Constipation has a high prevalence rate (>30 %) in psychiatric patients with psychotropic drugs. Common pharmacological and non-pharmacological interventions for constipation might have longer-term negative and adverse effects that would outweigh their short-term efficacy in symptom reduction. This randomized controlled trial aims to investigate the effect of self-administered acupressure for the management of constipation, in hospitalized psychiatric patients.
Seventy-eight patients were recruited in matched pairs in terms of gender, age and laxative use from five acute psychiatric wards in Hong Kong. Each of these matched pairs of patients was randomly assigned to either a self-administered acupressure (n = 39) or a sham group (n = 39), using computer-generated random numbers. After baseline measurement, the intervention and sham group received the same training in self-administered acupressure and supervised practice once per day for 10 days, except light pressure on non-acupoints was taught to the sham group. The acupoints chosen for acupressure included Zhongwan (RN12), right and left Tianshu (ST25), right and left Quchi (LI11). Participants’ symptoms and quality of life regarding constipation were measured at baseline and immediately and 2 weeks after completion of the interventions with constipation assessment scale and patient assessment of constipation quality of life questionnaire, respectively.
After 2 weeks follow-up, participants who had received self-administered acupressure indicated significantly greater improvements in both symptom severity (P = 0.0003) and quality of life (P = 0.0004) when compared with the sham group.
The psychiatric patients with constipation who practiced self-administered acupressure for 10 days improved their symptom severity and perceived quality of life immediately and 2 weeks after completion of the intervention in comparison with the sham group.
Trial registration: The trial was registered with the ClinicalTrials.gov (Reg. No: NCT02187640)
Constipation is a common and chronic physical health problem worldwide. In Hong Kong and the United States, the prevalence of constipation in the general population is about 14.3 and 12.0–19.0 %, respectively , . Untreated constipation can have severe consequences such as fecal impaction and bowel obstruction, which may lead to extended periods of hospitalization, or even premature mortality , . Constipation contributes to 13.7 million days of restricted activities and 3.4 million days of bed disability each year in the United States and several other developed countries –. More than $725 million per year is spent on laxatives for management of constipation in the United States ; similar high costs related to this disorder have been reported in Hong Kong and many Western countries.
More than one-third of psychiatric patients who take psychotropic drugs (e.g., antipsychotics and antidepressants) suffer from constipation. The high rate of constipation among psychiatric patients may result not only from the side effects of psychotropic drugs (mainly the inhibitory effects of anticholinergics on acetylcholine), but also from patients’ limited exercise, sedentary lifestyle, negative symptoms (e.g., abolition and social withdrawal), loss of energy, poor mental state, poor dietary practice, and insufficient fiber intake. Psychiatric patients with constipation may feel embarrassed about seeking medical consultation and health advice and/or lack the initiative to change their unhealthy lifestyle and behaviors, resulting in negative consequences for their daily lives and health.
The most common pharmacological and non-pharmacological interventions for constipation can produce short-term symptom relief. Although pharmacological therapies such as laxatives can stimulate bowel movement, these medications may produce many long-term side effects (e.g., metabolic disturbances and hepatotoxicity) that can far outweigh their therapeutic effects of symptom reduction. Non-pharmacological interventions can be categorized as traumatic (e.g., acupuncture) or non-traumatic (e.g., auriculotherapy, reflexology, behavioral therapy, and abdominal massage). Recent evidence suggests that acupuncture is effective in relieving symptoms of constipation. However, acupuncture is a traumatic intervention, which may limit its clinical application as an alternative treatment. Non-traumatic and complementary therapies, such as auriculotherapy, behavioral therapy, and reflexology, have been seldom used or found ineffective in the treatment of constipation. In one randomized controlled trial, abdominal massage therapy decreased the severity of constipation and increased bowel movement after 8 weeks, but this did not lead to a decrease in laxative intake.
