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1.
BMJ Open ; 14(1): e078989, 2024 01 12.
Article in English | MEDLINE | ID: mdl-38216200

ABSTRACT

INTRODUCTION: Uterine fibroids affect 30%-77% of reproductive-age women and are a significant cause of infertility. Surgical myomectomies can restore fertility, but they often have limited and temporary benefits, with postoperative complications such as adhesions negatively impacting fertility. Existing medical therapies, such as oral contraceptives, gonadotropin hormone-releasing hormone (GnRH) analogues and GnRH antagonists, can manage fibroid symptoms but are not fertility friendly. This study addresses the pressing need for non-hormonal, non-surgical treatment options for women with fibroids desiring pregnancy. Previous preclinical and clinical studies have shown that epigallocatechin gallate (EGCG) effectively reduces uterine fibroid size. We hypothesise that EGCG from green tea extract will shrink fibroids, enhance endometrial quality and increase pregnancy likelihood. To investigate this hypothesis, we initiated a National Institute of Child Health and Human Development Confirm-funded trial to assess EGCG's efficacy in treating women with fibroids and unexplained infertility. METHODS AND ANALYSIS: This multicentre, prospective, interventional, randomised, double-blinded clinical trial aims to enrol 200 participants with fibroids and unexplained infertility undergoing intrauterine insemination (IUI). Participants will be randomly assigned in a 3:1 ratio to two groups: green tea extract (1650 mg daily) or a matched placebo, combined with clomiphene citrate-induced ovarian stimulation and timed IUI for up to four cycles. EGCG constitutes approximately 45% of the green tea extract. The primary outcome is the cumulative live birth rate, with secondary outcomes including conception rate, time to conception, miscarriage rate, change in fibroid volume and symptom severity scores and health-related quality of life questionnaire scores. ETHICS AND DISSEMINATION: The FRIEND trial received approval from the Food and Drug adminstration (FDA) (investigational new drug number 150951), the central Institutional Review Board (IRB) at Johns Hopkins University and FRIEND-collaborative site local IRBs. The data will be disseminated at major conferences, published in peer-reviewed journals and support a large-scale clinical trial. TRIAL REGISTRATION NUMBER: NCT05364008.


Subject(s)
Catechin/analogs & derivatives , Infertility , Leiomyoma , Pregnancy , Child , Female , Humans , Tea , Quality of Life , Prospective Studies , Leiomyoma/complications , Leiomyoma/drug therapy , Leiomyoma/surgery , Infertility/therapy , Fertility , Ovulation Induction/methods , Gonadotropin-Releasing Hormone/therapeutic use , Pregnancy Rate , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
2.
Arch Gynecol Obstet ; 309(3): 949-959, 2024 03.
Article in English | MEDLINE | ID: mdl-37831177

ABSTRACT

PURPOSE: This case series examined the safety and effectiveness of hysteroscopic myolysis using laser-induced interstitial thermo-therapy (LITT) for treating heavy menstrual bleeding (HMB) in premenopausal women with FIGO type 1 or 2 uterine fibroids, not planning for future fertility. Additionally, a comprehensive review of innovative, minimally invasive, incisionless myolysis techniques was conducted. METHODS: Women with HMB, sonographically diagnosed with a single FIGO type 1 or 2 fibroid, underwent hysteroscopic myolysis using the Leonardo® diode laser. Effectiveness was assessed via transvaginal ultrasound measurement of myoma size, volume and vascularization pre and post-procedure. Moreover, we also evaluated any improvements in symptoms using the Pictorial Blood Loss Assessment Chart (PBAC score) scores. RESULTS: The procedure resulted in significant HMB reductions and noticeable fibroid size, volume, and vascularization decrease in all three patients, with no reported complications. The literature review revealed both advantages and limitations of the minimally invasive, incisionless myolysis techniques. CONCLUSIONS: Hysteroscopic laser myolysis is a safe and effective therapeutic intervention for patients experiencing HMB, diagnosed with FIGO type 1 or 2 fibroids, and not planning for future fertility. The procedure resulted in significant reductions in menstrual blood loss and fibroid size. Despite the promising results, it is essential to note the limitations of this report, including its case series design, a small number of patients, and a short follow-up period. Further research is necessary to confirm these results.


