In this section of the website we report on published research and make out own comments on what is reported. For more information on the studies published see http://www.ncbi.nlm.nih.gov/pubmed. We felt that it would be important for women to learn about current research as a means of opening up treatment options. At the moment there is a big gap between research that is reported and options that filter down to the patient.
TREATMENT OF VULVODYNIA
Self-management, amitriptyline, and amitriptyline plus triamcinolone in the
management of vulvodynia.
J Womens Health (Larchmt). 2009 Feb;18(2):163-9.
Brown CS, Wan J, Bachmann G, Rosen R.
OBJECTIVE: To conduct a prospective study to determine the efficacy of self-management interventions, amitriptyline, and amitriptyline plus topical triamcinolone in reducing vulval pain in women with vulvodynia.
METHODS: This was a randomized, prospective study of 53 women between the ages of 18 and 72 with vulvodynia. Participants undertook one of three treatment interventions for a period of 12 weeks: self-management, oral amitriptyline (10-20 mg/day), or opical triamcinolone plus oral amitriptyline (10-20 mg/day). The McGill Pain questionnaire (MPQ) was used to measure changes in qualitative pain using the ain rating index (PRI) and in quantitative pain using the present pain intensity PPI) scale. RESULTS: Of the 53 randomized subjects, 43 completed the trial. There were no statistically significant differences in PRI or PPI scores among the three treatment groups. Significant within-group differences were observed in the self-management group on the PRI and in the amitriptyline group on the PPI.
CONCLUSIONS: This first randomized, prospective trial suggests that self-management has a modest effect and that low-dose amitriptyline (with and
without topical triamcinolone) is not effective in reducing pain in women with
Comments on study
This is the best type of research to be carried out in medicine - a randomised trial when a coin it tossed and the individual gets treatment A or B (or in this case A,B, or C) It eliminates bias on the part of the doctor and the patient. This type of research is sadly lacking in vulval disease, although randomised trials can be difficult to setup e.g. researching the benefit of the Oxalate diet would be difficult because how can you control for a diet?. The McGill pain questionnaire is a method of objectively assessing pain in patients and is useful to compare groups as it gives a score.
Outcome of study
This study suggests that there is no difference in outcome between self-management, amitryptyline tablets and amitryptyline and triamcinolnone (which is a steroid ointment applied to the vulva). Negative studies are worth reporting in the medical literature but are less frequently so than positive ones so it is interesting to note no difference with the treatments the authors have suggested. General clinical practice in the UK is to try a drug such as amitryptyline as an initial treatment in those women with unprovoked vulvodynia and there is much literature to suggest it does works. This study suggests that the benefits might not be as great as we can expect. For further information on the drug treatment of vulvodynia see **. Topical steroids do not seem to benefit patients with unprovoked vulvodynia and in general are not prescribed such drugs as the pain is neuropathic (from the nerve endings) and there is a risk of skin irritancy from the use of creams on the skin that can make symptoms worse
For Unprovoked vulvodynia self management (i.e. education, good skin care, and pain killers) is recommended. Drugs such as the tricyclic antidepressants e.g. amitryptyline or Nortryptyline (the latter has fewer side-effects) can be discussed with your doctor, however, we feel is the best way to tackle the chronic pain is to combine all the treatments and remain holistic!
Topical gabapentin in the treatment of localized and generalized vulvodynia.
Obstet Gynecol. 2008 Sep;112(3):579-85.
Boardman LA, Cooper AS, Blais LR, Raker CA.
Department of Obstetrics and Gynecology, Women and Infants' Hospital of Rhode
OBJECTIVE: To evaluate the clinical efficacy and tolerability of topical gabapentin in the treatment of women with vulvodynia.
METHODS: A retrospective study was designed to ascertain clinical responses to topical gabapentin. Patient demographic and medical characteristics, including present and prior treatment for vulvodynia, were routinely collected. The final outcome was defined by a comparison between pretreatment and posttreatment mean pain scores based on a discrete visual analog scale of 0 to 10. Categorical data were compared by Fisher exact test, continuous variables between groups by the Wilcoxon rank sum test, and mean change in pain score between pretreatment and posttreatment by paired Student t test
RESULTS: Between January 2001 and December 2006, 51 women with vulvodynia (19 or 37% with generalized vulvodynia, 32 or 63% with localized) were treated with 2% to 6% gabapentin. After a minimum of 8 weeks of therapy, the mean pain score among the 35 evaluable women was significantly reduced from 7.26 to 2.49 (mean change -4.77, 95% confidence interval -5.47 to -4.07). Overall, 28 of 35 (80%) demonstrated at least a 50% improvement in pain scores. Among patients with localized vulvodynia, sexual function improved in 17 of 20 with evaluable results (6 of 9 reinstituted vaginal intercourse, whereas all 11 patients experiencing decreased frequency of intercourse reported increased frequency after treatment). Discontinuations occurred in 7 of 50 (14%) treated.
