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).

The comparison of fennel infusion plus dry cupping versus metformin in management of oligomenorrhoea in patients with polycystic ovary syndrome: a randomised clinical trial.

Oligomenorrhoea treatment with hormone therapy and Metformin is not usually well tolerated and is associated with a broad range of side effects. In Persian medicine, the management of oligomenorrhoea can be done with fennel and dry cupping. A clinical trial was conducted on 61 patients with oligomenorrhoea. The patients randomly received treatment for 6 months in two groups: fennel infusion plus dry cupping (Group A); versus treatment with Metformin (Group B). On the days between the two periods, the patients' BMI, pain levels and side effects were assessed. Thirty-one patients (mean age: 26.68) in Group A, and 30 patients (mean age: 28.90) in Group B were enrolled. The mean numbers of days between the two periods after 3 and 6 months in Group A was, respectively, 32.59 and 30.69, versus 40.66 and 431.22 in Group B. The mean pain severity dropped significantly in Group A. Fennel seed infusion plus a dry cupping uses a safe and effective therapeutic intervention in the management of oligomenorrhoea. IMPACT STATEMENT What is already known on this subject? Polycystic ovary syndrome (PCOS) is a common endocrine disorder in women. Some common clinical manifestations of this syndrome include menstrual disorders such as oligomenorrhoea and amenorrhoea. The recommended therapeutic interventions include oral intervention, as well as metformin, which are associated with an increased risk of vascular thromboembolism, digestive complications such as nausea, and dizziness, and vitamin B12 deficiency. Therefore, the use of complementary medicine in controlling and treating PCOS is considered a valuable intervention in conventional medicine. In Persian traditional medicine, medicinal fennel (with the scientific name of Foeniculum Vulgare Mill) is commonly used in this regard. The practice of dry cupping during the monthly period that ends with ovulation is also recommended. What do the results of this study add? The present study concludes that fennel seed infusion plus a dry cupping therapy is effective and safe in reducing the days between two menstrual periods and manages oligomenorrhoea. What are the implications of these findings for clinical practice and/or further research? A clinical study is suggested for assessing the effect of fennel seed infusion plus dry cupping on oligomenorrhoea, with a large sample size and a longer follow up time.

Restoration of menses with nonpharmacologic therapy in college athletes with menstrual disturbances: a 5-year retrospective study.

BACKGROUND: Functional hypothalamic amenorrhea is common among female athletes and may be difficult to treat. Restoration of menses (ROM) is crucial to prevent deleterious effects to skeletal and reproductive health. OBJECTIVES: To determine the natural history of menstrual disturbances in female college athletes managed with nonpharmacologic therapies including increased dietary intake and/or decreased exercise expenditure and to identify factors associated with ROM. STUDY DESIGN: A 5-yr retrospective study of college athletes at a major Division I university. METHODS: 373 female athletes' charts were reviewed. For athletes with menstrual disturbances, morphometric variables were noted. Months to ROM were recorded for each athlete. RESULTS: Fifty-one female athletes (19.7%) had menstrual disturbances (14.7% oligomenorrheic, 5.0% amenorrheic). In all, 17.6% of oligo-/amenorrheic athletes experienced ROM with nonpharmacologic therapy. Mean time to ROM among all athletes with menstrual disturbances was 15.6 ± 2.6 mo. Total absolute (5.3 ± 1.1 kg vs. 1.3 ± 1.1 kg, p < .05) and percentage (9.3% ± 1.9% vs. 2.3% ± 1.9%, p < .05) weight gain and increase in body-mass index (BMI; 1.9 ± 0.4 kg/m2 vs. 0.5 ± 0.4 kg/m2, p < .05) emerged as the primary differentiating characteristics between athletes with ROM and those without ROM. Percent weight gain was identified as a significant positive predictor of ROM, OR (95% CI) = 1.25 (1.01, 1.56), p < .05. CONCLUSIONS: Nonpharmacologic intervention in college athletes with menstrual disturbances can restore regular menstrual cycles, although ROM may take more than 1 yr. Weight gain or an increase in BMI may be important predictors of ROM.

Impact of electro-acupuncture and physical exercise on hyperandrogenism and oligo/amenorrhea in women with polycystic ovary syndrome: a randomized controlled trial.

