| ObjectiveOur research used testosterone, skin lesion changes and Pillsbury classification as index, to evaluate the therapeutic effect of the pathogenesis of acne associated with scraping therapy treating damp heat type acne patients. It is shown that the scraping therapy treating damp heat type acne with significant advantage, compared to the acupuncture control group.Method1.Research ObjectThe patients with acne were accumulated through open recruitment from July2012-September2013in Acupuncture Chinese Academy of traditional Chinese medicine hospital outpatient.2. Research planTo select a prospective, randomized and a controlled study plan.2.1Random method:Use random method to randomize total of84patients into experimental group (scraping group) of42cases and control group (acupuncture group) of42cases. Random sequence is generated by SPSS software, hidden in a non transparent envelope, all the random envelope is preserved by a person who does not involve in this research. After the baseline evaluation and signed the informed consent, the researcher will open an envelope according to the sequence of the patients who got into group, to get the random number for each patient.2.2There is a standard to definitive diagnosis, inclusion criteria, exclusion criteria, fall offs, and terminated tests. 3.Intervention Plan3.1Scraping therapy group3.1.1Scrapingregion(1) Backside region:Select Du meridian located at the back, bladder meridian with a total of5lines.(2) Facial region:Select total of4regions including frontal region, supra and infra orbital region, zygomatic upper and lower region, and mandibular region.Frontal region:extra nerve points-Yin Tang; gall bladder meridian of foot Shao yang-Yang Bai.Supra and infra orbital region:extra nerve points-Yu Yao and Tai Yang; stomach meridian of foot Yang ming-Cheng qi, Si bai.Zygomatic upper and lower region:Small intestine meridian of hand Tai yang-Quan liao; Large intestine meridian of hand Yang ming-Ying xiang; Stomach meridian of hand Yang ming-Xia guan.Mandibular region:Ren meridian-Cheng jiang; Stomach meridian of foot Yang ming-Jia che.3.1.2Scraping apparatusOur research have selected water buffalo horn scraping plate, one per person, sterilize after every use.(wipe with75%alcohol for sterilization)Scraping medium Jin Long Kang scraping moisturizing oil (Backside region) and Jin Long Kang scraping lotion (facial region).3.1.3Manipulation Method(1) Scraping of the backside region:Patient should take prone position, use alcohol cotton ball to sterilize the surface of the skin that is to be scraped. Then apply Jin Long Kang scraping moisturizing oil and use water buffalo plate to scrape first, the dorsal midline with heavy scraping method, from top to bottom, scrape Da Zhui to Zhang Qiang about10-20times.Then scrape the two side lines of the bladder meridian which is apart from the spine1.5inches. Position the corner of the scraping plate to the acupoint Da Zhui then apply heavy,linear scraping method etc, transport plate method and scrape each side 20-30times.Finally, scrape the second side lines of the bladder meridian which is apart from the spine3inches. Manipulation method is the same as the first side lines. Each side should be scraped20-30times,15-20minutes should be consumed for the whole backside. After scraping, patients should be told to drink2large cups of warm water (>300ml) in order to promote water metabolism.(2) Scraping of the facial region:special scraping plate should be selected for face. Patient should take prone position, and use Kleenex to wipe the area that is to be scraped. Then apply Jin Long Kang scraping lotion.Frontal region:Angle of5°～15°should be made between the plate and the surface of the skin. Take the midline of the frontal region as a starting line, then scrape to the left and to the right toward the forehead headline, Tou Wei, scrape with light method about10-20times. Strength should be moderate and steady, with consistent smooth movement, and ensure not to stretch the skin.Meridians and acupoints in this region or at the edge of this region, should be stimulated individually. E.g. point pressure and massage Shen Ting, Tou Wei, Yin Tang, Yang Bai etc. acupoints.Supra and infra orbital region:Place the former1/3of the scraping plate converge to the nasal root, and make an angle of5°～15°with the skin surface. Then scrape to the left and to the right, appress close to the edge of the orbital bone hole to front ear. Apply with light scraping method10-20times. When scraping, patients should close their eyes and be aware not to press the eye when scraping. Apply with same method in the "infra orbital region" and scrape10-20times.zygomatic upper and lower region:Start to scrape from nasal alar to the left and the right side along the lower edge of the orbital bone to the front ear. Apply light scraping method10-20times. Use the same method as above, scrape from nasal alar to Ying Xiang acupoint to the front of the earlobe10-20times. Once you reach the front of the ear, rest and apply pressure.Mandibular region:Place the scraping plate at the bottom midline of the face, press the skin of the lower mandibular, make an angle of5°～15°between the plate and the skin, then scrape along the edge of the mandible to the earlobe direction10-20times. Once you reach the front of the ear, rest and apply pressure.3.2Acupuncture Control GroupAcupoint selection:Yang Bai, Quan Liao, Da Zhui, He Gu, Qu Chi, Nei Ting, Zu San Li, San Yin Jiao, Yin Ling Quan and Ah Shi (lesion diameter>lcm)Needle instrument:Hua Tuo brand disposable acupuncture needle,0.25mmx25mm filiform needle.Manipulation:Patient should take prone position, select0.25mmx25mm filiform needle, puncture needle in fast speed, suitable with reinforcing-reducing method until deqi sensation, retain the needle for20min.4. Evaluation Index4.1Therapeutic effect indexMain evaluation index4.1.1Classification of acne improvement level before and after the treatmentThe Pillsbury classification method is used for the evaluation of the acne classification. It is internationally recognized for the qualitative description on the severity of the acneSecondary efficacy indicators4.1.2Subside and improvement level of total and each parts of skin lesion before and after the treatmentSkin lesion count and evaluation method:record the numbers of all types of new and old skin lesions (acne, papules, pustules, nodules, cysts). Evaluation standard:one papule or acne:0.5score; one pustule:1score; one nodule:2score; one cyst: diameter≤cm,2score, diameter>1cm,3score. Total skin lesion score:the sum of each type of skin lesion score equals to the score of the total skin lesion.4.1.3The level of serum testosterone in patients before and after the treatmentEach patient should proceed with serum testosterone testing before treatment and after8times of treatment.4.1.4Therapeutic evaluation after the treatment Criteria of curative effect "Clinical disease diagnosis standard of TCM"(1) Recovery:Skin lesion score decrease to≥90%before treatment, no new skin lesion or skin lesion score<1.5score.