Samir Khalife, MD

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 This study compared group cognitive-behavioral therapy (12-week trial),      surface electromyographic biofeedback (12-week trial), and vestibulectomy in      the treatment of dyspareunia resulting from vulvar vestibulitis. Subjects      were 78 women randomly assigned to 1 of 3 treatment conditions and assessed      at pretreatment, posttreatment and 6-month follow-up via gynecological      examinations, structured interviews and standard questionnaires pertaining      to pain (Pain Rating Index and Sensory scale of the McGill Pain      Questionnaire, vestibular pain index, pain during intercourse), sexual      function (Sexual History Form, frequency of intercourse, Information      subscale of the Derogatis Sexual Functioning Inventory), and psychological      adjustment (Brief Symptom Inventory). As compared with pretreatment, study      completers of all treatment groups reported statistically significant      reductions on pain measures at posttreatment and 6-month follow-up, although      the vestibulectomy group was significantly more successful than the 2 other      groups. However, the apparent superiority of vestibulectomy needs to be      interpreted with caution since seven women who had been assigned to this      condition did not go ahead with the intervention. All 3 groups significantly      improved on measures of psychological adjustment and sexual function from      pretreatment to 6-month follow-up. Intent-to-treat analysis supported the      general pattern of results of analysis by-treatment-received. Findings      suggest that women with dyspareunia can benefit from both medical and      behavioral interventions.
 
 
 


 
 Chronic or recurrent pain involving the female reproductive system is a      neglected, poorly understood, and costly women's health problem (Walling and      Reiter, 1995). Dyspareunia, or painful intercourse, a recurrent acute pain      which can be located anywhere from the vaginal introitus to the uterus and      adnexae, affects 10 - 15% of women in North America (Laumann et al., 1994).      Perhaps the most common type of premenopausal dyspareunia is vulvar      vestibulitis syndrome, a condition characterized by a sharp, burning pain      located within and limited to the vulvar vestibule (vaginal entry) and      elicited primarily via pressure applied to the area. This distressing      syndrome has no clear etiological determinants, although it has been      associated with repeated yeast infections and other urogenital inflammatory      conditions (Goetsch, 1991; Bergeron et al., 1997). Despite a prevalence rate      of 15% in general gynecologic practice, there are no randomized trials      evaluating treatments for vulvar vestibulitis. 
 
 Among the more commonly used therapeutic modalities are cognitive-behavioral      therapy, biofeedback and vestibulectomy. Typical cognitive-behavioral      interventions aim at reducing the pain and improving sexual function; they      include Kegel exercises, vaginal dilatation, and relaxation (Meana and Binik,      1994). In terms of treatment outcome, there have only been two uncontrolled      studies conducted with a population of premenopausal women, and these show      that 43 to 68% of women who undergo individual behavioral therapy treatments      benefit from a significant improvement or complete relief of their pain (Abramov      et al., 1994; Weijmar Schultz et al., 1996). However, these treatments were      either unstandardized or multidisciplinary, which limits the conclusions      that can be drawn regarding the efficacy of cognitive-behavioral therapy.     
 
 Surface electromyographic (sEMG) biofeedback has been used successfully in      the treatment of various chronic pain syndromes (e.g. headaches) and has      recently been adapted to dyspareunia. In a study conducted by Glazer et al.      (1995), 33 women suffering from different types of vulvar pain underwent      sEMG biofeedback training in order to reduce the instability and      hypertonicity of their pelvic floor muscles. After an average of 16 weeks of      practice, 22 of the 28 women who were abstaining from intercourse at the      beginning of the study resumed this activity, and 52% of the women in the      entire sample reported pain free intercourse. 
 
 Along with attempts to relieve the pain via various topical applications,      gynecologists developed a surgery designed to excise the painful tissue in      the vulvar vestibule. Although still a controversial procedure,      vestibulectomy is becoming a frequently recommended surgical intervention      and has been the most investigated treatment for vulvar vestibulitis, with      over 20 retrospective studies evaluating its efficacy. Although the success      rates of this minor day surgery range from 43 - 100%, with the majority of      estimates surpassing the 60% mark, these conclusions are weakened by      multiple methodological flaws (Bergeron et al., 1997). There is thus no firm      knowledge as to whether vestibulectomy meets optimal standards of care.      Furthermore, its invasiveness may not appeal to many patients. It is      conceivable that non-invasive behavioral treatment modalities could provide      comparable outcomes without the inherent risks and disadvantages of a      surgical procedure. As such, they would represent a much needed alternative      to vestibulectomy.
 
 The purpose of the present study was thus to prospectively evaluate and      compare the differential efficacy of group cognitive-behavioral therapy (GCBT),      sEMG biofeedback, and vestibulectomy in relieving dyspareunia as well as      improving sexual function and psychological adjustment.
 
