Efficacy and safety of acupuncture on oligomenorrhea due to polycystic ovary syndrome: An international multicenter, pilot randomized controlled trial.

BACKGROUND: Polycystic ovary syndrome (PCOS) is one of the most common disorders of reproductive endocrinology affecting women of reproductive age. Our study aims to explore the feasibility of a full-scale trial to evaluate the efficacy and safety of acupuncture for PCOS. METHODS: This study is a two-armed, parallel, multi-country, multi-center, pilot randomized controlled trial (RCT) for PCOS with oligomenorrhea. We will recruit 60 women aged 20 to 40 years with oligomenorrhea due to PCOS. The participants will be randomly assigned to acupuncture and control groups. The acupuncture group will undergo a total of 40 sessions for 16 weeks with usual care. The control group will be managed with usual care (regular meals, sufficient sleep, and appropriate exercise) only. The primary clinical outcome is mean change in menstrual frequency from baseline to 16 weeks and 32 weeks (follow-up) after the start of the trial. The secondary outcomes are menstrual period, levels of estradiol, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and total testosterone, LH/FSH ratio, antral follicle count and ovarian volume, body mass index, waist hip ratio, acne severity, and health-related quality of life questionnaire scores at 16 and 32 weeks after the start of the trial. DISCUSSION: This is the first protocol for multi-country, multi-center RCTs for PCOS in Korea and China. The control group in this study will be subjected to usual care (regular meals, enough sleep, and appropriate exercise). The results of this study will provide evidence for future clinical decisions and guidelines.This trial has been registered at ClinicalTrials.gov (Identifier: NCT04509817).

Standardised versus individualised multiherb Chinese herbal medicine for oligomenorrhoea and amenorrhoea in polycystic ovary syndrome: a randomised feasibility and pilot study in the UK.

OBJECTIVES: To explore feasibility of a randomised study using standardised or individualised multiherb Chinese herbal medicine (CHM) for oligomenorrhoea and amenorrhoea in women with polycystic ovary syndrome (PCOS), to pilot study methods and to obtain clinical data to support sample size calculations. DESIGN: Prospective, pragmatic, randomised feasibility and pilot study with participant and practitioner blinding. SETTING: 2 private herbal practices in the UK. PARTICIPANTS: 40 women diagnosed with PCOS and oligomenorrhoea or amenorrhoea following Rotterdam criteria. INTERVENTION: 6 months of either standardised CHM or individualised CHM, 16 g daily taken orally as a tea. MAIN OUTCOME MEASURES: Our primary objective was to determine whether oligomenorrhoea and amenorrhoea were appropriate as the primary outcome measures for the main study. Estimates of treatment effects were obtained for menstrual rate, body mass index (BMI), weight and hirsutism. Data were collected regarding safety, feasibility and acceptability. RESULTS: Of the 40 participants recruited, 29 (72.5%) completed the study. The most frequently cited symptoms of concern were hirsutism, weight and menstrual irregularity. Statistically significant improvements in menstrual rates were found at 6 months within group for both standardised CHM (mean difference (MD) 0.18±0.06, 95% CI 0.06 to 0.29; p=0.0027) and individualised CHM (MD 0.27±0.06, 95% CI 0.15 to 0.39; p<0.001), though not between group (p=0.26). No improvements were observed for BMI nor for weight in either group. Improvements in hirsutism scores found within group for both groups were not statistically significant between group (p=0.09). Liver and kidney function and adverse events data were largely normal. Participant feedback suggests changing to tablet administration could facilitate adherence. CONCLUSIONS: A CHM randomised controlled trial for PCOS is feasible and preliminary data suggest that both individualised and standardised multiherb CHMs have similar safety profiles and clinical effects on promoting menstrual regularity. These data will inform the design of a study in primary care that will incorporate an appropriate control. TRIAL REGISTRATION NUMBER: ISRCTN 31072075; Results.

Comparison between effects of myo-inositol and D-chiro-inositol on ovarian function and metabolic factors in women with PCOS.

