Controlled Clinical Report on Modified Xiebai San for Advanced Non-Small Cell Lung Cancer

The "Sichuan Journal of Traditional Chinese Medicine" (2005, 1: 36) once published a clinical report on treating middle- and advanced-stage non-small cell lung cancer (NSCLC) with Modified Xiebai San. The control group received radiotherapy and chemotherapy alone; the treatment group used the same radiochemotherapy regimen and course as the control group, concurrently with Modified Xiebai San.

The controlled trial results were as follows: in the treatment group of 32 cases, there were 4 complete remissions (12.5%), 14 partial remissions (43.8%), 9 with no change (28.1%), and 5 with progression (15.6%), for an overall response rate of 56.3%; in the control group of 30 cases, there were 2 complete remissions (6.2%), 9 partial remissions (30%), 10 with no change (33.3%), and 9 with progression (30%), for an overall response rate of 36.7%. The difference between the two groups was significant (P<0.01).

The base formula used in the treatment group was: Dangshen (Codonopsis) 18g, Wuweizi (Schisandra) 9g, Fuling (Poria) 12g, Qingpi (Unripe Tangerine Peel) 6g, Sangbaipi (Mulberry Root Bark) 15g, Digupi (Lycium Bark) 10g, Gancao (Licorice) 9g. Qi-deficiency patients add Huangqi (Astragalus) 30g; spleen-lung qi deficiency add Baizhu (Atractylodes) 12g and Banxia (Pinellia) 12g; yin deficiency add Shashen (Glehnia) 15g, Maimendong (Ophiopogon) 12g, and Baihe (Lily Bulb) 12g; chest tightness and pain add Yujin (Curcuma) 12g and Gualoupi (Trichosanthes Peel) 12g; wheezing add Suzi (Perilla Seed) 9g, Mahuang (Ephedra) 6g, and Xingren (Apricot Kernel) 12g; yellow phlegm add Huangqin (Scutellaria) 9g and Lugen (Phragmites Root) 15g. One decoction per day, decocted in water to 200 ml, taken in two divided doses morning and evening. Twenty-eight days constitute one course; efficacy is evaluated after two courses.

The base formula in this controlled experiment was built by adding herbs to Xiebai San. Xiebai San is the representative TCM formula for clearing and discharging lung heat, stopping cough, and calming wheezing; it treats lung-heat cough and wheezing marked by dyspneic cough, steaming heat of the skin that is especially severe in the late afternoon, a red tongue with yellow coating, and a rapid fine pulse. Moreover, in the author's experience, Xiebai San also has a fairly good effect on pleural effusion; adding Cheqian (Plantago), Huainiuxi (Achyranthes), and Yimucao (Motherwort) improves its effect on pleural effusion.

On the basis of Xiebai San, the base formula adds Dangshen, which fortifies the spleen and boosts the lung and supplements qi and blood; Wuweizi, which boosts qi and generates fluids, tonifies the kidneys and quiets the heart, and also stops cough; Fuling, which fortifies the spleen and drains dampness and also has anti-cancer action; Qingpi, which breaks qi and disperses accumulation and can inhibit tumor progression; and Gancao, which supplements qi and middle and also stops cough. These herbs complement Xiebai San: they assist it in clearing lung heat, reducing swelling and dispersing nodules, fortifying the spleen and promoting diuresis, boosting qi and nourishing the heart, and enhancing immunity, while also relieving common symptoms of advanced NSCLC such as cough, copious phlegm, and chest tightness.

Qi-deficiency patients are added raw Huangqi for a stronger qi-boosting effect; spleen-lung qi-deficiency patients are added Baizhu and Banxia for better spleen-fortifying, diuretic, and phlegm-resolving effect; yin-deficiency patients are given Shashen, Maimendong, and Baihe, which turns the formula into a combination with Shengmai San; further adding Shashen and Baihe makes its yin-nourishing, lung-moistening, and cough-stopping effect more pronounced. Those with chest tightness and pain are given Yujin and Gualoupi to resolve stagnation, stop pain, and scour out phlegm and disperse nodules; those with wheezing are given the three common cough- and wheezing-stopping herbs Suzi, Mahuang, and Xingren for better symptomatic treatment; those with yellow phlegm have exuberant lung heat, and adding Huangqin and Lugen to clear lung heat will ease the yellow phlegm.

Thus the formula used in this controlled clinical study provides symptomatic treatment. Combined with radiochemotherapy for middle- and advanced-stage NSCLC, it can improve patients' quality of life and prolong survival. The herbs used in this formula are all mild in nature with very few toxic side effects, so safety is high, ensuring the principle of safe and effective clinical medication. This prescription therefore has considerable clinical reference value.