 
 


 
 Participants were 87 women suffering from vulvar vestibulitis. They were      selected from a pool of 168 women suffering from different types of      dyspareunia recruited between January and July 1996 through local media      announcements and professional referral. This study protocol was approved by      our institution's ethics review board. Participants met the following      inclusion criteria: 1) pain during intercourse which is a) subjectively      distressing, b) occurs(ed) on most intercourse attempts, and c) has lasted      for at least six months; women who stopped attempting intercourse as a      result of the pain were included if the pain could be confirmed during the      gynecological examinations (N=1); 2) pain limited to intercourse and other      activities involving vestibular pressure (e.g. bicycling); 3) moderate to      severe pain in one or more locations of the vestibule during the cotton-swab      test (cf Procedure); this was operationalized as a minimum average patient      pain rating of 4 on a scale of 0 to 10. Exclusion criteria were the      following: 1) pelvic or vulvar pain not clearly linked to intercourse; 2)      presence of one of the following: a) major medical and/or psychiatric      illness, b) active infection, and c) vaginismus; 3) ongoing treatment for      dyspareunia; 4) pregnancy; 5) age less than 18 or greater than 50.
 
 
 


 
 On the first visit, each potential participant underwent two independent      gynecological evaluations carried out according to the following      standardized protocol: 1) a urine sample was obtained; 2) a brief interview      about obstetrical/gynecological history, including painful intercourse, was      conducted by the gynecologist performing the first examination; 3) vaginal      cultures were taken for Candida, Gardnerella and Trichomonas, as well as a      Pap smear if the patient had not been tested in the past year; 4) a      cotton-swab palpation of six vestibular sites (in a clockwise fashion: at 12      o'clock, then between 12 to 3 and 3 to 6, at 6 o'clock, then between 6 to 9      and 9 to 12); this is commonly referred to as the cotton-swab test and      constitutes the main diagnostic tool for vulvar vestibulitis. Patients rated      the pain at each site on a scale of 0 (no pain) to 10 (worst pain ever); 5)      a standard gynecological examination was carried out. In addition, any other      physical findings were noted, as were the gynecologists' final diagnoses. A      structured interview and standardized questionnaires followed the      gynecological examinations. 
 
 Potential participants were asked to remain untreated and to discontinue use      of potential chemical allergens for a minimum of six weeks, at which point      they were scheduled for two additional gynecological examinations, identical      to the initial ones. The order of gynecologists carrying out the examination      at time 1 was reversed at time 2. Based on the above procedure, we found      substantial inter-rater reliability (k=0.68) for the diagnosis of vulvar      vestibulitis and moderate test-retest reliability (k=0.54) (Bergeron et al.,      manuscript submitted for publication).
 
 Participants who did not meet our selection criteria (N = 58) were referred      appropriately. Those meeting our criteria were given detailed explanations      about the three treatments by the principal investigator. Twenty-three women      met the criteria but declined participation. These 23 women were not      significantly different from the women who agreed to be randomized on any of      the sociodemographic or pretreatment variables. The remaining 87      participants having provided written consent were randomized to one of the      three treatments using blocked randomization. They were required to forego      receiving other interventions for the entire duration of the study. All      treatments were free of charge. 
 
 
 


 
 The vestibulectomy condition consisted of a minor day surgical procedure of      30 minutes performed under general anesthesia and involving the excision of      the vestibular area to a depth of 2 mm and a width of 1 cm, all the way up      to the urethra, with vaginal advancement when necessary. Participants were      randomly assigned to one of the two participating gynecologists.      Participants met with their gynecologist before surgery to receive      information regarding the procedure and six weeks postsurgery to receive      instructions concerning how to gradually resume intercourse.
 
 Biofeedback participants were randomly assigned to one of two Ph.D. level      clinical psychologists trained and supervised by H. I. Glazer, Ph.D.      Biofeedback training involved self-insertion of a small single-user sEMG      sensor into the vagina. The automated protocol consisted of the following:      1) One 60-second prebaseline rest period; 2) Six maximum intensity rapid      contractions or flicks (phasic contractions). Each contraction was preceded      by a 12-second rest period; 3) Six maximum intensity 12-second contractions      (tonic contractions). Each contraction was preceded by a 12-second rest      period; 4) One maximum intensity 60-second contraction (endurance      contraction) preceded by a 30-second rest; 5) One 60-second postbaseline      rest period. Participants received eight 45-minute sessions over a 12-week      period. This treatment also included training in the use of a portable sEMG      home trainer for daily practice sessions. Each of the two daily practice      sessions consisted of 60 repetitions of a 10-second relaxation period      alternated with a 10-second maximum contraction period. The following      biofeedback instrumentation was employed: a) a sEMG single-user vaginal      sensor (Model T6050) and a portable sEMG biofeedback instrument (U-Control      60Hz Model T8825) manufactured by Thought Technology Ltd., Montral, Canada;      b) computerized EMG data acquisition equipment consisting of the FlexiPlus      sEMG signal processing hardware and the Glazer Pelvic Floor Muscle      Rehabilitation Program, Version 2.2 (Biobehavioral Medical Rehabilitation,      Jacksonville, Florida) operating on a Pentium 166Hz laptop computer.
 
