The Place of Cannabinoids in the Treatment of Gynecological Pain.

Cannabis sativa (L), a plant with an extensive history of medicinal usage across numerous cultures, has received increased attention over recent years for its therapeutic potential for gynecological disorders such as endometriosis, chronic pelvic pain, and primary dysmenorrhea, due at least in part to shortcomings with current management options. Despite this growing interest, cannabis inhabits an unusual position in the modern medical pharmacopoeia, being a legal medicine, legal recreational drug, and an illicit drug, depending on jurisdiction. To date, the majority of studies investigating cannabis use have found that most people are using illicit cannabis, with numerous obstacles to medical cannabis adoption having been identified, including outdated drug-driving laws, workplace drug testing policies, the cost of quality-assured medical cannabis products, a lack of cannabis education for healthcare professionals, and significant and persistent stigma. Although currently lacking robust clinical trial data, a growing evidence base of retrospective data, cohort studies, and surveys does support potential use in gynecological pain conditions, with most evidence focusing on endometriosis. Cannabis consumers report substantial reductions in pelvic pain, as well as common comorbid symptoms such as gastrointestinal disturbances, mood disorders such as anxiety and depression, and poor sleep. Substitution effects were reported, with >50% reduction or cessation in opioid and/or non-opioid analgesics being the most common. However, a substantial minority report not disclosing cannabis consumption to their health professional. Therefore, while such deprescribing trends are potentially beneficial, the importance of medical supervision during this process is paramount given the possibility for withdrawal symptoms.

Cannabis, whether purchased illicitly, or obtained through legal means, is commonly used by those with chronic pelvic pain, especially people with endometriosis. People report several benefits from using cannabis, including being able to reduce their normal medications including opioid based painkillers, but often don't tell their health professional about this. This could lead to issues with withdrawal symptoms, so clinicians should be aware of the high prevalence of use of cannabis in this population.

Allied health and complementary therapy usage in Australian women with chronic pelvic pain: a cross-sectional study.

BACKGROUND: Chronic pelvic pain (CPP) causes non-cyclical pelvic pain, period pain, fatigue and other painful symptoms. Current medical and surgical management strategies are often not sufficient to manage these symptoms and may lead to uptake of other therapies. AIMS: To determine the prevalence of allied health (AH) and complementary therapy (CM) use, the cost burden of these therapies and explore predictive factors for using allied health or complementary medicines. MATERIALS AND METHODS: An online cross-sectional questionnaire using the WERF EndoCost tool was undertaken between February to April 2017. People were eligible to participate in the survey if they were aged 18-45, living in Australia and had chronic pelvic pain. RESULTS: From 409 responses, 340/409 (83%) of respondents reported a diagnosis of endometriosis. One hundred and five (30%) women with self-reported endometriosis, and thirteen (18%) women with other forms of CPP saw at least one AH or CM practitioner in the previous two months, with physiotherapists and acupuncturists the most common. Women who accessed CM or AH services spent an average of $480.32 AUD in the previous two months. A positive correlation was found between education and number of AH or CM therapies accessed in the past two months (p < 0.001) and between income level and number of therapists (p = 0.028). CONCLUSIONS: Women with CPP commonly access AH and CM therapies, with a high out of pocket cost. The high cost and associations with income and education levels may warrant a change to policy to improve equitable access to these services.

Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal Symptoms: A Randomized Clinical Trial.

