Efficacy And Safety Of Modified Cistanche Powder Adjunctive To Western Therapy For Kidney-Deficiency With Phlegm-Blood Stasis Type PCOS: Results And Discussion
Dec 15, 2025
2 Results
2.1 TCM Syndrome Scores
After treatment, scores for irregular menstruation or amenorrhea, soreness/weakness of the waist and knees, dull complexion, and fatigue were all lower in the treatment group than at baseline and than in the control group; in the control group, the post‑treatment scores for the above indicators were also lower than at baseline (P<0.05), see Table 1.
2.3 Glucose‑Metabolism Indicators
Post‑treatment levels of glucose‑metabolism indicators in both groups were lower than before treatment, with greater reductions in the treatment group than in the control group (P<0.05), see Table 3.
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2.4 Sex Hormone Levels
Post‑treatment levels of sex hormone indicators in both groups were lower than before treatment, with lower levels in the treatment group than in the control group (P<0.05), see Table 4.
2.5 Adverse Reactions
In the treatment group, there was 1 case each of mild dizziness and dry mouth; in the control group, there was 1 case of gastrointestinal discomfort and 2 cases of constipation. No abnormalities were observed in routine tests of cardiac, hepatic, or renal function or in routine urinalysis and stool tests in either group. The incidence of adverse reactions did not differ significantly between the two groups (4.35% vs 7.50%; χ²=0.090, P=0.764).
3 Discussion
Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting an estimated 5%–10% of women worldwide [8]. Its features include menstrual irregularities, elevated androgen levels, polycystic ovarian morphology, and insulin resistance with disordered glucose metabolism. Insulin resistance refers to diminished responsiveness of the body to insulin, resulting in elevated blood glucose and compensatory hyperinsulinemia, which creates a vicious cycle that not only increases the risk of type 2 diabetes but may also exacerbate PCOS symptoms [9–10]. In Western medicine, management of insulin resistance and glucose‑metabolism abnormalities in PCOS relies primarily on pharmacotherapy and lifestyle modification. Commonly used medications include metformin, an oral hypoglycemic agent that improves insulin sensitivity, reduces hepatic gluconeogenesis, and helps restore menstrual cyclicity and promote ovulation [11]. However, efficacy may be limited by factors such as treatment duration and adverse reactions, leaving unmet clinical needs.
Although classical TCM texts do not record the disease entity of PCOS by name, its clinical manifestations are dispersed among disorders such as "amenorrhea," "delayed menstruation," "infertility," and "scanty menses." The Su Wen (Plain Questions), "Shang Gu Tian Zhen Lun" chapter, records: "At two‑sevens, the Tian Gui arrives... the menses descend in due time, therefore fertility ensues," reflecting the TCM view that normal menstrual cycle, timing, and the color, quality, and quantity of menstrual blood depend on regulation by the kidney–Tian Gui–Chong and Ren–Uterus axis. The kidney stores essence and governs reproduction; kidney deficiency can therefore lead to reproductive dysfunction. Clinically, treatment often begins from the kidney, positing that insufficient kidney essence and inadequate Tian Gui form the foundation of absent menstrual flow. Danxi's Mastery of Medicine ("On Offspring") states: "In corpulent women, endowed with abundance and indulging in wine and rich foods, the menses are irregular and conception cannot occur; this is termed adiposity overflowing and obstructing the uterus." The Jingyue Quanshu holds: "Although all five viscera can generate phlegm, none are without involvement of the spleen and kidney. Spleen dampness transforms into phlegm; the kidney governs water, and water transgressing becomes phlegm." Kidney deficiency leads to disharmony of qi and blood, internal retention of dampness, generation of phlegm, and stasis of qi and blood; phlegm‑dampness and blood stasis obstruct ovulation and cause infertility. Accumulation within the uterine vessels and collaterals may enlarge the ovaries or produce polycystic‑like changes [12]. Consequently, PCOS patients commonly present with obesity, delayed menses or amenorrhea, infertility, and the mutual entanglement of phlegm‑dampness and blood stasis that further aggravates clinical symptoms. Therefore, phlegm‑dampness and blood stasis are both etiologic and exacerbating factors; clinically, treatment should prioritize tonifying the kidney while removing stasis and resolving phlegm.
In this study, post‑treatment TCM syndrome scores and overall clinical efficacy in the treatment group were superior to those in the control group. The Modified Cistanche Powder is a self‑formulated prescription derived by modification of the classical "Rou Cong Rong San" recorded in Taiping Shenghui Fang (Scroll 27). From the original, Cistanche, Cuscuta, Poria, and Achyranthes were retained, with the addition of prepared Rehmannia, dry‑fried Atractylodes, Angelica sinensis, Citrus peel, and Glycyrrhiza; with syndrome‑based additions of Pinellia (processed with ginger) for pronounced phlegm‑dampness and Rubia plus Persica kernel for marked blood stasis.