 GCBT was delivered by one of two Ph.D. level clinical psychologists in      two-hour group sessions with seven to eight women per group. Participants      received eight sessions over a 12-week period. They were randomly assigned      to either therapist taking into account the language of the group (French or      English). Therapists were trained and supervised via a treatment manual      designed specifically for this purpose by the first and second author      (Bergeron and Binik, 1998). Adherence to the treatment manual was assessed      by two independent clinical associates who viewed and coded a random sample      of videotapes representing a quarter of all entire therapy sessions, with an      inter-rater reliability of .87. Based on this coding of videotapes,      therapists adhered to the treatment manual 89.6% of the time. The treatment      package included the following: education and information about vulvar      vestibulitis and how dyspareunia impacts on desire and arousal; education      concerning a multifactorial view of pain; education about sexual anatomy;      progressive muscle relaxation; abdominal breathing; Kegel exercises; vaginal      dilatation; distraction techniques focusing on sexual imagery; rehearsal of      coping self-statements; communication skills training, and cognitive      restructuring. Such techniques aimed at reducing the fear of pain during      intercourse and other maladaptive affective and cognitive responses,      increasing sexual activity level, and reducing pain.
 
 
 


 
 With the exception of the vestibular pain index, which was part of the      gynecological examinations, the following outcome measures were administered      by an independent clinical associate at the first visit of the participant      selection process (pretreatment), at posttreatment, and at 6-month      follow-up. Data for three of the pain measures (vestibular pain index, the      Pain Rating Index and the Sensory scale of the McGill Pain Questionnaire)      were also collected at the second selection visit following the 6-week      baseline period.
 
 Pain dependent measures included: a) a vestibular pain index, derived from      the two independent gynecological examinations conducted at each assessment.      The participant pain ratings taken during the cotton-swab test at six      different points in the vulvar vestibule were averaged across the two      gynecological examinations (per assessment) to form one single index of      vestibular pain. Vestibular participant pain ratings have been found to      correlate significantly between gynecologists for each palpation site, with      correlation coefficients ranging from 0.42 to 0.64, p < .001 (Bergeron et      al., manuscript submitted for publication); b) a self-report measure of the      intensity of painful intercourse on a scale of 0 to 10, taken during the      structured interview; c) the Pain Rating Index (PRI) of the McGill Pain      Questionnaire (MPQ) (Melzack, 1975), and d) the Sensory scale of the MPQ.      For these last two measures, participants were asked to provide global      ratings of the pain they had experienced in the last three to six months,      depending on the assessment.
 
 Sexual function dependent measures included: a) the Global Sexual      Functioning score of the Sexual History Form (Nowinski and LoPiccolo, 1979),      which evaluates desire, arousal, orgasm, frequency of sexual activities, and      overall sexual satisfaction and has demonstrated good reliability and      validity (Creti et al., 1998); b) the Sexual Information scale of the      Derogatis Sexual Functioning Inventory (Derogatis and Melisaratos, 1979), a      reliable and valid measure of sexual knowledge; c) a self-report measure of      frequency of intercourse per month, taken during the structured interview.      Psychological adjustment was assessed using the Global Severity Index of the      Brief Symptom Inventory (BSI-GSI) (Derogatis, 1992), a 53-item self-report      inventory of psychological symptom patterns. 
 
 Treatment credibility was assessed at the first treatment session or during      the presurgery appointment using two questions rated on a scale of 0 (not at      all) to 10 (completely): 1) Up to what point do you think the treatment you      are receiving is logical in terms of its efficacy in alleviating vulvar      vestibulitis syndrome? and 2) How confident are you that the present      treatment will improve your pain condition? Treatment adherence for sEMG      biofeedback and GCBT was measured via frequency ratings of weekly practice      of exercises. Participant treatment evaluations involved two questions about      subjective improvement [scale of 0 (worse) to 5 (complete cure)] and      treatment satisfaction [scale of 0 (completely dissatisfied) to 10      (completely satisfied)]. These were part of the posttreatment and 6-month      follow-up structured interviews. 
 
 
 


 
 Data were analyzed using a repeated measures multivariate analysis of      variance (MANOVA) approach with time as the within-subjects variable and      treatment as the between-subjects variable. Outcome measures were clustered      per conceptual domain (treatment credibility, pain, sexual function, patient      treatment evaluations). When multivariate results were significant,      univariate analyses were conducted. If significant, these were followed by      planned contrasts or post-hoc comparisons with Bonferroni corrections. For      variables not significantly correlated with any other (psychological      adjustment), a repeated measures ANOVA approach was used. Greenhouse-Geisser      adjustment was applied to compensate for violations of homogeneity of      covariances. MANCOVA analyses on posttreatment and 6-month follow-up      measures using pretreatment measures as covariates were also conducted. We      report all the results of the MANOVAs because these analyses involve      unadjusted means; results of the MANCOVAs are reported only when they are      different from those of the MANOVAs. Results of analysis by treatment      actually received are presented first, followed by an intention to treat      analysis. Correlational and chi-square analyses were used to investigate the      relationship between between sociodemographic variables, pretreatment      dependent measures and treatment outcome on pain measures at 6-month      follow-up in order to determine relevant covariates.
 


