Effect Of A Modified Cistanche Deserticola Powder On Endocrine Metabolism in Patients With Polycystic Ovary Syndrome
Dec 15, 2025
[Abstract]
Objective: To explore the effect of a modified Cistanche powder on insulin resistance and abnormal glucose metabolism in patients with polycystic ovary syndrome (PCOS). Methods: Patients with PCOS admitted to our hospital between October 2019 and June 2023 were enrolled. Based on different treatment regimens, they were allocated to a treatment group (n=46) and a control group (n=40). The control group received conventional Western medicine, while the treatment group received a modified Cistanche powder in addition to the control regimen. Clinical outcomes were compared between the two groups. Results: After treatment, scores for irregular menstruation/amenorrhea, weakness of the waist and knees, dark complexion, and mental fatigue in the treatment group were lower than both baseline and the control group; the control group also showed reductions versus baseline (p<0.05). The overall effective rate in the treatment group was 91.30%, higher than 75.00% in the control group (p<0.05). Post‑treatment levels of HbA1c, FBG, FINS, and HOMA‑IR in the treatment group were lower than both baseline and the control group; the control group likewise improved versus baseline (p<0.05). After treatment, serum T, DHEAS, LH, FSH, PRL, and SHBG in the treatment group were lower than both baseline and the control group; corresponding indicators in the control group also decreased versus baseline (p<0.05). There was no significant difference in adverse reaction rates between the two groups (p>0.05). Conclusion: The modified Cistanche powder can improve clinical symptoms, insulin resistance, and abnormal glucose metabolism in patients with PCOS, regulate sex hormones, and enhance clinical efficacy without increasing adverse reactions.
[Keywords]: modified Cistanche deserticola powder; polycystic ovary syndrome; insulin resistance; glucose metabolism
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Background: Polycystic ovary syndrome is an endocrine disorder closely associated with multiple factors such as heredity, endocrine dysregulation, insulin resistance, and lifestyle [1]. Excess ovarian androgen production in these patients leads to ovulatory dysfunction and cyst formation, presenting with irregular menstruation, polycystic ovarian morphology, and hirsutism. PCOS is a major contributor to infertility in women of reproductive age and is linked with increased risks of miscarriage, metabolic derangements, and cardiovascular disease [2]. Current Western medical therapy centers on pharmacologic management, including treatment of hyperandrogenism, ovulation induction, and mitigation of insulin resistance. Metformin-widely used in PCOS with insulin resistance-can promote ovulation by alleviating insulin resistance, but its efficacy is limited and it may cause side effects and show relapse after discontinuation [3]. With advances in clinical medicine, integrated traditional Chinese and Western approaches have become mainstream in practice and can yield favorable outcomes in PCOS [4]. In traditional Chinese medicine (TCM), PCOS is primarily rooted in kidney dysfunction with manifestations of phlegm‑turbidity and blood stasis; a mixture of deficiency and excess leads to ovarian dysfunction and a spectrum of metabolic syndrome features. A self‑formulated "Modified Cistanche Powder" is designed to tonify the kidney and strengthen the spleen, dispel stasis and resolve phlegm, regulate endocrine function, and improve menstrual irregularities-especially suitable for the "kidney deficiency with phlegm and blood stasis" pattern. This study collected clinical data from PCOS patients to investigate the effects of this formula on insulin resistance and disordered glucose metabolism.
1 General Information and Methods
1.1 General Information
A total of 86 PCOS patients treated in the Department of Gynecology, Hubei Provincial Hospital of Traditional Chinese Medicine, between October 2019 and June 2023 were included. Grouping was based on treatment method. Treatment group (n=46): age 23–39 years (27.68±2.04); disease duration 1–7 years (3.15±0.82); body mass index 19.0–24.0 (22.97±0.87) kg/m² [translator's note: the source text shows "mg/m²"; corrected to kg/m²]. Control group (n=40): age 24–37 years (27.04±2.18); disease duration 1–8 years (3.03±0.74); body mass index 18.50–23.90 (23.08±0.72) kg/m². Baseline characteristics were comparable between groups (P>0.05). All patients provided written informed consent, and the study protocol was approved by the institutional ethics committee.
