A Randomised Placebo-Controlled Trial of a Traditional Chinese Herbal Formula in the Treatment of Primary Dysmenorrhoea

BACKGROUND: Most traditional Chinese herbal formulas consist of at least four herbs. Four-Agents-Decoction (Si Wu Tang) is a documented eight hundred year old formula containing four herbs and has been widely used to relieve menstrual discomfort in Taiwan. However, no specific effect had been systematically evaluated. We applied Western methodology to assess its effectiveness and safety for primary dysmenorrhoea and to evaluate the compliance and feasibility for a future trial. METHODOLOGY/PRINCIPAL FINDINGS: A randomised, double-blind, placebo-controlled, pilot clinical trial was conducted in an ad hoc clinic setting at a teaching hospital in Taipei, Taiwan. Seventy-eight primary dysmenorrheic young women were enrolled after 326 women with self-reported menstrual discomfort in the Taipei metropolitan area of Taiwan were screened by a questionnaire and subsequently diagnosed by two gynaecologists concurrently with pelvic ultrasonography. A dosage of 15 odorless capsules daily for five days starting from the onset of bleeding or pain was administered. Participants were followed with two to four cycles for an initial washout interval, one to two baseline cycles, three to four treatment cycles, and three follow-up cycles. Study outcome was pain intensity measured by using unmarked horizontal visual analog pain scale in an online daily diary submitted directly by the participants for 5 days starting from the onset of bleeding or pain of each menstrual cycle. Overall-pain was the average pain intensity among days in pain and peak-pain was the maximal single-day pain intensity. At the end of treatment, both the overall-pain and peak-pain decreased in the Four-Agents-Decoction (Si Wu Tang) group and increased in the placebo group; however, the differences between the two groups were not statistically significant. The trends persisted to follow-up phase. Statistically significant differences in both peak-pain and overall-pain appeared in the first follow-up cycle, at which the reduced peak-pain in the Four-Agents-Decoction (Si Wu Tang) group did not differ significantly by treatment length. However, the reduced peak-pain did differ profoundly among women treated for four menstrual cycles (2.69 (2.06) cm, mean (standard deviation), for the 20 women with Four-Agents-Decoction and 4.68 (3.16) for the 22 women with placebo, p = .020.) There was no difference in adverse symptoms between the Four-Agents-Decoction (Si Wu Tang) and placebo groups. CONCLUSION/SIGNIFICANCE: Four-Agents-Decoction (Si Wu Tang) therapy in this pilot post-market clinical trial, while meeting the standards of conventional medicine, showed no statistically significant difference in reducing menstrual pain intensity of primary dysmenorrhoea at the end of treatment. Its use, with our dosage regimen and treatment length, was not associated with adverse reactions. The finding of statistically significant pain-reducing effect in the first follow-up cycle was unexpected and warrants further study. A larger similar trial among primary dysmenorrheic young women with longer treatment phase and multiple batched study products can determine the definitive efficacy of this historically documented formula. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN23374750

Primary dysmenorrhea and uterine blood flow

OBJECTIVE: To examine pulsatility index (PI) and resistance index (RI) values in the uterine and arcuate arteries of patients with primary dysmenorrhea (PD) by color Doppler ultrasonography

A randomized controlled trial of coil removal prior to treatment of pelvic inflammatory disease

Objective: To evaluate the effects of removing coils on the treatment of mild and moderate pelvic inflammatory disease (PID). Methods: Of 126 women who had mild to moderate PID during coil usage, 60 were treated following coil removal and 66 without. Clinical symptoms, findings of gynecologic examination, erythrocyte sedimentation rates (mm/h), leukocyte counts (mm(-3)) were recorded before and after treatment and recovery rates of symptoms and findings were compared with Chi-square and Fisher's absolute Chi-square tests. Student's t-test was used for the comparison of mean sedimentation rates and leukocyte counts. Results: Recovery rates of pelvic pain, purulent vaginal discharge, dysuria/frequency and dyspareunia and clinical improvements in abdominal and cervical tenderness were significantly higher (P < 0.05) in the coil removed group. Conclusions: Removing the coil before medical therapy, increases the rates of clinical improvement in mild to moderate PID. (C) 2002 Elsevier Science Ireland Ltd. All rights reserved

Expression of IGR-IR and VEGF and trophoblastic proliferative activity in placentas from pregnancies complicated by IUGR

Intrauterine growth retardation (IUGR) is recognized as an important cause of low birth weight and elective preterm delivery. IUGR is associated with multiple causative factors, including placental dysfunction. The aim of this prospective study was to investigate the role of trophoblastic proliferative activity and type I insuline-like growth factor receptor (IGF-IR) and vascular endothelial growth factor (VEGF) expressions in the pathogenesis of IUGR. Immunohistochemistry using VEGF, IGF-IR, and Ki-67 antibodies was performed on formalin-fixed placental tissues of third-trimester pregnancies complicated by IUGR (n = 19) and pregnancies with appropriately grown fetuses (n = 27). In addition, histopathological examination of the placentas was performed, and histological findings were categorized into three groups: utero-placental vascular pathologies (UPVP), coagulation-related pathologies, and chronic inflammation. Statistical analysis revealed that villous trophoblastic IGF-IR immunostaining was significantly weaker in placentas with IUGR (p < 0.001), whereas trophoblastic Ki-67 proliferative index and VEGF immunoscoring did not show any significant difference. Histologically, UPVP and chronic inflammation were significant findings in placentas with IUGR (p = 0.04 and p = 0.04, respectively). In addition, placentas were significantly smaller in the IUGR group (p < 0.001). We conclude that villous trophoblastic IGF-IR expression may play a significant role in the pathogenesis of IUGR, and histopathological examination of placentas in pregnancies complicated by IUGR may yield significant findings. In contrast, based on our findings, trophoblastic proliferation and VEGF expression are unlikely to be significant parameters in the pathogenesis of IUGR

Different maternal serum hCG levels in pregnant women with female and male fetuses: does fetal hypophyseal adrenal gonadal axis play a role?

Fetal gender has a significant effect on maternal and cord blood hCG levels, particularly during the last trimester of the pregnancy. However, the reason for this difference is obscure. The aim of the present study was to investigate whether term fetal hypophyseal adrenal gonadal axis differs between female and male fetuses thereby causing different hCG levels. The study consisted of 60 women with singleton pregnancies in the third trimester. Thirtyone pregnant women were carrying female fetuses, whereas 29 were carrying male. Human chorionic gonadotropin (hCG), estradiol, progesterone, testosterone, dehydroepiandrosteronsulfate (DHEAS), prolactin and growth hormone levels were measured in maternal serum and umbilical cord blood