Polycystic ovary syndrome (PCOS), the most common endocrine disorder in women of reproductive age, is characterized by hyperandrogenism, oligo/amenorrhea, and polycystic ovaries. We aimed to determine whether low-frequency electro-acupuncture (EA) would decrease hyperandrogenism and improve oligo/amenorrhea more effectively than physical exercise or no intervention. We randomized 84 women with PCOS, aged 18-37 yr, to 16 wk of low-frequency EA, physical exercise, or no intervention. The primary outcome measure changes in the concentration of total testosterone (T) at week 16 determined by gas and liquid chromatography-mass spectrometry was analyzed by intention to treat. Secondary outcome measures were changes in menstrual frequency; concentrations of androgens, estrogens, androgen precursors, and glucuronidated androgen metabolites; and acne and hirsutism. Outcomes were assessed at baseline, after 16 wk of intervention, and after a 16-wk follow-up. After 16 wk of intervention, circulating T decreased by -25%, androsterone glucuronide by -30%, and androstane-3α,17ß-diol-3-glucuronide by -28% in the EA group (P = 0.038, 0.030, and 0.047, respectively vs. exercise); menstrual frequency increased to 0.69/month from 0.28 at baseline in the EA group (P = 0.018 vs. exercise). After the 16-wk follow-up, the acne score decreased by -32% in the EA group (P = 0.006 vs. exercise). Both EA and exercise improved menstrual frequency and decreased the levels of several sex steroids at week 16 and at the 16-wk follow-up compared with no intervention. Low-frequency EA and physical exercise improved hyperandrogenism and menstrual frequency more effectively than no intervention in women with PCOS. Low-frequency EA was superior to physical exercise and may be useful for treating hyperandrogenism and oligo/amenorrhea.

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.

Homeopathy for the treatment of menstrual irregularities: a case series.

OBJECTIVE: A preliminary study to evaluate the usefulness of homeopathic treatment in the care of menstrual irregularities. METHOD: Patients were diagnosed at the first appointment according to menstrual cycle over the past year: Amenorrhea (AM), Oligo-amenorrhea (OL-AM), OL, Taking hormone replacement therapy (HRT). All patients were prescribed an individualised, global homeopathic treatment. The main outcomes were: time to resumption of periods, change of clinical diagnosis at the end of follow-up or after 2 years. The secondary outcomes were: menstrual regularity at the end of follow-up, compared to pre-treatment frequency; flow characteristics; clinical course of acute and chronic concomitant symptoms. RESULTS: 18 consecutive cases of secondary amenorrhea (SA) and oligomenorrhea (OL) met the entry criteria. 8 women had SA, 2 were on HRT, 6 had OL-AM and 2 had OL. The average duration of considered follow-up was 21 months. The average time before the reappearance of menstruation was 58 days (s.d. 20) in the 8 women with SA at the time of the first appointment, for all cases 46 days (s.d. 42). Change of clinical diagnosis: 50% of women, who were diagnosed AM, recovered their ovulatory cycle (OV), whereas 12.5% remained amenorrheic; 33.3% of patients, who were initially OL-AM, showed an OV; 100% of oligomenorrheic and HRT patients recovered an OV. The average frequency of spontaneous cycles per year changes from 4.32 (s.d. 1.97) pre-treatment to 9.6 cycles per year at the end (s.d. 2.92). Four detailed case histories are reported.

[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.

[Effect of ear-acupuncture on the LH-concentration in serum in patients with secondary amenorrhea (author's transl)]. / Das Verhalten des LH-Serumspiegels nach Ohrakupunktur bei sekundãarer Amenorrhoe.

In 13 patients at an age of 17 to 26 years with intermittent or secondary amenorrhea an attempt was made to stimulate the pituitary gland by ear-acupuncture. The objective parameter for the comparison was the concentration of the luteinizing hormone (LH) in the serum during acupuncture and the LH-RH-releasing test. 6 of these patients were subjected to a so-called "placebo-acupuncture" to perform a blind-test. The results showed, that ear-acupuncture caused a significant decrease of the LH-concentration in the serum. The clinical results showing a positive effect of ear-acupuncture in the mentioned types of amenorrhea could therefore be explained as a rebound phenomenon.