Effect of Estradiol valerate plus dienogest on body composition of healthy women in the menopausal transition: a prospective one-year evaluation

In the menopausal transition (MT), combined oral contraceptive (COC) should be chosen accordingly to its neutrality on liver metabolism and to its ability to counter the increase of fat mass (FM) that occurs in this reproductive period of life. This prospective multi-centric observational study was conducted on 36 women in their MT at the Universities of Cagliari, Modena and Naples. The body weight (BW), the Body Mass Index (BMI), the waist to hip ratio (WHR), the measurement of body composition (BC) with the Multi-frequency Bioelectrical Impedance (MF-BIA) were performed before, at the 6th and at the 12th month of the study in which a group of women (control group; N.18) did not assume COC, whereas the other 18 women assumed the four-phasic COC containing estradiol valerate (EV) associated with dienogest (EV/DNG group). In comparison to controls in the EV/DNG group, a significant decrease (p?0.05) of BW (58.8?±?7.6 to 57.3?±?7.0), BMI (24.1?±?2.7 to 23.5?±?2.8), WHR (0.82?±?0.052 to 0.79?±?0.048) and FM (17.7?±?5.4 to 16.4?±?5.6) was observed. In controls, FM significantly increased (17.0?±?11 to 17.7?±?2.7; p?0.05). In conclusion, these results suggest that the anti-androgenic and progestinic activities of DNG associated with a weak estrogenic activity of EV, is a contraceptive method capable of counteracting the negative changes of BC occurring in the MT.     

The use of an oral contraceptive containing estradiol valerate and dienogest before office operative hysteroscopy: a feasibility study

To investigate the impact of a 3 months preoperative administration of an oral contraceptive, containing dienogest (DNG) and estradiol valerate (E₂V) on the outcome of office operative hysteroscopy (OOH). One-hundred and forty-two patients diagnosed at office hysteroscopy as having an asynchronous endometrium associated with either a broad-base sessile endometrial polyp (>1.5, <2.5 cm) or a uterine septum (>1/3 uterine cavity) or scheduled for tubal sterilization were enrolled into a prospective case-control study at University “Federico II” of Naples. 86/142 patients accepted the preoperative hormonal treatment (Group A), while 56/142 refused, thus becoming controls (Group B). Group A underwent OOH during the 10th–20th days of the third cycle of treatment. In Group B OOH was performed at enrolment, together with the diagnostic procedure. The study outcomes were: endometrial pattern, success rate, operating time, degree of surgical difficulty and pain score. An overall improvement of the endometrium was reported in 100% of cases in Group A. A statistically significant difference in success rate could not be demonstrated between two groups. Operative procedures were performed significantly quicker and easier in Group A than Group B (p < 0.001 and p < 0.05, respectively). The mean Visual Analog Scale (VAS) score was significantly lower in Group A (p < 0.001). A short pretreatment with combined oral contraceptive (COC) containing E₂V/DNG seems to have a favorable impact on endometrium which in turn may result in an improvement of the overall outcomes of OOH.     

Efficacy of dienogest in the treatment of symptomatic adenomyosis: a pilot study

Adenomyosis is a common disorder in premenopausal women that causes dysmenorrhea, pelvic pain and menorrhagia. Considering that adenomyosis is an estrogen-dependent disease, the medical treatment is based on this hormone. Effective and well-tolerated medical treatments for symptomatic adenomyosis are needed. Dienogest, an oral progestin, has been extensively investigated in the treatment of endometriosis. In this report, we present the results on the efficacy and safety of dienogest in the treatment of symptomatic adenomyosis. Seventeen patients with symptomatic adenomyosis were included in this study, of which 15 continued dienogest for up to 24 weeks. Dienogest significantly reduced adenomyosis-associated pelvic pain as well as serum CA-125 and CA19-9 levels. It also demonstrated a modest suppression of estradiol (>50?pg/?mL), which is consistent with the findings of other reports. During treatment, five patients experienced worsening anemia because of metrorrhagia, which is the most frequent adverse effect associated with dienogest. This report suggests that dienogest is an effective and well-tolerated therapy for symptomatic adenomyosis.     

Ibuprofen and naproxen-sodium in the treatment of primary dysmenorrhea: a double-blind cross-over study

The efficacy of ibuprofen and naproxen-sodium for the treatment of primary dysmenorrhea was evaluated in a double-blind cross-over study in 57 otherwise healthy women. The severity of pain reported by the patients was significantly (P less than 0.01) reduced during treatment with both ibuprofen and naproxen-sodium compared to the severity of pain before the first dose. The mean pain relief during treatment with ibuprofen was significantly (P less than 0.05) greater than during treatment with naproxen-sodium in the dosages indicated.     