Importance: Postmenopausal vaginal symptoms are common and frequently detrimental to a woman's quality of life. Fractional carbon dioxide vaginal laser is increasingly offered as a treatment, but the efficacy remains unproven. Objective: To determine the efficacy of fractional carbon dioxide laser for treatment of vaginal symptoms associated with menopause. Design, Setting, and Participants: A double-blind, randomized, sham-controlled trial with 12-month follow-up was undertaken at a single tertiary referral hospital in Sydney, Australia. Enrollment commenced on September 19, 2016, with final follow-up on June 30, 2020. Participants were postmenopausal women with vaginal symptoms substantive enough to seek medical treatment. Of 232 participants approached, 85 were randomized. Interventions: Three treatments using a fractional microablative carbon dioxide laser system performed 4 to 8 weeks apart, with 43 women randomized to the laser group and 42 to the sham group. Main Outcomes and Measures: The co-primary outcomes were symptom severity assessed using a visual analog scale (VAS; range, 0-100; 0 indicates no symptoms and 100 indicates the most severe symptoms) and the Vulvovaginal Symptom Questionnaire (VSQ; range, 0-20; 0 indicates no symptoms and 20 indicates the most severe symptoms) at 12 months. The minimal clinically important difference was specified as a 50% decrease in both VAS and VSQ severity scores. There were 5 prespecified secondary outcomes, including quality of life (range, 0-100; higher scores indicate better quality of life), the Vaginal Health Index Score (range, 5-25; higher scores indicate better health), and vaginal histology (premenopausal or postmenopausal status). Results: Of 85 randomized participants (mean [SD] age, 57 [8] years), 78 (91.7%) completed the 12-month follow-up. From baseline to 12 months, there was no significant difference between the carbon dioxide laser group and the sham group in change in symptom severity (VAS score for overall vaginal symptoms: -17.2 vs -26.6; difference, 9.4 [95% CI, -28.6 to 47.5]; VAS score for the most severe symptom: -24.5 vs -20.4; difference -4.1 [95% CI, -32.5 to 24.3]; VSQ score: -3.1 vs -1.6; difference, -1.5 [95% CI, -5.9 to 3.0]). There were no significant differences between the laser and sham group in the mean quality of life score (6.3 vs 1.4; difference, 4.8 [95% CI, -3.9 to 13.5]) and Vaginal Health Index Score (0.9 vs 1.3; difference, -0.4 [95% CI, -4.3 to 3.6]) or in histological comparisons between laser and sham treatment groups. There were 16 adverse events in the laser group and 17 in the sham group, including vaginal pain/discomfort (44% vs 68%), spotting, discharge, and lower urinary tract symptoms. No severe adverse events were reported in either group. Conclusions and Relevance: Among women with postmenopausal vaginal symptoms, treatment with fractional carbon dioxide laser vs sham treatment did not significantly improve vaginal symptoms after 12 months. Trial Registration: Australian and New Zealand Clinical Trials Registry: ACTRN12616001403426.

Effects of cannabis ingestion on endometriosis-associated pelvic pain and related symptoms.

BACKGROUND: The use of cannabis for symptoms of endometriosis was investigated utilising retrospective archival data from Strainprint Technologies Ltd., a Canadian data technology company with a mobile phone application that tracks a range of data including dose, mode of administration, chemovar and their effects on various self-reported outcomes, including pelvic pain. METHODS: A retrospective, electronic record-based cohort study of StrainprintTM users with self-reported endometriosis was conducted. Self-rated cannabis efficacy, defined as a function of initial and final symptom ratings, was investigated across the included symptom clusters of cramps, pelvic pain, gastrointestinal pain, nausea, depression, and low libido. Cannabis dosage form, dose and cannabinoid ratio information was also recorded. RESULTS: A total number of 252 participants identifying as suffering endometriosis recorded 16193 sessions using cannabis between April 2017 and February 2020. The most common method of ingestion was inhalation (n = 10914, 67.4%), with pain as the most common reported symptom being treated by cannabis (n = 9281, 57.3%). Gastrointestinal symptoms, though a less common reason for cannabis usage (15.2%), had the greatest self-reported improvement after use. Inhaled forms had higher efficacy for pain, while oral forms were superior for mood and gastrointestinal symptoms. Dosage varied across ingestion methods, with a median dose of 9 inhalations (IQR 5 to 11) for inhaled dosage forms and 1 mg/mL (IQR 0.5 to 2) for other ingested dosage forms. The ratio of THC to CBD had a statistically significant, yet clinically small, differential effect on efficacy, depending on method of ingestion. CONCLUSIONS: Cannabis appears to be effective for pelvic pain, gastrointestinal issues and mood, with effectiveness differing based on method of ingestion. The greater propensity for use of an inhaled dosage delivery may be due to the rapid onset of pain-relieving effects versus the slower onset of oral products. Oral forms appeared to be superior compared to inhaled forms in the less commonly reported mood or gastrointestinal categories. Clinical trials investigating the tolerability and effectiveness of cannabis for endometriosis pain and associated symptoms are urgently required.

