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

Abstract

BackgroundMost 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 FindingsA 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/significanceFour-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 lo...

Simultaneous determination of six bioactive constituents of Guizhi Fuling Capsule in rat plasma by UHPLC–MS/MS: Application to a pharmacokinetic study

“…Traditional Chinese medicine (TCM), when given for symptom relief, has gained widespread popularity among women with PD [2]. The typical prescriptions of TCM for the treatment of PD are reported as Gegen Decoction, Danggui Shaoyao San, Siwu Tang, Guizhi Fuling Wan, Guizhi Fuling Capsule and so on [6][7][8], which could exert synergistic therapeutic efficacies through multiple regulating humoral immunity and cellular immunity, and releasing inflammatory response [16,17]. In our previous investigation, the bioactive ingredients absorbed into the rat plasma were analyzed, we screened out six ingredients, including gallic acid (from Paeoniae Radix Alba), amygdalin (from Persicae Semen), albiflorin (from Paeoniae Radix Alba), paeoniflorin (from Paeoniae Radix Alba), paeonol (from Moutan Cortex), cinnamic acid (from Cinnamomi Ramulus) which exhibited significant correlation of drug concentration-time curve in rat plasma.…”

Effects of adlay hull extracts on uterine contraction and Ca2+mobilization in the rat

“…Because of these side effects, Chinese medicinal therapy is considered as a feasible alternative medicine for dysmenorrhea. For example, in the previous clinical study, the Chinese herbal formula Four-Agent Decoction (Si Wu Tang) was found to be an effective therapeutic agent for primary dysmenorrhea (48).…”

Inhibition of Neoplastic Transformation and Chemically-Induced Skin Hyperplasia in Mice by Traditional Chinese Medicinal Formula Si-Wu-Tang

“…Si-Wu-Tang [SWT, Si-Wu decoction (Chinese name), Samultang (Korean name), or Shimotsu-to (Japanese name)], comprising the combination of four herbs: Paeoniae ( Radix paeonia alba ), Angelicae ( Radix angelica Sinensis ), Chuanxiong ( Rhizoma chuanxiong ), and Rehmanniae ( Radix rehmanniae preparata ), is one of the most popular traditional medicines for women’s health [1]. It has been used in Eastern Asia for more than one thousand years and ranks first as the most frequently used Chinese medicines [2]. It is an inexpensive over-the-counter preparation used for the relief of menstrual discomfort, climacteric syndrome, peri- or post-menopausal syndromes and other estrogen-related diseases [1,2,3,4,5].…”

“…It has been used in Eastern Asia for more than one thousand years and ranks first as the most frequently used Chinese medicines [2]. It is an inexpensive over-the-counter preparation used for the relief of menstrual discomfort, climacteric syndrome, peri- or post-menopausal syndromes and other estrogen-related diseases [1,2,3,4,5]. In previous animal studies, SWT has shown sedative, anti-coagulant, and anti-bacterial activities, as well as a protective effect on radiation-induced bone marrow damage [6,7].…”