual medicine experts. As such, the criteria need to be readily operationalized and understood by clinicians who are not experts in female sexual disorders.
Changes to nosologic categories typically involve splitting populations, rather than merging or lumping them, in order to increase diagnostic precision and potentially enable clinicians to select treatments that are most likely to be effective. The lumping of diagnostic categories as a strategy for revision carries with it significant risks that the merged category will exclude many women who do not meet criteria for the new disorder, thereby compromising our ability to provide diagnosis and treatment for women with sexual disorders (DeRogatis et al., 2010b).
In conclusion, there is compelling evidence of syndrome specificity in premenopausal women with HSDD and FSAD that argues strongly against merging female desire and arousal disorders into a single interest/arousal disorder category. Any revisions to existing nosologic criteria in DSM-5 must be evidence-based; at this point, there is scant empirical evidence for the validity of the single category proposal.
Editorial assistance for this Letter was provided by Wendy Morris, Fleishman-Hillard Group Ltd. (contracted by Boehringer Ingelheim). Dr. DeRogatis is a Consultant to Boehringer Ingelheim, Biosante, Inc., Faber-Kramer Pharmaceuticals, and Endoceutics, Inc. Dr. Clayton led the development and validation of the Changes in Sexual Functioning Questionnaire (CSFQ), Sexual Interest and Desire Inventory (SIDI-F), and the Decreased Sexual Desire Screener (DSDS). She was Chair of the Third International Consultation on Sexual Medicine Committee for Standards for Clinical Trials in Sexual Dysfunction in Women: Research Designs and Outcomes Assessment (2009). She has been the Principal Investigator for many studies of Hypoactive Sexual Desire Disorder (HSDD): GlaxoSmithKline Phase IV trial of bupropion, Boehringer Ingelheim Phase III trials of flibanserin in premenopausal women, and BioSante Phase III trials of libigel in postmenopausal women. She is a Consultant to Boehringer Ingelheim, TransTech Pharma, and New England Research Institutes regarding Female Sexual Dysfunction (FSD), and to AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Labopharm, Pfizer, PGxHealth, sanofi-aventis, and Takeda about sexual effects of psychotropic medications. Dr. Clayton has been a speaker for CME programs on HSDD supported by Boehringer Ingelheim. She receives royalties from: “Satisfaction: Women, Sex, and the Quest for Intimacy” published by Ballantine Books/Random House, “Women’s Mental Health: A Comprehensive Textbook” published by Guilford Publications, and the CSFQ. Dr. Rosen is a Consultant to Boehringer Ingelheim, Endo Pharmaceuticals, Eli Lilly, and Johnson and Johnson. Dr. Sand is the Global Strategic Leader for the flibanserin clinical development program at Boehringer Ingelheim. Dr. Pyke has been the Team Member (for) Medicine for the flibanserin premenopausal HSDD clinical development project at Boehringer Ingelheim since 2003. He was involved in the management of protocol content, field conduct, and interpretation of results for two Phase 2 trials (over 400 patients evaluated), seven Phase 3 trials (over 6,000 patients evaluated), two trials of SSRI users (over 100 patients evaluated so far), and six non-treatment studies on validation of measures of FSD (over 1000 patients evaluated). In this role, he helped lead development and testing of an integrated set of diagnostic evaluations for FSD, including a 60-question structured clinical interview appropriate for DSM-IV-TR, checklists on DSM-IV-TR and AUAF consensus diagnostic criteria, an AUAF consensus contributory factors checklist, and a brief form for non-expert clinicians to diagnose HSDD; one or more of these forms have been used in diagnostic interviews conducted with over 10,000 women in North America and Europe.