Abstract: Objective To observe the clinical efficacy and recurrence rate of Qizhen granules combined with prednisone in the treatment of heavy baldness with liver and kidney deficiency. Methods Ninety patients with heavy baldness who were eligible for inclusion were randomly divided into group A, group B, and group C. They received the corresponding treatment for 3 months, and the efficacy was determined after 2 courses of treatment, and the recurrence was recorded after 3 months of follow-up. Results: The differences in clinical efficacy between group C, group A and group B were statistically significant (P<0.05), while the differences between group A and group B were not statistically significant (P>0.05); the recurrence rates of the three groups were 15.38%, 33.33% and 20.00%, respectively. Conclusion All three therapies were effective in treating heavy baldness with liver and kidney deficiency, among which Qizhen granules combined with prednisone had significant clinical efficacy and low recurrence rate in treating heavy baldness with liver and kidney deficiency.
Keywords: heavy baldness; Qizhen granule; liver-kidney deficiency type
C.I.C. Classification number: R758.71 Document identification code: A Article number: 1672-0709 (2010) 06-0362-02
Severe baldness refers to baldness in which the area of hair loss is greater than 1/3 of the scalp area or the course of the disease is more than 1 year without a trend of improvement [1]. It belongs to the category of refractory trichomatosis and is a skin disease that severely damages the appearance of patients, causing more mental pain than the hair loss itself and causing a certain psychological burden.From December 2007 to September 2009, our department used single herbal formula granules (herbal decoction-free granules) provided by Guangdong Fang Fang Pharmaceutical Co. The oral treatment of 30 cases of heavy baldness of liver and kidney deficiency type achieved satisfactory results, which are reported below.
1. Data and methods
1.1 Clinical data All 98 patients with heavy baldness were diagnosed from December 2007 to September 2009 at the Department of Dermatology, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine [2], and the patients were divided into three groups by randomized single-blind method according to the order of consultation. Among them, one case in group A withdrew from treatment halfway after 2 months of treatment because of studying in Hong Kong, one case withdrew because of headache after taking the medication, and one case withdrew after 3 months of medication because of gallbladder stone surgery; two cases in group B withdrew after taking the medication because of excitement, insomnia and gastrointestinal discomfort, one case withdrew because of significant increase in blood pressure during taking the medication, and one case withdrew after 3 months of medication because of mild The first case in group C was withdrawn because he received hair transplantation during the drug treatment. The final number of patients with heavy baldness who were eligible for inclusion and statistically treated was 90. There was no significant difference in age, duration of disease, gender and definite cause of onset of the disease among the three groups of patients with heavy baldness by statistical treatment (P>0.05), which were comparable. Exclusion criteria and shedding termination criteria: (1) pregnant and lactating women, those under 18 years of age or over 60 years of age, those allergic to the drugs used; (2) patients with combined heart, liver, kidney, endocrine and hematopoietic system diseases, and psychiatric diseases; (3) congenital alopecia: complete or partial absence of hair due to genetic factors or those with dysplastic and sparse hair development; (4) acquired alopecia: endocrine dysfunctional diseases (5) scarring alopecia: infectious skin diseases such as ringworm, balding folliculitis, certain non-infectious skin diseases such as lichen planus, limited scleroderma, discoid lupus erythematosus, superfluous organisms such as sebaceous nevus, and others such as mechanical and radiological causes; (6) inability to take medication on time and as required (6) those who cannot take the drugs on time and as required, cannot judge the efficacy, or have incomplete information that affects the judgment of efficacy or safety; (7) those who have serious adverse events, complications and special physiological changes and are not suitable to continue to receive the experiment; (8) those who are lost in the middle of treatment, those who request to withdraw from the experiment and those who withdraw from the experiment due to various other reasons.
1.2 Treatment method Group A: Single Chinese medicine formula granules (Chinese medicine no-decoction granules) provided by Guangdong Fang Fang Pharmaceutical Co., Ltd. were used to prepare Astragalus granules for oral administration, one dose each time, dissolved in hot boiled water 250mL and taken warmly once a day. Group B: Oral Prednisone (Prednisone Acetate Tablets, Guo medicine quanzi H12020689, Tianjin Tian medicine Pharmaceutical Co. Ltd.) 0.25mg/kg, once a day at 8:00 a.m., for 6 weeks, and gradually reduce the dosage for 6 months if effective. Group C: On the basis of the western medicine group, we also gave Qizhen granules, one dose each time, once a day. All three groups were treated for 3 months as a course of treatment, and the efficacy was judged after 2 courses of treatment, and the recurrence was recorded after 3 months of follow-up.
