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- ItemSomente MetadadadosBalneoterapia em insuficiência venosa crônica: revisão sistemática e metanálise(Universidade Federal de São Paulo (UNIFESP), 2020-11-26) Silva, Melissa Andreia De Moraes [UNIFESP]; Miranda Junior, Fausto [UNIFESP]; Universidade Federal de São PauloBackgroud: Chronic venous insufficiency, a slow and progressive disease, with a wide range of clinical manifestations, presents several types of treatment, including surgery, elastocompression and balneotherapy, the latter being an effective treatment, with reduced cost. Objective: To assess the efficacy and safety of balneotherapy for the treatment of people with chronic venous insufficiency. Methods: Systematic review of randomized and quasi-randomized clinical trials. The search was conducted in Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, AMED and CINAHL databases, the World Health Organization International Clinical Trials Registry Platform, the ClinicalTrials.gov trials register, Lilacs and IBECS and complemented by checking through manual search of relevant journals, books and conference abstracts. There were no language and date of publication restrictions. Randomized clinical trials that compared balneotherapy with no treatment or with other types of treatment in patients with chronic venous insufficiency were included. Primary outcomes were disease severity signs and symptoms score, health-related quality of life and adverse events of treatment, and secondary outcomes included pain, oedema, incidence of leg ulcer and skin pigmentation changes. Two review authors independently reviewed studies retrieved by the search strategies, assessed selected studies for complete analysis and performed study selection, data extraction and risk of bias assessment for included studies, following the Cochrane Collaboration recommendations. Where possible, we pooled data into metaanalyses. For binary outcomes (leg ulcer incidence and adverse events), we presented the results using odds ratio (OR) with 95% confidence intervals (CI). For continuous outcomes (disease severity, health-related quality of life (HRQoL), pain, oedema, skin pigmentation), we presented the results as a mean difference (MD) with 95% CI. Results: We included seven randomised controlled trials with 891 participants. Six studies (836 participants) evaluated balneotherapy versus no treatment. One study evaluated balneotherapy versus a phlebotonic drug (Melilotus officinalis) (55 participants). There was a lack of blinding of participants and investigators, imprecision and inconsistency, which downgraded the certainty of the evidence. For the balneotherapy versus no treatment comparison, there probably was no improvement in favour of balneotherapy in disease severity signs and symptom score as assessed using the Venous Clinical Severity Score. Balneotherapy probably resulted in a moderate improvement in HRQoL as assessed by the Chronic Venous Insufficiency Questionnaire 20 (CVIQ20) at three months, nine months and 12 months. There was no clear difference in HRQoL between balneotherapy and no treatment at six months. Balneotherapy probably slightly improved pain compared with no treatment. There was no clear effect related to oedema between the two groups at 24 days. There probably was no improvement in favour of balneotherapy in the incidence of leg ulcers. There was probably a reduction in incidence of skin pigmentation changes in favour of balneotherapy at 12 months. The main complications reported included erysipelas, thromboembolic events and palpitations, with no clear evidence of an increase in reported adverse effects with balneotherapy. There were no serious adverse events reported in any of the studies. For the balneotherapy versus a phlebotonic drug (melilotus officinalis) comparison, we observed no clear difference in pain symptoms and oedema. This single study did not report on the other outcomes of interest. Conclusion: We identified moderate- to low-certainty evidence that suggests that balneotherapy can result in an improvement in pain, quality of life and changes in skin pigmentation. There is no clear effect on signs and symptoms of disease severity, adverse effects, leg ulcers and edema when compared to no treatment.