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".
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
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.
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".
Longhua Hospital
Shanghai, China
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.
Time frame: At baseline, week 4 (in treatment), week 8 (end of treatment), and the follow-up period (week 12 and week 20 after randomization).
Bristol Stool Scale
A scale to classify the patient's voluntary bowel movement stool.
Time frame: 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
Time frame: 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
Time frame: At baseline and at week 8 (end of treatment).
Self-rating Anxiety Scale（SAS）
A measure of somatic symptoms associated with anxiety reactions.
Time frame: At baseline and at week 8 (end of treatment).
Self-rating Depression Scale（SDS）
A self-rating scale to assess patients' depression
Time frame: 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
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Time frame: 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.
Time frame: During 1-8 weeks