Subject(s)
Leiomyoma , Menorrhagia , Myoma , Uterine Neoplasms , Humans , Female , Menorrhagia/surgery , Lasers, Semiconductor/therapeutic use , Leiomyoma/complications , Leiomyoma/surgery , Leiomyoma/drug therapy , Menstruation , Uterine Neoplasms/complications , Uterine Neoplasms/surgery , Uterine Neoplasms/drug therapy
3.
Curr Opin Obstet Gynecol ; 35(4): 300-305, 2023 Aug 01.
Article in English | MEDLINE | ID: mdl-37266579

ABSTRACT

PURPOSE OF REVIEW: Vitamin D deficiency has been implicated as a contributing factor to a spectrum of reproductive health burden, including difficulty conceiving, pathogenesis of gynaecological disorders such as uterine fibroids and endometriosis, to metabolic and endocrine burden of polycystic ovarian syndrome (PCOS). RECENT FINDINGS: There have been recent publications showing that in infertile women who are supplemented with vitamin D, there are higher pregnancy rates; there are improved ovarian reserve parameters in women with diminished ovarian reserve; curtailed fibroid growth in those with uterine myomas; lessened dysmenorrhea in endometriosis patients; and improved menstrual regularity, lowered testosterone, AMH and insulin levels in women with PCOS. In infertile men, sperm parameters, especially motility, are positively correlated with vitamin D serum levels. SUMMARY: Vitamin D status appears to be relevant to reproductive physiology, and to physiological processes underlying common gynaecological disorders as well as for reproductive success.


Subject(s)
Endometriosis , Infertility, Female , Leiomyoma , Polycystic Ovary Syndrome , Vitamin D Deficiency , Pregnancy , Humans , Male , Female , Vitamin D , Infertility, Female/etiology , Endometriosis/complications , Semen , Vitamins , Vitamin D Deficiency/complications , Polycystic Ovary Syndrome/complications , Leiomyoma/complications , Anti-Mullerian Hormone
4.
J Womens Health (Larchmt) ; 32(5): 546-552, 2023 05.
Article in English | MEDLINE | ID: mdl-37023398

ABSTRACT

Objective: The aim of this study is to examine complementary and alternative medicine (CAM) use among women with symptomatic uterine fibroids in the United States. Materials and Methods: In this cross-sectional analysis of baseline data from a multicenter, prospective cohort study of premenopausal women undergoing surgery for symptomatic fibroids and who enrolled in the Uterine Leiomyoma Treatment with Radiofrequency Ablation study from 2017 to 2019, we contrast women indicating use of at least one CAM modality specifically for fibroid symptoms against women using CAM for other reasons and CAM nonusers. Multivariable logistic regression models were performed to identify participant characteristics independently associated with CAM use for fibroids. Results: Among 204 women, 55% were Black/African American and the mean age was 42 (standard deviation 6.6) years. CAM use was common (67%), with 42% (95% confidence interval [CI]: 35%-49%) reporting use of CAM specifically to treat fibroid symptoms. Most commonly, CAM treatments used for fibroids were diet (62%) and herbs (52%), while CAM treatments for other reasons were exercise (80%) and massage (43%). On average, each participant who reported CAM use utilized three different types of CAM modalities. In a multivariable model, participants were more likely to use CAM for fibroids if they had pelvic pressure (odds ratio [OR] 2.50, 95% CI: 1.07-5.87, p = 0.04), a body-mass index lower than average (OR 0.76, 95% CI: 0.60-0.97, p = 0.03), and a lower health-related quality of life score (OR 0.61, 95% CI: 0.46-0.81, p = 0.001). Conclusions: In this diverse sample of women with symptomatic fibroids, CAM use was highly prevalent. Our findings highlight the need for providers to query patients about CAM use and understand the role of CAM in fibroid management. ClinicalTrials.gov Identifier: NCT02100904.


Subject(s)
Complementary Therapies , Leiomyoma , Uterine Neoplasms , Humans , Female , United States , Adult , Uterine Neoplasms/therapy , Uterine Neoplasms/complications , Prospective Studies , Quality of Life , Cross-Sectional Studies , Leiomyoma/therapy , Leiomyoma/complications
6.
J Minim Invasive Gynecol ; 27(4): 930-937.e1, 2020.
Article in English | MEDLINE | ID: mdl-31352067

ABSTRACT

STUDY OBJECTIVE: To develop a risk prediction model for occult uterine sarcoma using preoperative clinical characteristics in women undergoing hysterectomy for presumed uterine leiomyomata. DESIGN: Cases of uterine sarcoma were identified from the electronic medical records. Age/race-matched controls were selected at a 2:1 ratio (controls:cases) from a cohort of 45 188 women who underwent hysterectomy for uterine leiomyomata or abnormal bleeding during the same time interval. Unadjusted conditional logistic regression was performed to identify risk factors for occult uterine sarcomas, defined as no preoperative suspicion for malignancy. A risk prediction model was developed using a weighted logistic regression model, and the performance of the model was assessed using the receiver operator characteristic curve and corresponding area under the curve. SETTING: A large integrated health care system in California PATIENTS: Women 18 years of age and older who underwent a hysterectomy and were diagnosed with a uterine sarcoma and matched controls from 2006 to 2013. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: There were 117 cases of occult uterine sarcomas that met inclusion criteria during the study period. The final risk prediction model included age, race/ethnicity, number of myomas, uterine weight, uterine size increase, degree of pelvic pain, and recent history of blood transfusion. The risk prediction model showed high accuracy based on the receiver operating characteristic curve method (area under the curve = 0.83; 95% confidence interval, 0.77-0.90); however, the positive predictive values were low (0.048 or less) at all risk thresholds. CONCLUSION: Multiple clinical features are associated with the presence of a uterine sarcoma, but when incorporated into a prediction model, they fail to provide significantly more information about women who may have an unrecognized sarcoma and only marginally improve the certainty about women who are not likely to have sarcoma.


