Acupuncture for Functional Constipation in Older Adults

A Randomized Controlled Clinical Trial of Acupuncture in Nourishing Kidney and Dredging Fu Organs for Functional Constipation in Older Adults

Through a scientific and standardized randomized controlled study, we observe the effectiveness and safety of acupuncture in the treatment of functional constipation in the elderly through the method of "nourishing kidney and dredging Fu organs".

Study Overview

• Status: Completed
• Conditions: Constipation - Functional
• Intervention / Treatment: Device: acupuncture; Device: sham acupuncture

Detailed Description

Functional constipation is a common disease of old people. To date, there has not specific therapy on it. Former research showed acupuncture may work for functional constipation. In the trial, patients in the acupuncture and sham acupuncture groups will receive 24 acupuncture treatments over an 8-week period. This RCT is designed to confirm the efficacy and safety of acupuncture in functional constipation treatment.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200032
    • Longhua Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Meet Rome IV Diagnostic Criteria for Constipation and TCM Diagnostic Criteria of constipation with yin deficiency syndrome;
• No gender restriction, age 60-80;
• FC that is classified as mild or moderate;
• Have not used any medicine for constipation at least 2 weeks before treatment (except emergency treatment);
• Have not participated in other medical clinical trials over the past one month;
• Those who can understand various evaluation scales, complete the evaluation and cooperate with the completion of the planned course of treatment;
• Sign the informed consent.

Exclusion Criteria:

• Irritable bowel syndrome and constipation caused by tumors, inflammatory reactions, endocrine and metabolic diseases, and drugs;
• Constipation caused by organic diseases;
• Patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system, infectious diseases, tumors, and mental diseases;
• Those who voluntarily give up or cannot cooperate with treatment and observation due to various circumstances;
• Patients with cognitive impairment or aphasia;
• Those who take other drugs during treatment, which affect the efficacy and judgment (except emergency treatment).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture group; Participants will receive acupuncture treatment at Zhao Hai(KI 6), Da Zhong(KI 4), Tai Xi(KI 3), Tian Shu(ST 25), and Shang Ju Xu(ST 37) bilaterally. Each treatment will last 30 minutes and participants will receive the treatment 3 times per week (every other day) for 8 weeks, 24 sessions in total. Follow-up time is week 4 and week 12 after treatment (ie, week 12 and week 20).	Device: acupuncture; All acupoints will be routinely sterilized at first. After the insertion of the needles, manipulations of lifting, twirling, and thrusting are performed on all needles to reach de qi, which is a sensation typically associated with needling including soreness, numbness, swelling, heaviness, and other feelings. This is considered to be an important component of the therapeutic effect of acupuncture.
Placebo Comparator: Sham acupuncture group; Participants will receive sham acupuncture treatment on bilateral sham Zhao Hai(KI 6), Da Zhong(KI 4), Tai Xi(KI 3), Tian Shu(ST 25), and Shang Ju Xu(ST 37) that match real acupuncture points. The duration of needle retention, treatment period, and follow-up in the control group is the same as that in the intervention group.	Device: sham acupuncture; The placebo needles chosen for this study are flat-tipped needles without a tip, which could not be pierced into the skin. In the meanwhile, an external patch device will fix the needles, which are visually pierced into the skin. After the treatment, the acupuncturist will press the acupuncture point with a dry cotton ball so that the patient can feel the pulling out of the "needle".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in the mean number of CSBMs per week compared to baseline during the 8-week treatment period	Complete Spontaneous Bowel Movements (CSBMs) refers to the frequency of a bowel movement that occurred in the absence of laxatives or manipulation.	At baseline, week 4 (in treatment), week 8 (end of treatment), and the follow-up period (week 12 and week 20 after randomization).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bristol Stool Scale	A scale to classify the patient's voluntary bowel movement stool.	At baseline and at week 8 (end of treatment).
Patient Assessment of Constipation-Symptoms (PAC-SYM)	A scale to assess the condition of the patient's constipation-related symptoms	At baseline and at week 8 (end of treatment).
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)	A brief but comprehensive assessment of the daily life quality of patients with FC, containing 28 items	At baseline and at week 8 (end of treatment).
Self-rating Anxiety Scale（SAS）	A measure of somatic symptoms associated with anxiety reactions.	At baseline and at week 8 (end of treatment).
Self-rating Depression Scale（SDS）	A self-rating scale to assess patients' depression	At baseline and at week 8 (end of treatment).
Weekly usage of emergency bowel medications	The proportions of participants using medications and doses for emergency treatment	At baseline and at week 8 (end of treatment).
Incidence of adverse events	The adverse events (AEs) assessment aims at evaluating the AEs of acupuncture treatment.	During 1-8 weeks

Collaborators and Investigators

• Sponsor: Yin Ping
• Collaborators: Longhua Hospital; Shanghai Municipal Hospital of Traditional Chinese Medicine
• Investigators: Principal Investigator: PING YIN, Shanghai University of Traditional Chinese Medicine

Publications and helpful links

General Publications

• Dunstan DA, Scott N. Norms for Zung's Self-rating Anxiety Scale. BMC Psychiatry. 2020 Feb 28;20(1):90. doi: 10.1186/s12888-019-2427-6.
• Zhou K, Fang J, Wang X, Wang Y, Hong Y, Liu J, Wang L, Xue C, Wang P, Liu B, Zhu B. Characterization of de qi with electroacupuncture at acupoints with different properties. J Altern Complement Med. 2011 Nov;17(11):1007-13. doi: 10.1089/acm.2010.0652. Epub 2011 Oct 14.
• Dunstan DA, Scott N. Clarification of the cut-off score for Zung's self-rating depression scale. BMC Psychiatry. 2019 Jun 11;19(1):177. doi: 10.1186/s12888-019-2161-0.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): March 1, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 21Y11923900

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No