02/04/2026
Modified Shen Ling Bai Zhu San in the Treatment of Acne Vulgaris
A total of 120 patients with acne vulgaris were randomly assigned into treatment group and control group, with 60 subjects in each group.
The inclusion criteria were as follows:
1) Subject is actively seeking and receiving treatment for acne vulgaris;
2) Skin condition classified as mild (Grade I) or moderate (Grade II) according to the modified Pillsbury scale;
3) Subject must be at least 18 years old;
4) Informed consent signed.
There was no significant difference in general data (gender, age, degree of skin lesion) between the two groups, the two groups were therefore statistically comparable (P > 0.05).
Both groups followed routine treatment measures for acne vulgaris, including diet and lifestyle modification. The control group was treated with oral isotretinoin soft capsules (Shanghai Xinyi Yanan Pharmaceutical Co., Ltd, 10 mg per capsule), one capsule twice daily. Fusidic acid cream was applied to the affected areas twice daily after the face was cleaned.
In addition to the same treatment protocol, the treatment group received modified Shen Ling Bai Zhu San formula, which is consisted of: Sheng Bai Zhu 12 g (生白术 Rhizoma Atractylodis Macrocephalae), Bai Bian Dou (raw) 15 g (白扁豆 (生) Semen Dolichoris Album), Shan Yao 15 g (山藥 Rhizoma Dioscoreae), Yi Yi Ren (raw) 20 g (生薏苡仁 Semen Coicis), Sha Ren 5 g (砂仁 Fructus Amomi), Dang Shen 10 g (黨參 Radix Codonopsis), Fu Ling 15 g (茯苓 Poria), Lian Zi 10 g (蓮子 Semen Nelumbinis), Jie Geng 6 g (桔梗 Radix Platycodonis), and Gan Cao 6 g (甘草 Radix Glycyrrhizae). 400ml of decoction was prepared daily and taken orally in two divided doses in the morning and evening. Course of treatment was 6 months for both groups.
Routine blood tests, liver and kidney function indicators (alanine aminotransferase, aspartate aminotransferase, serum creatinine, and blood urea nitrogen), lesion counts, and patient satisfaction score (assessed by a questionnaire designed by the Dermatology Department of Lishui Hospital of Traditional Chinese Medicine) were monitored before and after the treatment.
The result was considered as:
1. Cured: if symptoms and lesions completely resolved without scarring
2. Markedly Effective: if lesions resolved by at least 60% with significant symptom improvement
3. Improved: if lesions resolved by 30-60% with symptom alleviation
4. Ineffective: when the above criteria was not met.
The total effective rate = (Cured + Markedly Effective) case/ total number of cases x 100%
According to the study, the total effective rate in the treatment group was 91.67%, which was significantly higher than 78.33% in the control group (P < 0.05). After six months of treatment, no significant differences were observed between the two groups in RBC count, WBC count, platelet count, or liver and kidney function indicators (P > 0.05). The numbers of comedones, papules, pustules, and total skin lesions were significantly lower in the treatment group than in the control group (P < 0.05), and patient satisfaction scores were also significantly higher (P < 0.05). These findings suggest that modified Shen Ling Bai Zhu San may improve clinical outcomes, reduces lesion burden, and enhances patient satisfaction for patients with mild to moderate acne vulgaris.
Qiu, YD, et al. Chinese Archives of Traditional Chinese Medicine. 2025. 43(1): 217-220.