Subject(s)
Leiomyoma , Pelvic Neoplasms , Sarcoma , Uterine Neoplasms , Adolescent , Adult , Female , Humans , Hysterectomy/methods , Leiomyoma/complications , Leiomyoma/surgery , Pelvic Neoplasms/surgery , Retrospective Studies , Sarcoma/complications , Sarcoma/diagnosis , Sarcoma/surgery , Uterine Neoplasms/complications , Uterine Neoplasms/diagnosis , Uterine Neoplasms/surgery , Uterus/pathology
8.
Ann Vasc Surg ; 52: 90-95, 2018 Oct.
Article in English | MEDLINE | ID: mdl-29777846

ABSTRACT

BACKGROUND: Despite growing endovascular experience within the vascular surgery community, some catheter-based interventions-such as uterine artery embolization (UAE)-remain outside the clinical scope of most vascular surgeons, owing in part to established referral patterns and limited awareness among referring colleagues. We present our experience with a vascular surgery-based, multidisciplinary UAE program at an academic tertiary referral center. METHODS: In a collaborative effort between vascular surgeons and gynecologists, a pelvic vascular disease program has been established to provide palliative, prophylactic, and therapeutic embolizations including, but not limited to, UAE. For UAE, inclusion criteria are women over the age of 18 years with symptomatic uterine fibroids demonstrated on magnetic resonance imaging and a negative endometrial biopsy. Exclusion criteria are desire for future pregnancy and previous embolization(s). Technique and perioperative protocol is presented. Data including symptom resolution, reintervention rates, and complications were prospectively gathered and retrospectively reviewed. RESULTS: Over an 18-month period, 30 patients with symptomatic fibroids were referred for potential UAE. Five patients were excluded because of uncertainty about future pregnancy wishes (4) and prior embolization (1). Twenty-four bilateral and 2 unilateral UAEs were performed (mean age, 46.3 years [range 28-53 years]). Presenting symptoms were pelvic and abdominal pain (25), cramps (25), menorrhagia (25), dysmenorrhea (25), urinary frequency (12), and dyspareunia (5). Technical success, defined as successful microcatheterization of uterine arteries and delivery of a particulate liquid embolic agent (embospheres, 500-700 microns), was 100%. There were no perioperative or delayed complications. Twenty-one patients (87.5%) reported complete symptomatic relief without further intervention at the time of last follow-up. Three patients (12.5%) reported pain relief but had persistent vaginal bleeding requiring hysterectomy 12 months after UAE. All patients underwent a 23-hr observation postoperatively for pain control. Mean follow-up was 7.4 months (1-23 months) and included pelvic ultrasound assessment of fibroid size at 1, 3, and 6 months after UAE and annually thereafter. One patient was lost to follow-up. Fibroid shrinkage was noted in all patients. Given the willingness and capability to work-up, admit, treat, and follow-up patients, vascular surgery was deemed the preferred service for UAE by the referring gynecologists. CONCLUSION: Within the framework of a collaborative, multidisciplinary program, vascular surgery can play a prominent role in providing safe and effective UAE.


Subject(s)
Delivery of Health Care, Integrated/organization & administration , Leiomyoma/therapy , Patient Care Team/organization & administration , Referral and Consultation , Tertiary Care Centers , Uterine Artery Embolization , Uterine Neoplasms/therapy , Vascular Surgical Procedures/organization & administration , Adult , Cooperative Behavior , Female , Humans , Interdisciplinary Communication , Leiomyoma/complications , Leiomyoma/diagnostic imaging , Leiomyoma/pathology , Middle Aged , Program Evaluation , Retrospective Studies , Specialization , Surgeons , Time Factors , Treatment Outcome , Uterine Artery Embolization/adverse effects , Uterine Neoplasms/complications , Uterine Neoplasms/diagnostic imaging , Uterine Neoplasms/pathology , Vascular Surgical Procedures/adverse effects , Young Adult
9.
Int J Gynaecol Obstet ; 135(2): 140-144, 2016 Nov.
Article in English | MEDLINE | ID: mdl-27575538