 
 Nine women (seven assigned to      vestibulectomy, one assigned to biofeedback, and one assigned to GCBT) who      had agreed to participate dropped out of the study before receiving      treatment. They were not different from the women who completed treatment on      any of the sociodemographic or pretreatment dependent measures except for      the Global Severity Index of the Brief Symptom Inventory (t = -4.76, p <      .0001), on which they showed significantly more psychological distress. No      further data were collected concerning these women. There were significantly      more pretreatment drop-outs in the vestibulectomy condition, x2 (2, N = 87)      = 8.92, p < .01 than in the two other conditions. This higher level of      attrition for the vestibulectomy condition is consistent with clinical      practice. 
 
 In the biofeedback condition, there were two drop-outs at      the posttreatment assessment as well as eight more at the 6-month follow-up.      In the vestibulectomy condition, there were three drop-outs at the 6-month      follow-up assessment. There were significantly more 6-month follow-up      drop-outs in the biofeedback condition, x2 (2, N = 78) = 13.06, p < .001.      The 13 drop-outs were not significantly different from the women who      completed all three assessments on any of the sociodemographic or      pretreatment variables. They were included in the analyses by using      imputations for missing values (carrying values forward) and reducing the      error degrees of freedom by the number of estimated values in order to      minimize the risk of Type I error (Nich and Carroll, 1997). The final sample      size thus included the 78 participants who actually received treatment.      Detailed sociodemographic characteristics of the sample are shown in     

. There were no significant differences between treatment groups      on any of the sociodemographic or pretreatment variables. In addition, none      of the sociodemographic variables were significantly correlated with the      pretreatment dependent measures.
 
 Finally, in terms of the use of      ongoing treatments during the course of the study, five participants out of      76 (7%) reported having used other means to alleviate their pain at      post-treatment , and five participants out of 65 (8%) reported having done      so at the 6-month follow-up. Other means included mild remedies such as sitz      baths, relaxation, massage, etc. The number of participants having tried to      alleviate their pain in other ways did not differ as a function of treatment      condition at either posttreatment, x2 (2, N = 76) = .74, p = .69, or 6-month      follow-up, x2 (2, N = 65) = 3.63, p = .16.
 
 
 

3.2. Outcome:      Analysis by-treatment-received


 
 (1) Treatment credibility ratings      were high for all three groups, as shown in 

.      Results from the MANOVA indicated a significant treatment main effect, F(4,      136) = 4.41, p < .002. Univariate analyses demonstrated that GCBT      participants' ratings were significantly lower than those of the      vestibulectomy participants for logic of treatment, F(2, 69) = 4.32, p <      .02, and for confidence in treatment, F(2, 69) = 9.21, p < .0001. Planned      comparisons showed that GCBT participants' ratings were also significantly      lower than those of the biofeedback participants for confidence in      treatment, F(2, 69) = 12.05, p < .001. Correlational analyses with      Bonferroni correction revealed that logic of treatment was inversely related      to self-reported pain during intercourse at 6-month follow-up, r = -.35, p <      .01. No other relationship was found between treatment credibility and other      dependent measures. We nonetheless conducted a separate set of outcome      analyses using logic of treatment as a covariate. Results of these analyses      are reported only when they differ from the results of the regular set of      analyses.
 
 (2) Treatment adherence was defined as complying with at      least 70% of the homework exercises. Based on this definition, 65% of GCBT      participants complied with treatment, as compared to 57% of biofeedback      participants. Chi-square analyses revealed no significant difference in      adherence between treatment conditions. For the biofeedback and the GCBT      groups either analyzed separately or collapsed together, there were no      significant correlations between degree of adherence to treatment and      6-month follow-up pain measures. 
 
 (3) The means and standard      deviations for the pain and sexual function measures, the BSI-GSI, and the      participant evaluations by treatment and time of assessment are shown in     

. There were no significant differences      between the pretreatment measures and those taken immediately after the      6-week baseline period for the vestibular pain index, the PRI and the      Sensory scale of the MPQ.
 