Effect of alpha-lipoic acid at the combination with mefenamic acid in girls with primary dysmenorrhea: randomized,double-blind,placebo-controlled clinical trial

Primary dysmenorrhea is a common gynecologic disorder and is one of the main causes for referral to the gynecology clinic. This study aimed to determine the effects of alpha-lipoic acid (ALA) and mefenamic acid and a combination compared with placebo on the girls with primary dysmenorrhea. This double-blind, placebo-controlled clinical trial done on population consisted of female students living in dormitories of Qazvin University of Medical Sciences who had moderate to severe dysmenorrhea using the Visual Analog Scale (VAS) questionnaire. Participants were randomly divided into four groups (n?=?100): ALA, mefenamic acid, ALA?+?mefenamic acid and placebo groups. ALA and mefenamic acid were administrated in 600?mg and 250?mg, respectively. The severity of the pain was measured in the beginning and the end of the study. Statistical analysis was performed using SPSS software (SPSS Inc., Chicago, IL). Our final results suggested that, although mefenamic acid significantly decreased the menstrual pain, ALA supplementation, 600?mg, would be more efficient than mefenamic acid in 250?mg. Also, the combination of ALA and mefenamic acid significantly has been far. Considering the ALA supplementation effect on pain relief in patients with primary dysmenorrhea, this antioxidant can be recommended for the healing of symptoms of these patients.     

Cyproterone acetate versus a continuous monophasic oral contraceptive in the treatment of recurrent pelvic pain after conservative surgery for symptomatic endometriosis.

OBJECTIVE: To evaluate the efficacy and safety of cyproterone acetate versus an oral contraceptive in the treatment of endometriosis-associated recurrent pelvic pain. DESIGN: Randomized controlled trial. SETTING: Academic center. PATIENT(S): Ninety women with recurrent moderate or severe pelvic pain after conservative surgery for symptomatic endometriosis. INTERVENTION(S): Six months of continuous treatment with oral cyproterone acetate, 12.5 mg/d, or an oral contraceptive containing ethinyl estradiol, 0.02 mg, and desogestrel, 0.15 mg. MAIN OUTCOME MEASURE(S): Degree of satisfaction with therapy. RESULT(S): Six patients in the cyproterone acetate arm and nine in the oral contraceptive arm withdrew because of side effects (n = 9), treatment inefficacy (n = 4), or loss to follow-up (n = 2). At 6 months, dysmenorrhea, deep dyspareunia, and nonmenstrual pelvic pain scores were substantially reduced, and significant improvements were observed in health-related quality-of-life, psychiatric profile, and sexual satisfaction; no major between-group differences were seen. Subjective and metabolic side effects were limited. According to an intention-to-treat analysis, 33 of 45 (73%) of patients in the cyproterone acetate group and 30 of 45 (67%) in the oral contraceptive group were satisfied with the treatment received. CONCLUSIONS: Both cyproterone acetate and a continuous monophasic oral contraceptive were effective, safe, and inexpensive therapy for recurrent pain after conservative surgery for endometriosis.     

地诺孕素用于难治性子宫内膜异位症疼痛的临床研究

目的评价地诺孕素(DNG)对于难治性子宫内膜异位症(内异症)疼痛的临床疗效和安全性。方法本研究将难治性内异症疼痛定义为:(1)内异症相关疼痛时间≥12个月,疼痛视觉模拟评分(VAS)≥60 mm;(2)既往经口服避孕药、左炔诺孕酮宫内缓释系统等2种以上药物治疗效果不满意,VAS评分降幅<50%;或应用促性腺激素释放激素激动剂、米非司酮等可控制疼痛,但停药后疼痛再次发生;(3)疼痛经手术或反复手术后,仍不能控制。本研究对2016年11月至2020年2月48例符合标准的难治性内异症疼痛患者口服DNG(2 mg/d)的治疗情况进行回顾性分析,比较用药前后VAS评分、CA125水平、雌二醇、FSH、LH、内异症病灶大小的变化,并记录副作用。结果DNG用药时间为(20.1±12.8)个月。用药3个月时VAS评分由基线的(77.9±15.8)mm显著降低至(20.8±10.7)mm(P<0.01),CA125水平由基线的(95±139)kU/L显著降低至(38±45)kU/L(P<0.05)。随着用药时间延长,疼痛缓解的治疗效果继续维持,CA125继续维持在低水平。卵巢子宫内膜异位囊肿经用药12个月后囊肿最大径线由(3.1±1.0)cm显著缩小至(1.9±1.2)cm(P<0.05)。用药期间雌二醇平均水平维持在124.82~221.04 pmol/L,FSH、LH水平无明显变化。主要副作用是不规则出血(75%,36/48)。结论DNG能有效缓解内异症疼痛,且耐受性好,可作为复杂的难治性内异症疼痛患者长期治疗的选择之一。     