1.2 Diagnostic Criteria
Western medicine diagnosis met relevant criteria for PCOS [5], with ultrasound demonstrating polycystic ovarian changes.
TCM diagnosis conformed to the pattern of "kidney deficiency with phlegm and blood stasis." Primary manifestations: delayed menstrual cycles with dark‑red color, viscous flow or clots, progression to amenorrhea, and infertility despite prolonged marriage. Secondary manifestations: soreness and weakness of the lumbar region and knees, dull facial complexion, dizziness and tinnitus, fatigue and lack of strength, dark or stasis‑spotted tongue, thin‑white or greasy‑white coating, and a deep‑slippery pulse.
Inclusion criteria: (1) Met both Western and TCM diagnostic criteria; (2) age 21–35 years; (3) no history of hormonal or other relevant treatments in the prior 12 weeks; (4) no fertility plans in the next 3 months; (5) good treatment compliance; (6) complete clinical data.
Exclusion criteria: (1) other endocrine diseases (e.g., diabetes mellitus, Cushing's syndrome, hyperprolactinemia); (2) severe cardiac, hepatic, pulmonary dysfunction or organic diseases; (3) psychiatric disorders impairing communication; (4) malignancies; (5) ovarian cysts or intrauterine pathology; (6) known drug allergy/atopic constitution.
1.3 Methods
Control group: Metformin hydrochloride tablets (Bristol‑Myers Squibb Shanghai Co., Ltd.; NMPA approval No. H20023370; 0.5 g/tablet) were administered 1 tablet twice daily with meals for 3 consecutive months.
Treatment group: On the basis of the control regimen, patients received the Modified Cistanche Powder with the following composition per daily dose: Cistanche deserticola (Rou Cong Rong) 15 g; Cuscuta chinensis (Tu Si Zi) 20 g; prepared Rehmannia glutinosa (Shu Di) 15 g; Poria cocos (Fu Ling) 15 g; dry‑fried Atractylodes macrocephala (Chao Bai Zhu) 15 g; Angelica sinensis (Dang Gui) 12 g; Achyranthes bidentata (Niu Xi) 12 g; Citrus reticulata pericarp (Chen Pi) 10 g; Glycyrrhiza uralensis (Gan Cao) 6 g. For pronounced phlegm‑dampness, add Pinellia ternata processed with ginger (Jiang Ban Xia) 10 g; for marked blood stasis, add Rubia cordifolia (Qian Cao) 10 g and Prunus persica seed (Tao Ren) 10 g. The hospital dispensary decocted one daily dose to 400 mL; 200 mL was taken orally morning and evening. Medication was paused during menstruation. Treatment lasted 3 months.
1.4 Outcome Measures
(1) TCM syndrome scoring: Before and after treatment, scores were assigned per Traditional Chinese Gynecology [6] for irregular menstruation/amenorrhea, lumbar and knee soreness/weakness, dull complexion, and fatigue. Each item was rated 0, 2, 4, or 6 according to severity; lower scores indicate better symptom recovery.
(2) Clinical efficacy: Post‑treatment efficacy was assessed per relevant criteria [7]. Markedly effective: syndrome score improved by ≥70%; Effective: 30%–69%; Ineffective: <30%. Total effective rate = (markedly effective + effective)/n × 100%.
(3) Glucose‑metabolism indicators: Before and after treatment, 4 mL fasting venous blood was collected, centrifuged, and serum analyzed. HbA1c was measured with a Bio‑Rad D‑10 analyzer; fasting blood glucose (FBG) with a Siemens ADVIA 2400 (oxidase method); fasting insulin (FINS) with a fully automated chemiluminescence analyzer (Snibe Maglumi X8). HOMA‑IR was calculated as FBG × FINS / 22.5; insulin resistance was defined as HOMA‑IR ≥ 2.69.
