OBJECTIVE: Uterine artery pulsatility index change by a traditional Chinese herbal formula, Four-Agents-Decoction (SiWu Tang), treating primary dysmenorrhea. DESIGN: A randomized double-blind clinical trial. MATERIALS AND METHODS: The data of the 75 subjects were extracted for this study after the primary dysmenorrhea was confirmed by a trans-abdominal ultrasonography and normal serum level of CA-125. The pain intensity data during the first five days of each menstrual cycle were collected using a horizontal unmarked visual analogue scale (VAS) of 0–10 cm (0 cm represents no pain and 10 cm denotes severe pain). Pulsatility indices of uterine arteries and the sizes of uterus and ovaries were measured during pelvic ultrasonography in the screening and post-treatment phases. Data were extracted from the clinical trial database and matched by menstrual cycles. Pain intensity, pulsatility index of uterine artery, vital signs, and blood biochemicals were included in the analysis. Two tailed paired t-test was used to compare the difference between pre- and post-treatment in the two treatment groups separately with significance level set at P<.05. Spearman’s correlation was tested for associations. RESULTS: Intra-individual change in blood pressure was elevated when pain intensity and uterine artery pulsatility indices were reduced in the 75 women who had no missing values. The change in overall pain intensity by treatment was positively correlated with the changes in left PI (r ¼ .313, P¼.006) and right PI (r .214, P¼.065). Although statistically insignificant, the changes in PI were negatively correlated with the changes in systolic blood pressure as well as diastolic blood pressure. The change in overall pain score negatively correlated with the change in menstrual cycle length (r _.232, P¼.045); the latter was also positively correlated with the changes in systolic blood pressure (r ¼.280, P¼.015) and diastolic blood pressure (r .180, P¼.122). CONCLUSIONS: The indirect inverse relationship of blood pressure with the uterine blood flow and pain intensity further indicates the pain improvement by Four-Agents-Decoction in treating primary dysmenorrhea. Uterine artery pulsatility index may also serve as an objective measure for menstrual pain.
Date:
2007-09
Relation:
Fertility and Sterility. 2007 Sep;88(Suppl. 1 ):S192-S193.