(2) Effective:Skin lesion score decrease to≥70%before treatment, new skin lesion score<2score.(3) Improvement:Skin lesion score decrease to≥30%before treatment, no new skin lesion or skin lesion score<3score.(4) Ineffective:Skin lesion score decrease to≥30%before treatment, no new skin lesion or skin lesion score<5score.Note:clinical remission rate=(score before treatment-score after treatment)/scorebefore treatment*100%4.2Safety observation index:Observe any adverse events and outcomes during scraping and acupuncture treatment process.4.3Observation on compliance:Calculate the compliance of the patients with scraping and acupuncture, number of treatments>7times are considered as good compliance. If it is considered as poor compliance, you should find the reason and record it.5. Statistical methodBy using the SPSS19.0statistical software, the calculation of the data should be indicated with the mean standard deviation (x±s). The two groups before and after the treatment was compared using independent samples t test. Compare the use of paired samples t test in two groups before and after treatment in group. Curative effect comparison of rating information is done with the Mann-Whitney test. Proceed analysis with the effect after the treatment and baseline data, relationship between disease and correlation method. P<0.05was indicated as statistical significance.Result1.Completion of the baseline data and the comparison of the casesThere were no differences in sex, age, course of acne (years), papules numbers, pustules numbers, Pillsbury score, androgen (testosterone) value and the first age of acne between two groups, comparability of (t test, P>0.05,)Scraping therapy group had3fall offs due to its poor compliance, total treatment of39cases; Acupuncture control group had one terminated treatment due to the local redness and itchiness after acupuncture treatment.3cases of fall offs because treatment period was not ensured, total treatment of38cases. In84cases of patients enrolled, total of7cases fall off,77cases completed treatment. Off elimination rate was5.9%.2. Therapeutic analysis after4weeks of treatment Main therapeutic index2.1Acne classification improvement level (Pillsbury score) After4weeks of treatment, the Pillsbury score in two groups have significantly decreased, before and after difference were statistically significant (P<0.05); but the comparison between Pillsbury score in two groups were no difference (P>0.05). This shows that both scraping therapy and acupuncture treatment shows significant improvement in the Pillsbury score with the damp heat type acne patients, but both scraping and acupuncture methods show no difference. Secondary efficacy indicators:2.2Level of subside and improvements in total and different part skin lesions After4weeks of treatment, the total skin lesion score of patients in two groups have significantly decreased (P>0.05). The skin lesion score in frontal region, cheek, nose, chin and the back in two groups besides the neck and the upper chest, have shown with significant decrease, and statistically significant before and after the difference (P<0.05). This shows that both scraping therapy and acupuncture treatment can significantly improve the lesion score of damp heat type acne patients, but both scraping and acupuncture methods show no difference.2.3Improvement in each type of skin lesions2.3.1Papule or acne scoreAfter4weeks of treatment, the papule or acne score of patients in two groups have significantly decreased, there is a statistical significance in before and after difference (P<0.05); The papule or acne score shows significant difference between the two groups of patients after the treatment(P<0.05). The score of the treatment group is lower than the control group. This shows that both the scraping therapy and the acupuncture treatment significantly improves the papule or acne score in damp heat type acne patients, and the therapeutic effect of the treatment group shows more outstanding result than the control group.2.3.2PustulesAfter4weeks of treatment, the pustule score of patients in two groups have significantly decreased, and there is a statistical significance in between before and after differences (P<0.05); The papule and acne score in two groups of patients show no differences (P>0.05). This shows that both scraping therapy and acupuncture treatment can significantly improve the pustules score of damp heat type acne patients, but both scraping and acupuncture methods show no difference.2.4Serum Testosterone LevelAfter4weeks of treatment, the serum testosterone level of patients in two groups have significantly decreased (P＜0.05), but the serum testosterone level control group did not show significant differences (P>0.05); There is a difference in the serum testosterone level with patients between two groups (P<0.05), and the treatment group is significantly lower than the control group. This shows that the scraping therapy can significantly lower the level of the serum testosterone than the control group.3. Follow up examinationPatients were followed up for a month, for recovered and effective patients recrudescence, treatment group of39cases,2were lost to follow up,1took medication,3were recrudescent, recrudescence rate is8.33%. Control group of38cases,2were lost to follow up,2took medication,2were recrudescent, and the recrudescence rate is5.88%.Conclusion 1.Scraping therapy can improve the facial papule, acne score and serum testosterone level of damp heat type acne patients.2. Both Scraping and Acupuncture treatment can significantly improve the acne classification level (Pillsbury) and the skin lesion score in damp heat type acne patients, and there is no difference in between these two treatments.3. Scraping therapy in improvement of damp heat type facial acne patients and the number of acne is more outstanding than the acupuncture therapy. This might be caused by scraping therapy which decreases the serum of testosterone level. Next, we can further on experiment and discuss on the related mechanism of scraping treating acne. |
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