(4) Sex hormones: Before and after treatment, serum testosterone (T), dehydroepiandrosterone sulfate (DHEAS), luteinizing hormone (LH), follicle‑stimulating hormone (FSH), prolactin (PRL), and sex hormone‑binding globulin (SHBG) were measured using a fully automated chemiluminescent immunoassay analyzer (Siemens IM1600, Ireland).
(5) Adverse reactions: Adverse events occurring during hospitalization were recorded in both groups.
1.5 Statistical Methods
Data were analyzed with SPSS 24.0. Normally distributed continuous data were expressed as mean ± standard deviation (x̄±s) and compared between groups using the t‑test. Categorical data were expressed as percentages and compared using the χ² test. A two‑sided p<0.05 was considered statistically significant.
Add‑on: Positioning and optimization for developers and researchers
For industry (product developers and marketers)
Differentiation and claim framing: The formula, as an adjunct to metformin, showed a 16.3‑percentage‑point higher total effective rate (91.3% vs 75.0%) without increasing adverse reactions in this single‑center study. In markets such as the United States, avoid disease‑treatment claims; consider compliant structure/function positioning like "supports healthy glucose metabolism," "supports insulin sensitivity," and "supports menstrual cycle regularity," accompanied by the standard dietary‑supplement disclaimer.
Standardization strategy: Consider standardizing extracts to well‑recognized Cistanche markers (e.g., phenylethanoid glycosides such as echinacoside and acteoside/verbascoside) alongside fingerprinting of the whole‑formula profile. Define a manufacturing target range for key markers and batch‑to‑batch specifications.
Formulation and dosage form: Translate the decoction into consumer‑friendly dosage forms (granules, capsules, or standardized extract tablets). Preserve the core herb ratio; document processing (e.g., dry‑fried Atractylodes) to maintain TCM intent.
Quality and compliance: Implement botanical authentication (macroscopy, microscopy, DNA barcoding), contaminant testing (heavy metals, pesticide residues, aflatoxins, microbiology), and GMP controls. Verify legal sourcing and species identity (e.g., Cistanche deserticola vs related species). Prepare a global dossier aligning with local regulations (e.g., US cGMP 21 CFR Part 111; EU food supplement rules).
Co‑administration guidance: Since the clinical regimen added the formula to metformin, provide physician‑facing educational materials about monitoring glucose and menstrual parameters when co‑used. Consumer labels should direct patients to consult healthcare providers, especially if taking antidiabetic drugs.
For academic researchers
Trial design upgrades: Plan a multicenter, randomized, double‑blind, placebo‑controlled trial with adequate power; pre‑register the protocol; prespecify primary endpoints (e.g., HOMA‑IR and ovulation rate) and key secondary endpoints (menstrual regularity, androgen indices, live‑birth or pregnancy rates).
Mechanistic work: Explore effects on insulin signaling and androgen synthesis; profile phenylethanoid glycoside exposure (PK/PD). Integrate microbiome and metabolomics to map host–metabolite interactions.
Standardization and reproducibility: Publish the exact herb ratio, sourcing, authenticated voucher specimens, extraction/decoction parameters, and chemical fingerprints. Report effect sizes with confidence intervals, not only p‑values. Include safety monitoring for hepatic and renal function and GI tolerability.
Subgroup analyses: Evaluate BMI strata, baseline insulin resistance severity, and TCM pattern differentiation to identify responders. Consider metformin‑intolerant cohorts and herb‑only arms to isolate formula effects.
Data translation: Develop clinician‑friendly endpoints (e.g., ovulation and pregnancy rates) and patient‑reported outcomes to facilitate guideline uptake.
Note: The above optimization does not alter the scientific content of your translation. If you'd like, I can also format this as a journal manuscript (IMRaD), prepare a bilingual (CN–EN) version, or generate a one‑page industry brief with compliant US/EU claim language.