ABSTRACT

OBJECTIVE: To compare the efficacy of thermal balloon ablation (TBA) with that of vaginal hysterectomy in the treatment of leiomyoma-induced heavy menstrual bleeding (HMB). METHODS: An open-label randomized controlled trial was conducted between November 1, 2012, and October 31, 2014, in a tertiary care hospital in Delhi, India. Eligible women with HMB (aged ≥40 years, uterus size ≤14 weeks of pregnancy, leiomyoma ≤5 cm, uterocervical length ≤12 cm) were randomly assigned (1:1) to undergo TBA or vaginal hysterectomy using computer-generated random number tables. The primary outcome was the number of women in the TBA group with HMB 6 months after surgery. Analyses were by intention to treat. RESULTS: Each group contained 20 women. No women in the TBA group had HMB at 6 months. Nineteen women were amenorrheic by 6 months and one was hypomenorrheic. CONCLUSION: TBA can replace vaginal hysterectomy in some perimenopausal women with uterine leiomyomas. Clinical Trials Registry India: CTRI/2016/07/007119.


Subject(s)
Hyperthermia, Induced , Hysterectomy, Vaginal , Leiomyoma/complications , Menorrhagia/surgery , Adult , Female , Humans , India , Middle Aged , Operative Time , Postoperative Complications/epidemiology , Quality of Life
10.
Am J Obstet Gynecol ; 215(6): 745.e1-745.e12, 2016 Dec.
Article in English | MEDLINE | ID: mdl-27393268

ABSTRACT

BACKGROUND: Since 1995 uterine artery embolization has been described as an alternative for hysterectomy in patients with symptomatic fibroids. Many studies including several randomized controlled trials established uterine artery embolization as a valuable treatment. These randomized controlled trials reported outcomes in terms of health-related quality of life, clinical outcomes, efficacy, and cost-effectiveness after 1, 2, and 5 years of follow-up. OBJECTIVE: The purpose of this study was to compare clinical outcome and health-related quality of life 10 years after uterine artery embolization or hysterectomy in the treatment of heavy menstrual bleeding caused by uterine fibroids in a randomized controlled trial. STUDY DESIGN: In all, 28 Dutch hospitals recruited patients with symptomatic uterine fibroids who were eligible for hysterectomy. Patients were 1:1 randomly assigned to uterine artery embolization or hysterectomy. The outcomes assessed at 10 years postintervention were reintervention rates, health-related quality of life, and patient satisfaction, which were obtained through validated questionnaires. Study outcomes were analyzed according to original treatment assignment (intention to treat). RESULTS: A total of 177 patients were randomized from 2002 through 2004. Eventually 81 uterine artery embolization and 75 hysterectomy patients underwent the allocated treatment shortly after randomization. The remaining patients withdrew from the trial. The 10-year questionnaire was mailed when the last included patient had been treated 10 years earlier. The mean duration of follow-up was 133 months (SD 8.58) accompanied by a mean age of 57 years (SD 4.53). Questionnaires were received from 131 of 156 patients (84%). Ten years after treatment, 5 patients underwent secondary hysterectomy resulting in a total of 28 of 81 (35%) (24/77 [31%] after successful uterine artery embolization). Secondary hysterectomies were performed for persisting symptoms in all cases but 1 (for prolapse). After the initial treatment health-related quality of life improved significantly. After 10 years, generic health-related quality of life remained stable, without differences between both groups. The urogenital distress inventory and the defecation distress inventory showed a decrease in both groups, probably related to increasing age, without significant differences between study arms. Satisfaction in both groups remained comparable. The majority of patients declared being (very) satisfied about the received treatment: 78% of the uterine artery embolization group vs 87% in the hysterectomy group. CONCLUSION: In about two thirds of uterine artery embolization-treated patients with symptomatic uterine fibroids a hysterectomy can be avoided. Health-related quality of life 10 years after uterine artery embolization or hysterectomy remained comparably stable. Uterine artery embolization is a well-documented and less invasive alternative to hysterectomy for symptomatic uterine fibroids on which eligible patients should be counseled.


Subject(s)
Hysterectomy/methods , Leiomyoma/therapy , Menorrhagia/therapy , Uterine Artery Embolization/methods , Uterine Neoplasms/therapy , Adult , Cost-Benefit Analysis , Female , Follow-Up Studies , Health Status , Humans , Hysterectomy/economics , Leiomyoma/complications , Menorrhagia/etiology , Middle Aged , Patient Satisfaction , Quality of Life , Retreatment , Surveys and Questionnaires , Treatment Outcome , Uterine Artery Embolization/economics , Uterine Neoplasms/complications
11.
Clin Exp Obstet Gynecol ; 42(2): 224-7, 2015.
Article in English | MEDLINE | ID: mdl-26054124

ABSTRACT

OBJECTIVE: To evaluate the efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) in the treatment of leiomyoma related menorrhagia and to assess the effect of LNG-IUS on uterine, leiomyoma, and ovarian volume. MATERIALS AND METHODS: In this prospective before and after study, LNG-IUS was inserted in 38 women with myoma-related menorrhagia. The patients were evaluated for serum levels of hemoglobin, hematocrit and uterine, leiomyoma, and ovarian volume at the time of insertion and at six months. RESULTS: Significant reduction in the Pictorial Blood Loss Assessment Chart (PBAC) score and increases in serum hemoglobin levels and in amenorrhea was observed within three months. However, there was no statistically significant reduction in the myoma and uterine volume. Ovarian volume, also, did not changed significantly. CONCLUSION: The use of LNG-IUS is effective in reducing menorrhagia associated with leiomyomas with improvement in hemoglobin levels and may be a simple and effective alternative to surgical treatment of leiomyoma-related abnormal uterine bleeding (AUB-L) without significant influence on the volume of leiomyoma and ovarian and uterine volume.


