Evaluation of the efficacy and safety of gravitational therapy in a cohort of patients with systemic sclerosis.

Abstract

Background: The exposure to artificial gravity (AG) through human centrifugation is the basis of the treatment called gravity therapy (GT), in which the mechanical stimulation over the vessel wall, induces the synthesis and release of prostacyclin. It has been used for more than four decades in Uruguay in the treatment of different vascular-based pathologies. In patients with systemic sclerosis (SSc) it has shown good benefits and excellent safety profile over the years. However, there is a lack of knowledge in the scientific community about GT and its results.

Objective: To evaluate the effectiveness of GT in cutaneous and vascular involvement, in the quality of life and functional capacity and its safety profile in patients with SSc.

Methodology: It is a descriptive and retrospective study of patients with SSc assisted in an autoimmunity center in Montevideo, treated with GT in the last 10 years.

Results: Fifty patients were included, 48 women (96%) and 2 men (4%) with a mean age of 62 ± 12 years. The mean time of evolution of SSc at the time of inclusion in the study at the beginning of GT was 6.8 ± 3.2 years and 2.8 ± 3.2 years respectively. After GT, a significant improvement in the modified Rodnan skin score (mRSS) was observed (pre-GT 19.2 ± 8.7 vs. post-GT 5.4 ± 5.0, p < 0.05), which was not related to the time of disease progression at the beginning of GT nor to the skin extension or immunological profile. The degree of improvement post-GT was related to a higher initial mRSS (R = 0.84, p < 0.05). Also, a significant improvement was observed in the number of patients with puffy fingers (pre-GT 50% vs. post-GT 20% patients, p < 0.05), but not in telangiectasias, pitting scars or sclerodactyly. The severity of Raynaud's phenomenon significantly decreased (pre-GT: grade 3-4, 43/48 (89.6%) patients vs. post-GT: grade ≤2, 42/47 (89.4%) patients, p < 0.05) as well as the vascular pain measured with VAS (0-10 scale) (pre-GT: 7.6 ± 2.2 vs. post-TG: 1.4 ± 1.2, p < 0.05). The healing of digital ulcers was also recorded. Regarding the results reported by patients, 97% reported improvement in the quality of life and 89.5% improvement in the ability to carry out activities of daily living. No significant adverse effects were recorded.

Conclusions: GT improved cutaneous and vascular involvement, the quality of life and the functional capacity in patients with SSc with an excellent safety profile. Randomized, controlled clinical trials are needed to corroborate these observational results.