临床温泉学试验中的设盲挑战：一项范围综述

Challenges of blinding in clinical balneology trials: a scoping review.

作者信息

Szendi Katalin, Lohner Szimonetta, Szenczi Ágnes, Murányi Edit, Berényi Károly, Németh Balázs

机构信息

Department of Public Health Medicine, Medical School, University of Pécs, Pécs, Hungary.

Department of Public Health Medicine, MTA-PTE Lendület "Momentum" Evidence in Medicine Research Group, Medical School, University of Pécs, Pécs, Hungary.

出版信息

BMC Complement Med Ther. 2025 Apr 11;25(1):132. doi: 10.1186/s12906-025-04878-y.

DOI:10.1186/s12906-025-04878-y

PMID:40217213

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11992841/

Abstract

BACKGROUND

In evidence-based medicine, randomized, placebo-controlled, double-blind clinical trials are considered the 'gold standard' of study design. Efforts must be made to advance evidence-based balneology in a similar manner. The objective of this scoping review was to assess the intervention types of experimental and control groups used in clinical balneology trials to map the proportion of open-label, single- and double-blind studies.

METHODS

Eligibility criteria: i) prospective interventional clinical trial, ii) focused on the therapeutic effect of natural medicinal and mineral water, iii) administered head-out immersion, iv) compared with any other intervention or no treatment, v) in adult patients, and vi) with no restrictions on study design or language. Two authors independently searched the Medline, Embase and Cochrane databases for trials published in any language between 1990 and 12 February 2025.

RESULTS

The 109, included trials were categorized into eight groups according to the treatment of the experimental and control groups and the use of blinding. Studies in the lower categories (1, 2, 3) completely lack blinding. In categories 4a-b-c, tap water control was used in parallel with medicinal/mineral water. Category 4c was the first category where the 'gold standard' of evidence-based medicine was implemented. Finally, in the last two categories (5a-b), validated placebo water was used. Low-category papers constituted the largest group, accounting for 74% of the total number of publications. From 1990 to the present, only 11% of publications chose the double-blind setup. Most higher category papers were published in Hungary. Over time, there has been no clear improvement in study design.

CONCLUSIONS

Future balneological research should prioritize rigorous experimental designs, particularly by incorporating validated placebo water and double-blind methodologies. Without these improvements, the ability to draw reliable conclusions about the true efficacy of balneotherapy remains limited.

REGISTRATION

The scoping review protocol was registered prospectively in OSF registries (Registration DOI https://doi.org/10.17605/OSF . IO/XHS4B, internet Archive link https://archive.org/details/osf-registrations-xhs4b-v1 , Date registered June 26, 2022).

摘要

背景

在循证医学中，随机、安慰剂对照、双盲临床试验被视为研究设计的“金标准”。必须努力以类似方式推进循证温泉疗法。本范围综述的目的是评估临床温泉疗法试验中使用的实验组和对照组的干预类型，以确定开放标签、单盲和双盲研究的比例。

方法

纳入标准：i）前瞻性干预临床试验，ii）关注天然药用矿泉水和矿泉水的治疗效果，iii）采用头露出水面的浸泡方式，iv）与任何其他干预措施或不治疗进行比较，v）针对成年患者，vi）对研究设计或语言无限制。两位作者独立检索了Medline、Embase和Cochrane数据库，以查找1990年至2025年2月12日期间以任何语言发表的试验。

结果

纳入的109项试验根据实验组和对照组的治疗方法以及盲法的使用情况分为八组。较低类别（1、2、3）的研究完全没有采用盲法。在4a - b - c类别中，自来水对照与药用/矿泉水并行使用。4c类别是实施循证医学“金标准”的第一类。最后，在最后两类（5a - b）中，使用了经过验证的安慰剂水。低类别论文构成了最大的组，占出版物总数的74%。从1990年至今，只有11%的出版物选择了双盲设置。大多数较高类别的论文发表在匈牙利。随着时间的推移，研究设计没有明显改善。