Myo-inositol and D-chiro-inositol are capable of improving the ovarian function and metabolism of polycystic ovary syndrome (PCOS) patients. The aim of this work is to compare the effects of myo-inositol and D-chiro-inositol in PCOS. We enrolled 50 patients, with homogeneous bio-physical features, affected by PCOS and menstrual irregularities, and we randomly divided them into two groups: 25 were treated with 4 g of myo-inositol/die plus 400 mcg of folic acid/die orally for six months, 25 with 1 g of D-chiro-inositol/die plus 400 mcg of folic acid/die orally for six months. We analyzed in both groups pre-treatment and post-treatment BMI, systolic and diastolic blood pressure, Ferriman-Gallwey score, Cremoncini score, serum LH, LH/FSH ratio, total and free testosterone, dehydroepiandrosterone sulfate (DHEA-S), Δ-4-androstenedione, SHBG, prolactin, glucose/immunoreactive insulin (IRI) ratio, homeostatic model assessment (HOMA) index, and the resumption of regular menstrual cycles. Both the isoforms of inositol were effective in improving ovarian function and metabolism in patients with PCOS, although myo-inositol showed the most marked effect on the metabolic profile, whereas D-chiro-inositol reduced hyperandrogenism better.

Low-frequency electroacupuncture and physical exercise decrease high muscle sympathetic nerve activity in polycystic ovary syndrome.

We have recently shown that polycystic ovary syndrome (PCOS) is associated with high muscle sympathetic nerve activity (MSNA). Animal studies support the concept that low-frequency electroacupuncture (EA) and physical exercise, via stimulation of ergoreceptors and somatic afferents in the muscles, may modulate the activity of the sympathetic nervous system. The aim of the present study was to investigate the effect of these interventions on sympathetic nerve activity in women with PCOS. In a randomized controlled trial, 20 women with PCOS were randomly allocated to one of three groups: low-frequency EA (n = 9), physical exercise (n = 5), or untreated control (n = 6) during 16 wk. Direct recordings of multiunit efferent postganglionic MSNA in a muscle fascicle of the peroneal nerve before and following 16 wk of treatment. Biometric, hemodynamic, endocrine, and metabolic parameters were measured. Low-frequency EA (P = 0.036) and physical exercise (P = 0.030) decreased MSNA burst frequency compared with the untreated control group. The low-frequency EA group reduced sagittal diameter (P = 0.001), while the physical exercise group reduced body weight (P = 0.004) and body mass index (P = 0.004) compared with the untreated control group. Sagittal diameter was related to MSNA burst frequency (Rs = 0.58, P < 0.005) in the EA group. No correlation was found for body mass index and MSNA in the exercise group. There were no differences between the groups in hemodynamic, endocrine, and metabolic variables. For the first time we demonstrate that low-frequency EA and physical exercise lowers high sympathetic nerve activity in women with PCOS. Thus, treatment with low-frequency EA or physical exercise with the aim to reduce MSNA may be of importance for women with PCOS.

Epilepsy therapy: issues for women and men.

It has been suggested that polycystic ovary syndrome is a common finding in women treated with valproate. However, in a recent study this suggestion could not be confirmed. There is currently no clear evidence that valproate contributes to the development of the polycystic ovary syndrome. Focal epileptic discharges may have an impact on the hypothalamic-pituitary-ovarian or -testicular axis. In the case of successful epilepsy surgery the impact of epilepsy on endocrine functioning may cease. This may lead to a normalization of disturbed menstrual cycles in women, and leads to a post-surgical increase of serum androgens in men. Both findings are supplemented by the results of animal experiments. Children exposed to antiepileptic drugs during pregnancy show a normal psychomotor and cognitive development. However, newly developed as well as traditional antiepileptic drugs increase the risk that a child exposed to these drugs during pregnancy will develop a malformation.

[Has oligomenorrhea a pathological meaning? The importance of this symptom in internal medicine]. / Tiene la oligomenorrea un significado patológico? Importancia de este síntoma en medicina interna.