In this formula, Cistanche (Rou Cong Rong) warms and tonifies kidney yang and benefits essence and blood; Cuscuta (Tu Si Zi) is neutral, warms yang, and nourishes essence without being overly drying or cloying, serving as a "key medicinals for supplementing the liver, spleen, and kidney." Together they function as the sovereign drugs, tonifying the kidney, nourishing essence, and helping to regulate endocrine function. Prepared Rehmannia (Shu Di Huang) nourishes blood and yin and replenishes essence and marrow-"Those skilled at tonifying yang must seek yang within yin; with yin's assistance, yang is engendered inexhaustibly"; Poria (Fu Ling) strengthens the spleen and promotes urination to leach dampness; Atractylodes (Bai Zhu), especially when dry‑fried, fortifies the spleen and augments qi, aiding regulation of fluid metabolism-these three constitute the minister drugs. Angelica (Dang Gui) nourishes and invigorates blood to regulate menstruation; Achyranthes (Niu Xi) tonifies the liver and kidney, dispels stasis, and unblocks the channels; Citrus peel (Chen Pi) harmonizes the middle and resolves phlegm-these serve as assistant drugs. Glycyrrhiza (Gan Cao) harmonizes the middle and the actions of the other herbs as the envoy drug [13–14]. With syndrome‑pattern modifications-Pinellia for drying dampness and transforming phlegm in phlegm‑damp predominance, and Rubia with Persica kernel for promoting blood circulation and removing stasis when stasis is significant-the integrated combination tonifies the kidney and strengthens the spleen, dispels stasis and resolves phlegm, regulates endocrine function, improves menstrual irregularities, and enhances therapeutic effect. Our findings suggest that adding Modified Cistanche Powder on top of standard Western therapy can significantly improve clinical symptoms in PCOS patients with the "kidney deficiency with phlegm and blood stasis" pattern and increase efficacy. Peng Yun et al. [15] similarly reported significant benefits of Chinese herbal medicine combined with acupoint embedding for this pattern phenotype of PCOS, improving clinical symptoms, sex hormone levels, ovarian function, and menstrual regulation, which is consistent with our study and supports the clinical effectiveness of the Modified Cistanche Powder.
Our results showed that post‑treatment glucose‑metabolism indicators were lower in the treatment group than in the control group. The underlying rationale may be as follows: Cistanche may modulate endocrine function to improve reproductive function; polysaccharides in Poria may have immunomodulatory and hypoglycemic potential; Angelica may influence glucose metabolism indirectly via effects on endothelial function and circulation; Achyranthes may improve hemorheology and thus indirectly affect glucose metabolism. Prior studies have shown a clear association between HOMA‑IR and the development of PCOS: when pancreatic β‑cells mount a compensatory response, insulin secretion increases, deranging glucose metabolism; at the same time, the liver secretes very‑low‑density lipoprotein cholesterol, leading to combined glucose and lipid metabolic abnormalities [16]. Within our formula, prepared Rehmannia may improve insulin sensitivity through antioxidant and anti‑inflammatory effects [17]; glycyrrhizic acid constituents in licorice (Glycyrrhiza) exert immunomodulatory and anti‑inflammatory actions that may help improve insulin sensitivity. Thus, multiple constituents in the Modified Cistanche Powder likely act through several pathways to favorably influence HbA1c, FBG, FINS, and HOMA‑IR in PCOS patients. Consistent with our findings, Hao Songli et al. [18] reported that a "tonifying kidney and resolving phlegm" formula combined with Western medicine delivered good efficacy in PCOS with insulin resistance (IR), suppressing IR and inflammatory responses.
We also observed that post‑treatment sex hormone indicators were lower in the treatment group than in the control group, suggesting that the Modified Cistanche Powder effectively improves sex hormone profiles in PCOS. Previous research indicates that acupuncture combined with "Peiyuan Huatan Tang" in obese PCOS can significantly alleviate symptoms and modulate endocrine and hormonal levels [19]. Our study using the Modified Cistanche Powder reached a similar conclusion. Potential reasons include: Cistanche and Angelica may help balance sex hormones such as LH and FSH through endocrine modulation; prepared Rehmannia may act on the hypothalamic–pituitary–gonadal axis to influence hormone secretion; Poria may modulate adrenocortical function, affecting synthesis and secretion of hormones such as DHEAS; Achyranthes may regulate endocrine function via improved hemorheology; licorice may modulate steroidogenesis and metabolism via steroid‑like actions. Therefore, the Modified Cistanche Powder may beneficially affect hormone levels in PCOS through multiple mechanisms. Lai Dongjian et al. [20] similarly found that combined acupuncture and herbal therapy in PCOS with kidney deficiency and phlegm‑stasis pattern not only reduced sex hormone levels but also improved clinical efficacy, in agreement with our results. Finally, regarding safety, the incidence of adverse reactions did not differ between groups, suggesting that adding the Modified Cistanche Powder to Western therapy in kidney‑deficiency‑type PCOS does not increase serious adverse events.
In summary, the Modified Cistanche Powder can improve clinical symptoms, insulin resistance, and glucose‑metabolism abnormalities in PCOS patients; it can also regulate sex hormones, enhance efficacy, and does not increase adverse reactions.
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