Efficacy of digestive enzyme supplementation in functional dyspepsia: A monocentric, randomized, double-blind, placebo-controlled, clinical trial
Functional dyspepsia is a form of dyspepsia lacking in clear causes following clinical assessment. Dyspepsia is characterized by episodic or persistent abdominal pain or discomfort of the upper gastrointestinal (GI) tract. Its onset has been linked with a deficiency or dysfunction of digestive enzym...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2023-12-01
|
| Series: | Biomedicine & Pharmacotherapy |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S0753332223016566 |
| _version_ | 1797404567129817088 |
|---|---|
| author | Hammad Ullah Alessandro Di Minno Roberto Piccinocchi Daniele Giuseppe Buccato Lorenza Francesca De Lellis Alessandra Baldi Hesham R. El-Seedi Shaden A.M. Khalifa Gaetano Piccinocchi Xiang Xiao Roberto Sacchi Maria Daglia |
| author_facet | Hammad Ullah Alessandro Di Minno Roberto Piccinocchi Daniele Giuseppe Buccato Lorenza Francesca De Lellis Alessandra Baldi Hesham R. El-Seedi Shaden A.M. Khalifa Gaetano Piccinocchi Xiang Xiao Roberto Sacchi Maria Daglia |
| author_sort | Hammad Ullah |
| collection | DOAJ |
| description | Functional dyspepsia is a form of dyspepsia lacking in clear causes following clinical assessment. Dyspepsia is characterized by episodic or persistent abdominal pain or discomfort of the upper gastrointestinal (GI) tract. Its onset has been linked with a deficiency or dysfunction of digestive enzymes. Thus, consumption of digestive multi-enzymatic preparations may be effectively used for the reduction of symptoms. The aim of this study is to assess the effectiveness and tolerability of the supplementation of a normal diet with a multi-enzyme blend obtained from fungal fermentation, in a randomized, placebo-controlled, double-blind, clinical trial. Enrolled subjects (n = 120, male: 63, female: 57), aged 18–59 years, were randomized (allocation ratio 1:1) to receive either 2 capsules per day of the food supplement (containing 200 mg of the multi-enzyme blend/capsule) or placebo, for 2 months. The primary outcome of the study (i.e., improvements in quality of life) was evaluated by the Nepean Dyspepsia Index-SF (NDI-SF) questionnaire, while the secondary outcomes (i.e., severity of pain and the quality of sleep) were assessed through the Visual Analogue Scale (VAS) and Pittsburgh Sleep Quality Index (PSQI) questionnaire. The results showed an improvement in NDI-SF1, NDI-SF2–5, VAS, and PSQI scores in subjects treated with the multi-enzyme blend, indicating an improvement in quality of life and of sleep, and a decreased severity of pain, following the supplementation with digestive enzymes, without side effects. In conclusion, treatment with digestive enzymes was found to be effective in the reduction of functional dyspepsia symptoms and in the improvement of sleep quality, and is well-tolerated. |
| first_indexed | 2024-03-09T02:56:53Z |
| format | Article |
| id | doaj.art-42f4c026c7a44b348a203dc2ed97ab6c |
| institution | Directory Open Access Journal |
| issn | 0753-3322 |
| language | English |
| last_indexed | 2024-03-09T02:56:53Z |
| publishDate | 2023-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Biomedicine & Pharmacotherapy |
| spelling | doaj.art-42f4c026c7a44b348a203dc2ed97ab6c2023-12-05T04:14:33ZengElsevierBiomedicine & Pharmacotherapy0753-33222023-12-01169115858Efficacy of digestive enzyme supplementation in functional dyspepsia: A monocentric, randomized, double-blind, placebo-controlled, clinical trialHammad Ullah0Alessandro Di Minno1Roberto Piccinocchi2Daniele Giuseppe Buccato3Lorenza Francesca De Lellis4Alessandra Baldi5Hesham R. El-Seedi6Shaden A.M. Khalifa7Gaetano Piccinocchi8Xiang Xiao9Roberto Sacchi10Maria Daglia11Department of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, ItalyDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, Italy; CEINGE-Biotecnologie Avanzate, Via Gaetano Salvatore 486, 80145 Naples, ItalyLevel 1 Medical Director Anaesthesia and Resuscitation A. U. O. Luigi Vanvitelli, Via Santa Maria di Costantinopoli, 80138 Naples, ItalyDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, ItalyDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, ItalyDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, ItalyInternational Research Center for Food Nutrition and Safety, Jiangsu University, Zhenjiang 212013, China; Department of Chemistry, Faculty of Science, Islamic University of Madinah, Madinah 42351, Saudi ArabiaPsychiatry and Psychology Department, Capio Saint Göran’s Hospital, Sankt Göransplan 1, 112 19 Stockholm, SwedenComegen S.c.S., Società Cooperativa Sociale di Medici di Medicina Generale, Viale Maria Bakunin 41, 80125 Naples, ItalySchool of Food and Biological Engineering, Jiangsu University, Zhenjiang 212013, ChinaApplied Statistic Unit, Department of Earth and Environmental Sciences, University of Pavia, Viale Taramelli 24, 27100 Pavia, ItalyDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, Italy; International Research Center for Food Nutrition and Safety, Jiangsu University, Zhenjiang 212013, China; Corresponding author at: Department of Pharmacy, University of Napoli Federico II, Via D. Montesano 49, 80131 Naples, Italy.Functional dyspepsia is a form of dyspepsia lacking