A cross-sectional study of traditional Chinese medicine practitioner's knowledge, treatment strategies and integration of practice of chronic pelvic pain in women.

BACKGROUND: Chronic pelvic pain (CPP) in women is persistent, intermittent cyclical and non-cyclical lower abdominal pain, lasting for more than 6 months. Traditional Chinese Medicine (TCM) is a popular treatment option for women's health conditions, but little is known about how treatment for CPP is delivered by TCM practitioners. The aim of this survey was to explore practitioners understanding and treatment of women with CPP, and how they integrate their management and care into the health care system. METHOD: An online cross-sectional survey of registered TCM practitioners in Australia and New Zealand between May and October 2018. Survey domains included treatment characteristics (e.g. frequency), evaluation of treatment efficacy, referral networks, and sources of information that informed clinical decision making. RESULTS: One hundred and twenty-two registered TCM practitioners responded to this survey, 91.7% reported regular treatment of women with CPP. Treatment decisions were most-often guided by a combination of biomedical and TCM diagnosis (77.6%), and once per week was the most common treatment frequency (66.7%) for acupuncture. Meditation (63.7%) and dietary changes (57.8%) were other commonly used approaches to management. The effectiveness of treatment was assessed using multiple approaches, most commonly pain scales, (such as the numeric rating scale) and any change in use of analgesic medications. Limitations to TCM treatment were reported by over three quarters (83.7%) of practitioners, most commonly due to cost (56.5%) and inconvenience (40.2%) rather than safety or lack of efficacy. Sources informing practice were most often Integration within the wider healthcare system was common with over two thirds (67.9%) receiving referrals from health care providers. CONCLUSION: TCM practitioners seeing women with various CPP symptoms, commonly incorporate both traditional and modern diagnostic methods to inform their treatment plan, monitor treatment progress using commonly accepted approaches and measures and often as a part of multidisciplinary healthcare for women with CPP.

Manual Acupuncture Plus Usual Care Versus Usual Care Alone in the Treatment of Endometriosis-Related Chronic Pelvic Pain: A Randomized Controlled Feasibility Study.

Objective: To determine the acceptability and feasibility of acupuncture for the treatment of endometriosis-related chronic pelvic pain. Design: A prospective, randomized controlled feasibility study. Setting: Outpatient setting in Sydney, Australia. Subjects: Participants who were aged 18-45 years, had a confirmed laparoscopic diagnosis of endometriosis in the past 5 years, and had regular menstrual periods and mean pelvic pain scores ≥4/10. Interventions: Sixteen acupuncture treatments delivered by registered acupuncturists using a standardized point protocol over 8 weeks, twice per week plus usual care compared with usual care alone. Outcome measures: Primary outcome measures were feasibility, safety, and acceptability of the acupuncture intervention. Secondary outcomes were changes in self-reported pelvic pain scores, changes in quality of life as measured by the Endometriosis Health Profile (EHP-30), changes in descending pain modulation, and changes in systemic inflammation (plasma interleukin [IL-6] concentrations). Results: Twenty-nine participants were eligible to participate, with 19 participants completing the trial. There was unequal withdrawals between groups; the acupuncture group had a withdrawal rate of 14% compared with 53% in usual care. Adverse events were uncommon (6.7%) and generally mild. A 1.9 point decrease in median nonmenstrual pain scores and a 2.0 decrease in median menstrual pain scores between baseline and end of trial were observed in the acupuncture group only. Improvements in all domains of the EHP-30 were seen in the acupuncture group, with no changes seen in usual care. There was no difference between baseline and end of treatment in IL-6 concentrations for either group. Conclusions: Acupuncture was an acceptable, well-tolerated treatment and it may reduce pelvic pain and improve quality of life; however, usual care was not an acceptable control group. Trial Registration: anzctr.org.au: ACTRN12617000053325. Prospectively registered January 11, 2017.