Effect of estradiol valerate on the pregnancy rate in patients receiving letrozole for induction of ovulation

Background

Letrozole is as effective as clomiphene citrate for induction of ovulation in patients with PCOS. Adequate endometrial development is required for pregnancy to occur, and pregnancy rates were found to be higher when the endometrium reached at least 10 mm thickness.

Comparison of fennel and mefenamic acid for the treatment of primary dysmenorrhea.

OBJECTIVES: To compare the effect of Foeniculum vulgare variety dulce (Sweet Fennel) vs. mefenamic acid for the treatment of primary dysmenorrhea. METHODS: A cohort of seventy women, 15-24 years old from a local university and high-school, who complained of dysmenorrhea were enrolled in this study. Ten cases were excluded due to evidence of secondary dysmenorrhea. The remaining 60 patients were graded mild, moderate and severe on the basis of a verbal multidimensional scoring system. Thirty patients with mild dysmenorrhea were also excluded from the study. Each of the 30 cases with moderate to severe dysmenorrhea was evaluated for three cycles. In the first cycle no medication was given (control cycle), in the second cycle the cases were treated by mefenamic acid (250 mg q6h orally) and in the third cycle, essence of Fennel's fruit with 2% concentration (25 drops q4h orally), was prescribed at the beginning of the cycle. These cycles were compared day by day for the effect, potency, time of initiation of action and also complications associated with each treatment modality, by using a self-scoring system. Intensity of pain was reported by using a 10-point linear analog technique. Statistical analyses were performed by the independent sample t-test, paired t-test and repeated measurement analysis method. RESULTS: In the study group the mean age of menarche was 12.5+/-1.3 years, the mean duration of menstruation was 6.6+/-1.4 days with the mean cycle days of 27+/-3. The findings observed during menses were as follows: headache in 26.7%, nausea in 63.3%, vomiting in 23.3%, diarrhea in 33.3%, fatigue in 93.3% and leaving the daily tasks undone was reported in 86.9% of the cases. Both of the drugs effectively relieved menstrual pain as compared with the control cycles (P<0.001). The mean duration of initiation of action was 67.5+/-46.06 min for mefenamic acid and 75+/-48.9 min for fennel. The difference was not statistically significant (P=0.57). Mefenamic acid had a more potent effect than fennel on the second and third menstrual days (P<0.05), however, the difference on the other days was not significant. No complication was reported in mefenamic acid treated cycles, but five cases (16.6%) withdrew from the study due to fennel's odor and one case (3.11%) reported a mild increase in the amount of her menstrual flow. CONCLUSIONS: The essence of fennel can be used as a safe and effective herbal drug for primary dysmenorrhea, however, it may have a lower potency than mefenamic acid in the dosages used for this study.     

Rose tea for relief of primary dysmenorrhea in adolescents: a randomized controlled trial in Taiwan

Primary dysmenorrhea occurs in as many as 50% of female adolescents and is associated with significant decreases in academic performance, sports participation, and socialization with peers. Complementary and alternative medicine treatment options are of interest to patients and health care providers. The use of rose tea to alleviate menstrual pain has long been a part of folk knowledge around the world but has not been studied scientifically. To determine the effectiveness of drinking rose tea as an intervention for reducing pain and psychophysiologic distress in adolescents with primary dysmenorrhea, 130 female adolescents were randomly assigned to an experimental (n = 70) and a control (n = 60) group. Preintervention and postintervention data at 1 month, 3 months, and 6 months were gathered on the biopsychosocial outcomes of dysmenorrhea. The results showed that compared with the control group, the experimental group perceived less menstrual pain, distress, and anxiety and showed greater psychophysiologic well-being through time, at 1, 3, and 6 months after the interventions. Findings suggest that drinking rose tea is a safe, readily available, and simple treatment for dysmenorrhea, which female adolescents may take to suit their individual needs.     