 (4) Results from the MANOVA conducted on      the pain measures indicated a significant time main effect, F(8, 68) =      18.44, p < .01 and a significant time X treatment interaction, F(16, 136) =      3.26, p < .01. Univariate analyses indicated the following: 1) For the      vestibular pain index, there was a significant time main effect, F(2, 74) =      53.68, p < .01, a significant treatment main effect, F(2, 75) = 6.24, p <      .01, and a significant time X treatment interaction effect, F(4, 148) =      13.24, p < .01. Analysis of simple effects and planned comparisons revealed      that at posttreatment, vestibulectomy participants had significantly lower      pain levels than both GCBT, F(2, 75) = 17.75, p < .01, and biofeedback      participants, F (2, 75) = 20.60, p < .01. The same pattern held true at the      6-month follow-up, F(2, 75) = 7.72, p < .01, and F(2, 75) = 8.99, p < .01.      Participants from all three treatments improved significantly from      pretreatment to 6-month follow-up: vestibulectomy, F(2, 74) = 59.66, p <      .01, biofeedback, F(2, 74) = 6.59, p < .01, and GCBT, F(2, 74) = 10.26, p <      .01. Planned comparisons showed that both vestibulectomy, F(2, 74) = 9.86, p      < .01 and biofeedback, F(2, 74) = 99.95, p < .01 participants significantly      improved from pre- to posttreatment. 2) For the self-reported pain intensity      during intercourse, there was a significant time main effect, F(2, 74) =      45.93, p < .01. Post-hoc analyses revealed that participants significantly      improved from pre- to posttreatment, F( 2, 74) = 45.45, p < .01, and from      posttreatment to 6-month follow-up, F(2, 74) = 11.71, p < .01. MANCOVA      analyses yielded the following: a treatment main effect was found, F(2, 74)      = 3.74, p < .05, indicating that for posttreatment and 6-month follow-up      taken together, vestibulectomy participants were significantly more improved      than those from GCBT. Planned comparisons indicated that they were also      significantly more improved than those from biofeeback, F(2, 74) = 5.17, p <      .01. 3) For the MPQ-PRI, there was a significant time main effect, F(2, 74)      = 12.22, p < .01. Post-hoc analyses revealed that participants significantly      improved from pre- to posttreatment, F(2, 74) = 6.66, p < .01, and from      posttreatment to 6-month follow-up, F(2, 74) = 11.09, p < .01. 4) For the      Sensory scale of the MPQ, there was a significant time main effect, F(2, 74)      = 9.77, p < .01. Post-hoc analyses demonstrated that participants      significantly improved from pre- to posttreatment, F(2, 74) = 6.17, p < .01,      and from posttreatment to 6-month follow-up, F(2, 74) = 8.20, p < .01.      MANCOVA analyses yielded the following: a treatment main effect was found,      F(2, 74) = 3.79, p < .05, indicating that for posttreatment and 6-month      follow-up taken together, vestibulectomy participants were significantly      more improved than those from GCBT. Planned comparisons indicated that they      were also significantly more improved than those from biofeeback, F(2, 74) =      4.23, p < .05. Average percentages of pain reduction by dependent measure      and treatment condition are shown in 

.
 
 (5) Results from the MANOVA conducted on sexual function measures indicated      a time main effect, F(8, 68) = 4.00, p < .01, but no interaction effect.      Univariate analyses indicated the following: 1) For the Sexual History Form,      there was a significant time main effect, F(2, 74) = 5.60, p < .01. Planned      comparisons demonstrated that participants significantly improved from      posttreatment to 6-month follow-up, F(2, 74) = 10.53, p < .01. The mean for      normal women aged 21-46 is .46 (Creti et al., 1998). 2) For the Information      subscale of the DSFI, there was a significant time main effect, F(2, 74) =      3.91, p < .05. Planned comparisons revealed that participants significantly      improved from pre- to posttreatment, F(2, 74) = 4.63, p < .05. However, this      effect did not hold when logic of treatment was used as a covariate, F(2,      68) = 2.70, p = .07. Means at all three assessment times are above the mean      for female non-patient normals (21.31) (Derogatis and Melisaratos, 1979). 3)      For frequency of intercourse, there was a significant time main effect, F(2,      74) = 10.80, p < .01, showing that participants significantly improved from      posttreatment to 6-month follow-up. Planned comparisons did not demonstrate      a significant difference between pretreatment and 6-month follow-up. When      logic of treatment was used as a covariate, results also yielded a      significant time X treatment interaction effect, F(4, 136) = 3.68, p < .01.      Analysis of simple effects revealed that vestibulectomy participants      significantly improved from posttreatment to 6-month follow-up, F(2, 68) =      13.25, p < .01. Means at all three assessment times are below the mean      frequency of intercourse for women aged 25-29 (7.5 times/month) (Laumann et      al., 1994). Results from the ANOVA conducted on the BSI-GSI indicated a time      main effect, F(2, 74) = 7.29, p < .01. Planned comparisons revealed that      participants displayed significantly better psychological adjustment at      post- as compared to pretreatment, F(2, 74) = 6.72, p < .01. Means at all      three assessments are below the clinical cut-off point (T-score = 63) (Derogatis      and Melisaratos, 1983). 
 
 (6) Results from the MANOVA conducted on      participant evaluations indicated a significant time X treatment      interaction, F(4, 144) = 3.85, p < .01. Univariate analyses indicated the      following: 1) For subjective improvement, there was a significant time main      effect, F(1, 73) = 4.96, p < .05, showing that participants reported a      significant improvement from posttreatment to 6-month follow-up. However,      this effect did not hold when logic of treatment was used as a covariate,      F(1, 67) = 3.61, p = .06. 2) For treatment satisfaction, there was a      significant time X treatment interaction, F(2, 73) = 4.55, p < .05. Analyses      of simple effects revealed that biofeedback participants were significantly      less satisfied at 6-month follow-up as compared to posttreatment, F(1, 73) =      6.57, p < .05, and that they were significantly less satisfied than      vestibulectomy participants at 6-month follow-up, F(2, 73) = 4.18, p < .05.      Planned comparisons indicated that they were also significantly less      satisfied than GCBT participants at 6-month follow-up, F(2, 73) = 4.17, p <      .05. 
 
