Clinical trial NCT01863966: Hot Water Drinking Therapy in Achalasia
Official title: Efficacy and Safety Study of Hot Water Drinking Therapy in Achalasia Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Achalasia
Keywords: Achalasia
Hot water drinking therapy
Pneumatic dilation
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: From clinical observation that some achalasia patients drink water to help swallow food, the investigators have proposed a systemic hot water drinking therapy. This study is to observe its efficacy on achalasia symptoms and explore its mechanism.

Detailed description: 1. Achalasia patients will participate hot water drinking therapy: to drink 200ml of hot water before and after a meal, as well as 2 hours before sleep and to chew food carefully and swallow with hot soup.
2. Patients are followed by achalasia associated symptom scores, barium esophagram and endoscopy.
3. If patients are unsatisfied with hot water drinking therapy, they receive pneumatic dilation

Eligibility criteria: Inclusion Criteria:

* achalasia patients diagnosed by endoscopy, barium esophagram and manometry

Exclusion Criteria:

* could not drink water
* poor compliance
* severe comorbidities
* esophageal stenosis secondary to erosions and cancer

Primary outcomes:
measure: Change from baseline achalasia symptom score at 1 month
timeFrame: baseline and 1 month
Secondary outcomes:
measure: Number of patients with adverse effects
timeFrame: Week 1
measure: Change from baseline in barium esophagram at 1 year
timeFrame: baseline and 1 year
measure: Endoscopy at 1 year
timeFrame: year 1
measure: Pneumatic dilation rate and relative efficacy
timeFrame: any time
measure: Change from baseline in achalasia symptom score at 1 year
timeFrame: baseline and 1 year
measure: Change from baseline achalasia symptom scores at 5 years
timeFrame: baseline and 5 years
measure: Change from baseline in barium esophagram at 5 years
timeFrame: baseline and 5 years
measure: Endoscopy at 5 years
timeFrame: year 5
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science
Study officials:
affiliation: Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science
name: Meiyun Ke, M.D.
role: STUDY_DIRECTOR
References:
citation: Triadafilopoulos G, Tsang HP, Segall GM. Hot water swallows improve symptoms and accelerate esophageal clearance in esophageal motility disorders. J Clin Gastroenterol. 1998 Jun;26(4):239-44. doi: 10.1097/00004836-199806000-00003.
citation: Ren Y, Ke M, Fang X, Zhu L, Sun X, Wang Z, Wang R, Wei Z, Wen P, Xin H, Chang M. Response of esophagus to high and low temperatures in patients with achalasia. J Neurogastroenterol Motil. 2012 Oct;18(4):391-8. doi: 10.5056/jnm.2012.18.4.391. Epub 2012 Oct 9.