The effectiveness of a modified Gui Zhi Fu Ling Wan formulation (Gynoclear™) for the treatment of endometriosis: a study protocol for a placebo-controlled, double-blind, randomised controlled trial.

BACKGROUND: Endometriosis is the presence of tissue similar to that of the endometrium outside the uterine cavity and is the most common cause of chronic pelvic pain. Current non-surgical treatments such as non-steroidal anti-inflammatories, oral contraceptive pills and hormonal treatments have limited effectiveness, and the side effect profile is bothersome. This study will evaluate the efficacy of Gynoclear™ by change in endometriosis-related pain based on the Endometriosis Pain Daily Diary (EPPD) scores. METHODS: This randomised, double-blind, placebo-controlled trial will recruit a minimum of 90 adult participants across Australia who have a laparoscopic visualisation/confirmation of endometriosis in the last 5 years and have current moderate or greater pelvic pain. Participants will be randomly allocated in a 1:1 ratio to receive either Gynoclear™ (active) or placebo. Gyncolear's active ingredients are Carthamus tinctorius (Safflower), Cinnamomum cassia (Chinese cinnamon), Poria cocos (Hoelen), Paeonia suffriticosa (Tree peony), Paeonia lactiflora (Peony) and Salvia miltiorrhiza (Red sage). Participants are asked to complete a total of 5 months' worth of pain diary entries via the EPDD v3, including 1-month screening, 2-month treatment period and 1-month post-treatment follow-up. The primary outcome variable is change in endometriosis-related pain based on the EPDD v3 scores. Secondary outcomes include change in health-related quality of life via the Endometriosis Health Profile (EHP-30), SF-12 and EQ-5D scores as well as changes in rescue analgesic usage, dyspareunia and fatigue via the EPDD. DISCUSSION: This study will determine the safety and efficacy of Gynoclear™ to reduce the severity and duration of non-cyclical pelvic pain, dysmenorrhoea, dyspareunia and other symptoms of endometriosis. Study outcomes will be of interest to health professionals and members of the public who suffer from endometriosis. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12619000807156 . Registered on 3 June 2019.

Cannabis Use, a Self-Management Strategy Among Australian Women With Endometriosis: Results From a National Online Survey.

OBJECTIVE: This study sought to determine the prevalence, tolerability, and self-reported effectiveness of cannabis in women with endometriosis. METHODS: A cross-sectional online survey was conducted between October and December 2017. Recruitment targeted women with endometriosis through social media postings from endometriosis advocacy groups. Women aged 18 to 45, living in Australia, and with surgically confirmed endometriosis were eligible to participate. Survey questions investigated the types of self-management used, change in symptoms or medication use, costs, and adverse events. RESULTS: A total of 484 responses were included for analysis, with 76% of the women reporting the use of general self-management strategies within the last 6 months. Of those using self-management, 13% reported using cannabis for symptom management. Self-reported effectiveness in pain reduction was high (7.6 of 10), with 56% also able to reduce pharmaceutical medications by at least half. Women reported the greatest improvements in sleep and in nausea and vomiting. Adverse effects were infrequent (10%) and minor. CONCLUSION: Australian law currently requires legal medicinal cannabis use to follow specific, regulated pathways that limit prescription by this method; however, self-reported illicit use of cannabis remains relatively common in Australian women with endometriosis. Women report good efficacy of cannabis in reducing pain and other symptoms, with few adverse effects reported. Further clinical research is warranted to determine the effectiveness of cannabis in managing endometriosis symptoms. In locations where medicinal cannabis is more accessible, there remains a paucity of evidence for its clinical efficacy with endometriosis-associated symptoms.

