Evidence map›Paper›PMID 29730741›Full record

Trial reportClinical rheumatology2018

Is balneotherapy effective for fibromyalgia? Results from a 6-month double-blind randomized clinical trial.

Antonella Fioravanti, Patrizia Manica, Roberto Bortolotti, Gabriele Cevenini, Sara Tenti, Giuseppe Paolazzi

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical rheumatology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02548065 (Efficacy and Tolerability of Balneotherapy With Mineral Water Named" Debole of Vetriolo" in Patients With Fibromyalgia Syndrome), which is not on this map. Cited by 29 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 4 pooled it
4.2field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02548065 nacompletednot on this map

Efficacy and Tolerability of Balneotherapy With Mineral Water Named" Debole of Vetriolo" in Patients With Fibromyalgia Syndrome (FS): A Randomized Double Blind Controlled Clinical Trial

TypeinterventionalSponsorAzienda Ospedaliera Universitaria SeneseRan2015 to 2017Enrolled100ConditionsFibromyalgia SyndromeArmsBalneotherapy, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 4 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Therapeutic Patient Education for Fibromyalgia during Spa Therapy: The FiETT Randomized Controlled Trial.International journal of environmental research and public health · 2022
    Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Article
  14. Article
  15. Review
  16. Challenges of blinding in clinical balneology trials: a scoping review.BMC complementary medicine and therapies · 2025
    Article
  17. Article
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Antonella FioravantiRheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Viale Bracci 1, 53100, Siena, Italy.
Patrizia ManicaThermal Resort of Levico and Vetriolo, Levico Terme, Trento, Italy.
Roberto BortolottiRheumatology Unit, S. Chiara Hospital, Trento, Italy.
Gabriele CeveniniDepartment of Medical Biotechnologies, University of Siena, Siena, Italy.
Sara TentiRheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Viale Bracci 1, 53100, Siena, Italy. sara_tenti@hotmail.it.
Giuseppe PaolazziRheumatology Unit, S. Chiara Hospital, Trento, Italy.
University of Siena · ITOspedale Santa Chiara · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this study was to assess the efficacy and tolerability of balneotherapy (BT) in patients with primary fibromyalgia syndrome (FS). In a prospective, randomized, controlled, double-blind trial with a 6-month follow-up, 100 FS patients were randomized to receive a cycle of BT with highly mineralized sulfate water (BT group) or with tap water (control group). Clinical assessments were performed at screening visit, at basal time, and after treatment (2 weeks, 3 and 6 months). The primary outcome measures were the change of global pain on the Visual Analogue Scale (VAS) and Fibromyalgia Impact Questionnaire total score (FIQ-Total) from baseline to 15 days. Secondary outcomes included Widespread Pain Index, Symptom Severity Scale Score, Short Form Health Survey, State-Trait Anxiety Inventory (STAI), and Center for Epidemiologic Studies Depression Scale. We performed an intent-to-treat analysis. The Kolmogorov-Smirnov test was applied to verify the normality distribution of all quantitative variables and the Student's t test to compare sample data. In the BT group, we observed a significant improvement of VAS and FIQ-Total at the end of the treatment that persisted until 6 months, while no significant differences were found in the control group. The differences between groups were significant for primary parameters at each time point. Similar results were obtained for the other secondary outcomes except for the STAI outcome. Adverse events were reported by 10 patients in the BT group and by 22 patients in the control group. Our results support the short- and long-term therapeutic efficacy of BT in FS.

trial registrationNCT02548065.

Indexed as

BalneologyAdultAgedDouble-Blind MethodFemaleFibromyalgiaHumansItalyMaleMiddle AgedProspective StudiesTreatment OutcomeYoung AdultBalneotherapyDouble-blind trialFibromyalgiaSpa therapy

Identifiers

PMID29730741
OpenAlexW2801929479

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.