棕榈叶Ledum palustre 200cH预防COVID-19疫苗接种后注射部位疼痛和压痛：一项双盲、随机、安慰剂对照试验的中期结果

IF 1.7 Q2 Medicine

Advances in integrative medicine Pub Date : 2025-09-11 DOI:10.1016/j.aimed.2025.100574

Subhranil Saha , Abhijit Rana , Aritra Roy Chowdhury , Satyajit Naskar , Pulakendu Bhattacharya , Subhasish Ganguly , Sangita Saha , Amitava Paul , Shyamal Kumar Mukherjee

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引用次数: 0

摘要

背景：COVID-19疫苗经常导致注射部位附近的皮肤副作用，如红肿。本试验旨在确定Ledum palustre 200cH在预防COVID-19疫苗接种后注射部位疼痛和压痛方面是否比安慰剂更有效。方法在印度西孟加拉邦一家顺势疗法医院疫苗部进行为期一个月的双盲、随机、安慰剂对照、平行对照临床试验。尽管预期样本量为218人，但由于印度的COVID-19免疫运动突然终止，只能招募122名参与者。干预措施为Ledum palustre 200cH （n = 61）或具有相同外观的安慰剂（n = 61）。主要结果测量是注射部位的疼痛和压痛程度，于第1、2、3、5和7天测量，然后每周一次，持续一个月，使用0-100 mm视觉模拟量表（VAS）。结果试验提前终止。Kaplan-Meier生存分布显示，verum组疼痛缓解时间（中位数：2天，95% %置信区间（CI） 1.7-2.3）显著早于安慰剂组（中位数：3天，95% % CI 2.6-3.4）；Mantel-Cox log-rank检验：χ12 = 21.632,p <； 0.001。与安慰剂（中位数：3天，95% % CI 2.5-3.4）相比，早期缓解的压痛倾向于verum（中位数：2天，95% % CI 1.7-2.3）也显示了类似的趋势；Mantel-Cox log-rank检验：χ12 = 20.172,p <； 0.001。结论palustre 200cH对新冠肺炎疫苗接种后注射部位疼痛和压痛的早期缓解效果明显优于安慰剂；然而，这些结果应该谨慎解释，因为试验的动力不足。应该进行结论性和强有力的试验来验证这些发现。审判registrationCTRI / 2022/10/046839;UTN: u1111 - 1284 - 2437。

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Ledum palustre 200cH in preventing injection site pain and tenderness following COVID-19 vaccination: Interim results of a double-blind, randomized, placebo-controlled trial

Background

The COVID-19 vaccine frequently results in cutaneous side effects, such as redness and swelling, near the injection site. This trial was carried out to determine whether Ledum palustre 200cH is more effective than a placebo at preventing injection site pain and tenderness after the COVID-19 vaccination.

Methods

This one-month, double-blind, randomized, placebo-controlled, parallel-arm clinical trial was conducted at the vaccination department of a homeopathic hospital in West Bengal, India. Despite the desired sample size being projected at 218, only 122 participants could be enrolled because of the abrupt termination of the COVID-19 immunization campaign in India. Interventions were Ledum palustre 200cH (n = 61) or placebos with the same appearance (n = 61). The main outcome measure was the degree of pain and tenderness at the injection site was measured on days 1, 2, 3, 5, and 7, then once a week for a month, using a 0–100 mm visual analog scale (VAS).

Results

The trial was terminated prematurely. The Kaplan-Meier survival distributions revealed that the time to resolution of pain was statistically significantly earlier in the verum group (median: 2 days, 95 % confidence interval (CI) 1.7–2.3) than placebo (median: 3 days, 95 % CI 2.6–3.4); Mantel-Cox log-rank test: χ₁² = 21.632, p < 0.001. Similar trends were revealed by earlier resolution of tenderness favoring verum (median: 2 days, 95 % CI 1.7–2.3) against placebo (median: 3 days, 95 % CI 2.5–3.4); Mantel-Cox log-rank test: χ₁² = 20.172, p < 0.001.

Conclusion

Ledum palustre 200cH produced significantly better effects than placebos by earlier resolution of pain and tenderness in injection sites following COVID-19 vaccination; however, these results should be interpreted with caution because the trial was underpowered. Conclusive and robust trials should be undertaken to validate the findings.

Trial registration

CTRI/2022/10/046839; UTN: U1111-1284-2437.

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来源期刊

Advances in integrative medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-

CiteScore

3.20

自引率

11.80%

发文量

审稿时长

15 weeks

期刊介绍： Advances in Integrative Medicine (AIMED) is an international peer-reviewed, evidence-based research and review journal that is multi-disciplinary within the fields of Integrative and Complementary Medicine. The journal focuses on rigorous quantitative and qualitative research including systematic reviews, clinical trials and surveys, whilst also welcoming medical hypotheses and clinically-relevant articles and case studies disclosing practical learning tools for the consulting practitioner. By promoting research and practice excellence in the field, and cross collaboration between relevant practitioner groups and associations, the journal aims to advance the practice of IM, identify areas for future research, and improve patient health outcomes. International networking is encouraged through clinical innovation, the establishment of best practice and by providing opportunities for cooperation between organisations and communities.