Reporting Quality and Evidence Support in Randomized Controlled Trials of Herbal Medicine Formulas for Vestibular Migraine

Category Systematic review
Pre-printSSRN
Year 2025
BackgroundVestibular migraine (VM) is a prevalent condition characterized by recurrent episodes of dizziness, vertigo, and/or headache, which are often challenging to diagnose and treat. Numerous randomized controlled trials (RCTs) have highlighted the significant characteristics and potential benefits of herbal medicine formulas (HMFs) for the treatment of VM. However, there remains insufficient evidence to recommend the routine use of HMFs for the treatment of VM. The completeness of the reporting of RCTs is the key to guaranteeing the validity of the results. This study aimed to comprehensively evaluate the reporting quality and evidence support of RCTs of HMFs for VM.MethodsWe performed a comprehensive search across eight databases from their inception to August 2024. The included studies were primarily RCTs assessing the effectiveness and safety of HMFs for treating VM. The quality of the RCTs was evaluated using the Consolidated Standards of Reporting Trials (CONSORT) guidelines, along with its extension for Chinese medicine formulas (CONSORT-CHM Formulas). A meta-analysis was conducted to assess the effectiveness and safety of HMFs for the treatment of VM following the Cochrane methodology. High-frequency herbal medicines (HMs) for VM treatment were identified as those appearing with a cumulative frequency exceeding 50% among the top-ranked HMs.ResultsA total of 33 RCTs involving 2,358 patients with VM were included. The mean score for CONSORT reporting items was 14.24, while the mean score for CONSORT-CHM reporting items was 13.64. Few trials adequately reported essential elements such as appropriate titles, sample size calculations, allocation concealment, randomization implementation, and descriptions of blinding within the CONSORT core items. For CONSORT-CHM, less than half of the studies specified the formula names, dosage forms, and targeted traditional Chinese medicine (TCM) patterns in their titles and abstracts. Most studies demonstrated a high risk of bias, particularly regarding randomization sequence generation, allocation concealment, and blinding. The meta-analysis indicates that HMFs are effective in treating VM with minimal adverse effects; however, the high heterogeneity in certain outcomes suggests a potential risk of bias. The five most frequently used herbs across all studies were, in descending order: Gastrodiae Rhizoma, Rhizoma Pinelliae, Rhizoma Chuanxiong, Poria, Atractylodis Macrocephalae Rhizoma.ConclusionsThe evidence from the meta-analysis supports the use of HMFs for the treatment of VM, with a low incidence of adverse events. However, the CONSORT and CONSORT-CHM reporting items were underreported. Researchers should adhere strictly to the CONSORT and CONSORT-CHM guidelines to standardize the completeness of RCTs, ensuring that all study designs and methods are fully reported.
Epistemonikos ID: d5e2cc677146d0351650a2fd724314abf36808a5
First added on: Apr 08, 2025