BACKGROUND: Oligomenorrhea, defined as a menstrual cycle lasting 36 to 90 days, can be a normal condition in the first years after the menarche. When it persists or appears after a period of normal menstrual cycles, an underlying illness must be sought. AIM: To assess ovulation and causes of anovulatory cycles in women with oligomenorrhea, compared with causes of secondary amenorrhea. PATIENTS AND METHODS: One hundred one women of less the 35 years old, presenting with oligomenorrhea persisting 5 years after menarche or lasting more than two years after a period of normal menstrual cycles, were studied. Ovulation was studied measuring serial plasma progesterone during normal or induced (with intramuscular progesterone) menstrual cycles. RESULTS: Eighty nine percent of women had anovulatory oligomenorrhea. The main causes were polycystic ovarian disease in 51% and hypothalamic dysfunction in 31%. Thirty percent of women with secondary amenorrhea had polycystic ovarian disease and 14% had hyperprolactinemia. Women older than 20 years old or with more than 10 years of gynecological age had a higher frequency of polycystic ovarian disease and a lower prevalence of hypothalamic dysfunction. CONCLUSIONS: There is a high frequency of anovulatory oligomenorrheas. Therefore, this symptom deserves a thorough endocrinological assessment to uncover underlying diseases. Special attention must be paid to polycystic ovary syndrome, due to its importance in internal medicine as a risk factor for myocardial infarction, high blood pressure, and type 2 diabetes mellitus.

[The effect of a decrease in body weight in patients with the polycystic ovary syndrome]. / Vliianie snizheniia massy tela u bol'nykh s sindromom polikistoznykh iaichnikov.

Eighty patients with the polycystic ovaries syndrome and excessive body mass were examined. In 60 patients body mass reduction resulted from diets and in 20 it occurred over the course of acupuncture. Such treatment resulted in pregnancy in 27 (33.7%) patients. Therefore, diets or acupuncture for body mass reduction are recommended for patients with polycystic ovaries and obesity as the first stage of treatment.

[Comparative analysis of the data of acupuncture electrodiagnosis and hormonal status of women with oligomenorrhea]. / Sravnitel'nyi analiz dannykh akupunkturnoi élektrodiagnostiki i gormonal'nogo statusa zhenshchin s oligomenoreei.

This study has compared acupuncture electrodiagnostic and hormonal data of oligomenorrheic women before and after an acupuncture regimen. According to the pretreatment hormonal status the patients were assigned to 3 groups: (1) ovarian hypofunction; (2) ovarian hypofunction with hyperandrogenism; (3) ovarian hypofunction with functional hyperprolactinemia. The treatment normalized the hormonal status in all 3 groups. The hormonal status of oligomenorrheic patients was found to correlate with conductivity of the skin at biologically active sites.

Trabecular bone density and menstrual function in women runners.

Osteoporosis results in decreased bone mineral mass and reduced trabecular bone density. Although its etiology remains unknown, studies have revealed differential changes in the bone mineral densities of postmenopausal women, anorexic women, and amenorrheic female athletes. Correlations have also been made between estrogen deficiency and osteoporosis in both premenopausal and postmenopausal women. In order to examine the possibility of osteopenia, a group of 36 female runners between the ages of 15 and 44 years were evaluated for bone mineral density, menstrual function, and dietary habits. Serum calcium, phosphorus, and parathyroid hormone (PTH) levels were also determined for each participant, as were complete blood counts. Using dual photon absorptiometry, all participants underwent a 20 minute scan of the lumbar spine with specificity to the L1-14 vertebrae. The 36 subjects included 19 oligomenorrheic and 17 eumenorrheic women. Results of bone density analyses revealed that the oligomenorrheic runners had significantly lower calibrated bone mineral density (CBMD) than their eumenorrheic counterparts (P less than or equal to 0.01). Likewise, the PTH levels of the oligomenorrheic runners were also significantly lower (P less than or equal to 0.01). Analysis of dietary logs revealed no significant differences between the dietary habits, the calcium intake, or the caloric intake of the two groups. The data from this study indicate that there is a relationship between reduced serum PTH levels and the oligomenorrheic state. The loss of the protective effect of estrogen in the oligomenorrheic runners possibly contributed to their reduced bone mineral densities and could be a contributing factor in osteopenia.