Clinical Study on 1 068 Cases of Acne Treated by Fire Needle Therapy
HUANG Shu , ZHOU Jian-wei , ZHANG Yan , CHEN Chun-tao  Acupuncture & Moxibustion Research Institute, Sichuan Academy of Traditional Chinese Medicine, Chengdu 610031, R R. China

[ Abstract ] Objective: To investigate the clinical efficacies of fire acupuncture in treat various types of acne. Methods: An open test was designed. One thousand and eighty-six patients who visited for clinical service were collected as a sample. Results: The cure and marked effective rate was 78.5% for lung heat type, 80.8% for heat toxin type, 77.4% for disharmony of the Thoroughfare and Conception Vessels type and 80.1% for blood stasis and phlegm accumulation type. Statistical analysis showed no significant differences in therapeutic effect between different types (P>0.05). Conclusion: Fire acupuncture has an exact therapeutic effect on various types of acne without toxic side effects.
[ Key Words ]Acne; Fire-needle Therapy; Syndrome Differentiation Treatment
[CLC Number] R246.7
[Document Code] A
 
Based on the previous large-sample, multiple center, and randomly controlled clinical trials on fire needle therapy and acne, the authors have performed an open clinical trial on 1 068 cases since 2004 to further clarify its safety and efficacy. The report is now as follows.

1 Clinical Data

1.1 General data
All the 1 068 cases were from the outpatient department of dermatology of the three research centers, including 424 males and 644 females. The shortest duration: 2 weeks; the longest duration: 11 years; the average duration: 2.2 years; ages: 14-46 years old; the average age: 26 years old; patterns: lung-heat (432 cases); toxic-heat (234 cases); blood stasis and phlegm retention (176 cases); and disharmony of the Thoroughfare and Conception Vessels (226 cases).

1.2 Diagnostic criteria

1.2.1 Diagnostic criteria in Western medicine
 This is based on the Clinical Study Guidelines for New Chinese Medicine[1], Pill Sburv, and International Revised Grading on Acne. The diagnosis, grading, and classification methods are as follows.
  
Diagnostic criteria: Acne starts from adolescence and usually appears symmetrically in the areas full of sebaceous glands including the face, upper chest, and back. The skin lesion mainly involves nodules and cysts as well as seborrhea.
  
Grading of severity is as follows.
Grade I (mild): Scattered or multiple blackheads, scattered inflammatory papules, and 10-30 focuses.
Grade II (mild moderate): Pimples, some  papules, and shallow pustules, and 31-50 focuses in the face.
Grade III (severe moderate):  Deep inflammatory papules and pustules, 50-100 focuses and less than 3 nodules in the  face, neck, chest, and back.
Grade IV (severe):  Deep inflammatory papules and pustules, more than 100 focuses, more than three nodules or  cysts, and possibly forming of scarring in the upper body.
 Nature of the skin lesion: Inflammatory acne, redness,  obvious  infiltrative  inflammation,  and nodular cystic lesion.

1.2.2  Syndrome  differentiation  in  traditional Chinese medicine
This is based on the Newly Revised TCM Dermatology[2].
 
Those with lung-heat may present with blackheads, red face, scattered papules that are consistent with hair follicles, and absence of subjective symptoms. The tongue appears pale-red with thin and yellow coating. The pulse is superficial and rapid.
 
Those with damp-heat in the spleen and stomach may present with oily skin, redness, swelling, and pain of the skin lesion, foul breath, constipation, and dark-yellow urine. The tongue appears red with yellow and greasy coating. The pulse is slippery.
 
Those with blood stasis may present with hard, recurrent nodular cysts in dark color and possible forming of scarring. The tongue appears dark with ecchymosis or petechia. The pulse is hesitant.
Those with phlegm retention may present with soft, round, and glossy cysts, abdominal distension, and loose stools. The tongue coating appears slippery or greasy. The pulse is slippery.
 
The  female  cases  with  disharmony  of the Thoroughfare and Conception Vessels may present with worsened skin lesion before the period.

1.3 Inclusive criteria
 
Those who conform to the diagnostic criteria and TCM criteria for pattern identification; severity  from grade II to grade IV. Aged from 15 to 45 years old; discontinue orally-administered drugs, external drugs, and other therapies; and those who signed the informed consent.

1.4 Exclusive criteria
  Those with grade I severity; occupational acne caused by chemical materials or acne caused by drugs; those who are scared of needles, or with allergic or scarring constitution; those with complications of primary diseases involving cardiovascular conditions, liver, kidney, or hematopoietic system or mental disorders; and women during pregnancy.

1.5 Rejecting criteria
Those who do not conform to the inclusive criteria but are admitted mistakenly or those who conform to the inclusive criteria but do not get the required treatment; those without complete data that may affect the evaluation on efficacy and safety; those who fail to continue the treatment because of accidents during treatment; and those who do not cooperate with the doctor during the treatment.

2 Study Methods
2.1 Trial design
  An open trial design was selected on the basis of 210 cases. The case samples have been collected according to the open trial design method. The clinical study of this project has been done in three clinical trial centers with the required study design.
2.2 Treatment method
2.2.1 Selection of points
Local: Tip, central, or basal area of each node or cyst.
Distal: Feishu (BL 13), Geshu (BL 17), and Pishu (BL 20).

2.2.2 Acupuncture tool
The dragon fire needle of 0.4 mm × 45 mm with natural brand was selected[3].The needle should be examined before puncturing the patients: change or blunt the needle tip in case the tip is in poor condition or too s