Nutritional supplements and herbal medicines for women with polycystic ovary syndrome; a systematic review and meta-analysis.

BACKGROUND: Polycystic ovary syndrome (PCOS) is a common, reproductive endocrinopathy associated with serious short and long term health risks. Many women with PCOS use ingestible complementary medicines. This systematic review examined the effect on menstrual regulation and adverse effects from randomised controlled trials. METHODS: Randomised controlled trials (RCTs) that compared herbal or nutritional supplements to placebo or active controls in women with PCOS were eligible for inclusion. Electronic databases were searched to July 2017. Study selection and assessment of quality were conducted independently by two review authors. RESULTS: Twenty four studies (1406 women) investigating seven nutritional supplements and four herbal medicines were included. No one study was assessed as having a low risk of bias. Four trials reported on the primary endpoint menstrual regulation. There was no evidence on improved menstrual regularity for calcium plus vitamin D compared to Metformin (RR: 0.66, 95% CI 0.35 to 1.23, p = 0.19), reduced amenorrhoea for Camellia sinensis compared to placebo (RR: 0.17, 95% CI 0.02 to 1.72, p = 0.13) and no difference in the number of menses per month for Cinnamomum sp. against placebo (MD 0.05, 95% CI -0.36 to 1.36, p = 0.26). Adverse effects were investigated in seven studies (164 women). Mild adverse effects were found for Cinnamomum sp. compared to placebo (17 women, RR: 0.36, 95% CI 0.03 to 0.70, p = 0.03). No difference was found for adverse effects between inositol, B complex vitamins, vitamin D, chromium and placebo. Improved reproduction, metabolic hormones and hyperandrogenism was found for inositol and improved cholesterol for omega three fish oils. CONCLUSION: There is no high quality evidence to support the effectiveness of nutritional supplements and herbal medicine for women with PCOS and evidence of safety is lacking. High quality trials of nutritional supplements and herbal medicines examining menstrual regulation and adverse effects in women with PCOS are needed.

Combined Lifestyle and Herbal Medicine in Overweight Women with Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial.

Polycystic ovary syndrome (PCOS) is a common, complex reproductive endocrinopathy characterized by menstrual irregularities, hyperandrogenism and polycystic ovaries. Lifestyle modification is a first-line intervention; however, there are barriers to success for this form of self-care, and women often seek adjunct therapies including herbal medicines. This pragmatic, randomized controlled trial, delivered in communities of Australia in overweight women with PCOS, compared the effectiveness and safety of a lifestyle intervention plus herbal medicine against lifestyle alone. All participants were helped to construct a personalized lifestyle plan. The herbal intervention consisted of two tablets. Tablet 1 contained Cinnamomum verum, Glycyrrhiza glabra, Hypericum perforatum and Paeonia lactiflora. Tablet 2 contained Tribulus terrestris. The primary outcome was oligomenorrhoea/amenorrhoea. Secondary outcomes were hormones; anthropometry; quality of life; depression, anxiety and stress; pregnancy; birth outcomes; and safety. One hundred and twenty-two women gave their consent. At 3 months, women in the combination group recorded a reduction in oligomenorrhoea of 32.9% (95% confidence interval 23.3-42.6, p < 0.01) compared with controls, estimated as a large effect (ηp2  = 0.11). Other significant improvements were found for body mass index (p < 0.01); insulin (p = 0.02) and luteinizing hormone (p = 0.04); blood pressure (p = 0.01); quality of life (p < 0.01); depression, anxiety and stress (p < 0.01); and pregnancy rates (p = 0.01). This trial provides evidence of improved effectiveness and safety for lifestyle intervention when combined with herbal medicines in women with PCOS. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd.