A number of other non-pharmacological complementary therapies with self-administrable procedures have been recommended for managing constipation in people with chronic illness. Acupressure is the application of pressure to specific acupoints on the body and is believed to open up the flow of qi, the energy that restores balance to the human body. Acupressure has been shown to be effective in the management of acute and chronic diseases, such as breathlessness in patients with chronic obstructive pulmonary disease, nausea and vomiting in cancer patients undergoing chemotherapy, and pain in those with dysmenorrhea Acupressure can improve symptoms of constipation in people with stroke and neurological disorder as well as older people residing in care homes for the aged . However, there is limited evidence of the effects of acupressure in treating medication- and/or lifestyle-induced constipation in hospitalized psychiatric patients.
A “stepped care” system has recently been proposed to enhance both the efficiency and effectiveness of treatment for chronic health problems. The stepped care approach to patient care comprises a sequence of treatment options offered to patients, ranging from low-intensity and less expensive, optimal interventions to more complex and intensive approaches, depending on what is deemed necessary and beneficial for individual patients. In the stepped care system, the self-help approach to illness management is a treatment approach that offers user-friendly, convenient, and less expensive interventions. In addition to reducing treatment costs, self-help treatments or interventions may also enhance the self-care ability and self-efficacy of service users, especially those with chronic illnesses. Chinese medicine practitioners have developed and validated standardized manuals and procedures for acupressure as a user-friendly way to guide self-application of the technique among adult psychiatric patients.
This randomized controlled trial aims to investigate the efficacy of self-administered acupressure in treating constipation in hospitalized psychiatric patients. Such patients often experience major psychological distress because of symptoms of constipation. The constipation assessment scale (CAS) is a universal assessment tool with good reliability and validity for a diverse patient population with constipation. The CAS has demonstrated satisfactory internal consistency, good test–retest reliability, and significant contrasts between cancer patients with constipation and healthy controls. In addition, severe constipation can result in reduced life satisfaction. The symptom-specific patient assessment of constipation quality of life questionnaire (PAC-QoL) is commonly used to assess perceived quality of life in relation to the life impacts of constipation in hospitalized psychiatric patients. This scale has demonstrated good internal consistency, test–retest reliability, and construct validity in patients with chronic constipation. The Chinese versions of the CAS and PAC-QoL (Additional file 1) used in this trial were validated and indicated satisfactory content validity, and satisfactory levels of equivalence with the original version, test–retest reliability, and internal consistency in a pilot study of 20 Chinese adult psychiatric patients with constipation.
This was a randomized controlled trial with a repeated-measures sham-group design and was conducted between April and November 2013. A flow diagram of the study procedure is presented in Fig. 1, according to the CONSORT statement. The controlled trial was registered with the ClinicalTrials.gov.
1. Recruitment, retention and group allocation of participants during the study
In the absence of previous similar research on acupressure for constipation in psychiatric patients, the sample size calculation was based on Cohen’s standard medium effect size (f = 0.40 with 80 % power at 5 % alpha level) for healthcare and behavioral studies, taking into account an expected 20 % attrition rate. It was calculated that 39 participants per group (78 participants in total) would be required for analysis of variance tests on the main study outcomes (symptom severity and quality of life), as calculated with G*Power version 3.13 (free download from MacUpdate at http://www.macupdate.com/apps). Seventy-eight eligible adult psychiatric patients volunteered to participate in this study. These patients were recruited over 6 months from five adult psychiatric wards in one 1000-bed regional mental hospital in Hong Kong. A few patients (n = 6) refused to participate or were not selected because of lack of interest in participating or time constraints. Participants had been admitted to the hospital for acute psychiatric treatment (e.g., psychotropic medication) and rehabilitation before discharge.
