Effects of one-year supplementation with Phyllanthus niruri on fibrosis score and metabolic markers in patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial
Background and purpose: and purpose: Non-alcoholic fatty liver disease (NAFLD) is a significant global health concern with limited pharmacotherapy options. This study aimed to evaluate the effectiveness of a standardized extract of Phyllanthus niruri in mild-to-moderate NAFLD. Materials and methods:...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-06-01
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| Series: | Heliyon |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2405844023038598 |
| _version_ | 1797812062001299456 |
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| author | Muhammad Radzi Abu Hassan Rosaida Hj Md Said Zalwani Zainuddin Haniza Omar Siti Maisarah Md Ali Siti Aishah Aris Huan-Keat Chan |
| author_facet | Muhammad Radzi Abu Hassan Rosaida Hj Md Said Zalwani Zainuddin Haniza Omar Siti Maisarah Md Ali Siti Aishah Aris Huan-Keat Chan |
| author_sort | Muhammad Radzi Abu Hassan |
| collection | DOAJ |
| description | Background and purpose: and purpose: Non-alcoholic fatty liver disease (NAFLD) is a significant global health concern with limited pharmacotherapy options. This study aimed to evaluate the effectiveness of a standardized extract of Phyllanthus niruri in mild-to-moderate NAFLD. Materials and methods: This was a 12-month randomized controlled trial, in which adults with a controlled attenuation parameter (CAP) score >250 dB/m and a fibrosis score <10 kPa were randomly assigned to receive a standardized P. niruri extract at a dose of 3,000 mg daily (n = 112) or a placebo (n = 114). The primary outcomes were changes in CAP score and liver enzyme levels, while the secondary outcomes were changes in other metabolic parameters. The analysis was performed on an intention-to-treat basis. Results: After 12 months, there was no significant difference in the change of CAP score between the intervention and control groups (−15.05 ± 36.76 dB/m vs. −14.74 ± 41.08 dB/m; p = 0.869). There was also no significant difference in the changes of liver enzyme levels between the two groups. However, the intervention group showed a significant reduction in fibrosis score, which was not observed in the control group (−0.64 ± 1.66 kPa versus 0.10 ± 1.61 kPa; p = 0.001). No major adverse events were reported in either group. Conclusion: This study showed that P. niruri did not significantly reduce CAP score and liver enzyme levels in patients with mild-to-moderate NAFLD. However, a significant improvement in fibrosis score was observed. Further research is needed to determine its clinical benefits at different dosages for NAFLD treatment. |
| first_indexed | 2024-03-13T07:33:00Z |
| format | Article |
| id | doaj.art-e57ab0b059bf4605b35f514f20dc9845 |
| institution | Directory Open Access Journal |
| issn | 2405-8440 |
| language | English |
| last_indexed | 2024-03-13T07:33:00Z |
| publishDate | 2023-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Heliyon |
| spelling | doaj.art-e57ab0b059bf4605b35f514f20dc98452023-06-04T04:24:10ZengElsevierHeliyon2405-84402023-06-0196e16652Effects of one-year supplementation with Phyllanthus niruri on fibrosis score and metabolic markers in patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trialMuhammad Radzi Abu Hassan0Rosaida Hj Md Said1Zalwani Zainuddin2Haniza Omar3Siti Maisarah Md Ali4Siti Aishah Aris5Huan-Keat Chan6Clinical Research Centre, Hospital Sultanah Bahiyah, Jalan Langgar, 05460, Alor Setar, Kedah, MalaysiaMedical Department, Hospital Ampang, Jalan Mewah Utara, Taman Pandan Mewah, 68000, Ampang Jaya, Selangor, MalaysiaMedical Department, Hospital Sultanah Bahiyah, Jalan Langgar, 05460, Alor Setar, Kedah, MalaysiaMedical Department, Hospital Selayang, Jalan Lingkaran Tengah 2, 68100 Batu Caves, Selangor, MalaysiaClinical Research Centre, Hospital Sultanah Bahiyah, Jalan Langgar, 05460, Alor Setar, Kedah, MalaysiaClinical Research Centre, Hospital Sultanah Bahiyah, Jalan Langgar, 05460, Alor Setar, Kedah, MalaysiaClinical Research Centre, Hospital Sultanah Bahiyah, Jalan Langgar, 05460, Alor Setar, Kedah, Malaysia; Corresponding author.Background and purpose: and purpose: Non-alcoholic fatty liver disease (NAFLD) is a significant global health concern with limited pharmacotherapy options. This study aimed to evaluate the effectiveness of a standardized extract of Phyllanthus niruri in mild-to-moderate NAFLD. Materials and methods: This was a 12-month randomized controlled trial, in which adults with a controlled attenuation parameter (CAP) score >250 dB/m and a fibrosis score <10 kPa were randomly assigned to receive a standardized P. niruri extract at a dose of 3,000 mg daily (n = 112) or a placebo (n = 114). The primary outcomes were changes in CAP score and liver enzyme levels, while the secondary outcomes were changes in other metabolic parameters. The analysis was performed on an intention-to-treat basis. Results: After 12 months, there was no significant difference in the change of CAP score between the intervention and control groups (−15.05 ± 36.76 dB/m vs. −14.74 ± 41.08 dB/m; p = 0.869). There was also no significant difference in the changes of liver enzyme levels between the two groups. However, the intervention group showed a significant reduction in fibrosis score, which was not observed in the control group (−0.64 ± 1.66 kPa versus 0.10 ± 1.61 kPa; p = 0.001). No major adverse events were reported in either group. Conclusion: This study showed that P. niruri did not significantly reduce CAP score and liver enzyme levels in patients with mild-to-moderate NAFLD. However, a significant improvement in fibrosis score was observed. Further research is needed to determine its clinical benefits at different dosages for NAFLD treatment.http://www.sciencedirect.com/science/article/pii/S2405844023038598Herbal medicineFibrosisLiver cirrhosisNon-alcoholic fatty liver diseasePhyllanthus |
| spellingShingle | Muhammad Radzi Abu Hassan Rosaida Hj Md Said Zalwani Zainuddin Haniza Omar Siti Maisarah Md Ali Siti Aishah Aris Huan-Keat Chan Effects of one-year supplementation with Phyllanthus niruri on fibrosis score and metabolic markers in patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial Heliyon Herbal medicine Fibrosis Liver cirrhosis Non-alcoholic fatty liver disease Phyllanthus |
| title | Effects of one-year supplementation with Phyllanthus niruri on fibrosis score and metabolic markers in patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial |
| title_full | Effects of one-year supplementation with Phyllanthus niruri on fibrosis score and metabolic markers in patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial |
| title_fullStr | Effects of one-year supplementation with Phyllanthus niruri on fibrosis score and metabolic markers in patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial |
| title_full_unstemmed | Effects of one-year supplementation with Phyllanthus niruri on fibrosis score and metabolic markers in patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial |
| title_short | Effects of one-year supplementation with Phyllanthus niruri on fibrosis score and metabolic markers in patients with non-alcoholic fatty liver disease: A randomized, double-blind, placebo-controlled trial |
| title_sort | effects of one year supplementation with phyllanthus niruri on fibrosis score and metabolic markers in patients with non alcoholic fatty liver disease a randomized double blind placebo controlled trial |
| topic | Herbal medicine Fibrosis Liver cirrhosis Non-alcoholic fatty liver disease Phyllanthus |
| url | http://www.sciencedirect.com/science/article/pii/S2405844023038598 |
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