Efficacy and Safety of Fire Needle Therapy Combined With Cortex Phellodendri Compound Fluid Wet Compress for Acute Herpes Zoster: a Randomized Controlled Trial.

Conditions

Acute Herpes Zoster

Keywords

acute Herpes zoster, fire needle therapy, Cortex Phellodendri compound fluid, randomized controlled trial

Brief summary

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.

Detailed description

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.

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Interventions

PROCEDUREFire needle

At the beginning of the fire needle therapy, the patient was instructed to exposure the lesion in a comfortable position. And the Ashi point (lesion area) was disinfected with iodophor. The 95% alcohol lamp was lit and held by the left hand. Then the needle was held by the right hand in the outer flame of the alcohol lamp to heat the needle body, making the tip of the needle whiten. Subsequently, the needle was quickly and accurately puncted into the base of the herpes at a depth of about 2-5 mm, straight in and out. According to the number of herpes, the early-onset herpes was puncted first, and about 5 to 10 blisters were selected for each puncture. The acupuncture was performed 1-5 times according to the size of the herpes. The treatment was performed once every other day for total 5 sessions.

DRUGCortex Phellodendri compound fluid wet compress

For the Chinese herbal wet compress treatment, CPCF (Shandong Hanfang Pharmaceutical Co., LTD.) was decocted using forsythia, honeysuckle, phellodendron, dandelion, and centipede. Appropriate amount of liquid was diluted with 5 times the volume of water. Then according to the area of skin lesions, several pieces of medical fat-free cotton gauze with thickness of 8 layers were put into the liquid completely wet. After wringing out to a semi-dry state, the gauze was applied to the lesion for 15 minutes/time, 3 times a day, for 10 days.

DRUGbasic treatment

The basic treatment 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

No

Inclusion criteria

1. males and females, aged 18-80 years old; 2. diagnosed as acute HZ with the course of disease within 7 days; 3. without history of other treatment before enrollment.

Exclusion criteria

1. specific types of HZ, including Ramsay Hunt Syndrom, ophthalmic, disseminated, deep, purpuric and central nervous system HZ; 2. pregnancy and lactation; 3. allergic to the related Chinese herbals; 4. 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.

Design outcomes

Primary

Measure	Time frame	Description
herpes zoster symptom and sign quantitative scoring scale	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	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	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%.

Secondary

Measure	Time frame	Description
Visual analog scale	From enrollment to day 10	The pain intensity due to HZ was evaluated by a visual analog scale (VAS) ranging from 0 to 10 (0: no pain, 1-3: mild, 4-6: moderate, 7-10: severe) at day 0 and day 10.
questionnaire of Dermatology Life Quality Index	From enrollment to day 10	—
incidence of postherpetic neuralgia	From enrollment to day 90	The incidence of postherpetic neuralgia was analysed at day 90.
Pittsburgh sleep quality index	From enrollment to day 10	—
Hamilton Anxiety Scale	From enrollment to day 10	—

Countries

China

Outcome results

None listed