Subject(s)
Intrauterine Devices, Medicated , Leiomyoma/therapy , Levonorgestrel/administration & dosage , Menorrhagia/therapy , Uterine Neoplasms/therapy , Adult , Amenorrhea , Female , Hemoglobins/analysis , Humans , Intrauterine Devices , Leiomyoma/complications , Menorrhagia/etiology , Middle Aged , Prospective Studies , Uterine Neoplasms/complications
12.
Eur J Obstet Gynecol Reprod Biol ; 182: 220-5, 2014 Nov.
Article in English | MEDLINE | ID: mdl-25445104

ABSTRACT

OBJECTIVE: To examine the use of medical management, uterus-preserving surgery (UPS), and complementary treatments among women with uterine fibroids. STUDY DESIGN: Prospective cohort study of 933 premenopausal women ages 31-54 years with symptomatic fibroids who participated in the Study of Pelvic Problems, Hysterectomy, and Intervention Alternatives (SOPHIA) for an average of 4.3 years (SD 2.5 years). Incident use of fibroid treatments was determined through annual interviews. Linear regression models were used to compare changes in fibroid-related symptoms among women who underwent UPS versus those who did not undergo surgery. RESULTS: Participants were racially and ethnically diverse, with a mean age of 43 years. During study follow-up, 531 participants (57%) did not undergo UPS or hysterectomy, 250 (27%) had at least one UPS, and 152 (16%) underwent hysterectomy. Complementary and alternative treatments were commonly used, including exercise (45%), diet (34%), herbs (37%), and acupuncture (16%): participants reported significant symptom improvement and few side effects with these interventions. In multivariable linear regression models, women who did not undergo surgery during the study reported improvement in dyspareunia (p<.001), pelvic pain (p<.001), and menstrual cramps (p<.001). However, women who underwent UPS reported greater overall resolution of "pelvic problems" compared with women who did not have surgical treatment (difference in change score 1.18 on a four-point Likert scale, p<.001). CONCLUSION: UPS are effective treatments for women with fibroids, but many women use hormonal or complementary treatments and report significant symptom improvement without surgical intervention.


Subject(s)
Leiomyoma/therapy , Organ Sparing Treatments , Uterine Neoplasms/therapy , Acupuncture Therapy , Adult , Analgesics, Opioid/therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Contraceptives, Oral, Hormonal/therapeutic use , Diet , Dyspareunia/etiology , Endometrial Ablation Techniques , Exercise , Female , Follow-Up Studies , Humans , Hysterectomy , Leiomyoma/complications , Low Back Pain/etiology , Middle Aged , Pelvic Pain/etiology , Plant Preparations/therapeutic use , Prospective Studies , Treatment Outcome , Uterine Artery Embolization , Uterine Hemorrhage/etiology , Uterine Myomectomy , Uterine Neoplasms/complications
13.
Lik Sprava ; (3-4): 78-82, 2014.
Article in Ukrainian | MEDLINE | ID: mdl-25286603

ABSTRACT

Efficacy Erbisol in combination with Lymphomyosot and Echinacea compositum C in medical rehabilitation of women of reproductive age with fatigue syndrome and chronic gynecological pathology was studied. It was found that this complex of medications promotes faster and more effective reduction of the level of circulating immune complexes in the serum, achievement of persistent clinical remission of disease and liquidation of fatigue syndrome manifestations, what improves the quality of life of patients.


Subject(s)
Biological Factors/therapeutic use , Endometriosis/drug therapy , Fatigue Syndrome, Chronic/drug therapy , Leiomyoma/drug therapy , Polycystic Ovary Syndrome/drug therapy , Adult , Antigen-Antibody Complex/blood , Echinacea/chemistry , Endometriosis/complications , Endometriosis/physiopathology , Fatigue Syndrome, Chronic/complications , Fatigue Syndrome, Chronic/physiopathology , Female , Humans , Leiomyoma/complications , Leiomyoma/physiopathology , Plant Extracts/therapeutic use , Polycystic Ovary Syndrome/complications , Polycystic Ovary Syndrome/physiopathology , Quality of Life , Treatment Outcome
14.
Med Pregl ; 67(3-4): 111-7, 2014.
Article in English | MEDLINE | ID: mdl-24961054

