Clinical trial NCT05496543: Acupuncture for Functional Constipation in Older Adults
Official title: A Randomized Controlled Clinical Trial of Acupuncture in Nourishing Kidney and Dredging Fu Organs for Functional Constipation in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation - Functional
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Municipal Hospital of Traditional Chinese Medicine
name: Longhua Hospital
First posted: 2022-08-11
Enrollment: 84
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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".

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The change in the mean number of CSBMs per week compared to baseline during the 8-week treatment period
timeFrame: At baseline, week 4 (in treatment), week 8 (end of treatment), and the follow-up period (week 12 and week 20 after randomization).
Secondary outcomes:
measure: Bristol Stool Scale
timeFrame: At baseline and at week 8 (end of treatment).
measure: Patient Assessment of Constipation-Symptoms (PAC-SYM)
timeFrame: At baseline and at week 8 (end of treatment).
measure: Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)
timeFrame: At baseline and at week 8 (end of treatment).
measure: Self-rating Anxiety Scale（SAS）
timeFrame: At baseline and at week 8 (end of treatment).
measure: Self-rating Depression Scale（SDS）
timeFrame: At baseline and at week 8 (end of treatment).
measure: Weekly usage of emergency bowel medications
timeFrame: At baseline and at week 8 (end of treatment).
measure: Incidence of adverse events
timeFrame: During 1-8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: PING YIN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.