Criteria for participation in this study included being: (1) Hong Kong Chinese residents, aged between 18 and 64; (2) willing and mentally competent to learn about, and engage in, self-care and acupressure, as assessed and recommended by the attending psychiatrists; and (3) diagnosed with constipation under the Rome III diagnostic criteria . In relation to these criteria, participants must have presented in the past 6 months with the following symptoms of constipation: (a) rarely having loose stools without the use of laxatives, (b) insufficient evidence of irritable bowel syndrome, and (c) any two or more of the following cardinal symptoms:
1. Straining at defecation, at least, a quarter of the time,
2. Lumpy and/or hard stools, at least, a quarter of the time,
3. A sensation of incomplete evacuation, at least, a quarter of the time,
4. A sensation of anorectal obstruction/blockage, at least, a quarter of the time,
5. Manual maneuvers to facilitate defecation, at least, a quarter of the time, and/or,
6. Three or fewer defecations per week.
Participants with the following symptoms were excluded:
(1) mental instability over the past month as indicated by their attending psychiatrist;
(2) anatomical and physiological disorders of the gastrointestinal tract, such as mal-rotation, fistula, and colonic neuropathies;
(3) various comorbidities of mental illness such as metabolic and endocrine diseases, lead poisoning, and vitamin D intoxication;
(4) previous training in acupressure; and
(5) physical disability involving the upper limbs or pregnancy.
The attending psychiatrist assessed and confirmed whether each participant was mentally competent to participate and whether they understood the instructions for the intervention and the responses to the outcome questionnaires. Informed written consent (Additional file 2) was obtained from participants judged competent to take part in the study. These participants were asked to complete baseline measures of socio-demographic characteristics and study outcomes. Participants were then matched in pairs according to gender, a factor associated with symptom severity and quality of life in previous studies on psychiatric patients with constipation. Two sets of matched pairs of participants were listed and the paired participants in one list were then randomly assigned to either the self-administered acupressure or sham group using computer-generated random number sequences; their matched pairs were assigned to the corresponding study group. Participants in the sham group received similar training and implemented a similar acupressure procedure to the acupressure group, except that they were taught to use sham acupoints and perform abdominal massage with light pressure. Participants in this group were offered acupressure training and supervised practice after the study if the intervention was effective.
Training in self-administered acupressure for relieving constipation was performed according to a standard guideline or protocol for practice. This consisted of two simple procedures, as follows: first, the participant was taught to use the Acupen, a device used to apply constant pressure of 29.5–40.0 newton force onto five acupoints, lasting for approximately 1 min. The five acupoints were Zhongwan (RN12), which is located in the upper abdomen and on the anterior midline 4 cun (just over 10 cm) above the center of the umbilicus ; the right and left Tianshu (ST25), located in the central abdominal region and 2 cun (just over 5 cm) lateral to the umbilicus ; and the right and left Quchi (LI11), located at the lateral end of the transverse elbow crease when the forearm is flexed and at the midpoint of the line connecting Chize (LU5) to the lateral epicondyle of the humerus. Participants were informed of the specific sensations (e.g., soreness and relaxation) that should be experienced when pressure is applied accurately to the acupoints. Second, gentle rubs (with the palm) with pressure on the abdomen in clockwise circular movements around 2 cun from the umbilicus were performed for another 8 min. The positions of the acupoints and use of the Acupen were illustrated with colored photographs and pictures for the participants’ easy reference. The acupressure and abdominal massage were performed once a day for 10 days in a group setting, supervised by a trained psychiatric nurse and preferably at least 2 h after a meal. The main procedure and features of the acupressure intervention are summarized (in Additional file 3), according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA).
The sham group was trained to perform acupressure in a similar way to the intervention group, except that they used five sham acupoints and mild abdominal massage with slight pressure only. Participants in the sham group were not told about the sensations (e.g., soreness and relaxation) induced by acupressure on the real acupoints. The acupressure and sham group programs were reviewed and agreed upon by a panel of six Chinese medical practitioners and acupressure therapists; minor amendments were made to a few terms about acupoints and the administration of acupressure in the programs.
A training workshop was conducted by an experienced Chinese medical practitioner who had practiced acupressure for 10 years. The workshop was designed to equip five mental health nurses (one in each psychiatric ward under study) with acupressure, abdominal massage, and group supervision skills. The trained nurses were then supervised to teach a group of patients about acupressure until the practitioner was satisfied with and confirmed their competence to train their patients in acupressure with the aid of a manual for self-administered acupressure. Each of the nurses also practiced training a group of four patients in self-administered acupressure under the supervision of the practitioner prior to the start of the study interventions. The treatment fidelity among the five trained nurses was confirmed by the research team according to the items in the treatment manual, and their performance was found to be 93–98 % accurate for all items.