1.3 Evaluation criteria of efficacy The evaluation criteria of efficacy of baldness were formulated with reference to the relevant contents of the 3rd series of “Guidelines for Clinical Research on New Chinese Medicines” [2]. Clinical cure: hair loss stops, all hair grows out, and its distribution density, thickness and color are the same as those of healthy hair area, and sebum secretion returns to normal. Effective: hair loss stops, hair regrowth reaches more than 70%, its density, thickness and color are close to the healthy hair area, and sebum secretion is obviously reduced. Effective: hair loss stops, hair regeneration reaches more than 30%, including the growth of fine hair and white hair. Ineffective: hair loss regeneration is less than 30% or continues to fall out. Total effective rate=[(clinically cured+effective+improved)/total number of cases]×100%.
1.4 Statistical methods All data information was entered in Excel and statistically processed by SPSS16.0 software. The rank sum test was used to compare the clinical efficacy of the three groups.
1.5 Safety evaluation method At each follow-up visit or consultation after drug administration, patients were asked and recorded in detail about possible adverse reactions. Systemic adverse reactions such as gastrointestinal reactions, allergic reactions, etc. Record in detail their symptoms, time of occurrence, duration, severity (mild, moderate, severe), drug relevance (irrelevant, possibly irrelevant, possibly relevant, relevant), measures taken and regression, etc. The incidence of adverse reactions = number of cases of adverse reactions/total number of cases*100%.
2.Results
2.1 Efficacy analysis After 6 months of treatment, the total effective rate was 70.0% in group A, 80.0% in group B, and 93.3% in group C. The clinical recovery rate was 33.3% in group A, 40.0% in group B, and 60.0% in group C. By rank sum test, the difference in clinical efficacy between group C and groups A and B was statistically significant (Z=-2.795, P=0.005<0.05; Z=-1.993, P=0.046<0.05), while the difference between group A and group B was not statistically significant (Z=-0.934, P=0.350>0.05). See Table 1.
Table 1 Comparison of clinical efficacy of the three groups Example (%)
Group
Number of cases (n)
Clinically cured
Apparent effect
Effective
Ineffective
Total effective rate
Group A
30
10(33.3)
3(10.0)
8(26.7)
9(30.0)
70.0
Group B
30
12(40.0)
5(16.7)
7(23.3)
6(20.0)
80.0
Group C
30
18(60.0)
7(23.3)
3(10.0)
2(6.7)
93.3
2.2 Safety analysis There were 2 cases of gastrointestinal reactions in group A, and the incidence of adverse reactions was 6.7%; 1 case of dizziness and insomnia, 4 cases of gastrointestinal reactions, 2 cases of increased appetite and mild obesity, and 1 case of mildly elevated blood pressure in group B, and the incidence of adverse reactions was 26.67%; 2 cases of insomnia and 2 cases of gastrointestinal reactions in group C, and the incidence of adverse reactions was 13.33%. All symptoms disappeared at the end of treatment.
2.3 Follow-up Follow-up was done by follow-up and telephone follow-up, see Table 2.
Table 2 Comparison of recurrence in the three groups
Group
Number of follow-up cases
Number of recurrence cases
Recurrence rate (%)
Recurrence
Telephone follow-up
Group A
23
3
4
15.38
Group B
24
3
9
33.33
Group C
21
4
5
20.00
3. Discussion
The causes of the pathogenesis of heavy baldness are not fully understood by modern medicine. At present, it is believed that the disorder of the body’s immune function is the main cause of its pathogenesis, and it is also related to psychoneurological factors, vasodilatory function, genetics, endocrine disorders, and local infections [3]. Ancestral medicine believes that heavy baldness is mostly caused by blood and kidney deficiency, and is closely related to the liver and kidneys. The liver and kidney are located in the middle and lower jiao, and in the relationship between the five elements, they are related to each other, that is, if the mother is solid, the son will be strong, and if water is connoted, the wood will be glorious. In the relationship between the internal organs, the relationship between the liver and kidney is extremely close, there is a “liver and kidney homologation” said. The liver collects blood, the hair is the remainder of the blood, the kidney collects essence, its Hua for the hair, essence and blood is the material basis of the liver and kidney homologation. The relationship between blood and essence is actually the mutual nourishment and transformation between essence and blood. Therefore, if the liver and kidney are deficient, blood deficiency cannot nourish the skin, and the couples are not solid, so the pores are opened and the wind evil takes advantage of the deficiency to enter, and the wind and blood are dry, the hair loses its nourishment and falls off.