CONCLUSION: Topical gabapentin seems to be well-tolerated and associated with significant pain relief in women with vulvodynia.
LEVEL OF EVIDENCE: III.
Comments on study
This study was retrospective ie the data was collected sometime after the treatment had finished. This does make the data slightly weaker than if the data was collected prospectively (the recall of the pros and cons of treatment is better this way). The benefits of treatment were measure using a visual analogue score which is a well tested method of assessing pain objectively (0/10 is no pain and 10/10 is the worse pain ever). Many pain clinics use this technique to objectively assess pain levels as well as asking the patient ‘how much pain do you have?' which is more subjective. The treatment is novel. Gabapentin is a second line drug treatment for chronic unprovoked pain (not just vulval pain). Is it usually tried when patients do not respond to drugs such as the tri-cyclic antidepressants. It is usually given in tablet form and this study is a first as it is used as a cream which might potentially avoid the side-effects of a tablet preparation.
Outcome of study
80% of the women at follow-up had reported an improvement of greater than 50% which is very encouraging. Many women also resumed sexual intercourse. It is not clear what the side-effects of treatment were, however, as cream can irritate vulval skin and 14% of patients discontinued treatment.
This was an American study and is worthy of a similar trial in the UK to see if such good results can be reproduced. Gabapentin cream is not routinely available in the UK and it is not clear to us at the VPS if the drug can be made up. It is also not clear also whether it is worth trying it if you have failed on tablet-form of Gabapentin. You might need to discuss this with your doctor (who will then need to discuss it with a pharmacist)
Provoked pain (sexual pain)
The use of Amielle vaginal trainers as adjuvant in the treatment of vestibulodynia: an observational multicentre study.
Medscape J Med. 2008 Jan 30;10(1):23.
Murina F, Bernorio R, Palmiotto R.
OBJECTIVE: To assess the effectiveness of a specific set of vaginal dilators (Amielle Comfort) as a part of vestibulodynia therapy.
STUDY DESIGN: Fifteen women referred for vestibulodynia, localized vulvodynia, were advised to use vaginal dilators (Amielle Comfort) accompanied by standardized instructions, after previously receiving 1 or more therapies for the vestibulodynia.
RESULTS: The post-treatment Marinoff scale for dyspareunia significantly improved in patients after vaginal dilator treatment compared with baseline values (2.2 +/- 0.4 vs 1.1 +/- 0.9; P < .01), and the Female Sexual Function Index scores were significantly improved compared with the prestudy values (16.3 +/- 5.5 vs 25.3 +/- 7.5; P < .01). CONCLUSION: Among women with previous therapy for vestibulodynia, vaginal dilator use was associated with improvement in symptoms. Vaginal dilators can play an important role in overcoming pelvic floor muscular responses that remain and sometimes increase after pain perception has decreased.
Comments on study
Women with vestibulodynia have touch sensitive areas on the vulva (see**). This phenomenon is called allodynia when the sensation of touch/pressure is felt as pain. We are not quite sure why this happens, but it can produce sexual pain and pain with the use of tampons. For some women understandably, there is a fear of touching the vulval area - a phobia, which can leas to sexual avoidance , so when sex is finally attempted there can be vaginismus (or involuntary contraction of the vaginal muscles) which leads to more pain. There has been a change in focus on vestibulodynia treatment to encourage women to touch and massage the vulval area. This is called desensitization and can help reduce the allodynia problem and increase confidence of having penetrative sex. The use of the vaginal trainers (of which Amielle is one make) can also help (see ** for more info on vaginal trainers). These pieces of plastic can be introduced into the vagina to help relax the pelvic floor muscles and allow the woman to feel more comfortable with an object in the vagina other than a penis. Relaxation is the key!