 (7) Treatment success was defined as self-reported great      improvement or complete relief of pain on the subjective improvement measure      of the participant treatment evaluations (4 or 5 on a scale of 0 to 5). At      6-month follow-up, 68.2% of vestibulectomy participants, 34.6% of      biofeedback participants, and 39.3% of GCBT participants can be said to have      a successful outcome. However, 9.1% of vestibulectomy participants (N = 2)      reported being worse at posttreatment as compared to pretreatment. These two      participants' subjective impression was confirmed by all their pain measures      except the vestibular pain index, which showed no change.
 
 
 

3.3.      Outcome: Intent-to-treat analysis      


 
 (1) Intent-to-treat analysis was conducted by using imputations      for missing values (carrying values forward) of the nine pre-treatment      drop-out participants. Results from the MANOVA conducted on the pain      measures indicated a significant time main effect, F(8, 77) = 12.06, p < .01      and a significant time X treatment interaction, F(16, 154) = 2.10, p < .01.      Univariate analyses indicated the following: 1) For the vestibular pain      index, there was a significant time main effect, F(2, 83) = 34.66, p < .01,      a significant treatment main effect, F(2, 84) = 3.72, p < .05, and a      significant time X treatment interaction effect, F(4, 166) = 8.06, p < .01.      Analysis of simple effects and planned comparisons revealed that at      posttreatment, vestibulectomy participants had significantly lower pain      levels than both GCBT, F(2, 84) = 10.73, p < .01, and biofeedback      participants, F (2, 84) = 10.59, p < .01. At the 6-month follow-up,      vestibulectomy participants had significantly lower pain levels than      biofeedback participants only, F(2, 84) = 4.10, p < .05. Participants from      all three treatments improved significantly from pretreatment to 6-month      follow-up: vestibulectomy, F(2, 83) = 36.32, p < .01, biofeedback, F(2, 83)      = 5.13, p < .01, and GCBT, F(2, 83) = 10.19, p < .01. 2) For the      self-reported pain intensity during intercourse, there was a significant      time main effect, F(2, 83) = 37.89, p < .01, indicating that participants as      a whole improved from pre-treatment to 6-month follow-up. 3) For the MPQ-PRI,      there was a significant time main effect, F(2, 83) = 12.55, p < .01,      indicating that participants as a whole improved from pre-treatment to      6-month follow-up. 4) For the Sensory scale of the MPQ, there was a      significant time main effect, F(2, 83) = 9.59, p < .01, indicating that      participants as a whole improved from pre-treatment to 6-month follow-up.     
 
 Results from the MANOVA conducted on sexual function measures      indicated a time main effect, F(6, 79) = 4.05, p < .01, but no interaction      effect. Univariate analyses indicated the following: 1) For the Sexual      History Form, there was a significant time main effect, F(2, 83) = 5.19, p <      .01, indicating that participants improved from pre-treatment to 6-month      follow-up. 2) For the Information subscale of the DSFI, there was a      significant time main effect, F(2, 83) = 3.90, p < .05, indicating that      participants improved from pre-treatment to 6-month follow-up. 3) For      frequency of intercourse, there was a significant time main effect, F(2, 83)      = 7.89, p < .01, showing that participants improved from posttreatment to      6-month follow-up. Results from the ANOVA conducted on the BSI-GSI revealed      a significant time main effect, F(2, 83) = 7.46, p < .01, indicating that      participants displayed better psychological adjustment at 6-month follow-up      as compared to pretreatment.
 
 
 


 
 Four      main conclusions can be drawn from the results of this study: 1) there are      potentially efficacious medical and psychosocial treatments for vulvar      vestibulitis; 2) based on results of the intent-to-treat analysis for the      vestibular pain index measure, vestibulectomy is significantly more      successful than sEMG biofeeback; 3) the three treatments provide equally      positive sexual function and psychological adjustment outcomes; 4) gains are      maintained at 6-month follow-up for participants in all treatment      conditions.
 
 However, these results need to be interpreted with      caution since there were significantly more participants in the      vestibulectomy condition who refused to undergo the treatment they had been      randomized to, as compared to participants in the two other treatment      conditions. Such differential failure to accept randomization clouds      interpretation of the data. Indeed, the final sample of women who received      vestibulectomy may have been biased in favor of this procedure and thus may      not be representative of the population of women with vulvar vestibulitis      encountered in clinical settings. We have attempted to correct this problem      by conducting an a posteriori intent-to-treat analysis which included the      vestibulectomy pre-treatment drop-outs; this analysis confirmed the general      pattern of results found with analysis by-treatment-received. One of the      functions of an intent-to-treat strategy is to preserve the comparability of      groups allowed by randomization (Newell, 1992).
 
 Differential      treatment credibility constitutes yet another factor which complicates      interpretation of the findings. Considering that participants were      significantly less confident in the efficacy of GCBT as compared to      vestibulectomy and biofeedback, one can question whether this study      represents a fair comparison of treatments, especially when evaluating      interventions as disparate as CBT and surgery. We have tried to limit the      impact of this problem by conducting additional analyses using the two      treatment credibility items as covariates. Results of these analyses      cancelled the effects of two variables, namely sexual knowledge (the      Information subscale of the DSFI) and subjective improvement from      posttreatment to 6-month follow-up. Future research comparing interventions      with different underlying mechanisms will need to examine more thoroughly      the issue of treatment credibility.
 