Vitamin E and fish oil,separately or in combination,on treatment of primary dysmenorrhea: a double-blind,randomized clinical trial

Primary dysmenorrhea is one of the most common complaints of women. The aim of this study was to investigate the adjuvant effect of vitamin E and omega-3 fatty acids, separately or in combination, supplements on pain in the treatment of primary dysmenorrhea. This clinical trial conducted on students of university. Qualified girls completed the VAS before randomization. Arrangement was determined according to the severity of the pain (mild 0–3; moderate 3.1–6; severe 6.1–10). One hundred patients were randomly assigned to four groups receiving omega-3 (n?=?25), vitamin E (n?=?25), vitamin E- omega-3 (n?=?25), or placebo (n?=?25). Three hundred milligrams of omega-3 capsules (180?mg EPA and 120?mg DHA) and 200 international units (IU) vitamin E were administered daily. Severity of the pain measured in the beginning and the end of the study. Omega-3 and vitamin E supplements effectively relieved menstrual pain compared with the placebo. But in group with combination of vitamin E?+?omega-3 has a considerable effect on menstrual pain when compared with other groups (p?相似文献   

Non-steroidal anti-inflammatory drug modulates oxidative stress and calcium ion levels in the neutrophils of patients with primary dysmenorrhea

Primary dysmenorrhea is a common inflammatory disease with an uncertain pathogenesis, although one consistent finding is increased neutrophil activity. We aimed to investigate the effects of a non-steroidal anti-inflammatory drug (NSAID) on oxidative stress and Ca²⁺ levels in neutrophils from patients with primary dysmenorrhea. Blood samples were obtained for neutrophil isolation from six female patients with primary dysmenorrhea (patients) and six healthy female subjects. The NSAID (diclofenac) was taken daily by the patient group for 6 weeks before a second blood sample was taken. Neutrophils isolated after diclofenac treatment were investigated in three settings: (1) after incubation with verapamil and diltiazem (V + D), (2) after incubation with 2-aminoethoxydiphenyl borate (2-APB), and (3) with neither exposure. Neutrophil lipid peroxidation and stimulated intracellular Ca²⁺ levels were higher in the patients than in the controls, although their levels were reduced after six weeks of treatment with diclofenac. Ca²⁺ levels from neutrophils obtained after diclofenac treatment were further decreased after incubation with V + D or 2-APB, compared with those exposed to neither agent. Neutrophil glutathione peroxidase and total antioxidant status were lower in the patients than in the controls and higher post-treatment with diclofenac. Reduced glutathione levels were similar in the control, patient, and treatment groups. In conclusion, we observed the importance of Ca²⁺ influx into the neutrophils and oxidative stress in the pathogenesis of the patients with primary dysmenorrhea. The NSAID diclofenac appeared to provide a protective effect against oxidative stress and Ca²⁺ entry through modulation of neutrophil VGCC and TRP calcium channels.     

A dose-ranging study to determine the efficacy and safety of 1, 2, and 4 mg of dienogest daily for endometriosis

Objectives

To compare the efficacy and safety of dienogest at doses of 1, 2, and 4 mg/day orally in the treatment of endometriosis.

Methods

An open-label, randomized, multicenter, 24-week comparative trial in women with histologically confirmed endometriosis. Efficacy was assessed by second-look laparoscopy and patient-reported symptoms. Statistical tests included χ² and Wilcoxon signed rank tests.

Results

Dienogest reduced mean revised American Fertility Society scores from 11.4 to 3.6 (n = 29; P < 0.001) in the 2-mg group and from 9.7 to 3.9 (n = 35; P < 0.001) in the 4-mg group. Dienogest at 2 and 4 mg/day was associated with symptom improvements in substantial proportions of women. Both dienogest doses were generally well tolerated, with low rates of treatment discontinuation due to adverse events. The 1-mg dose arm was discontinued owing to insufficient bleeding control.

Conclusion

Dienogest at 2 mg once a day is recommended as the optimal dose in future studies of endometriosis.     

