Objective: To observe the clinical effect of Toutong Chongji (Granules for Headache) in treating headache due to exuberance of Yang of the liver.

Methods: The cases were selected according to Clinical Study Guide of New TCM Drugs in Treating of Headache (Volume 11 of Clinical Study Guide of New TCM Drugs, Published by Ministry of Health), and fitted the diagnosis criterion of headache due to exuberance of Yang of the liver. The patients were divided into two groups by the randomized number method. The treatment group had 100 patients. 10g of granules were taken orally, 3 times a day.

Toutong Chongji was constituted by 12 Chinese Traditional Medicines: Forsythia Fruit, Mulberry Leaf, Chrysanthemum Flower, Kudzuvine Root, Folium Nelumbinis, Spica Prunellae, Rhizoma Imperatae, etc. It had the function of clearing away excessive heat relieving constipation and alleviating pain through adjusting the function of the liver. The control group had 30 patients. 6g of Zhengtianwan (ZTW) pills were taken orally, 3 times a day. One treatment course was 10 days.

Criteria for therapeutic effect:
Clinical recovery: headache and related symptoms disappear;

Markedly improved: headache strength decreased by 2 grade, related symptoms alleviated, or headache attacking time and duration reduced by 2/3 or more;

Improvement: headache strength decreased by 1 grade, interval of attacking prolonged or existent time cut down less than 2/3;

Ineffective: headache strength decreased by less than 1 grade, or persistent time of headache cut down to less than l/3, or headache aggravated, persisted time prolonged.

Results: The treatment group: clinical recovery rate was 23.0%, markedly improvement at was 45.0%, improvement rate was 21.0%, ineffective rate was 11.0%; The control group: clinical recovery rate was 13.3%, markedly improvement rate was 33.3%, improvement rate was 30.0%, ineffective rate was 23.4%. Two groups had significant differences (P<0.05) by edit analysis. In addition, the effective time of the treatment group was 2.10±0.96d on average, control group was 3.67±l.45d, and statistical data indicated that two groups had significant differences (P<0.05). All these showed that Toutong Chongji efficacy is better than that of ZTW. Toutong Chongji can be applied on headache due to exuberance of Yang of the liver, and won't be limited in headache’s character, location, extent, and course etc.

Conclusion: Toutong Chongji had markedly therapeutic effect on headache due to exuberance of Yang of the liver; it's better than ZTW.

By Li Jinglin.