At present, modern medicine has not found a safe and effective treatment plan for patients with heavy baldness. Corticosteroids have relatively definite efficacy in the treatment of heavy baldness, and corticosteroids are mostly used clinically to treat this disease [4]. Due to the many side effects of systemic application of corticosteroids, there are limitations of clinical single use, such as in China, Hudongliu et al [5] believed that corticosteroids should be used rationally and attention should be paid to their combination with Chinese medicine. In the formula of Qizhen granules, Astragalus membranaceus is used to nourish qi and generate blood, while Shu Di Huang nourishes yin and tonifies the kidney, both of which are used together as the monarch medicine. Radix Astragali, Cornu Cervi Pantotrichum, Radix Shou Wu, Semen Cuscutae and Radix Huang Jing nourish the liver and kidney, fill in the essence and nourish the blood, regenerate the hair and make up for the deficiency of the innate; Yam and Ganoderma lucidum benefit the qi, strengthen the spleen and stomach, and nourish the source of hair growth; the six medicines together with the monarch benefit the qi, strengthen the spleen and nourish the blood, nourish the liver and kidney, and are used as the subject medicine. Dan Pi clears deficiency heat, Ze Xie dampness and drainage of kidney turbidity, Fu Ling strengthens the spleen and permeates dampness, the three drugs together not only reduce the nourishing and greasy Astragalus, Shu Di Huang, and can control Cornu Cervi Pantotrichum, Shou Wu and Semen Cuscutae of warm and dry, used as an adjuvant. Licorice nourishes the spleen and benefits the qi, harmonizes all the medicines, and is used as the making medicine. The whole formula is nourishing but not greasy, warm but not dry, with both nourishing and diaphoretic, nourishing the liver and kidney, benefiting the qi and strengthening the spleen, and waxing the hair. The results of this study showed that all three treatments were effective in patients with heavy baldness with liver and kidney deficiency, among which Qizhen Granules and Prednisone had comparable clinical efficacy in patients with heavy baldness with liver and kidney deficiency, especially Qizhen Granules combined with Prednisone had the most significant clinical efficacy, which not only had fewer adverse effects, but also had a lower recurrence rate and was convenient to take clinically.
Currently, the treatment of heavy baldness has been diversified, and from the results of this study, we can see the advantages of the recent efficacy of the integrated therapy of Chinese and Western medicine. However, the clinical dosage of corticosteroids in the treatment of heavy baldness is more appropriate and can achieve more desirable therapeutic effects, and the extent to which the combination with Chinese medicine can reduce the occurrence of side effects of corticosteroids and the long-term efficacy are yet to be further studied.
References.
[1] Zhang Jingzheng, Liu Rongqing, Ye Qingdai. Comparative observation on the treatment of heavy baldness with long-pressin and prednisone [J]. Journal of Clinical Dermatology,1990,6:299-301.
[2] Ministry of Health of the People’s Republic of China. Guiding principles for clinical research on new Chinese medicines [S]. Beijing: China Medical Science and Technology Press, 2002.
[3] Chen Dacan, P Guowei. Clinical diagnosis and treatment of dermatological diseases in Chinese medicine [M]. Beijing:People’s Health Publishing House,2000:159.
[4] Chen Xiuyang,Hudongliu. Advances in Chinese and Western medicine research on severe baldness[J]. Medical Theory and Practice,2009,22(11):1309-1311.
[5] Hudongliu,Chen Dacan,P Guowei,et al. Treatment of heavy baldness by Chinese and Western medicine and research trends[J]. Journal of Traditional Chinese Medicine,2003,21(11):1932-1933.