A socio-demographic and clinical data sheet (Additional file 4) was completed at baseline. The primary and secondary outcome measures were scores on the Chinese versions of the CAS and the PAC-QoL questionnaire, respectively. These outcome measures were administered by the researcher (who was blind to participants’ group assignment) at recruitment, immediately after the 10-day interventions, and 2 weeks after the interventions.
The 8-item CAS has been frequently used to assess constipation symptoms in the previous 7 days, such as abdominal distention or bloating, frequency of bowel movements, oozing of liquid stool, and rectal pain with bowel movements. Subjects were asked to rate each item on a 3-point Likert scale: 0 = no problem, 1 = some problems, and 2 = severe problems. Higher total scores (possible range 0–16) indicate more severe constipation symptoms.
The 28-item PAC-QoL consists of four subscales: satisfaction with constipation symptoms and treatment (five items), physical discomfort (four items), psychosocial discomfort (eight items), and worries and concerns (11 items) . Items are rated on a five-point Likert scale, ranging from 0 = none of the time or not at all to 4 = all of the time or extremely. The total and subscale scores were averaged by the total number of items, and then each average score (ranging from 0 to 4) was used for comparison. The lower the average total and subscale scores, the better the person’s perceived health-related quality of life.
Descriptive statistics (frequency and mean [standard deviation]) were used to describe the socio-demographic data and scores on the outcome variables (PAC-QoL and CAS). The homogeneity of the two study groups was assessed by comparing their baseline outcome scores and socio-demographic characteristics using the Chi-square test (for nominal variables) and the independent sample t-test or Mann–Whitney U test (for continuous variables). The mean scores of the two outcome variables were not normally distributed and there were significant differences in PAC-QoL mean scores between groups at the baseline. Therefore, the generalized estimating equation (GEE) test was used to compare differences in CAS and PAC-QoL mean scores between the treatment and sham groups across time (pretest and two post-tests), followed by contrast tests. For outcome measures showing significant results in the GEE test, subgroup analyzes were performed to examine any significant differences in mean scores between subgroups for gender, age, type of antipsychotic drug used, use of laxatives, and tendency to suppress defecation. The level of significance for all statistical tests was set at 0.05.
Ethical approval (NTW-2012-0009) and permission to conduct the study were obtained from the Human Subjects Research Ethics Committee at The Hong Kong Polytechnic University and the Clinical Research Ethics Committee of the Hospital Authority, Hong Kong. The aim and procedure of the study were explained to the participants who met the study criteria and those who agreed to participate provided written consent.
Characteristics of participants
Seventy-eight participants were recruited over 6 months and randomly allocated into either the self-administered acupressure or sham group (n = 39 in each group). Ten participants withdrew during the intervention period (attrition rate = 12.9 %) because of deterioration in their mental state; thus, 33 and 35 members of the acupressure and sham groups, respectively, completed the intervention and the two follow-up measures. Based on an examination of the participants’ diaries, the adherence rates of performing the acupressure therapy and sham program were 95.2 % (95 % CI 92.3–98.2 %) and 92.7 % (95 % CI 90.1–95.3 %), respectively, indicating non-significant differences between the groups.
The demographic and clinical characteristics of the 68 participants are summarized in Table 1. Most (n = 54, 79.4 %) had been diagnosed with schizophrenia (n = 29, 87.9 % and n = 25, 71.4 % in the acupressure and sham groups, respectively). Two-thirds (65.7 %) were aged between 41 and 60, and 33.3 % (n = 11) of the acupressure group and 37.1 % (n = 13) of the sham group were aged between 40 and 50. More than half (58.8 %; n = 19 in the acupressure and n = 21 in the sham group) of each group consumed less than 20–35 g/day of fiber (the World Health Organization recommends that 20–35 g/day as the optimal daily fiber intake ). Chi-square tests revealed no statistically significant differences between the treatment and sham groups on any of the demographic and clinical characteristics, indicating the homogeneity of the two groups at recruitment.
