Herbal medicine Shaofu Zhuyu decoction for primary dysmenorrhea: a systematic review protocol

Dysmenorrhea is a common gynecological complaint in adolescent and young females. Dysmenorrhea is characterized by lower abdominal pain that occurs during menstruation [1]. Different types of studies have found a consistently high prevalence of dysmenorrhea in women of different ages and nationalities with an estimated prevalence ranging from 45 to 97 % [2]. Ten percent of these women suffer from symptoms severe enough to render them incapacitated for 1 to 3 days each menstrual cycle [3]. Period pain can lead to absences from school or work [4]. In the USA alone, it was estimated that in the mid-1980s, 600 million hours were lost from work, which led to an economic loss of two billion dollars; in today’s dollars, this figure would be much higher [5].

The mechanisms of primary dysmenorrhea have been attributed to high serum levels of prostaglandin E2 (PGE2), prostaglandin F2-α (PGF2-α), and leukotriene [6]. Severe myometrial contractions, vasoconstriction, uterine ischemia, and subsequent dysmenorrheic pain result from the release of these cytokines. Moreover, withdrawal of progesterone before the beginning of the menstrual cycle initiates arachidonic acid release and further elevates cytokine levels due to the degradation of arachidonic acid. Higher cytokine levels contribute to a higher intensity of dysmenorrheic pain and associated symptoms [7]. Non-steroid anti-inflammatory drugs (NSAIDs), therefore, are the primary treatment for this condition but are limited by inadequate pain control, gastrointestinal discomfort, and an impact on renal function. Combined oral contraceptives are also frequently used but are not universally accepted possibly due to their potential side effects including inducing endometriosis [8]. Therefore, complementary and alternative medicine (CAM) is in high demand in many countries [9]. In one large study, as many as 48 % of women reported the use of CAM as an alternative to prescription medication or to enhance the effectiveness of their prescription medications [10, 11]. Recenlty, it was reported that Shaofu Zhuyu (SFZY) decoction have the efficacy of uterine smooth muscle constriction and manifested an anti-inflammatory efficacy [12]. Also, SFZY decoction improved hemorheological factor of blood stasis and regulation for activity on rat ovary [13].

Herbal medicine is currently used in hospitals and clinics in Korea [14], China [2], Taiwan [15], and Japan [16] for the treatment of primary dysmenorrhea. SFZY decoction was first described in the Yi Lin Gai Cuo, which is a famous formula that has been used for treating primary dysmenorrhea in China since the Qing dynasty. This decoction is used, particularly in gynecology, for blood stasis accompanied by masses and gatherings in the lower abdomen [17]. Clinically, it has been used for the treatment of chronic pelvic inflammatory disease, infertility, endometrial hyperplasia, myoma uteri, and uterine cancer [18]. Many reports have described its efficacy for treating vascular disorders and pain [19], endometriosis [20], cancer [21], and menstrual irregularities in vivo [22]. SFZY decoction composed of ten herbs by Quin-ren Wang in Qing dynasty: Fructus Foeniculi, Zingiberis Rhizoma, Cinnamomi Cortex, Paeoniae Rubra Radix, Angelica Sinensis Radix, Carthami Flos, Myrrha, Corydalis Rhizoma, Typhae Pollen, and Trogopterori Faeces, in the ratio of 0.5:1:1:1:3:1:1:1:3:2 on a dry weight basis [12]. The detail of composition is shown Table 1. The composition of China came from Qing dynasty and decoction of Korean came from DongUiBoGam. SFZY decoctions have shown an effect on uterine muscles and may help to prevent and cure dysmenorrhea. SFZY decoctions are considered an effective prescription for treating primary dysmenorrhea [23], which has been reported as one of the most common gynecological disorders in young women [24].

Recently, many studies have reported treatments using herbal formulas. The Cochrane Review on Chinese herbal medicine showed promising evidence for the use of Traditional Chinese Medicine (TCM) in reducing menstrual pain in primary dysmenorrhea. Unfortunately, many of the studies supporting the use of Chinese herbs were of poor quality [25, 26].

Currently, no relevant systematic reviews of the efficacy of SFZY decoctions for treating primary dysmenorrhea are conducted.

The aim of this study is to systematically review the available literature regarding the efficacy of SFZY decoctions in treating primary dysmenorrhea.