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Low‐dose melatonin for sleep disturbances in early‐stage cirrhosis: A randomized, placebo‐controlled, cross‐over trial
Background and aim Melatonin is used to treat sleep disturbances (SDs). The aim of this study was to investigate the safety and efficacy of low‐dose melatonin for SDs in early‐stage cirrhosis. Methods In a single‐center, randomized, double‐blind, placebo‐controlled, cross‐over clinical trial, patien...
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| Published in: | JGH open 2020-08, Vol.4 (4), p.749-756 |
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| creator | De Silva, Arjuna P Niriella, Madunil A Ediriweera, Dileepa S De Alwis, Jerome P Liyanage, Isurujith K Ettickan, Ushanthani Liyanapathirana, Kasun V Undugodage, Chandimani Silva, H. Asita Silva, H. Janaka |
| description | Background and aim
Melatonin is used to treat sleep disturbances (SDs). The aim of this study was to investigate the safety and efficacy of low‐dose melatonin for SDs in early‐stage cirrhosis.
Methods
In a single‐center, randomized, double‐blind, placebo‐controlled, cross‐over clinical trial, patients with early‐stage (Child‐Turcotte‐Pugh [CTP] class A or B) cirrhosis with SDs, without hepatic encephalopathy, were randomized to placebo or 3 mg of melatonin for 2 weeks. After 2 weeks, the patients were given a washout period of 1 week and crossed over to melatonin or placebo for a further 2 weeks. The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) were used to measure sleep quality and daytime sleepiness, respectively. Analysis of results was based on intention to treat, and linear mixed‐effect models were used to evaluate the effect of melatonin. Analysis was conducted using R‐programming language 3.5.1.
Results
Seventy one patients were recruited (mean age: 61.9 ± 8.7 years, males: 46 [64.8%], and CTP Class A = 52 [73.2%] and Class B = 19 [26.8%]). Sixty patients completed the study (mean age: 61.7 ± 8.8 years, males: 40 [66.6%], and CTP Class A = 45 [75.0%] and Class‐B = 15 [25.0%]). Two patients dropped out due to adverse events. Nine patients were lost to follow up. Patients given melatonin had a significantly lower PSQI and ESS compared to both pretreatment (P |
| doi_str_mv | 10.1002/jgh3.12356 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_doaj_</sourceid><recordid>TN_cdi_doaj_primary_oai_doaj_org_article_96a1f18781d34047af8ded76b8555d3c</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><doaj_id>oai_doaj_org_article_96a1f18781d34047af8ded76b8555d3c</doaj_id><sourcerecordid>2430888374</sourcerecordid><originalsourceid>FETCH-LOGICAL-c5426-2b2f2b34d14cbbba6a07bce9a3d71bc2b85940187bfbc6a3355311d5bcfc13813</originalsourceid><addsrcrecordid>eNp9ks1u1DAQgCMEolXphQdAlrggxLb-iROHA1JVQVu0Ehc4W_6Z7HrlxIudtFoOiEfgGXkSnE2pWg492Zr5_HnGnqJ4SfAJwZieblZrdkIo49WT4pCypl40uMZP7-0PiuOUNhhjIuqGs-p5ccBoLWhTVYfFz2W4-fPrtw0JUAdeDaF3PWpDRMkDbJF1aRijVr2BhHIGVPS7fCANagXIuBjXIbn0Hp2hqHobOvcD7Du09cqADhk0oR9i8H6KmhhSyrFwDREN0Sn_onjWKp_g-HY9Kr59-vj1_HKx_HJxdX62XBhe0mpBNW2pZqUlpdFaq0rhWhtoFLM10YZqwZty6k-32lSKMc4ZIZZr0xrCBGFHxdXstUFt5Da6TsWdDMrJfSDElVRxcMaDbCpF2qwSxLISl7VqhQVbV_kOzi0z2fVhdm1H3YE1kBtU_oH0YaZ3a7kK17IuCeG8yoI3t4IYvo-QBtm5ZMB71UMYk6QlY_n3GjGhr_9DN2GMfX6qicJCCFaXmXo7U_sHjtDeFUOwnKZETlMi91OS4Vf3y79D_81EBsgM3DgPu0dU8vPFJZulfwHY3c0D</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2430888374</pqid></control><display><type>article</type><title>Low‐dose