Individualized homoeopathic medicines in treatment of chronic tonsillitis in adults: Randomized, double-blind, placebo-controlled, pilot trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual analogue scale (VAS) scores of sore throat pain model (STPM)
研究概览
简要总结
Thepatient’s quality of life is significantly negatively impacted by chronictonsillitis. Chronic tonsillitis is said to benefit from homeopathic medicines,however there is currently inadequate evidence to support this claim. We evaluated the efficacy ofindividualized homeopathic medicines (IHMs) in treating chronic tonsillitis inadults in comparison with placebos. Inthis 3-month, double-blind, randomized (1:1), placebo-controlled trial, 60 adultpatients with chronic tonsillitis were randomized to receive either IHMs oridentical-looking placebos. Conventional management was advised concurrently toall individuals. The primary outcome was disease severity using the visualanalogue scale (VAS) scores of sore throat pain model (STPM) comprising of the sorethroat pain intensity VAS (STPIS-VAS), difficulty swallowing scale VAS (DSS-VAS),and swollen throat scale VAS (SWOTS-VAS); secondary outcomes were the Tonsiland adenoid health status instrument (TAHSI) scores and Glasgow benefitinventory (GBI) scale – all measured at baseline, and every month, up to 3months. Group differences were calculated on the intention-to-treat sample usingunpaired t-tests primarily, and two-ways repeated measure analysis of variancesecondarily. After3 months of intervention, inter-group differences became statisticallysignificant favoring IHMs against placebos on STPIS-VAS (mean difference: -1.2,95% CI -1.8 to -0.7, P < 0.001, d = 1.142), DSS-VAS (mean difference:-1.3, 95% CI -1.9 to -0.7, P < 0.001, d = 1.129), and SWOTS-VAS(mean difference: -1.4, 95% CI -2.0 to -0.8, P < 0.001, d = 1.167).Secondary outcomes also revealed significance favoring homeopathy over placebo after3 months – TAHSI (mean difference: -13.1, 95% CI -20.3 to -5.9, P < 0.001,d = 0.943), and GBI (mean difference: -10.6, 95% CI -16.3 to -4.9, P< 0.001, d = 0.967). TAHSI subscales and GBI subscales also yielded similarsignificant results. Secondary analyses failed to demonstrate any significant effecton the primary outcome, but showed significance on the secondary outcomes and inmost of the subscales. Thus, IHMsconsiderably outperformed placebos in the treatment of adult patients withchronic tonsillitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Three or more episodes of acute tonsillitis per year since last 2 years or patients with clinical sign and symptoms of chronic tonsillitis (ICD-10-CM Diagnosis Code J35.01)
- •Patients of either sex
- •Age range 18-65 years
- •Literate patients; ability to read and write in Bengali and/or English
- •Patients providing written informed consent.
排除标准
- •Presence of peritonsillar abscess or acute or chronic respiratory disease, occlusion of pharynx due to enlargement of tonsils
- •Severe co-morbidity including previous malignant disease during the past 5 years prior to enrolment
- •Previous surgery in the past 6 month or need for surgery of the nose, para-nasal sinuses, adenoid of tonsils.
- •Presence of neurological or psychiatric diseases affecting quality of life
- •Cases already undergoing homoeopathic treatment for any chronic diseases since last 6 months
- •Treatment with systemic antibiotics, gluco-corticoids or immune modulators during the week prior to inclusion
- •Substance abuse and/or dependence
- •Pregnant, puerperial and lactating women
- •Self-reported immune-compromised state.
结局指标
主要结局
Visual analogue scale (VAS) scores of sore throat pain model (STPM)
时间窗: At baseline, every month, up to 3 months
次要结局
- Tonsil and adenoid health status instrument (TAHSI) scores(At baseline, every month, up to 3 months)
- Glasgow benefit inventory (GBI) scale(Every month up to 3 months)