Pelvic exenteration for the treatment of gynecological malignancies

Twenty-three patients undergoing pelvic exenteration for primary and recurrent gynecological malignancies from 1976 to 1994 are reported. Fifteen patients underwent total pelvic exenteration, 3 underwent anterior exenteration, and 5 underwent a posterior procedure. Eight patients had exenteration as their primary treatment (primary group), and 15 underwent exenteration as secondary treatment (recurrent group). In the primary group, two patients developed recurrence and died of it at 6 and 20 months after operation. Five patients are still being followed up and are alive without disease. Four of these 5 patients have survived more than 5 years. In the recurrent group, 12 patients were followed up and three died of complications during the early years. Seven patients died of cancer with the mean survival time of 16.6 months. The mean age, average operating time, and mean blood loss in the primary and recurrent groups were 57 vs. 53 years, 8 hours and 20 min vs. 8 hours and 10 min, and 4,120 vs. 4,190 ml, respectively. The overall cumulative 5-year survival rate was 34.7%, being 68.6% in the primary group and 16.7% in the recurrent group. It is noteworthy that the 5-year survival rate was 51.3% in the patients who had surgical margins free of disease. In conclusion, pelvic exenteration should be considered an acceptable therapeutic option when appropriately selected.     

散结镇痛胶囊对子宫内膜异位症及子宫腺肌病痛经治疗效果观察

目的评价散结镇痛胶囊对子宫内膜异位症及子宫腺肌病痛经的临床治疗价值。方法以2008年12月至2009年3月北京协和医院收治的61例主诉中重度痛经症状的子宫内膜异位症和子宫腺肌病患者为研究对象,45例进入研究组(给予散结镇痛胶囊治疗),16例进入对照组(给予非甾体抗炎药治疗),进行前瞻性对照研究。结果研究组用药后痛经症状完全缓解8例,部分缓解30例,无效7例,有效率84.4%;对照组痛经完全缓解0例,部分缓解6例,有效率37.5%,两组相比差异有统计学意义(P<0.05)。两组子宫体积大小无明显变化。结论散结镇痛胶囊能有效缓解子宫内膜异位症和子宫腺肌病患者的痛经症状,副反应小。     

The efficacy of Implanon for the treatment of chronic pelvic pain associated with pelvic congestion: 1-year randomized controlled pilot study

Objective  To evaluate the beneficial effects of Implanon on pelvic pain in women with pelvic congestion syndrome (PCS). The efficacy of pain control, amount and frequency of menstrual loss, degree of patient’s satisfaction and objective pelvic venography scores were investigated. Methods  In a prospective open-labelled study, 25 consecutive women complaining of chronic pelvic pain were recruited. Pretreatment objective peruterine venography and diagnostic laparoscopy of pure PCS together with subjective pelvic pain scores, prefilled questionnaire of Hospital Anxiety and Depression Scale (HADS), visual analogue scale (VAS), verbal rating scale (VRS) and quantified menstrual loss using the pictorial blood loss chart were documented in all cases. After identification, 23 subjects with pure PCS were randomly assigned to have either Implanon inserted subcutaneously (12 cases) or no treatment (11 cases). Patients were followed up at 1, 3, 6, 9 and 12 months. A symptom diary for side effects, VAS, VRS and menstrual scores were used to assess the subjective response to treatment. At the end of the study, all patients underwent repeat venography to assess the long-term objective response. After 12 months, subjects having Implanon inserted were requested to rate their overall degree of satisfaction with therapy. Results  All 25 women recruited in the study completed follow-up. Two cases were excluded from the study and referred to the psychiatry department after a negative evaluation for disease and HADS scores relevant for depression. An improvement in symptoms was observed throughout the 12 months amongst the Implanon group versus no treatment. The greatest changes in pain assessed using either the VAS or VRS were between the pretreatment scores and those after 6 months (7.7 ± 1.3 vs. 4.6 ± 3.0 for VAS, P < 0.001; and 25 ± 13.8 vs. 19 ± 18.9 for VRS, P < 0.002). The monthly quantified blood loss fell from 204 (196) pretreatment to 90 (157) at 6 months (P < 0.001) and then to 64 (32) at 9 months (P < 0.002). Objective repeat venography score was reduced significantly at 1 year after treatment compared with the baseline evaluation as well as with the control group (4.5 ± 1.2 vs. 8.6 ± 0.5; P = 0.001 and 4.2 ± 0.9 vs. 8.5 ± 0.6; P = 0.0002, respectively). At final satisfaction assessment, 2 (17%) women were very satisfied 8 (66%) were satisfied, and 2 (17%) were uncertain. The implant was retained by all women at the end of the study. Conclusion  Implanon seems to be an effective hormonal alternative for long-term treatment of properly selected patients with pure PCS-related pelvic pain.