Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial
Abstract Background Postprandial distress syndrome (PDS) is referred to as meal-related functional dyspepsia (FD) and causes a reduced quality of life (QoL) for patients. Several randomized controlled trials (RCTs) have suggested that acupuncture is an effective treatment for FD, but few studies wer...
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| Format: | Article |
| Language: | English |
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BMC
2017-11-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2285-9 |
| _version_ | 1828476758980034560 |
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| author | Jing-Wen Yang Li-Wen Zhang Guang-Xia Shi Yi Du Jun Wang Jing-Jie Zhao Yan Cao Jian-Feng Tu Shuai Zhang Cheng Tan San-San Chen Cun-Zhi Liu |
| author_facet | Jing-Wen Yang Li-Wen Zhang Guang-Xia Shi Yi Du Jun Wang Jing-Jie Zhao Yan Cao Jian-Feng Tu Shuai Zhang Cheng Tan San-San Chen Cun-Zhi Liu |
| author_sort | Jing-Wen Yang |
| collection | DOAJ |
| description | Abstract Background Postprandial distress syndrome (PDS) is referred to as meal-related functional dyspepsia (FD) and causes a reduced quality of life (QoL) for patients. Several randomized controlled trials (RCTs) have suggested that acupuncture is an effective treatment for FD, but few studies were particularly for PDS. This pilot study was designed to determine the feasibility and efficacy of acupuncture in patients with PDS characterized by postprandial fullness and early satiation according to the Rome III criteria. Methods This is a multi-center, two-arm, blinded (participants), pilot RCT. Forty-two participants who meet the inclusion criteria will be randomly assigned to the verum acupuncture group or minimal acupuncture group in a 1:1 ratio. Both treatments consist of 12 sessions of 20 min duration over four weeks (three sessions per week). The primary outcome measurement is the proportion of persons who improve as assessed using the global outcome by the overall treatment effect (OTE) at end-of-treatment (EOT) (four weeks after randomization). Global assessment at weeks 8 and 16 after randomization is one of the secondary outcomes. The other secondary outcomes including symptoms, disease-specific QoL, and depression and anxiety will be assessed at weeks 4, 8, and 16 after randomization. Discussion This pilot study will help determine the feasibility and efficacy of acupuncture in patients with PDS. Trial registration ISRCTN Registry, ISRCTN18135146 . Registered on 7 July 2016. |
| first_indexed | 2024-12-11T06:33:22Z |
| format | Article |
| id | doaj.art-b7c0578a4da64957b0de10fd18d46b55 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-11T06:33:22Z |
| publishDate | 2017-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-b7c0578a4da64957b0de10fd18d46b552022-12-22T01:17:27ZengBMCTrials1745-62152017-11-011811810.1186/s13063-017-2285-9Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trialJing-Wen Yang0Li-Wen Zhang1Guang-Xia Shi2Yi Du3Jun Wang4Jing-Jie Zhao5Yan Cao6Jian-Feng Tu7Shuai Zhang8Cheng Tan9San-San Chen10Cun-Zhi Liu11Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture NeuromodulationDepartment of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture NeuromodulationDepartment of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture NeuromodulationDepartment of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical UniversityAcupuncture and Moxibustion Department, Dongzhimen Hospital Affiliated to Beijing University of Traditional Chinese MedicineDepartment of Traditional Chinese Medicine, Beijing Friendship Hospital, Capital Medical UniversityDepartment of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture NeuromodulationDepartment of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture NeuromodulationDepartment of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture NeuromodulationAcupuncture and Moxibustion Department, Dongzhimen Hospital Affiliated to Beijing University of Traditional Chinese MedicineAcupuncture and Moxibustion Department, Dongzhimen Hospital Affiliated to Beijing University of Traditional Chinese MedicineDepartment of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Key Laboratory of Acupuncture NeuromodulationAbstract Background Postprandial distress syndrome (PDS) is referred to as meal-related functional dyspepsia (FD) and causes a reduced quality of life (QoL) for patients. Several randomized controlled trials (RCTs) have suggested that acupuncture is an effective treatment for FD, but few studies were particularly for PDS. This pilot study was designed to determine the feasibility and efficacy of acupuncture in patients with PDS characterized by postprandial fullness and early satiation according to the Rome III criteria. Methods This is a multi-center, two-arm, blinded (participants), pilot RCT. Forty-two participants who meet the inclusion criteria will be randomly assigned to the verum acupuncture group or minimal acupuncture group in a 1:1 ratio. Both treatments consist of 12 sessions of 20 min duration over four weeks (three sessions per week). The primary outcome measurement is the proportion of persons who improve as assessed using the global outcome by the overall treatment effect (OTE) at end-of-treatment (EOT) (four weeks after randomization). Global assessment at weeks 8 and 16 after randomization is one of the secondary outcomes. The other secondary outcomes including symptoms, disease-specific QoL, and depression and anxiety will be assessed at weeks 4, 8, and 16 after randomization. Discussion This pilot study will help determine the feasibility and efficacy of acupuncture in patients with PDS. Trial registration ISRCTN Registry, ISRCTN18135146 . Registered on 7 July 2016.http://link.springer.com/article/10.1186/s13063-017-2285-9Postprandial distress syndromeFunctional dyspepsiaAcupunctureRandomized controlled trialMinimal acupuncture |
| spellingShingle | Jing-Wen Yang Li-Wen Zhang Guang-Xia Shi Yi Du Jun Wang Jing-Jie Zhao Yan Cao Jian-Feng Tu Shuai Zhang Cheng Tan San-San Chen Cun-Zhi Liu Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial Trials Postprandial distress syndrome Functional dyspepsia Acupuncture Randomized controlled trial Minimal acupuncture |
| title | Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial |
| title_full | Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial |
| title_fullStr | Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial |
| title_full_unstemmed | Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial |
| title_short | Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial |
| title_sort | acupuncture for postprandial distress syndrome apds study protocol for a randomized controlled trial |
| topic | Postprandial distress syndrome Functional dyspepsia Acupuncture Randomized controlled trial Minimal acupuncture |
| url | http://link.springer.com/article/10.1186/s13063-017-2285-9 |
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