melatonin for sleep disturbances in early‐stage cirrhosis: A randomized, placebo‐controlled, cross‐over trial</title><source>Wiley Online Library Open Access</source><source>Publicly Available Content Database</source><source>PubMed Central (Training)</source><creator>De Silva, Arjuna P ; Niriella, Madunil A ; Ediriweera, Dileepa S ; De Alwis, Jerome P ; Liyanage, Isurujith K ; Ettickan, Ushanthani ; Liyanapathirana, Kasun V ; Undugodage, Chandimani ; Silva, H. Asita ; Silva, H. Janaka</creator><creatorcontrib>De Silva, Arjuna P ; Niriella, Madunil A ; Ediriweera, Dileepa S ; De Alwis, Jerome P ; Liyanage, Isurujith K ; Ettickan, Ushanthani ; Liyanapathirana, Kasun V ; Undugodage, Chandimani ; Silva, H. Asita ; Silva, H. Janaka</creatorcontrib><description>Background and aim
Melatonin is used to treat sleep disturbances (SDs). The aim of this study was to investigate the safety and efficacy of low‐dose melatonin for SDs in early‐stage cirrhosis.
Methods
In a single‐center, randomized, double‐blind, placebo‐controlled, cross‐over clinical trial, patients with early‐stage (Child‐Turcotte‐Pugh [CTP] class A or B) cirrhosis with SDs, without hepatic encephalopathy, were randomized to placebo or 3 mg of melatonin for 2 weeks. After 2 weeks, the patients were given a washout period of 1 week and crossed over to melatonin or placebo for a further 2 weeks. The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) were used to measure sleep quality and daytime sleepiness, respectively. Analysis of results was based on intention to treat, and linear mixed‐effect models were used to evaluate the effect of melatonin. Analysis was conducted using R‐programming language 3.5.1.
Results
Seventy one patients were recruited (mean age: 61.9 ± 8.7 years, males: 46 [64.8%], and CTP Class A = 52 [73.2%] and Class B = 19 [26.8%]). Sixty patients completed the study (mean age: 61.7 ± 8.8 years, males: 40 [66.6%], and CTP Class A = 45 [75.0%] and Class‐B = 15 [25.0%]). Two patients dropped out due to adverse events. Nine patients were lost to follow up. Patients given melatonin had a significantly lower PSQI and ESS compared to both pretreatment (P < 0.001) and postplacebo scores (P < 0.001). Incidence of adverse events was similar (two each of abdominal pain, one each of headache, one each of dizziness) in both groups.
Conclusion
Melatonin seems safe and effective for use in patients with SDs in early‐stage cirrhosis in the short term. However, larger and longer‐term studies to assess efficacy and safety are required before its clinical use can be recommended.
