Effects and safety of varying doses of guizhi fuling capsule in patients with primary dysmenorrhea: a multi-center, randomized, double-blind, placebo-controlled clinical study / 中国中药杂志

To evaluate the effects and safety of varying doses of Guizhi Fuling capsule on treating primary dysmenorrhea. From August 2010 to March 2011, 240 subjects (aged 18-30) with primary dysmenorrheal, were enrolled in 8 sites. They were randomized into Guizhi Fuling capsule high dose group, low dose group and placebo control group, 80 cases in each group. These patients were treated for three consecutive menstrual cycles, then were followed up in another three consecutive menstrual cycles. Visual analogue scales (VAS) was used to determine the pain intensity. During the treatment, the high-, low-dose and placebo groups efficiency on pain relief are 68.42%, 67.57% and 47.89% respectively. Guzhi Fuling (included high- and low- dose group) significantly relieves the pain compared to placebo. In follow-up, Guzhi Fuling groups are still superior to the placebo group (73.68%, 72.97% and 53.52%). During the treatment, pain duration reduces 57.88% in high dose group, while 46.17% in low dose group, and 30.40% in placebo group. In follow-up, pain lasting time decrease 67.93%, 53.56%, 47.46%, respectively. Guizhi Fuling significantly reduces the pain duration compared to placebo and high-dose is better than low-dose. The efficacy of Guzhi Fuling (high- and low-dose) displays certain dosage-effect relationship. Among these group, no serious adverse event was reported. Guizhi Fuling capsule at high or low dose significantly relieves the pain, improves symptoms, reduces the duration of pain, and has a better overall treatment effect and long-term treatment effect in patients with primary dysmenorrhea.

Study on the reliability and validity of the Chinese Menopause Rating Scale (CMRS) / 中华流行病学杂志

Objective To evaluate the feasibility,reliability,validity and responsiveness of a Chinese Menopause Rating Scale (CMRS).Methods Cross-sectional survey and convenience sampling were adopted. Participants:women with menopause syndrome and those in menopause but without menopause syndrome were recruited.All participants were asked to complete the CMRS,Kupperman Index,WHOQOL-BREF and MENQOL.The Self-control observation design was adopted when the responsiveness was evaluated.Patients were treated with TCM for weeks.MRSTCM was evaluated before and after the treatment.Results (1) Feasibility:3343 participants including 2320 patients and 1023 menopause women,were surveyed in 8 different settings.The recovery rate of CMRS was 100%,with a response rate as 99.7%.The completion of the CMRS took 10.30 minutes on average.(2)Reliability:Cronbach's alpha of CMRS,soma dimension,psychology dimension and community dimension of CMRS were 0.93,0.87,0.89 and 0.73 respectively,with the correlation coefficient of split half of the CMRS.Soma dimension,psychology dimension and community dimension were 0.92,0.89,0.86 and 0.73 respectively and the test-retest correlation coefficient of MRSTCM,the soma dimension,psychology dimension and community dimension were as 0.88,0.91,0.85 and 0.77 respectively.(3) Validity:CMRS was established on the basis of connotation of menopause syndrome,and a series of steps were adopted to modify the scale.CMRS was applicable for patients with menopause syndrome.CMRS seemed to have had good content-related validity.The result of exploratory factor analysis was accorded with the theory frame of CMRS by and large.The correlations between CMRS and KI,CMRS and WHOQOLBREF,CMRS and MENQOL seemed good.The CMRS was able to discriminate between groups of people with or without menopausal syndrome and bad good discriminative validity.(4) Responsibility:The CMRS was measured based on 174 patients with menopausal syndrome before and after the TCM therapy.Our result showed that the CMRS having the ability to measure the clinically important differences.Conclusion CMRS was suitable for outcome assessment of menopausal syndrome.This primary research proved that the CMRS had good feasibility,reliability,validity as well as responsiveness.