Enhancing Oral 5-ASA Effectiveness in Mild-to-Moderate Ulcerative Colitis through an H. erinaceus-Based Nutraceutical Add-on Multi-Compound: The “HERICIUM-UC” Two-Arm Multicentre Retrospective Study

Tursi, Antonio; D’Avino, Alessandro; Brandimarte, Giovanni; Mocci, Giammarco; Pellegrino, Raffaele; Savarino, Edoardo Vincenzo; Gravina, Antonietta Gerarda; the HERICIUM-UC Study Group,

doi:10.3390/pharmaceutics16091133

Open AccessArticle

Enhancing Oral 5-ASA Effectiveness in Mild-to-Moderate Ulcerative Colitis through an H. erinaceus-Based Nutraceutical Add-on Multi-Compound: The “HERICIUM-UC” Two-Arm Multicentre Retrospective Study

by

Antonio Tursi

^1,2,†

,

Alessandro D’Avino

^3,†,

Giovanni Brandimarte

⁴,

Giammarco Mocci

⁵

,

Raffaele Pellegrino

^6,*

,

Edoardo Vincenzo Savarino

⁷

,

Antonietta Gerarda Gravina

^6,*

and

the HERICIUM-UC Study Group

^‡

¹

Territorial Gastroenterology Service, Barletta-Andria-Trani Local Health Agency, Via Fornaci, 76123 Andria, Italy

²

Department of Medical and Surgical Sciences, Catholic University of Rome, Largo A. Gemelli, 00168 Roma, Italy

³

Department of Internal Medicine, IRCCS Istituto Dermopatico dell’Immacolata, 00167 Roma, Italy

⁴

Cristo Re Hospital, Via delle Calasanziane, 00167 Roma, Italy

⁵

SC Gastroenterologia, ARNAS Brotzu, Piazzale A. Ricchi, 09047 Cagliari, Italy

⁶

Hepatogastroenterology Division, Department of Precision Medicine, University of Campania Luigi Vanvitelli, Via L. de Crecchio, 80138 Napoli, Italy

⁷

Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padova, Via VIII Febbraio, 35121 Padova, Italy

^*

Authors to whom correspondence should be addressed.

^†

These authors contributed equally to this work and share the first authorship.

^‡

The members of the HERICIUM-UC collaborative study group are listed in Appendix A.

Pharmaceutics 2024, 16(9), 1133; https://doi.org/10.3390/pharmaceutics16091133

Submission received: 25 June 2024 / Revised: 3 August 2024 / Accepted: 16 August 2024 / Published: 28 August 2024

(This article belongs to the Special Issue Further Research in Polyphenols Formulations)

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Abstract

Mild-to-moderate ulcerative colitis (UC) management is centred on 5-aminosalicylic acid (5-ASA) derivatives. Whether supplementing 5-ASA with nutraceuticals can provide real advantages in UC-relevant outcomes is unclear. This retrospective multicentre study compared clinical remission, response rates, and faecal calprotectin levels in a two-arm design, including patients treated with 5-ASA alone and those with additional H. erinaceus-based multi-compound supplementation. In the 5-ASA alone group, clinical response rates were 41% at three months (T₁) and 60.2% at six months (T₂), while corresponding clinical remission rates were 16.9% and 36.1%. In the nutraceutical supplementation group, clinical response rates were 49.6% (T₁) and 70.4% (T₂), with clinical remission rates of 30.4% (T₁) and 50.9% (T₂). No significant differences in clinical response rates between the groups at T₁ (p = 0.231) and T₂ (p = 0.143) emerged. Clinical remission rates differed significantly at both time points (p = 0.029 and p = 0.042, respectively). Faecal calprotectin levels decreased significantly in both groups during the retrospective follow-up (p < 0.05), and this was more pronounced in nutraceutical supplementation patients at both T₁ (p = 0.005) and T₂ (p = 0.01). No adverse events were reported. This multi-component nutraceutical supplementation offers real-world potential in controlling disease activity in patients with mild-to-moderate UC.

Keywords: ulcerative colitis; nutraceuticals; Hericium erinaceus; 5-ASA; prebiotics; probiotics; berberine; quercetin; niacin; biotin

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MDPI and ACS Style

Tursi, A.; D’Avino, A.; Brandimarte, G.; Mocci, G.; Pellegrino, R.; Savarino, E.V.; Gravina, A.G.; the HERICIUM-UC Study Group. Enhancing Oral 5-ASA Effectiveness in Mild-to-Moderate Ulcerative Colitis through an H. erinaceus-Based Nutraceutical Add-on Multi-Compound: The “HERICIUM-UC” Two-Arm Multicentre Retrospective Study. Pharmaceutics 2024, 16, 1133. https://doi.org/10.3390/pharmaceutics16091133

AMA Style

Tursi A, D’Avino A, Brandimarte G, Mocci G, Pellegrino R, Savarino EV, Gravina AG, the HERICIUM-UC Study Group. Enhancing Oral 5-ASA Effectiveness in Mild-to-Moderate Ulcerative Colitis through an H. erinaceus-Based Nutraceutical Add-on Multi-Compound: The “HERICIUM-UC” Two-Arm Multicentre Retrospective Study. Pharmaceutics. 2024; 16(9):1133. https://doi.org/10.3390/pharmaceutics16091133

Chicago/Turabian Style

Tursi, Antonio, Alessandro D’Avino, Giovanni Brandimarte, Giammarco Mocci, Raffaele Pellegrino, Edoardo Vincenzo Savarino, Antonietta Gerarda Gravina, and the HERICIUM-UC Study Group. 2024. "Enhancing Oral 5-ASA Effectiveness in Mild-to-Moderate Ulcerative Colitis through an H. erinaceus-Based Nutraceutical Add-on Multi-Compound: The “HERICIUM-UC” Two-Arm Multicentre Retrospective Study" Pharmaceutics 16, no. 9: 1133. https://doi.org/10.3390/pharmaceutics16091133

APA Style

Tursi, A., D’Avino, A., Brandimarte, G., Mocci, G., Pellegrino, R., Savarino, E. V., Gravina, A. G., & the HERICIUM-UC Study Group. (2024). Enhancing Oral 5-ASA Effectiveness in Mild-to-Moderate Ulcerative Colitis through an H. erinaceus-Based Nutraceutical Add-on Multi-Compound: The “HERICIUM-UC” Two-Arm Multicentre Retrospective Study. Pharmaceutics, 16(9), 1133. https://doi.org/10.3390/pharmaceutics16091133

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Enhancing Oral 5-ASA Effectiveness in Mild-to-Moderate Ulcerative Colitis through an H. erinaceus-Based Nutraceutical Add-on Multi-Compound: The “HERICIUM-UC” Two-Arm Multicentre Retrospective Study

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