ABSTRACT

INTRODUCTION: Cesarean section is more frequent in pregnant women with uterine myomas, and is usually complicated with perioperative hemorrhage. In some cases, cesarean myomectomy represents an inevitable surgery, adding risk of hemorrhage occurrence. Massive obstetric hemorrhage is the most common cause of maternal mortality and morbidity. The aim of this study was to show our experience and results of the implementation of intraoperative blood salvage during cesarean section in the patients with uterine myomas. MATERIAL AND METHODS: The study encompassed four patients with uterine myomas who had cesarean delivery at our Department in the period from 2010 to 2011. RESULTS: Postoperative transfusion of packed red blood cells was given to one patient. No complications resulting form the intraoperative blood salvage were recorded in our research. CONCLUSION: Intraoperative blood salvage should be applied in patients with uterine myoma, and certainly in those who are planned for cesarean myomectomy and particularly in cases when massive intraoperative hemorrhage is expected.


Subject(s)
Blood Transfusion, Autologous , Cesarean Section/adverse effects , Leiomyoma/complications , Operative Blood Salvage , Postpartum Hemorrhage/therapy , Uterine Neoplasms/complications , Adult , Erythrocyte Transfusion , Female , Humans , Middle Aged , Pregnancy , Retrospective Studies
15.
N Engl J Med ; 366(5): 409-20, 2012 Feb 02.
Article in English | MEDLINE | ID: mdl-22296075

ABSTRACT

BACKGROUND: The efficacy and safety of oral ulipristal acetate for the treatment of symptomatic uterine fibroids before surgery are uncertain. METHODS: We randomly assigned women with symptomatic fibroids, excessive uterine bleeding (a score of >100 on the pictorial blood-loss assessment chart [PBAC, an objective assessment of blood loss, in which monthly scores range from 0 to >500, with higher numbers indicating more bleeding]) and anemia (hemoglobin level of ≤10.2 g per deciliter) to receive treatment for up to 13 weeks with oral ulipristal acetate at a dose of 5 mg per day (96 women) or 10 mg per day (98 women) or to receive placebo (48 women). All patients received iron supplementation. The coprimary efficacy end points were control of uterine bleeding (PBAC score of <75) and reduction of fibroid volume at week 13, after which patients could undergo surgery. RESULTS: At 13 weeks, uterine bleeding was controlled in 91% of the women receiving 5 mg of ulipristal acetate, 92% of those receiving 10 mg of ulipristal acetate, and 19% of those receiving placebo (P<0.001 for the comparison of each dose of ulipristal acetate with placebo). The rates of amenorrhea were 73%, 82%, and 6%, respectively, with amenorrhea occurring within 10 days in the majority of patients receiving ulipristal acetate. The median changes in total fibroid volume were -21%, -12%, and +3% (P=0.002 for the comparison of 5 mg of ulipristal acetate with placebo, and P=0.006 for the comparison of 10 mg of ulipristal acetate with placebo). Ulipristal acetate induced benign histologic endometrial changes that had resolved by 6 months after the end of therapy. Serious adverse events occurred in one patient during treatment with 10 mg of ulipristal acetate (uterine hemorrhage) and in one patient during receipt of placebo (fibroid protruding through the cervix). Headache and breast tenderness were the most common adverse events associated with ulipristal acetate but did not occur significantly more frequently than with placebo. CONCLUSIONS: Treatment with ulipristal acetate for 13 weeks effectively controlled excessive bleeding due to uterine fibroids and reduced the size of the fibroids. (Funded by PregLem; ClinicalTrials.gov number, NCT00755755.).


Subject(s)
Leiomyoma/drug therapy , Menorrhagia/drug therapy , Norpregnadienes/therapeutic use , Receptors, Progesterone/antagonists & inhibitors , Uterine Neoplasms/drug therapy , Administration, Oral , Adult , Anemia/etiology , Double-Blind Method , Female , Humans , Intention to Treat Analysis , Leiomyoma/complications , Leiomyoma/surgery , Menorrhagia/etiology , Middle Aged , Norpregnadienes/administration & dosage , Norpregnadienes/adverse effects , Uterine Neoplasms/complications , Uterine Neoplasms/surgery , Uterus/pathology , Young Adult
16.
J Minim Invasive Gynecol ; 19(2): 212-6, 2012.
Article in English | MEDLINE | ID: mdl-22296749