Table 1. Demographic and clinical characteristics of participants
Mean scores of outcome measure at baseline
At the baseline measurement, there were no statistically significant differences in CAS mean scores (Mann–Whitney U = −0.614, P = 0.539) between the acupressure and sham groups. However, the PAC-QoL mean scores were significantly different between the two groups (Mann–Whitney U = −3.495, P < 0.0005); the acupressure group [0.87 (SD = 0.09)] had a significantly lower mean score on the PAC-QoL than the sham group [1.28 (SD = 0.09)]. Therefore, the baseline PAC-QoL means scores were used as covariants for the analysis of the treatment effects.
Treatment effects of self-administered acupressure
The mean scores on the CAS and the PAC-QoL (and its subscales) at recruitment, immediately after intervention, and 2 weeks after intervention and comparisons between the two groups across time are summarized in Table 2. Over the 2-week follow-up, participants in the acupressure group showed significant improvements in CAS mean score and PAC-QoL mean score (Wald’s χ 2 = 13.11 and 39.09, respectively, both P < 0.0005) compared with the sham group. There were also significantly greater improvements in the acupressure group in all domains of the PAC-QoL (physical, psychosocial, worries and concerns, and satisfaction) compared with the sham group (Wald’s χ 2 = 17.70–39.09, all P < 0.0005). The mean scores for the CAS and PAC-QoL and its subscales for the pretest and two post-tests in the sham group were higher, indicating a worsening of both constipation symptoms and quality of life. The CAS mean score differences between the baseline and post-test 1 and between post-tests 1 and 2 were 0.18 and 0.94, respectively. The PAC-QoL mean score differences between the baseline and post-test 1 and between post-tests 1 and 2 were 0.08 and 0.28, respectively.
Table 2. Summary of outcome measures’ comparison between acupressure and sham groups before, immediate after intervention, and 2 weeks after intervention
The results of contrast tests on the variables with significant treatment effects indicated that the participants in the acupressure group experienced significantly greater improvements in symptom severity at post-test 1 (mean difference = −2.00, P < 0.0005) and post-test 2 (mean difference = −3.14, P < 0.0005) than those in the sham group. There was a significant difference in the quality of life between the groups at baseline. Changes in mean PAC-QoL scores from baseline to post-tests 1 and 2 were compared for the groups. The acupressure group reported a significantly greater reduction than the sham group in mean PAC-QoL scores at both post-test 1 (mean difference between groups = −0.36, P < 0.0005) and post-test 2 (mean difference between groups = −0.55, P < 0.0005). The CAS and PAC-QoL mean scores over the 2-week follow-up indicated that the self-help acupressure program demonstrated a significant, positive effect on constipation. In addition, the mean score differences in the acupressure group were significantly improved from the baseline measurement to post-test 1 and post-test 2 (mean difference = −1.42 and −1.81, respectively, for CAS and mean difference = −0.21 and −0.20, respectively, for PAC-QoL).
The subgroup analyzes showed that those acupressure participants who had taken laxatives (n = 14) indicated significantly greater improvements in constipation symptoms (P < 0.0005) and perceived quality of life (P = 0.002) than those who had not used such medication over the 2-week follow-up. Despite these significant differences in treatment effects between the two subgroups, those acupressure participants who had not taken laxatives during the study period (n = 19) indicated significant within-group improvements in both constipation symptoms [i.e., the mean CAS score was reduced from 3.32 (SD = 0.279) at the baseline measurement to 2.32 (SD = 0.289) immediately after the intervention, and further reduced to 2.05 (SD = 0.361) at the 2-week follow-up] and perceived quality of life [i.e., the mean PAC-QoL score was reduced from 0.97 (SD = 0.072) at the baseline measurement to 0.94 (SD = 0.074) immediately after the intervention, even though it increased slightly to 1.02 (SD = 0.081) over the follow-up period].
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