Efficacy of Bee Venom Phonophoresis in Treating Chronic Sinusitis:

Официальное название

Efficacy of Bee Venom Phonophoresis in Treating Chronic Sinusitis: A Double-Blind Randomized Controlled Trial

Обзор

This double-blind, randomized controlled trial (BEE-SONIC) aims to evaluate the efficacy of bee venom phonophoresis in the treatment of chronic sinusitis. Thirty adult patients (aged 18-65 years) with clinically diagnosed chronic or acute sinusitis will be randomized into two groups: the intervention group will receive bee venom phonophoresis using low-to-moderate intensity ultrasound, while the control group will receive standard care consisting of oral decongestants and saline nasal irrigation. Primary outcomes include improvement in symptom severity (SNOT-22, Visual Analog Scale) and quality of life (SF-33). Secondary outcomes include reduction in facial pain, nasal congestion, and patient satisfaction. Data will be collected at baseline, midpoint, and post-intervention, and analyzed using paired t-tests and ANOVA. The study has received ethics approval from Sinai University's Human Research Ethics Committee, and informed consent will be obtained from all participants.

Подробное описание

Chronic sinusitis is a prevalent condition characterized by persistent inflammation of the paranasal sinuses, often resulting in nasal congestion, facial pain, and reduced quality of life. Conventional treatments, including antibiotics, nasal corticosteroids, and decongestants, may provide limited relief and can be associated with adverse effects. Bee venom possesses anti-inflammatory and analgesic properties, while phonophoresis - the use of ultrasound to enhance transdermal drug delivery - can facilitate deeper tissue penetration of therapeutic agents. Combining bee venom with phonophoresis may represent a novel, non-invasive treatment strategy for chronic sinusitis.

This randomized, double-blind, controlled clinical trial (BEE-SONIC) will enroll 30 adult participants aged 18-65 years with clinically diagnosed chronic or acute sinusitis. Participants will be randomly assigned to one of two groups: the intervention group will receive bee venom phonophoresis three times per week for the study duration, and the control group will receive standard care comprising oral decongestants and saline nasal irrigation. Ultrasound parameters for the intervention will be set at a frequency of 1 MHz and low-to-moderate intensity, with each sinus treated for 5-10 minutes per session.

The primary outcome measures are changes in symptom severity assessed by the Sino-Nasal Outcome Test (SNOT-22) and Visual Analog Scale (VAS) for pain, as well as quality of life measured by the SF-33 questionnaire. Secondary outcomes include reductions in facial pain and nasal congestion, and patient satisfaction with the treatment. Data will be collected at baseline, mid-intervention, and post-intervention. Statistical analysis will include descriptive statistics, paired t-tests, and ANOVA, with a significance threshold set at p \< 0.05.

Ethics approval has been obtained from Sinai University's Human Research Ethics Committee, and all participants will provide written informed consent prior to study enrollment. Confidentiality will be maintained throughout the trial, and findings will be disseminated through peer-reviewed publications and conference presentations.

Вмешательства

• Устройство Bee Venom Phonophoresis
  Ultrasound therapy device
• Препарат Standard Care (oral decongestants + saline nasal irrigation)
  (oral decongestants + saline nasal irrigation)
• Биопрепарат Bee Venom Phonophoresis
  bee venom extract prepared for topical use)

Первичные конечные точки

• Change in Sinusitis Symptom Severity [Срок оценки: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).]
• Change in Pain Intensity [Срок оценки: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).]

Вторичные конечные точки (1)

• Change in Quality of Life [Срок оценки: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).]

Критерии участия

Критерии включения

• Adults aged 18 to 65 years.
• Clinical diagnosis of chronic sinusitis (symptoms ≥ 12 weeks) or acute sinusitis confirmed by an otolaryngologist.
• Willing and able to provide written informed consent.

Критерии исключения

• Known allergy or hypersensitivity to bee venom or bee products.
• Skin conditions (e.g., eczema, dermatitis, open wounds) over the area of ultrasound application.
• Severe comorbid medical conditions (e.g., uncontrolled asthma, autoimmune disease, malignancy).
• Pregnancy or breastfeeding.
• Use of systemic corticosteroids, antibiotics, or other medications that may significantly alter sinusitis symptoms within 4 weeks prior to enrollment.
• Participation in another clinical trial within the past 30 days.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Sinai university — Cairo

Идентификаторы

NCT: NCT07151313 · SU.REC.2025(48H)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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