ABSTRACT

STUDY OBJECTIVE: To analyze the long-term efficacy of hydrothermal ablation (HTA) in women with a normal uterine cavity and submucous uterine myomas. DESIGN: Retrospective study (Canadian Task Force classification II-2). SETTING: Roskilde University Hospital surgical daycare unit. PATIENTS: One hundred sixty-six consecutive patients with abnormal uterine bleeding who underwent HTA from 2004 to 2008. All patients were asked to fill out a specific questionnaire that included questions related to postoperative bleeding patterns, complications, and satisfaction with the procedure. One hundred thirty-six patients (81.9%) completed the questionnaire, including 33 women (24.3%) with submucous myomas. INTERVENTION: The HTA procedure was performed in accordance with previous descriptions. MEASUREMENTS AND MAIN RESULTS: Mean (SD; 95% CI) follow-up was 33 (10.5; 25.5-31.8) months. Amenorrhea was achieved in 57 women with myomas (55.3%) and 17 women (51.5%) without myomas (p = .47). Postoperative light bleeding was reported in 26 women with myomas (25.2%) and 6 women (18.2%) without myomas. During follow-up, 13 women with myomas (12.6%) underwent hysterectomy, compared with 6 women without myomas (18.2%). Postoperatively, the mean (SD; 95% CI) number of days per month with bleeding was reduced in both groups, from 13.62 (7.90; 11.87-15.37) to 1.34 (2.32; 0.84-1.84) days in the group with myomas, and from 14.78 (8.81; 10.97-18.59), to 1.88 (4.38; 0.12-3.65) without myomas. Similarly, both groups reported improved quality of life: 74.8% and 72.7%, respectively (p = .59). Compared with patients with myomas 3 cm or smaller, patients with myomas larger than 3 cm demonstrated a significantly higher rate of severe bleeding postoperatively (p = .02). CONCLUSION: Our results demonstrate that HTA is associated with a high rate of amenorrhea in patients with or without submucous myomas. However, a significantly lower effect may be observed in patients with myomas larger than 3 cm.


Subject(s)
Endometrial Ablation Techniques/methods , Hydrotherapy/methods , Hyperthermia, Induced/methods , Leiomyoma/complications , Menorrhagia/surgery , Uterine Neoplasms/complications , Adult , Female , Follow-Up Studies , Humans , Hysteroscopy , Menorrhagia/complications , Middle Aged , Patient Satisfaction , Postoperative Complications , Quality of Life , Retrospective Studies , Surveys and Questionnaires , Treatment Outcome
17.
Fertil Steril ; 96(1): e13-5, 2011 Jul.
Article in English | MEDLINE | ID: mdl-21561613

ABSTRACT

OBJECTIVE: To report the usefulness of electroacupuncture (EA) for the management of menorrhagia due to submucous uterine fibroid. DESIGN: Case report. SETTING: University hospital. PATIENT(S): A 48-year-old woman with a symptomatic submucous uterine fibroid, who presented with severe menorrhagia. INTERVENTION(S): Electroacupuncture. MAIN OUTCOME MEASURE(S): Doppler ultrasonographic assessment of uterine blood flow and number of pads used during menorrhagia. RESULT(S): Doppler ultrasound revealed decreased blood flow of the uterine artery with EA stimulation. With repetitive sessions of EA fewer pads were used during menorrhagia. CONCLUSION(S): We present the first human case in which decreasing uterine artery blood flow with EA improved menorrhagia due to uterine fibroma. Electroacupuncture could be a useful, alternative, and relatively noninvasive tool for the management of fibroids with menorrhagia as a severe complaint.


Subject(s)
Electroacupuncture , Hemorrhage/therapy , Leiomyoma/therapy , Uterine Neoplasms/therapy , Electroacupuncture/methods , Female , Hemorrhage/diagnostic imaging , Hemorrhage/etiology , Humans , Leiomyoma/complications , Leiomyoma/diagnostic imaging , Middle Aged , Ultrasonography , Uterine Neoplasms/complications , Uterine Neoplasms/diagnostic imaging
18.
J Vasc Interv Radiol ; 20(7): 863-70, 2009 Jul.
Article in English | MEDLINE | ID: mdl-19555885

ABSTRACT

PURPOSE: To evaluate whether electroacupuncture is a safe and effective alternative to pharmacologic sedation/analgesia in uterine artery embolization (UAE) for leiomyomas. MATERIALS AND METHODS: A nonrandomized prospective study was undertaken in 70 consecutive patients (mean age, 39.5 years) undergoing UAE with polyvinyl alcohol (PVA) particles between August 2006 and January 2007. Thirty-three patients chose to undergo UAE under electroacupuncture anesthesia (EAA; group A) and 37 were treated under local pharmacologic anesthesia (group B). Pain scores (rated from 0 to 10) in both groups were compared during and after the procedure. The outcome of UAE was evaluated at 6 months. RESULTS: Mean pain scores during embolization were 0.36 in group A and 0.84 in group B; scores after embolization and before discharge were 3.00 in group A and 4.49 in group B; and scores at discharge were 0.97 in group A and 2.11 in group B. These differences were statistically significant after embolization and at hospital discharge (P= .02 and P= .0001, respectively). All patients except one in each group were discharged from the hospital 4-8 hours after UAE; the two who remained longer had severe pain. There were no significant differences in clinical outcomes, nor in uterine and leiomyoma volumes, at discharge and at 6 months (P > 0.99 and P= .72, respectively). CONCLUSIONS: There was a statistically significant postembolization pain reduction in patients treated under EAA versus local pharmacologic anesthesia and no differences in UAE outcomes between groups at 6 months.


