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. 2023 Jul 12;10:1219321. doi: 10.3389/fnut.2023.1219321

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Copyright © 2023 Ciaffi, Lisi, Mari, Mancarella, Brusi, Pignatti, Ricci, Vitali, Stefanelli, Assirelli, Neri, Naldi, Faldini and Ursini.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

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Mean change in body mass index [BMI – (A)], Fibromyalgia Impact Questionnaire [FIQ – (B)], Hospital Anxiety and Depression Scale [HADS – (C,D)], EuroQol 5D [EQ-5D – (E,F)] and 36-item Short Form Health Survey [SF-36 – (G,H)] from T-4 to T20. Level of significance of each measurement compared with T0 is indicated on the plots: ns = non-significant; * = <0.05; ** = <0.01; *** <0.001. (A) Mean BMI was 37.2 ± 3.8 at T-4 and 37.2 ± 4.0 at T0 (p = 0.995). During the ketogenic phase, mean BMI significantly decreased to 34.8 ± 3.9 at T4 (p < 0.001) and to 33.5 ± 3.6 at T8 (p < 0.001). Compared with FIGURE 4 (Continued)baseline values, the decrease in mean BMI was also significant during the carbohydrate reintroduction period, with 32.9 ± 3.5 at T12 (p < 0.001), 32.3 ± 3.4 at T16 (p < 0.001) and 32.1 ± 3.4 at T20 (p < 0.001). (B) Mean FIQ was 67.6 ± 13.9 at T-4 and 61.7 ± 22.2 at T0 (p = 0.124). Compared to T0, mean FIQ improved during the ketogenic period to 37.0 ± 23.0 at T4 (p < 0.001) and to 38.7 ± 21.6 at T8 (p < 0.001), with significant changes to 44.4 ± 25.0 observed also at T12 (p = 0.012), to 35.8 ± 23.7 at T16 (p < 0.001) and to 39.1 ± 25.9 at T20 (p = 0.002). (C) Mean HADS-A was 11.3 ± 4.1 at T-4 and 11.1 ± 4.0 at T0 (p = 0.633). Compared to T0, HADS-A significantly improved to 7.1 ± 3.7 at T4 (p < 0.001) and to 7.8 ± 4.1 at T8 (p < 0.001). Furthermore, HADS-A decreased to 8.3 ± 4.0 at T12 (p = 0.001), to 7.4 ± 3.4 at T16 (p < 0.001) and to 8.2 ± 3.5 at T20 (p = 0.004). (D) Mean HADS-D was 10.0 ± 3.5 at T-4 and 9.6 ± 3.7 at T0 (p = 0.571). Compared to T0, mean HADS-D significantly improved to 8.1 ± 3.8 at T4 (p = 0.021), to 7.9 ± 4.5 at T8 (p = 0.030) and to 6.9 ± 4.5 at T16 (p = 0.005). At T12 and T20, a non-significant reduction, respectively, to 8.6 ± 4.6 (p = 0.219) and to 8.0 ± 4.6 (p = 0.116) was observed. (E) Mean EQ-5D utility score was 0.61 ± 0.23 at T-4 and 0.64 ± 0.21 at T0 (p = 0.469). Compared to T0, mean EQ-5D utility score significantly increased to 0.78 ± 0.12 at T4 (p = 0.010), to 0.79 ± 0.12 at T8 (p = 0.003) and to 0.81 ± 0.13 at T16 (p = 0.002), while there was no significant difference between the baseline score and the values of 0.70 ± 0.24 (p = 0.333) and 0.73 ± 0.31 (p = 0.295) observed, respectively, at T12 and at T20. (F) Mean EQ-5D VAS score was 45.4 ± 19.0 at T-4 and 42.0 ± 23.7 at T0 (p = 0.297). Compared to T0, mean EQ-5D VAS score significantly improved to 59.1 ± 23.0 at T4 (p = 0.002), to 60.6 ± 22.5 at T8 (p = 0.009), to 57.0 ± 24.8 at T12 (p = 0.038), to 65.9 ± 25.2 at T16 (p < 0.001) and to 63.5 ± 30.1 at T20 (p = 0.022). (G) Mean SF-36 MCS was 34.3 ± 16.7 at T-4 and 33.5 ± 16.6 at T0 (p = 0.849). Compared to T0, mean SF-36 MCS significantly increased to 52.4 ± 24.0 at T4 (p < 0.001), to 50.1 ± 21.5 at T8 (p < 0.001), to 47.0 ± 26.6 at T12 (p = 0.010), to 55.5 ± 25.9 at T16 (p < 0.001) and to 49.8 ± 26.3 at T20 (p = 0.002). (H) Mean SF-36 PCS was 30.3 ± 14.8 at T-4 and 30.5 ± 17.0 at T0 (p = 0.942). Compared to T0, mean SF-36 PCS significantly increased to 47.3 ± 19.5 at T4 (p < 0.001), to 47.7 ± 20.0 at T8 (p < 0.001), to 41.6 ± 22.2 at T12 (p = 0.015), to 50.5 ± 20.9 at T16 (p < 0.001) and to 47.4 ± 23.8 at T20 (p = 0.009).