Hot Water Drinking Therapy in Achalasia

Not Applicable

• Conditions: Achalasia
• Interventions: Other: hot water drinking therapy; Procedure: Pneumatic dilation

• Registration Number: NCT01863966
• Lead Sponsor: Peking Union Medical College Hospital

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

Study Timeline

• Study Start: 2010-03
• Status Verified: 2013-05
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-23
• Last Update Submitted: 2013-05-23
• Study First Posted: 2013-05-29
• Last Update Posted: 2013-05-29
• Primary Completion: 2015-11
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hot water drinking therapy	hot water drinking therapy	Hot water drinking before,after meal and before sleep
Pneumatic dilation	Pneumatic dilation	Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation

Primary Outcome Measures

Name	Time	Method
Change from baseline achalasia symptom score at 1 month	baseline and 1 month	Dysphagia, Regurgitation and Chest Pain scores

Secondary Outcome Measures

Name	Time	Method
Number of patients with adverse effects	Week 1	adverse effects of drinking water like distention, nausea and belching
Change from baseline in barium esophagram at 1 year	baseline and 1 year	measure esophageal diameter
Endoscopy at 1 year	year 1	esophageal bezoars and esophageal cancer
Pneumatic dilation rate and relative efficacy	any time	Patients who are unsatisfied with hot water drinking therapy are to receive pneumatic dilation
Change from baseline in achalasia symptom score at 1 year	baseline and 1 year	Dysphagia,Regurgitation and Chest Pain scores
Change from baseline achalasia symptom scores at 5 years	baseline and 5 years	Dysphagia,Regurgitation and Chest Pain scores
Change from baseline in barium esophagram at 5 years	baseline and 5 years	measure esophageal diameter
Endoscopy at 5 years	year 5	esophageal bezoars and esophageal cancer

Trial Locations

Locations (1)

Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science; 🇨🇳 Beijing, China