in clear causes following clinical assessment. Dyspepsia is characterized by episodic or persistent abdominal pain or discomfort of the upper gastrointestinal (GI) tract. Its onset has been linked with a deficiency or dysfunction of digestive enzymes. Thus, consumption of digestive multi-enzymatic preparations may be effectively used for the reduction of symptoms. The aim of this study is to assess the effectiveness and tolerability of the supplementation of a normal diet with a multi-enzyme blend obtained from fungal fermentation, in a randomized, placebo-controlled, double-blind, clinical trial. Enrolled subjects (n = 120, male: 63, female: 57), aged 18–59 years, were randomized (allocation ratio 1:1) to receive either 2 capsules per day of the food supplement (containing 200 mg of the multi-enzyme blend/capsule) or placebo, for 2 months. The primary outcome of the study (i.e., improvements in quality of life) was evaluated by the Nepean Dyspepsia Index-SF (NDI-SF) questionnaire, while the secondary outcomes (i.e., severity of pain and the quality of sleep) were assessed through the Visual Analogue Scale (VAS) and Pittsburgh Sleep Quality Index (PSQI) questionnaire. The results showed an improvement in NDI-SF1, NDI-SF2–5, VAS, and PSQI scores in subjects treated with the multi-enzyme blend, indicating an improvement in quality of life and of sleep, and a decreased severity of pain, following the supplementation with digestive enzymes, without side effects. In conclusion, treatment with digestive enzymes was found to be effective in the reduction of functional dyspepsia symptoms and in the improvement of sleep quality, and is well-tolerated.http://www.sciencedirect.com/science/article/pii/S0753332223016566Functional dyspepsiaDigestive enzymesFood supplementsNepean dyspepsia indexQuality of lifeRandomized clinical trial |
| spellingShingle | Hammad Ullah Alessandro Di Minno Roberto Piccinocchi Daniele Giuseppe Buccato Lorenza Francesca De Lellis Alessandra Baldi Hesham R. El-Seedi Shaden A.M. Khalifa Gaetano Piccinocchi Xiang Xiao Roberto Sacchi Maria Daglia Efficacy of digestive enzyme supplementation in functional dyspepsia: A monocentric, randomized, double-blind, placebo-controlled, clinical trial Biomedicine & Pharmacotherapy Functional dyspepsia Digestive enzymes Food supplements Nepean dyspepsia index Quality of life Randomized clinical trial |
| title | Efficacy of digestive enzyme supplementation in functional dyspepsia: A monocentric, randomized, double-blind, placebo-controlled, clinical trial |
| title_full | Efficacy of digestive enzyme supplementation in functional dyspepsia: A monocentric, randomized, double-blind, placebo-controlled, clinical trial |
| title_fullStr | Efficacy of digestive enzyme supplementation in functional dyspepsia: A monocentric, randomized, double-blind, placebo-controlled, clinical trial |
| title_full_unstemmed | Efficacy of digestive enzyme supplementation in functional dyspepsia: A monocentric, randomized, double-blind, placebo-controlled, clinical trial |
| title_short | Efficacy of digestive enzyme supplementation in functional dyspepsia: A monocentric, randomized, double-blind, placebo-controlled, clinical trial |
| title_sort | efficacy of digestive enzyme supplementation in functional dyspepsia a monocentric randomized double blind placebo controlled clinical trial |
| topic | Functional dyspepsia Digestive enzymes Food supplements Nepean dyspepsia index Quality of life Randomized clinical trial |
| url | http://www.sciencedirect.com/science/article/pii/S0753332223016566 |
| work_keys_str_mv | AT hammadullah efficacyofdigestiveenzymesupplementationinfunctionaldyspepsiaamonocentricrandomizeddoubleblindplacebocontrolledclinicaltrial AT alessandrodiminno efficacyofdigestiveenzymesupplementationinfunctionaldyspepsiaamonocentricrandomizeddoubleblindplacebocontrolledclinicaltrial AT robertopiccinocchi efficacyofdigestiveenzymesupplementationinfunctionaldyspepsiaamonocentricrandomizeddoubleblindplacebocontrolledclinicaltrial AT danielegiuseppebuccato efficacyofdigestiveenzymesupplementationinfunctionaldyspepsiaamonocentricrandomizeddoubleblindplacebocontrolledclinicaltrial AT lorenzafrancescadelellis efficacyofdigestiveenzymesupplementationinfunctionaldyspepsiaamonocentricrandomizeddoubleblindplacebocontrolledclinicaltrial AT alessandrabaldi efficacyofdigestiveenzymesupplementationinfunctionaldyspepsiaamonocentricrandomizeddoubleblindplacebocontrolledclinicaltrial AT heshamrelseedi efficacyofdigestiveenzymesupplementationinfunctionaldyspepsiaamonocentricrandomizeddoubleblindplacebocontrolledclinicaltrial AT shadenamkhalifa efficacyofdigestiveenzymesupplementationinfunctionaldyspepsiaamonocentricrandomizeddoubleblindplacebocontrolledclinicaltrial AT gaetanopiccinocchi efficacyofdigestiveenzymesupplementationinfunctionaldyspepsiaamonocentricrandomizeddoubleblindplacebocontrolledclinicaltrial AT xiangxiao efficacyofdigestiveenzymesupplementationinfunctionaldyspepsiaamonocentricrandomizeddoubleblindplacebocontrolledclinicaltrial AT robertosacchi efficacyofdigestiveenzymesupplementationinfunctionaldyspepsiaamonocentricrandomizeddoubleblindplacebocontrolledclinicaltrial AT mariadaglia efficacyofdigestiveenzymesupplementationinfunctionaldyspepsiaamonocentricrandomizeddoubleblindplacebocontrolledclinicaltrial |