 Findings of the present study      cannot be easily accounted for by a placebo or attention effect for the      following reasons: 1) important differential treatment effects were found;      2) there were no significant changes in pain during the 6-week baseline      period, despite multiple gynecological examinations, an extensive      psychosexual evaluation, and the expectation of entering a treatment study;      3) GCBT participants did not experience a significant change in pain on the      vestibular pain index from pre- to posttreatment, even though this was the      treatment condition in which the women received the most clinical attention.      It is impossible however to totally discount the possibility of a placebo      effect since credible placebo controls in non-pharmacological studies are      difficult if not almost impossible to design (Turner et al., 1994; Schwartz      et al., 1997). In addition, findings do not apear to be a reflection of the      mere passage of time since the mean duration of vulvar vestibulitis prior to      study entry was close to five years and 39% of women reported trying a      number of different medical treatments before entering the study.      Nonetheless, only a wait-list control group equal in duration to the length      of treatment and follow-up could allow us to discount a passage of time      interpretation. However, such a design often increases drop-out rates      considerably (e.g. Peters and Large, 1990).
 
 Results of this study      show that vestibulectomy participants had significantly lower levels of pain      on the vestibular pain index than participants from the GCBT and biofeedback      conditions at posttreatment, and than participants from the biofeedback      condition at 6-month follow-up. When posttreatment and 6-month follow-up      assessments were taken together in the analysis by-treatment-received,      vestibulectomy participants also had significantly lower levels of pain      during intercourse and lower MPQ Sensory scores. Moreover, vestibulectomy is      characterized by a high success rate and by elevated percentages of pain      reduction (from 46.8% to 70.0%). This successful outcome needs nonetheless      to be considered within a larger perspective. Two out of 22 surgery      participants reported being worse after the intervention, and seven women      who had initially been randomized to vestibulectomy refused to go ahead with      the treatment. This high pretreatment drop-out rate suggests that a      significant percentage of women are reticent to undergo such an invasive      procedure. Moreover, adequate evaluation of vestibulectomy was limited by      the absence of systematic follow-up of pretreatment drop-outs and thus an      intent-to-treat analysis conducted on estimated rather than collected data.
 
 Average decreases in pain for GCBT participants are encouraging in light of      findings from a meta-analysis conducted by Flor et al. (1992), showing that      the average reduction in pain intensity for multidisciplinary pain clinic      patients across 65 studies was 37%. In addition, no participants dropped-out      of GCBT once the treatment had begun. GCBT may reduce anxiety by giving      participants more control over their pain and by changing the meaning of the      situation for them, thereby affecting cognitive and emotional factors. The      group aspect of the treatment may produce change in social expectations by      normalizing dyspareunia for participants. The significantly lower initial      treatment credibility of GCBT may have affected outcome; the negative      correlation between the logic of treatment and self-reported pain during      intercourse at 6-month follow-up supports this hypothesis. Such findings      highlight the need to improve the presentation of psychological pain      treatments to patients (Turk and Rudy, 1990). 
 
 Success rate as well      as decreases in pain for biofeedback participants are somewhat lower than      those reported in the first published retrospective study of biofeedback      (Glazer et al., 1995). This might be linked to the way the treatment was      delivered in this study as opposed to the Glazer et al. (1995) study, in      which participants were 1) thought to be 100% compliant with homework      exercises, 2) suffering from various types of vulvar pain as opposed to only      vulvar vestibulitis, 3) receiving other concomittant treatments.      Furthermore, the two therapists delivering the treatment in the present      study were less experienced than the therapist in the original Glazer et al.      (1995) study. The significantly higher 6-month follow-up drop-out rate and      the significantly lower satisfaction rate in the biofeedback show that a      substantial number of participants experienced difficulties in following      through with this intervention. This appears to be independent of the      outcome because participants in the GCBT did not drop-out and had similar      outcomes. It is possible that the large time investment and the repetitive      exercises may be responsible for this negative effect. 
 
 All three treatments have an equally positive effect on sexual      functioning and psychological adjustment. The finding that women assigned to      GCBT do not improve their sexual functioning significantly more than the      others remains puzzling. This may be due to the fact that improved sexual      function is dependent on the degree of pain that one experiences. However,      the results also show that a significant reduction in pain, as found in the      vestibulectomy condition, does not necessarily bring about increased      frequency of intercourse or better overall sexual functioning. These      conflicting results suggest that multimodal treatment approaches may be      essential to achieve significant improvement in all aspects of the disorder      (Bergeron et al., 1997)
 
 Indeed, medical and psychosocial treatments      are not mutually exclusive and can be combined in an effort to provide women      suffering from dyspareunia with the best possible outcomes. Within a      multidisciplinary framework, GCBT and sEMG biofeedback represent promising      alternatives to vestibulectomy because they do not involve significant      physical risks. Future studies should consider combining behavioral      interventions to evaluate whether their effects are additive and can equal      those of vestibulectomy. 
 