Outcome of study
The trial simply uses these trainers and assesses their benefit with standardized questionnaires before and after treatment. They do seem to help some of the women.
This is a simple trial and something that women with vestibulodynia can try themselves as the trainers can be bought over the counter (a simple vibrator might be tried in its place). See the sheet on densitisation which also includes instructions on pelvic floor exercises which can help. It is worth noting that this treatment can take time to work and needs investment and perseverance - it may take several months for the benefit to become apparent.
Influence of dietary oxalates on the risk of adult-onset vulvodynia.
J Reprod Med. 2008 Mar;53(3):171-8.
Harlow BL, Abenhaim HA, Vitonis AF, Harnack L.
OBJECTIVE: To examine the relationship between dietary oxalates and the development of vulvodynia.
STUDY DESIGN: We conducted a population-based, case-control study of women with and without vulvodynia from 9 ethnically diverse Boston-area communities. Conditional logistic regression analyses were used to estimate the odds of developing vulvodynia as a consequence of self-reported consumption patterns of high-oxalate foods and total weekly dietary oxalate. Oxalate consumption was referenced prior to the onset of symptoms in cases and to a matched reference date among controls.
RESULTS: Baseline clinical characteristics were similar among the 242 cases and 242 controls except for a higher reported incidence of pain/difficulty with first tampon insertion among cases (46.3% vs. 32.2%, p < 0.01). After adjusting for potential confounders, no differences were observed in consumption patterns of different high-oxalate foods between cases and controls, and there was no increase in risk of developing vulvodynia with increasing tertiles of estimated oxalate intake. In addition, we saw no association between increasing consumption of various food items high in oxalate content and the risk of vulvodynia. CONCLUSION: Dietary oxalate consumption does not appear to be associated with an elevated risk of vulvodynia.
Comments on study
Can dietary factors influence vulval pain levels? Possibly. Our own survey of women with vulval pain from 1998 suggested that in around one third of women with vulval pain can be aggravated by certain foods (commonly yeast product, sugary products and alcohol) however, this was a questionnaire survey and was limited in its conclusions. It is not clear what in the diet can cause or aggravate vulval pain but there is certainly a link. The oxalate theory for pain is covered on * from the website. Initial medical reports were very promising with some women reporting relief of symptoms with a low oxalate diet and calcium citrate supplements (the latter to help clear the oxalates from the body), however, subsequent studies (including this one) fail to make the link.
Outcome of study
This study reports no difference in the dietary habits between women with vulvodynia and controls, suggesting that oxalates might not be responsible for the development of symptoms. This was a population based study however and does not take into account the benefits to the individual women.
More research is needed in this area. Dietary factors might not be responsible for the development of symptoms, but we can draw no conclusions from this study for women with vulvodynia on how diet can influence the level of day to day pain. We would not discount the diet - vulvodynia connection , but would encourage you to explore this area for yourself.
J Reprod Med. 2008 Jun;53(6):435-40.
Is modified vestibulectomy for localized provoked vulvodynia an effective
long-term treatment? A follow-up study.
Eva LJ, Narain S, Orakwue CO, Luesley DM.
OBJECTIVE: To determine whether vestibulectomy is an effective long-term treatment and investigate the levels of patient satisfaction in women with
localized provoked vulvodynia, and to provide long-term follow-up data from a cohort of women whose short-term success rates have been published previously.
STUDY DESIGN: A retrospective case note review of 110 women with localized provoked vulvodynia and follow-up patient questionnaire. Patients were asked to quantify their pain scores before surgery, at 2 months after surgery and 1 year after surgery and score their satisfaction levels.
RESULTS: Mean pain scores continued to improve throughout the first postoperative year. The mean score was 9.17 preoperatively, 5.24 at 2 months after surgery and 2.48 at 1 year after surgery. Eighty-three percent of patients would recommend the procedure as effective treatment of localized provoked vulvodynia. The overall mean satisfaction score was 7.96, and long-term success appears to be reflected by short-term results.
CONCLUSION: Vestibulectomy is an effective long-term treatment for women with provoked localized vulvodynia; the procedure is associated with high levels of patient satisfaction and low complication rates. Shortterm success appears to be a good indicator of long-term improvement, and improvement continues throughout the first postoperative year.