Preoperative Mechanical Bowel Preparation for Abdominal, Laparoscopic, and Vaginal Surgery: A Systematic Review.

STUDY OBJECTIVE: Mechanical bowel preparation (MBP) continues to be widely used in gynecologic surgery, with the aim of reducing postoperative complications and improving the viewing and handling conditions in the surgical field. It is reported that MBP is an unpleasant patient experience and may be associated with adverse effects such as dehydration and electrolyte imbalance. This review evaluates the use of preoperative MBP compared with no MBP in adult patients undergoing open abdominal, laparoscopic, or vaginal surgery. Although the focus is on the use of MBP for gynecologic procedures, data from other surgical areas are covered when relevant. DESIGN: A comprehensive search of the databases Medline (from 1946), EMBASE (from 1947), PubMed, Cochrane Library Central (Register of Controlled Trials), and Google Scholar was performed to identify any randomized controlled trials (RCTs) and prospective or retrospective cohort studies comparing preoperative MBP to no MBP. RESULTS: Forty-three studies were identified in various surgical specialties, of which there were 5 RCTs in gynecology. The gynecologic studies reported no benefit for MBP in operative time or improved surgical field of view but did report a more unpleasant patient experience when MBP is used. RCTs from colorectal and urologic surgery were powered for infectious morbidity and anastomotic leak and did not demonstrate improved patient outcomes when MBP was used. CONCLUSION: Evidence from high-quality trials reports no or few benefits from MBP or rectal enema across surgical specialties. In the field of gynecologic surgery, high-quality evidence supports the view that MBP may be safely abandoned.

Herbal medicine for the management of polycystic ovary syndrome (PCOS) and associated oligo/amenorrhoea and hyperandrogenism; a review of the laboratory evidence for effects with corroborative clinical findings.

BACKGROUND: Polycystic ovary syndrome (PCOS) is a prevalent, complex endocrine disorder characterised by polycystic ovaries, chronic anovulation and hyperandrogenism leading to symptoms of irregular menstrual cycles, hirsutism, acne and infertility. Evidence based medical management emphasises a multidisciplinary approach for PCOS, as conventional pharmaceutical treatment addresses single symptoms, may be contra-indicated, is often associated with side effects and not effective in some cases. In addition women with PCOS have expressed a strong desire for alternative treatments. This review examines the reproductive endocrine effects in PCOS for an alternative treatment, herbal medicine. The aim of this review was to identify consistent evidence from both pre-clinical and clinical research, to add to the evidence base for herbal medicine in PCOS (and associated oligo/amenorrhoea and hyperandrogenism) and to inform herbal selection in the provision clinical care for these common conditions. METHODS: We undertook two searches of the scientific literature. The first search sought pre-clinical studies which explained the reproductive endocrine effects of whole herbal extracts in oligo/amenorrhoea, hyperandrogenism and PCOS. Herbal medicines from the first search informed key words for the second search. The second search sought clinical studies, which corroborated laboratory findings. Subjects included women with PCOS, menstrual irregularities and hyperandrogenism. RESULTS: A total of 33 studies were included in this review. Eighteen pre-clinical studies reported mechanisms of effect and fifteen clinical studies corroborated pre-clinical findings, including eight randomised controlled trials, and 762 women with menstrual irregularities, hyperandrogenism and/or PCOS. Interventions included herbal extracts of Vitex agnus-castus, Cimicifuga racemosa, Tribulus terrestris, Glycyrrhiza spp., Paeonia lactiflora and Cinnamomum cassia. Endocrine outcomes included reduced luteinising hormone (LH), prolactin, fasting insulin and testosterone. There was evidence for the regulation of ovulation, improved metabolic hormone profile and improved fertility outcomes in PCOS. There was evidence for an equivalent effect of two herbal medicines and the pharmaceutical agents bromocriptine (and Vitex agnus-castus) and clomiphene citrate (and Cimicifuga racemosa). There was less robust evidence for the complementary combination of spirinolactone and Glycyrrhiza spp. for hyperandrogenism. CONCLUSIONS: Preclinical and clinical studies provide evidence that six herbal medicines may have beneficial effects for women with oligo/amenorrhea, hyperandrogenism and PCOS. However the quantity of pre-clinical data was limited, and the quality of clinical evidence was variable. Further pre-clinical studies are needed to explain the effects of herbal medicines not included in this review with current clinical evidence but an absence of pre-clinical data.