This is a single‐centre, randomized, double‐blind, placebo‐controlled, cross‐over clinical trial, on patients with early‐stage [Child‐Turcotte‐Pugh class A or B] cirrhosis with sleep disturbances and without hepatic encephalopathy. The aim of this study was to assess the safety and efficacy of administrating 3mg of melatonin for two weeks on improving sleep disturbances. Melatonin seems safe and effective for use in patients with sleep disturbances in early‐stage cirrhosis, in the short term.</description><identifier>ISSN: 2397-9070</identifier><identifier>EISSN: 2397-9070</identifier><identifier>DOI: 10.1002/jgh3.12356</identifier><identifier>PMID: 32782966</identifier><language>eng</language><publisher>Melbourne: Wiley Publishing Asia Pty Ltd</publisher><subject>cirrhosis ; clinical trial ; Drug dosages ; Intervention ; Liver cirrhosis ; Males ; Melatonin ; Original ; Outpatient care facilities ; Patients ; Quality ; Sleep ; sleep disturbances ; treatment ; Variables</subject><ispartof>JGH open, 2020-08, Vol.4 (4), p.749-756</ispartof><rights>2020 The Authors. published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.</rights><rights>2020 The Authors. JGH Open: An open access journal of gastroenterology and hepatology published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.</rights><rights>2020. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5426-2b2f2b34d14cbbba6a07bce9a3d71bc2b85940187bfbc6a3355311d5bcfc13813</citedby><cites>FETCH-LOGICAL-c5426-2b2f2b34d14cbbba6a07bce9a3d71bc2b85940187bfbc6a3355311d5bcfc13813</cites><orcidid>0000-0001-5679-2893</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2430888374/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2430888374?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,11541,25731,27901,27902,36989,36990,44566,46027,46451,53766,53768,74869</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32782966$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>De Silva, Arjuna P</creatorcontrib><creatorcontrib>Niriella, Madunil A</creatorcontrib><creatorcontrib>Ediriweera, Dileepa S</creatorcontrib><creatorcontrib>De Alwis, Jerome P</creatorcontrib><creatorcontrib>Liyanage, Isurujith K</creatorcontrib><creatorcontrib>Ettickan, Ushanthani</creatorcontrib><creatorcontrib>Liyanapathirana, Kasun V</creatorcontrib><creatorcontrib>Undugodage, Chandimani</creatorcontrib><creatorcontrib>Silva, H. Asita</creatorcontrib><creatorcontrib>Silva, H. Janaka</creatorcontrib><title>Low‐dose melatonin for sleep disturbances in early‐stage cirrhosis: A randomized, placebo‐controlled, cross‐over trial</title><title>JGH open</title><addtitle>JGH Open</addtitle><description>Background and aim
Melatonin is used to treat sleep disturbances (SDs). The aim of this study was to investigate the safety and efficacy of low‐dose melatonin for SDs in early‐stage cirrhosis.
Methods
In a single‐center, randomized, double‐blind, placebo‐controlled, cross‐over clinical trial, patients with early‐stage (Child‐Turcotte‐Pugh [CTP] class A or B) cirrhosis with SDs, without hepatic encephalopathy, were randomized to placebo or 3 mg of melatonin for 2 weeks. After 2 weeks, the patients were given a washout period of 1 week and crossed over to melatonin or placebo for a further 2 weeks. The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) were used to measure sleep quality and daytime sleepiness, respectively. Analysis of results was based on intention to treat, and linear mixed‐effect models were used to evaluate the effect of melatonin. Analysis was conducted using R‐programming language 3.5.1.
Results
Seventy one patients were recruited (mean age: 61.9 ± 8.7 years, males: 46 [64.8%], and CTP Class A = 52 [73.2%] and Class B = 19 [26.8%]). Sixty patients completed the study (mean age: 61.7 ± 8.8 years, males: 40 [66.6%], and CTP Class A = 45 [75.0%] and Class‐B = 15 [25.0%]). Two patients dropped out due to adverse events. Nine patients were lost to follow up. Patients given melatonin had a significantly lower PSQI and ESS compared to both pretreatment (P < 0.001) and postplacebo scores (P < 0.001). Incidence of adverse events was similar (two each of abdominal pain, one each of headache, one each of dizziness) in both groups.
Conclusion
Melatonin seems safe and effective for use in patients with SDs in early‐stage cirrhosis in the short term. However, larger and longer‐term studies to assess efficacy and safety are required before its clinical use can be recommended.
