SUMMARY: 109 patients with pregnancy-induced-hypertension and preeclampsia (Hypertensive Disorders in Pregnancy, aka HDP) were randomly divided into control group (54 subjects) and treatment group (55 subjects) by random number table methods. All subjects met the diagnostic criteria of HDP according to the “Diagnosis and Treatment of Hypertension and Pre-Eclampsia in Pregnancy: a Clinical Practice Guideline in China (2015)” and the diagnostic criteria of “Endogenous Wind of Liver” in Traditional Chinese Medicine (TCM) according to the “Gynecology in Traditional Chinese Medicine (2002)”.
There was no significant difference in terms of age, gestational age and severity of preeclampsia between the two groups (P>0.05), and the two were therefore statistically comparable. In control group, subjects received conventional treatment, including oxygen inhalation and nutritional support; diuretic, antispasmodic, sedative, anticoagulant and other treatments were prescribed according to the individual needs, and oral labetalol hydrochloride tablets were also prescribed (50 tid in mild cases, or 100mg tid in severe cases).
In addition to the conventional treatment, subjects in the treatment group also received TCM herbal formula for nourishing Kidney and clearing Liver (滋腎清肝法), 1 dose (mixture of three 200ml decoctions) bid, morning and evening. The ingredients of the formula included: Shu Di Huang 21g (熟地黃 Radix Rehmanniae Praeparata), Huang Qi 黃耆 18g (Radix Astragali seu Hedysari), Tian Ma 12g (天麻 Rhizoma Gastrodiae), Gou Teng 12g (鉤藤 Ramulus Uncariae cum Uncis), Shan Zhu Yu 12 g (山茱萸 Fructus Corni), Bai Zhu 12 g (白朮 Rhizoma Atractylodis Macrocephalae), Huang Qin 9g (黃芩 Radix Scutellariae), and Gan Cao 6g (甘草 Radix Glycyrrhizae). Course of treatment was 4 weeks for both groups.
To evaluate the result, blood hypercoagulability, micro-inflammatory markers, maternal and fetal outcomes and adverse reactions were monitored before and after treatment. Clinical efficacy was categorized as follows:
Cured: TCM syndrome scores decreased by ≥95%, clinical symptoms resolved, and blood pressure returned to normal; Markedly Effective: TCM syndrome scores decreased by ≥70% and <95%, clinical symptoms significantly improved, and blood pressure decreased by >20 mmHg;
Effective: TCM syndrome scores decreased by ≥30% and <70%, clinical symptoms improved, blood pressure decreased by 10~20mmHg;
No Response: none of the criteria were met Total Effective Rate = number of (Cured + Markedly Effective + Effective) cases/total number of cases × 100%
According to the result, the level of platelet α-granule membrane protein (GMP-140) and von Willebrand factor (vWF) in the treatment group were lower than the control group, and prothrombin time (PT) were higher the control group (P< 0.05). The levels of tumor necrosis factor (TNF-α), high-sensitivity C-reactive protein (hs-CRP) and interleukin-6 (IL-6) in the treatment group were lower in the control group (P<0.05). The rates of infant asphyxia, placental abruption, and fetal growth retardation in treatment group were lower than the control group (P<0.05). The total effective rate was 89.09% in the treatment group and 72.22% in the control group, and the difference between the two groups was statistically significant (P<0.05). Since there was no significant difference in the incidence of adverse reactions between the treatment group and the control group (P>0.05), adding TCM herbal formula for nourishing Kidney and clearing Liver can be viewed as an effective and safe methods in treating HDP.
Cailing Guo, et al. Journal of Guangxi University of Chinese Medicine. 2022. 45 (4): 241-244