A survey of the use of complementary medicine by a self-selected community group of Australian women with polycystic ovary syndrome.

BACKGROUND: Polycystic ovary syndrome (PCOS) is a complex reproductive endocrinopathy affecting up to 20% of reproductive aged women. Whilst there are effective pharmaceutical treatment options, women with PCOS have expressed a strong desire for alternatives. This study investigates the use and attitudes of women with PCOS towards complementary medicine (CM). METHODS: Women as members of PCOS support groups responded to an anonymous on-line survey which examined rates and patterns of use for CM's, areas of health for use, perceptions of effectiveness, safety and demographic features. Data collection targeted women with PCOS using two consumer support groups. The first group self-selected following direct email to members of a land based consumer support group, the Polycystic Ovary Syndrome Association of Australia (POSAA). The second sample was generated through the electronic social network Facebook, using a snowball technique. Two surveys, identical in content, were collected by cloud based Survey Monkey. Data were described and associations between the variables, 'reasons for use' and 'perceptions of effectiveness' were explored. Non-response bias was assessed using a continuum of resistance model. RESULTS: 493 women participated in the study; 91.1% response rate from the POSAA group. Over 70% reported use of complementary medicine, usually nutritional and herbal supplements and 76.6% of CM users reported consultation with a complementary practitioner. Many participants were using CM to treat PCOS however most were using it to concurrently treat a range of health conditions, describing women's desire for more than single symptom management. Disadvantages for CM use were cited by 71% of respondents. Women using complementary medicine with specific treatment goals in mind reported greater self-perceived effectiveness, suggesting that informed use may improve women's satisfaction with CM. Adverse reactions were reported by 12.2% of women and the need for further research into adverse reactions for CM's was identified. Demographic and PCOS characteristics were similar to clinical populations of PCOS and non-response bias was shown as not significant. CONCLUSION: This study describes the prevalence of use for complementary medicine by women with PCOS as over 70% and adds to our understanding of women's experiences with CM and their motivations for use of CM.

Clinical and quality-of-life outcomes after fertility-sparing laparoscopic surgery with bowel resection for severe endometriosis.

STUDY OBJECTIVE: To describe the effect of fertility-sparing laparoscopic excision of endometriosis and bowel resection on clinical and quality-of-life outcomes. DESIGN: Prospective observational cohort study (Canadian Task Force classification II-2). SETTING: Australian tertiary referral center for the surgical treatment of endometriosis. PATIENTS: Seven consecutive patients with known endometriosis involving the bowel. INTERVENTION: Laparoscopic resection of all endometriosis, including laparoscopic bowel resection with end-to-end anastomosis with or without temporary ileostomy. MEASUREMENTS AND MAIN RESULTS: Preoperative and 12-month postoperative data were collected by use of visual analogue scores for dysmenorrhea, nonmenstrual pelvic pain, dyspareunia, and dyschezia. Validated research tools (SF12, EuroQOL, and Sexual Activity Questionnaire) also assessed quality of life. Reduction in median pain scores at baseline was demonstrated and at 12 months after operation for dysmenorrhea 71 (interquartile range 43-85) versus 5 (0-10); p=.028, nonmenstrual pelvic pain 74 (48-85) versus 11 (0-18); p=.046, dyspareunia 66 (0-98) versus 5 (0-8); p=.080, and dyschezia 48 (20-64) versus 20 (0-40); p=.173. All measures of quality of life were improved at 12 months after surgery, although not reaching statistical significance because of the small sample size. All three women wishing to conceive after operation have been successful, resulting in three live births at term. There were few complications associated with this surgery. CONCLUSION: Fertility-sparing laparoscopic excision of endometriosis with bowel resection results in improvements in all aspects of pain and quality of life. Results appear to parallel published data for conservative resection of endometriosis not involving bowel. For women with severe endometriosis involving bowel, this surgical treatment provides a viable alternative to pelvic clearance and successfully maintains fertility.