Comments on study
Vestibulectomy is the surgical removal of skin from the vestibule (inner labia) for women with sexual pain (vestibulodynia). We have covered the procedure in more detail on page** of the website. It has always been a controversial treatment as to many doctors and patients it seems a drastic step. Anecdotally there were concerns over the long term benefits of the procedure and whether the procedure made patients worse. This study aims to address the benefit to patients up to one year after the procedure which is a good length of time to assess success of treatment. It is not a prospective study in that it is depending on patient recall of their symptoms.
Outcome of study
The results are encouraging with many women satisfied up to one year post surgery.
It is difficult to suggest that surgery is of benefit to all women with vestibulodynia as this was a well-selected group of women with vulval pain. Some women who might have refused surgery and we have no comment on those women. Did they get better with physical treatment e.g. massage and trainers? If surgery has been offered to you by your doctors then the paper does suggest that it has some long-term benefits. Surgery should not be offered to women with unprovoked pain as this is unlikely to benefit.Can a vaginal TENS machine (transcutaneous nerve stimulator) help for women with vestibulodynia (sex related pain)?
British Journal of Obstetrics and Gynaecology. 2008 Aug;115(9):1165-70.
Transcutaneous electrical nerve stimulation to treat vestibulodynia: a randomised controlled trial.
Murina F, Bianco V, Radici G, Felice R, Di Martino M, Nicolini U.
OBJECTIVE: To assess the benefits of transcutaneous electrical nerve stimulation (TENS) in the treatment of vestibulodynia. DESIGN: Double-arm randomised placebo-controlled trial.
SETTING: An outpatient department for vulval disease.
POPULATION: Forty women with vestibulodynia, a vestibular discomfort mostly reported as a burning pain, occurring in the absence of relevant visible findings or a specific, clinically identifiable, neurological disorder.
METHODS: Twice a week active TENS or sham treatment were delivered through a vaginal probe via a calibrated dual channel YSY-EST device. Women of both groups underwent 20 treatment sessions.
MAIN OUTCOME MEASURES: Visual analogue scale (VAS), the short form of the McGill-Melzack Pain Questionnaire (SF-MPQ), the Marinoff Scale for dyspareunia and the Female Sexual Function Index questionnaire (FSFI) were assessed at baseline, at the end of treatment and at follow up 3 months after the end of treatment. RESULTS: The VAS and SF-MPQ scores (6.2 +/- 1.9 and 19.5 +/- 11.9 before treatment, respectively) improved significantly in the active TENS
group (2.1 +/- 2.7, P= 0.004 and 8.5 +/- 10.7, P= 0.001, respectively), but not in the placebo group. The Marinoff dyspareunia scale and the FSFI also showed a significant improvement.
CONCLUSIONS: TENS is a simple, effective and safe short-term (3 months) treatment for the management of vestibulodynia.
Comments on study
A TENS machine is a well established, safe means of alleviating chronic pain. Many systems are available to buy over-the-counter and are they are commonly used for back pain. The system usually involves a series of pads that are attached by wires to a machine which provides a source of electrical stimulation. The exact mechanism of how the TENS machine works is not known. In the skin there are many different types of nerve fibres which are used for specific functions. Motor nerves come from the central nervous system (brain and spinal cord) and have an action to perform e.g. contracting muscles. Whereas sensory nerves reports information to the brain such as sensations, sight, smell etc. In the skin there are several different types of nerves - C fibre activation sends the sensation of pain to the brain whereas A fibre activation send the sensation of touch, pressure our temperature. Electrical stimulation from a TENS machine at a certain setting would activate the A fibres and for reasons unclear would inactivate the C fibres giving pain relief. This electrical stimulation might simply ‘switch off' the nerve fibres. (See below for the details of the machine)
Outcome of study
The researchers measured the outcomes of their study using patient filled questionnaires. These give a scoring system to compare before and after. There was a significant benefit from the treatment compared to the placebo arm. Patients who had the treatment noticed better sexual functioning and reduced pain levels. One limitation of the study was that patients were only followed up for 3 months.
Women with sexual related pain from vestibulodynia may benefit from treatment from TENS using a vaginal probe. The authors conclude that the system can be used at home after a period of supervision rather than in the clinic. It is worth exploring as a treatment. Its value in women with unprovoked pain remained unclear - some women with unprovoked vulvodynia might experience an increase in pain but further research is needed.