Chinese herbal formula siwutang for treating primary dysmenorrhea: A systematic review and meta-analysis of randomized controlled trials.

Primary dysmenorrhea (PD) is a common gynecological disorder that usually begins in adolescence, and affects patients' daily activities and quality of life. Non-steroidal anti-inflammatory drugs (NSAIDS) are considered the first-line treatment, and hormonal contraceptives are also recommended for PD, but both are prone to side-effects. The Chinese herbal formula Siwutang (SWT) and its derivative formulas are a common treatment for PD in China. This review assessed the efficacy and safety of SWT for the treatment of PD. PubMed, EmBase, Cochrane CENTRAL, CNKI, Wanfang and CBM were searched. We included randomized controlled trials (RCTs) that investigated SWT for PD, compared with no intervention, placebo, or conventional Western medicine. The outcome measurements included pain intensity measured by visual analogue scale (VAS) or other validated scales, the Cox Menstrual Symptom Scale (CMSS), quality of life, response rate and adverse events. The Cochrane Collaboration's tool was used to assess the risk of bias. RevMan V.5.3 was used for data synthesis and meta-analysis. Risk ratio (RR) with 95 % confidence intervals (CIs) or mean difference (MD) with 95 % CIs was calculated for dichotomous data or continuous data, respectively. Heterogeneity among studies was evaluated using both a chi-square test and an I2 test. A total of 38 RCTs involving 3982 participants were identified. The methodological quality of the included trials was generally poor. Moreover, the results for SWT compared with placebo were unclear, as there was only 1 RCT. SWT improved pain intensity measured by VAS (3 RCTs, n = 220, MD:-2.61, 95 % CI:-3.72 to -1.51) when compared with conventional medicine, and these results were statistically significant. The meta-analysis showed the superior effect of SWT (including derivative formulas) on response rate (35 RCTs, n = 3,695, RR: 1.28, 95 % CI: 1.22-1.34) with medium heterogeneity (I2 = 48 %). Both original SWT and its derivative formula XFSWT had a higher response rate than conventional medicine (23 RCTs, n = 2,493, RR: 1.28, 95 % CI: 1.23-1.33) (11 RCTs, n = 1,076, RR: 1.36, 95 % CI: 1.20-1.53). These results were statistically significant. No trial reported on quality of life or CMSS. Adverse events were reported by 5 studies, and meta-analysis showed SWT may be safer than conventional medicine in terms of the incidence of adverse events (3 RCTs, n = 236, RR: 0.17, 95 % CI: 0.07-0.38, I2 = 0%). In conclusion, the included trials showed favorable effects of SWT for treating primary dysmenorrhea when compared with conventional medicine. SWT may be safer than conventional medicine, but insufficient data was reported. The level of evidence is low because of the high risk of bias. Thus, further well-designed clinical trials with large sample sizes are warranted. CRD42019136230 in PROSPERO 2019.

Li G ，Liu A ，Lin M ，Liao S ，Wen Z ... -  《-》

Effectiveness and Safety of Chinese Medicine at Shenque (CV 8) for Primary Dysmenorrhea: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Primary dysmenorrhea (PD) is the most common complaint associated with menstruation and affects up to three-quarters of women at some stage of their reproductive life. In Chinese medicine, navel therapy, treatment provided at Shenque (CV 8), is used as a treatment option for PD. To evaluate the effect of navel therapy on pain relief and quality of life in women with PD, compared with Western medicine (WM). China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), SinoMed and Wanfang Database, MEDLINE, the Cochrane Library, Embase, Web of Science, and the International Clinical Trial Registry of the U.S. National Institutes of Health were searched from their inceptions to April 1, 2021. Randomized controlled trials (RCTs) assessing therapeutic effects of navel therapy on PD were eligible for inclusion. RevMan 5.4 software was used for data analyses. The certainty of the evidence was assessed using the online GRADEpro tool. Totally 24 RCTs involving 2,614 participants were identified. Interventions applied to acupuncture point CV 8 included: herbal patching, moxibustion or combined navel therapy (using at least 2 types of stimulation). Compared to placebo, there was a significant effect in favor of navel therapy on reducing overall menstrual symptom scores at the end of treatment [mean difference: -0.82, 95% confidence interval (CI): -1.00 to -0.64, n=90; 1 RCT]. As compared with Western medicine, navel therapy had a superior effect on pain intensity as assessed by Visual Analogue Scale at the end of treatment [standardized mean difference (SMD): -0.64, 95% CI: -1.22 to -0.06, I2=80%, n=262; 3 RCTs]; on symptom resolution rate at 3-month follow-up (risk ratio: 1.94, 95% CI: 1.47 to 2.56, n=1527, I2=38%; 13 RCTs); and on global menstrual symptoms score at the end of treatment (SMD: -0.67, 95% CI: -0.90 to -0.45, I2=63%, n=990; 12 RCTs). Subgroup analyses showed either a better or an equivalent effect comparing navel therapy with Western medicine. No major adverse events were reported. The methodological quality of included trials was poor overall. Navel therapy appears to be more effective than Western medicine in decreasing menstrual pain and improving overall symptoms of PD. However, these findings need to be confirmed by well-designed clinical trials with adequate sample size (Systematic review registration at PROSPERO, No. CRD42021240350).

Yan LJ ，Fang M ，Zhu SJ ，Wang ZJ ，Hu XY ，Liang SB ，Wang D ，Yang D ，Shen C ，Robinson N ，Liu JP ... -  《-》

Chinese herbal medicine for primary dysmenorrhoea.

Zhu X ，Proctor M ，Bensoussan A ，Wu E ，Smith CA ... -  《Cochrane Database of Systematic Reviews》

Chinese herbal medicine for primary dysmenorrhoea.

Zhu X ，Proctor M ，Bensoussan A ，Smith CA ，Wu E ... -  《Cochrane Database of Systematic Reviews》

Acupuncture for dysmenorrhoea.

Smith CA ，Armour M ，Zhu X ，Li X ，Lu ZY ，Song J ... -  《Cochrane Database of Systematic Reviews》