In-vitro and in-vivo histochemical and thermal studies using a thermal balloon endometrial ablation system for varying treatment times.

BACKGROUND: To assess the immediate zone of thermal necrosis (ZTN) using an enzyme histochemical staining technique and serosal temperatures for the Cavaterm endometrial balloon ablation system for different treatment times. METHODS: A thermal balloon ablation was performed initially post- (n = 6) and subsequently pre-hysterectomy (n = 15). Eight to 12 tissue blocks from each uterus were sectioned and stained using diaphorase respiratory enzyme techniques. Patients in the in-vivo group had temperature measurements taken from four serosal points, a myometrial gradient profile, the balloon surface and the endocervical canal. RESULTS: The serosal temperature sensors did not demonstrate any rise in temperature above 44.1 degrees C. The mean temperature at the anterior wall, posterior wall, fundus and cornual areas was 37.1 (SD 1.3), 36.8 (SD 1.0), 37.4 (SD 1.8) and 36.7 degrees C (SD 1.0), respectively. The immediate mean maximum ZTN was greatest for the 15-min treatment time (3.1 mm, SD 1.5) compared to the 10- and 7-min treatment times (3.0 mm, SD 1.4 and 2.2 mm, SD 0.7, respectively). The maximum ZTN recorded was 5.6 mm. No full thickness injuries were demonstrated either histochemically or suggested by the temperature studies. CONCLUSIONS: This study confirms that Cavaterm thermal balloon ablation produces a reproducible thermal injury without evidence of serosal heating. Results suggest that the treatment time could be reduced to 10-min with no detrimental effect on the clinical outcomes. This hypothesis is currently being evaluated by clinical trials.

Quality of life should be considered the primary outcome for measuring success of endometrial ablation.

STUDY OBJECTIVE: To compare clinical and quality of life outcomes by validated instruments after endometrial ablation by four methods, and determine the primary outcome that most reflects procedure success. DESIGN: Descriptive cohort study (Canadian Task Force classification II-2). SETTING: Minimal-access gynecologic surgery unit in northeast England. PATIENTS: One hundred thirty-nine women. INTERVENTION: Endometrial ablation by one of four methods: Cavaterm, endometrial laser interstitial thermotherapy (ELITT), endometrial laser ablation (ELA), or NovaSure impedance-controlled system. MEASUREMENTS AND MAIN RESULTS: Clinical outcomes were assessed according to menstrual outcome. Whereas amenorrhea rates were significantly different among the four techniques (chi2 = 9.42, p = 0.02), combined amenorrhea and hypomenorrhea rates were not significantly different (67%, 69%, 69%, 62%, chi2 = 0.38, NS) for Cavaterm, ELITT, ELA, and NovaSure, respectively. Quality of life, measured preoperatively by the EQ-5D index and EQ-5D vas, SF-12 physical and mental component scores, and sexual activity questionnaire pleasure, habit, and discomfort scores, were substantially improved 12 months after treatment. No significant differences were seen in quality of life scores between women after endometrial ablation and the general population. CONCLUSION: Quality of life for women with menorrhagia is improved to a normal level by treatment with either first- or second-generation endometrial ablation.