This is a single‐centre, randomized, double‐blind, placebo‐controlled, cross‐over clinical trial, on patients with early‐stage [Child‐Turcotte‐Pugh class A or B] cirrhosis with sleep disturbances and without hepatic encephalopathy. The aim of this study was to assess the safety and efficacy of administrating 3mg of melatonin for two weeks on improving sleep disturbances. Melatonin seems safe and effective for use in patients with sleep disturbances in early‐stage cirrhosis, in the short term.</description><subject>cirrhosis</subject><subject>clinical trial</subject><subject>Drug dosages</subject><subject>Intervention</subject><subject>Liver cirrhosis</subject><subject>Males</subject><subject>Melatonin</subject><subject>Original</subject><subject>Outpatient care facilities</subject><subject>Patients</subject><subject>Quality</subject><subject>Sleep</subject><subject>sleep disturbances</subject><subject>treatment</subject><subject>Variables</subject><issn>2397-9070</issn><issn>2397-9070</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNp9ks1u1DAQgCMEolXphQdAlrggxLb-iROHA1JVQVu0Ehc4W_6Z7HrlxIudtFoOiEfgGXkSnE2pWg492Zr5_HnGnqJ4SfAJwZieblZrdkIo49WT4pCypl40uMZP7-0PiuOUNhhjIuqGs-p5ccBoLWhTVYfFz2W4-fPrtw0JUAdeDaF3PWpDRMkDbJF1aRijVr2BhHIGVPS7fCANagXIuBjXIbn0Hp2hqHobOvcD7Du09cqADhk0oR9i8H6KmhhSyrFwDREN0Sn_onjWKp_g-HY9Kr59-vj1_HKx_HJxdX62XBhe0mpBNW2pZqUlpdFaq0rhWhtoFLM10YZqwZty6k-32lSKMc4ZIZZr0xrCBGFHxdXstUFt5Da6TsWdDMrJfSDElVRxcMaDbCpF2qwSxLISl7VqhQVbV_kOzi0z2fVhdm1H3YE1kBtU_oH0YaZ3a7kK17IuCeG8yoI3t4IYvo-QBtm5ZMB71UMYk6QlY_n3GjGhr_9DN2GMfX6qicJCCFaXmXo7U_sHjtDeFUOwnKZETlMi91OS4Vf3y79D_81EBsgM3DgPu0dU8vPFJZulfwHY3c0D</recordid><startdate>202008</startdate><enddate>202008</enddate><creator>De Silva, Arjuna P</creator><creator>Niriella, Madunil A</creator><creator>Ediriweera, Dileepa S</creator><creator>De Alwis, Jerome P</creator><creator>Liyanage, Isurujith K</creator><creator>Ettickan, Ushanthani</creator><creator>Liyanapathirana, Kasun V</creator><creator>Undugodage, Chandimani</creator><creator>Silva, H. Asita</creator><creator>Silva, H. Janaka</creator><general>Wiley Publishing Asia Pty Ltd</general><general>John Wiley & Sons, Inc</general><general>Wiley</general><scope>24P</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0001-5679-2893</orcidid></search><sort><creationdate>202008</creationdate><title>Low‐dose melatonin for sleep disturbances in early‐stage cirrhosis: A randomized, placebo‐controlled, cross‐over trial</title><author>De Silva, Arjuna P ; Niriella, Madunil A ; Ediriweera, Dileepa S ; De Alwis, Jerome P ; Liyanage, Isurujith K ; Ettickan, Ushanthani ; Liyanapathirana, Kasun V ; Undugodage, Chandimani ; Silva, H. Asita ; Silva, H. Janaka</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5426-2b2f2b34d14cbbba6a07bce9a3d71bc2b85940187bfbc6a3355311d5bcfc13813</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>cirrhosis</topic><topic>clinical trial</topic><topic>Drug dosages</topic><topic>Intervention</topic><topic>Liver cirrhosis</topic><topic>Males</topic><topic>Melatonin</topic><topic>Original</topic><topic>Outpatient care facilities</topic><topic>Patients</topic><topic>Quality</topic><topic>Sleep</topic><topic>sleep disturbances</topic><topic>treatment</topic><topic>Variables</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>De Silva, Arjuna P</creatorcontrib><creatorcontrib>Niriella, Madunil A</creatorcontrib><creatorcontrib>Ediriweera, Dileepa S</creatorcontrib><creatorcontrib>De Alwis, Jerome P</creatorcontrib><creatorcontrib>Liyanage, Isurujith K</creatorcontrib><creatorcontrib>Ettickan, Ushanthani</creatorcontrib><creatorcontrib>Liyanapathirana, Kasun V</creatorcontrib><creatorcontrib>Undugodage, Chandimani</creatorcontrib><creatorcontrib>Silva, H. Asita</creatorcontrib><creatorcontrib>Silva, H. Janaka</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>JGH