Efficacy and Safety of Fire Needle Therapy Combined With Cortex Phellodendri Compound Fluid Wet Compress for Acute Herpes Zoster: a Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- herpes zoster symptom and sign quantitative scoring scale
研究概览
简要总结
Herpes zoster (HZ) results from a reactivation of varicella-zoster virus (VZV), which causes primary infection leading to chickenpox and remains latent in the ganglia. Fire needle therapy is a non-pharmacological treatment that combines heat therapy with traditional acupuncture. This technique involves heating sterilized needles and swiftly inserting them into specific points or areas of the skin. Chinese herbal wet compress therapy is directly delivering medications to the lesion site, facilitating rapid transdermal absorption. This method ensures stable local drug concentrations and effectively alleviates pain, swelling, and other clinical symptoms. In this study, we conducted a randomized controlled trial to evaluate the clinical efficacy and safety of fire needle therapy combined with CPCF wet compress for the treatment of acute HZ. 32 acute HZ patients were randomized into control (standard antiviral and analgesic therapy) and treated groups (standard therapy plus fire needle [5 sessions, every other day] and CPCF wet compress [3 times/day, 10 days]). After 10 days of treatment, fire needle combined with CPCF wet compress significantly enhances symptom relief, pain reduction, and quality of life in acute HZ, with favorable safety.
详细描述
Herpes zoster (HZ) results from a reactivation of varicella-zoster virus (VZV), which causes primary infection leading to chickenpox and remains latent in the ganglia. Fire needle therapy is a non-pharmacological treatment that combines heat therapy with traditional acupuncture. This technique involves heating sterilized needles and swiftly inserting them into specific points or areas of the skin. Chinese herbal wet compress therapy is directly delivering medications to the lesion site, facilitating rapid transdermal absorption. This method ensures stable local drug concentrations and effectively alleviates pain, swelling, and other clinical symptoms. In this study, we conducted a randomized controlled trial to evaluate the clinical efficacy and safety of fire needle therapy combined with CPCF wet compress for the treatment of acute HZ. 32 acute HZ patients were randomized into control (standard antiviral and analgesic therapy) and treated groups (standard therapy plus fire needle [5 sessions, every other day] and CPCF wet compress [3 times/day, 10 days]). After 10 days of treatment, fire needle combined with CPCF wet compress significantly enhances symptom relief, pain reduction, and quality of life in acute HZ, with favorable safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females, aged 18-80 years old;
- •diagnosed as acute HZ with the course of disease within 7 days;
- •without history of other treatment before enrollment.
排除标准
- •specific types of HZ, including Ramsay Hunt Syndrom, ophthalmic, disseminated, deep, purpuric and central nervous system HZ;
- •pregnancy and lactation;
- •allergic to the related Chinese herbals;
- •patients with contraindications to penciclovir, mecobalamin and pregabalin; (e) history of hypertrophic scar or keloid;
- •(f) severe cardiovascular, cerebrovascular, digestive, urinary or hematopoietic disease; (g) mental disease; (h) coagulation disorders.
研究组 & 干预措施
treated group
The patients received fire needle (5 sessions, every other day) combined with CPCF wet compress treatment (3 times/day, 10 days) in addition to the basic treatment of the control group.
干预措施: Fire needle (Procedure)
treated group
The patients received fire needle (5 sessions, every other day) combined with CPCF wet compress treatment (3 times/day, 10 days) in addition to the basic treatment of the control group.
干预措施: Cortex Phellodendri compound fluid wet compress (Drug)
treated group
The patients received fire needle (5 sessions, every other day) combined with CPCF wet compress treatment (3 times/day, 10 days) in addition to the basic treatment of the control group.
干预措施: basic treatment (Drug)
control group
The control group received basic treatment, which consisted of penciclovir 0.5g/time per day intravenously, mecobalamin 0.5mg/time three times a day orally and pregabalin 75mg/time twice a day orally for 10 days.
干预措施: basic treatment (Drug)
结局指标
主要结局
herpes zoster symptom and sign quantitative scoring scale
时间窗: From enrollment to day 10
The degree of the clinical symptoms and signs of HZ (including local pain, local itching, burning sensation, papular erythema, number of blisters, number of blister clusters, herpes character, ulcer, fever, local lymph node enlargement, and skin lesion area change) were divided into four grades: 0 (none), 1 (mild), 2 (moderate), and 3 (severe).
lesion improvement index n
时间窗: From enrollment to day 10
The lesion improvement index n was calculated by the formula: n (%) = (symptom and sign quantitative score at baseline - symptom and sign quantitative score at 10 days)/symptom and sign quantitative score at baselin ×100%.
the total improved rate
时间窗: From enrollment to day 10
The clinical improvement was graded as follows: clinical cure (n≥90%), significant improvement (70%≤n\<90%), moderate improvement (30%≤n\<70%), no improvement (n \< 30%). The total improved rate was calculated as cases of (clinical cure + significant improvement + moderate improvement)/total cases×100%.
次要结局
- questionnaire of Dermatology Life Quality Index(From enrollment to day 10)
- Pittsburgh sleep quality index(From enrollment to day 10)
- Hamilton Anxiety Scale(From enrollment to day 10)
- Visual analog scale(From enrollment to day 10)
- incidence of postherpetic neuralgia(From enrollment to day 90)
研究者
Weihui Zeng
Professor
Second Affiliated Hospital of Xi'an Jiaotong University