Hot Water Drinking Therapy in Achalasia

Achalasia Clinical Trial

— AHW  

Official title:

Efficacy and Safety Study of Hot Water Drinking Therapy in Achalasia Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01863966
• Other study ID #: PUMCH-AchaWater
• Status: Recruiting
• Phase: N/A
• First received: May 21, 2013
• Last updated: May 23, 2013
• Start date: March 2010
• Est. completion date: December 2015

Study information

• Verified date: May 2013
• Source: Peking Union Medical College Hospital
• Contact: Yutang Ren, M.D.
• Phone: +86-020-62786224
• Email: renytpumc[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia

Intervention

Other:
• hot water drinking therapy
Drink 200ml hot water 3min before and after a meal. Swallow food with hot water and drink 200ml hot water before sleep

Procedure:
• Pneumatic dilation
Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation under endoscope

Locations

Country	Name	City	State
China	Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline achalasia symptom score at 1 month	Dysphagia, Regurgitation and Chest Pain scores	baseline and 1 month	No
Secondary	Number of patients with adverse effects	adverse effects of drinking water like distention, nausea and belching	Week 1	Yes
Secondary	Change from baseline in barium esophagram at 1 year	measure esophageal diameter	baseline and 1 year	No
Secondary	Endoscopy at 1 year	esophageal bezoars and esophageal cancer	year 1	No
Secondary	Pneumatic dilation rate and relative efficacy	Patients who are unsatisfied with hot water drinking therapy are to receive pneumatic dilation	any time	No
Secondary	Change from baseline in achalasia symptom score at 1 year	Dysphagia,Regurgitation and Chest Pain scores	baseline and 1 year	No
Secondary	Change from baseline achalasia symptom scores at 5 years	Dysphagia,Regurgitation and Chest Pain scores	baseline and 5 years	No
Secondary	Change from baseline in barium esophagram at 5 years	measure esophageal diameter	baseline and 5 years	No
Secondary	Endoscopy at 5 years	esophageal bezoars and esophageal cancer	year 5	No