Elsevier

Maturitas

Volume 85, March 2016, Pages 19-26
Maturitas

Review article
Herbal medicine (Danggui Shaoyao San) for treating primary dysmenorrhea: A systematic review and meta-analysis of randomized controlled trials

https://doi.org/10.1016/j.maturitas.2015.11.013Get rights and content

Highlights

  • Danggui Shaoyao San (DSS; Dangguijakyak San or Tokishakuyakusan) is one of the herbal medicine (HM) for dysmenorrhea.

  • One recent systematic review of suggested that HM might be promising for treating dysmenorrhea. However, this review analysis is outdated and the information was not complete.

  • Four randomized clinical trials (RCTs) met our inclusion criteria. All of the included RCTs had a high risk of bias across their domains

  • Our systematic review and meta-analysis provides suggestive evidence of the superiority of superiority of DSS over analgesics and placebo for dysmenorrhea.

Abstract

Danggui Shaoyao San (DSS), a traditional herbal prescription, has long been used to treat menopause-related symptoms, including dysmenorrhea. We conducted a systematic review of randomized controlled trials to evaluate the efficacy of DSS for dysmenorrhea. We searched the following electronic databases through October 2015: PubMed; EMBASE; the Cochrane Library; AMED; five Korean databases (KoreaMed, DBPIA, OASIS, RISS, and KISS); three Chinese databases (CNKI, Wan Fang Database, and VIP), and one Japanese database (CiNii). The Cochrane criteria were used to assess the risk of bias for the individual studies. All randomized clinical trials (RCTs) of DSS or modified DSS were included. Data from all articles were extracted by two independent reviewers. Meta-analysis was used to pool the data. A total of 746 potentially relevant studies were identified, and four RCTs met our inclusion criteria. All of the included RCTs had a high risk of bias across their domains. Three RCTs showed favourable effects of DSS on response rate compared with conventional medicine, and a meta-analysis showed that DSS had superior effects compared to analgesics (RR: 1.31, 95%CI, 1.06–1.63, I2 = 73%). One RCT showed a beneficial effect of DSS on pain compared with placebo control. Our systematic review and meta-analysis provided suggestive evidence of the superiority of DSS over analgesics or placebo for dysmenorrhea. The quality of evidence for this finding was low to moderate because of a high risk of bias.

Introduction

Primary dysmenorrhea is menstrual pain without pelvic pathology occurring with ovulatory menstrual cycle and is the most common gynaecologic problem in women [1], [2], [3]. The reported estimated prevalence of dysmenorrhea is from 25% to 95% [2], [4], [5], [6], [7], [8]. Non-steroidal anti-inflammatory drugs (NSAIDs) reduce moderate to severe pain compared with placebo, while simple analgesics including aspirin and paracetamol may also be beneficial [9]. Severe adverse events associated with such treatments lead patients to seek supportive complementary and alternative medicine (CAM) [10], [11]. One systematic review showed that 32.9% of menopausal women were current CAM users and 47.7% had used CAM in the past 12 months [12]. Examples of CAM therapies for dysmenorrhea include acupuncture related therapies [13], [14], [15], [16], [17] and Chinese herbal medicine (CHM) [18], [19], [20], [21], [22], [23], [24]. In particular, CHM is a potential CAM therapy for dysmenorrhea that is widely used in East Asia [19], [20], [22], [25]. Danggui Shaoyao San (DSS), a CHM, is a traditional medicinal prescription that has long been used for the treatment of menopause-related symptoms in East Asia [25], [26]. DSS is composed of the following six herbs: Paeoniae Radix, Cnidii Rhizoma, Alismatis Rhizoma, Angelicae Radix, Poria Sclerotium, and Atractylodis Rhizoma alba. The mechanisms of DSS are believed to include improvement of ovarian hormones [27], oestrogenic action [28] and neurotoxicity effects [29] under postmenopausal conditions.

Only one systematic review (SR) of Chinese herbal medicine (CHM) for primary dysmenorrhea has been conducted. This SR included 39 randomized clinical trials (RCTs) comparing all types of CHM [18]. The findings of this review suggested that CHM was promising for managing primary dysmenorrhea. However, as this review included all types of CHM, a need remains for a study that focuses on specific type of prescription. Furthermore, there is a language bias because the literature search included only English and Chinese databases and this review is also outdated.

Therefore, the aim of this article was to update and provide a thorough, critical evaluation of the current evidence from RCTs of DSS for primary dysmenorrhea.

Section snippets

Study registration

The protocol for this SR was registered in PROSPERO 2015: CRD42015026423.

Data source

The following electronic databases were searched from their inception through October 2015: PubMed; Cochrane Library; EMBASE; five Korean medical databases (Korea Med, DBPIA, OASIS, Research Information Sharing Service [RISS], and Korean Studies Information Service System [KISS]); three Chinese medical databases (China National Knowledge [CNKI], Wan Fang Database, and Journal integration platform [VIP]); and one Japanese

Description of included trials

The searches identified 746 potentially relevant studies, of which three met our inclusion criteria (Fig. 1). The key data from all included RCTs are summarized in Table 1. Three RCTs originated from China [31], [32], [33] and one from Japan [34]. The three trials evaluated 435 women with primary dysmenorrhea. Modified DSS was used alone in three trials [31], [32], [33], and DSS was combined with diclofenac in one trial [34]. The details of the formula compositions of DSS are listed in Table 2.

Discussion

Few rigorous trials testing the effects of DSS for dysmenorrhea are currently available. Our systematic review and meta-analysis provide suggestive evidence of the superiority of DSS over analgesics and placebo treatment (Table 3). The quality of evidence for this finding was low to moderate because of a high risk of bias. The quality of reporting was generally poor in the included RCTs. Furthermore, the total number of RCTs and the total sample size included in our analysis were not sufficient

Conflict of interest

None declared.

Funding

No external funding received.

Provenance and peer review

Not commissioned; externally peer reviewed.

Acknowledgement

HWL and BSK were supported by Korea Institute of Oriental Medicine (K15290).

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