Subject(s)
Electroacupuncture/methods , Leiomyoma/therapy , Pelvic Pain/prevention & control , Transcutaneous Electric Nerve Stimulation/methods , Uterine Artery Embolization/methods , Uterine Neoplasms/therapy , Adult , Female , Humans , Leiomyoma/complications , Middle Aged , Pain , Pelvic Pain/etiology , Treatment Outcome , Uterine Neoplasms/complications
19.
Phytother Res ; 23(10): 1411-4, 2009 Oct.
Article in English | MEDLINE | ID: mdl-19274703

ABSTRACT

Abnormal uterine bleeding (AUB) is a common cause of referral to the gynecology clinic. Portulaca oleracea L., commonly named purslane, is used in Iranian folk medicine to treat AUB. To verify this use, ten premenopausal women with AUB comprising menorrhagia, metrorrhagia, polymenorrhea and intermenstrual bleeding who had not responded to standard drugs and were candidates for hysterectomy participated in the clinical trial. Endometrial biopsies demonstrated the etiologies of AUB in six (60%) patients, fibroma; one (10%) patient, endometrial hyperplasia and one (10%) patient, endometrial cyst. Endometrial biopsies of two (20%) subjects were normal. The subjects took 5 g of purslane seeds powder in a glass of water every 4 h orally 48 h after the onset of menstruation for 3 days. The participants were requested to report the effects of seeds powder on the volume, duration and pattern of bleeding. Eight (80%) patients reported that the duration and volume of bleeding had reduced and their patterns of periods had normalized. The seeds powder was ineffective in two (20%) patients. One of the patients had endometrial hyperplasia and the other had fibroma. No adverse effects were reported. AUB did not recur in the patients responding to treatment for the duration of a 3 months follow-up. The results suggest that purslane seeds could be effective and safe in the treatment of AUB.


Subject(s)
Endometrium/drug effects , Phytotherapy , Plant Preparations/therapeutic use , Portulaca , Uterine Hemorrhage/drug therapy , Adult , Cysts/drug therapy , Cysts/pathology , Drug Administration Schedule , Endometrial Hyperplasia/drug therapy , Endometrium/blood supply , Female , Humans , Iran , Leiomyoma/complications , Leiomyoma/drug therapy , Menstruation Disturbances/drug therapy , Middle Aged , Pilot Projects , Powders , Premenopause , Reference Values , Seeds , Uterine Hemorrhage/etiology , Uterine Neoplasms/complications , Uterine Neoplasms/drug therapy
20.
Arch. esp. urol. (Ed. impr.) ; 60(6): 684-687, jul.-ago. 2007. ilus
Article in Es | IBECS | ID: ibc-055527

ABSTRACT

Objetivo: Los tumores mesoteliales primarios de la vejiga son entidades raras, y de entre ellos el más frecuente es el leiomioma vesical, que puede crecer sin apenas manifestaciones clínicas o muy inespecíficas. Métodos: Presentamos el caso de un leiomioma vesical en dos pacientes y la revisión de la literatura. Resultados: El tratamiento fue mediante una resección transuretral, la evolución excelente y el seguimiento en consultas externas tras más de 5 años sin incidencias. Conclusiones: El abordaje quirúrgico sigue siendo la mejor solución, de fácil ejecución y con un porcentaje escaso de complicaciones. El pronóstico es bueno en cualquier caso y las recidivas son anecdóticas (AU)


Objective: Primary mesothelial tumors of the bladder are rare entities, being leiomyoma the most frequent of them. It may grow without any clinical symptoms or with very unspecific ones. Methods: We report two cases of bladder leiomyoma in 2 patients, and performed a bibliographic review. Results: They were treated by transurethral resection, with an excellent outcome, without incidences over five years of follow-up. Conclusions: Surgical treatment continues to be the best solution; it is easy to perform and has a very limited number of complications. Prognosis is good in any case and progression is anecdotic (AU)


Subject(s)
Female , Middle Aged , Humans , Leiomyoma/surgery , Neoplasms, Mesothelial/surgery , Urinary Bladder Neoplasms/surgery , Leiomyoma/complications , Leiomyoma/diagnosis , Transurethral Resection of Prostate/methods , Urologic Surgical Procedures/methods , Prognosis , Neoplasms, Mesothelial/complications , Neoplasms, Mesothelial/diagnosis , Urinary Bladder Neoplasms/complications , Urinary Bladder Neoplasms/diagnosis
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