 
 


 This article stands in partial fulfillment of Ms. Bergeron's PhD      requirements. The initial sample of women from which we recruited      participants for this study was also used to conduct a reliability study on      the diagnosis of vulvar vestibulitis syndrome (manuscript submitted for      publication). This research was supported by a Social Sciences and      Humanities Research Council of Canada Fellowship to S. Bergeron and by a      Health Canada (NHRDP 6605-4381-503) research grant to Y. M. Binik. We thank      Maria Amore, Genevive Bdard, Janet Bradley, Patricia Costantino, Dina      Giannopoulos, Louise Labelle, Terry Peled, Caroline Pukall, Dionne Rodrigues,      and Vivienne Zhao for their help in conducting this study. 

Note. sEMG = surface electromyographic; GCBT = group cognitive-behavioral      therapy.
 
 
 
 


 
 Variable Vestibulectomy sEMG Biofeedback GCBT


 
 Logic 
 
 
 
 M 8.31 8.14 7.32 
 
 
 
 SD 1.40 1.30 1.12      
 
 Confidence
 
 
 
 M 8.31 7.96 6.68 
 
 
 
 SD 1.49 1.35 1.36


 
 Pretreatment Posttreatment 6-month follow-up


 
 Pain
 
 Vestibular pain index 
 
 Vestibulectomy 6.34 1.85 1.89 1.68 1.90 2.24
 
 sEMG Biofeedback 5.79 1.59 4.55 2.36 4.42 2.63
 
 GCBT 5.45 1.88 5.26 2.00 3.89 2.09
 
 Pain intensity during intercourse
 
 Vestibulectomy 7.18 1.62 3.93 3.25 3.41 3.17
 
 sEMG Biofeedback 6.93 1.80 5.43 2.36 4.50 2.63
 
 GCBT 7.14 1.53 6.00 2.13 4.46 2.47
 
 MPQ-PRI
 
 Vestibulectomy 26.82 14.68 15.86 16.18 14.27 13.06
 
 sEMG Biofeedback 26.46 15.99 23.79 17.23 20.43 18.10
 
 GCBT 28.93 12.29 27.75 15.09 20.93 14.18
 
 MPQ-Sensory scale
 
 Vestibulectomy 17.86 8.40 10.82 9.74 9.45 8.19
 
 sEMG Biofeedback 17.07 8.34 15.57 10.18 13.82 10.66
 
 GCBT 18.61 7.28 18.68 8.69 14.75 8.87
 
 Sexual Function
 
 Sexual History Form
 
 Vestibulectomy 0.47 0.11 0.49 0.14 0.45 0.15
 
 sEMG Biofeedback 0.51 0.11 0.51 0.08 0.48 0.08
 
 GCBT 0.51 0.13 0.49 0.12 0.48 0.11
 
 Frequency of intercourse
 
 Vestibulectomy 4.61 4.30 1.44 2.85 5.74 5.47
 
 sEMG Biofeedback 3.38 2.91 3.43 3.04 4.04 4.56
 
 GCBT 3.69 3.22 3.25 3.84 3.92 3.77
 
 DSFI, Information subscale
 
 Vestibulectomy 21.68 1.91 22.41 1.74 22.46 1.90 sEMG Biofeedback 21.46 2.33      22.18 1.61 22.36 1.81
 
 GCBT 21.82 2.31 21.75 2.15 22.25 1.84
 
 Psychological Adjustment
 
 BSI-GSI
 
 Vestibulectomy 53.32 9.62 52.00 8.25 50.09 10.49
 
 sEMG Biofeedback 54.11 8.78 51.29 8.93 50.79 9.39
 
 GCBT 56.36 8.11 52.89 7.21 51.79 7.61
 
 Participant evaluations
 
 Satisfaction
 
 Vestibulectomy - 7.11 2.85 7.73 2.69
 
 sEMG Biofeedback - 6.54 2.55 5.62 3.03
 
 GCBT - 6.91 1.42 7.07 2.09
 
 Improvement
 
 Vestibulectomy - 3.27 1.49 3.32 1.46
 
 sEMG Biofeedback - 2.46 1.24 2.69 1.46
 
 GCBT - 2.43 1.07 3.00 1.09

Note. GCBT = group cognitive-behavioral therapy; sEMG = surface      electromyographic; MPQ-PRI = McGill Pain Questionnaire - Pain Rating Index;      DSFI = Derogatis Sexual Functioning Inventory; BSI-GSI = Brief Symptom      Inventory - Global Severity Index.
 
 
 
 
 

Variable Vestibulectomy sEMG Biofeedback GCBT

Vestibular pain index 70.0 23.7 28.6
 
 Pain intensity 52.5 35.0 37.5
 
 during intercourse
 
 MPQ-PRI 46.8 22.8 27.7
 
 MPQ-Sensory scale 47.1 19.0 20.7

Note. sEMG = surface electromyographic; GCBT = group cognitive-behavioral      therapy.

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A Randomized Comparison of Group Cognitive-behavioral Therapy, Surface Electromyographic Biofeedback, andVestibulectomy in the Treatment of Dyspareunia Resulting from Vulvar Vestibulitis

Author | Samir Khalife, MD

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