open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>De Silva, Arjuna P</au><au>Niriella, Madunil A</au><au>Ediriweera, Dileepa S</au><au>De Alwis, Jerome P</au><au>Liyanage, Isurujith K</au><au>Ettickan, Ushanthani</au><au>Liyanapathirana, Kasun V</au><au>Undugodage, Chandimani</au><au>Silva, H. Asita</au><au>Silva, H. Janaka</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Low‐dose melatonin for sleep disturbances in early‐stage cirrhosis: A randomized, placebo‐controlled, cross‐over trial</atitle><jtitle>JGH open</jtitle><addtitle>JGH Open</addtitle><date>2020-08</date><risdate>2020</risdate><volume>4</volume><issue>4</issue><spage>749</spage><epage>756</epage><pages>749-756</pages><issn>2397-9070</issn><eissn>2397-9070</eissn><abstract>Background and aim
Melatonin is used to treat sleep disturbances (SDs). The aim of this study was to investigate the safety and efficacy of low‐dose melatonin for SDs in early‐stage cirrhosis.
Methods
In a single‐center, randomized, double‐blind, placebo‐controlled, cross‐over clinical trial, patients with early‐stage (Child‐Turcotte‐Pugh [CTP] class A or B) cirrhosis with SDs, without hepatic encephalopathy, were randomized to placebo or 3 mg of melatonin for 2 weeks. After 2 weeks, the patients were given a washout period of 1 week and crossed over to melatonin or placebo for a further 2 weeks. The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) were used to measure sleep quality and daytime sleepiness, respectively. Analysis of results was based on intention to treat, and linear mixed‐effect models were used to evaluate the effect of melatonin. Analysis was conducted using R‐programming language 3.5.1.
Results
Seventy one patients were recruited (mean age: 61.9 ± 8.7 years, males: 46 [64.8%], and CTP Class A = 52 [73.2%] and Class B = 19 [26.8%]). Sixty patients completed the study (mean age: 61.7 ± 8.8 years, males: 40 [66.6%], and CTP Class A = 45 [75.0%] and Class‐B = 15 [25.0%]). Two patients dropped out due to adverse events. Nine patients were lost to follow up. Patients given melatonin had a significantly lower PSQI and ESS compared to both pretreatment (P < 0.001) and postplacebo scores (P < 0.001). Incidence of adverse events was similar (two each of abdominal pain, one each of headache, one each of dizziness) in both groups.
Conclusion
Melatonin seems safe and effective for use in patients with SDs in early‐stage cirrhosis in the short term. However, larger and longer‐term studies to assess efficacy and safety are required before its clinical use can be recommended.
This is a single‐centre, randomized, double‐blind, placebo‐controlled, cross‐over clinical trial, on patients with early‐stage [Child‐Turcotte‐Pugh class A or B] cirrhosis with sleep disturbances and without hepatic encephalopathy. The aim of this study was to assess the safety and efficacy of administrating 3mg of melatonin for two weeks on improving sleep disturbances. Melatonin seems safe and effective for use in patients with sleep disturbances in early‐stage cirrhosis, in the short term.</abstract><cop>Melbourne</cop><pub>Wiley Publishing Asia Pty Ltd</pub><pmid>32782966</pmid><doi>10.1002/jgh3.12356</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0001-5679-2893</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Wiley Online Library Open Access; Publicly Available Content Database; PubMed Central (Training) |
| subjects | cirrhosis clinical trial Drug dosages Intervention Liver cirrhosis Males Melatonin Original Outpatient care facilities Patients Quality Sleep sleep disturbances treatment Variables |
| title | Low‐dose melatonin for sleep disturbances in early‐stage cirrhosis: A randomized, placebo‐controlled, cross‐over trial |
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