Effectiveness, safety and cost-effectiveness of sacral neuromodulation for idiopathic slow-transit constipation: a systematic review.

AIM: Sacral neuromodulation (SNM) is a minimally invasive treatment option for functional constipation. Evidence regarding its effectiveness is contradictory, driven by heterogeneous study populations and designs. The aim of this study was to assess the effectiveness, safety and cost-effectiveness of SNM in children and adults with refractory idiopathic slow-transit constipation (STC). METHOD: OVID Medline, OVID Embase, Cochrane Library, the KSR Evidence Database, the NHS Economic Evaluation Database and the International HTA Database were searched up to 25 May 2023. For effectiveness outcomes, randomized controlled trials (RCTs) were selected. For safety outcomes, all study designs were selected. For cost-effectiveness outcomes, trial- and model-based economic evaluations were selected for review. Study selection, risk of bias and quality assessment, and data extraction were independently performed by two reviewers. For the intervention 'sacral neuromodulation' effectiveness outcomes included defaecation frequency and constipation severity. Safety and cost-effectiveness outcomes were, respectively, adverse events and incremental cost-effectiveness ratios. RESULTS: Of 1390 records reviewed, 67 studies were selected for full-text screening. For effectiveness, one cross-over and one parallel-group RCT was included, showing contradictory results. Eleven studies on safety were included (four RCTs, three prospective cohort studies and four retrospective cohort studies). Overall infection rates varied between 0% and 22%, whereas reoperation rates varied between 0% and 29%. One trial-based economic evaluation was included, which concluded that SNM was not cost-effective compared with personalized conservative treatment at a time horizon of 6 months. The review findings are limited by the small number of available studies and the heterogeneity in terms of study populations, definitions of refractory idiopathic STC and study designs. CONCLUSION: Evidence for the (cost-)effectiveness of SNM in children and adults with refractory idiopathic STC is inconclusive. Reoperation rates of up to 29% were reported.

An overview of interventions for constipation in adults.

INTRODUCTION: The increasing global prevalence of the symptoms of constipation adversely affects the quality of life (QOL) of symptomatic patients. An acceptable universal definition of constipation does not exist and a detailed history taking form each patient with various complaints including stool consistency, sensing of incomplete evacuation or a manual need to assist evacuation is required. Complexity of obtaining etiologic diagnosis and the wide range of therapeutic options can mislead physicians in choosing correct treatment. AREAS COVERED: This review, considers the pathophysiology of constipation and the diagnostic approach to identify the etiology of constipation. Available interventions including non-pharmacological, pharmacological, and invasive methods such as acupuncture and surgical management are discussed. This review utilized on PubMed, Google Scholar, Scopus, and clinicaltrials.gov to search for studies and reviews published between 2000 and 2020. EXPERT COMMENTARY: Constipation necessitates careful considerations to detect the exact pathophysiology. Medical history, focused physical assessments, and selected diagnostic tests help choosing the right management. Non-pharmacological methods are beneficial in most of the cases. If a satisfactory response is not achieved, over the counter or prescribed medications are available. Options for patients who failed to respond to available medications are addressed in this review.

Home Biofeedback for the Treatment of Dyssynergic Defecation: Does It Improve Quality of Life and Is It Cost-Effective?

OBJECTIVES: Biofeedback therapy, whether administered at home or in office settings, is effective for dyssynergic defecation (DD). Whether home biofeedback improves quality of life (QOL) and is cost-effective when compared with office biofeedback is unknown. METHODS: QOL was assessed in 8 domains (SF-36) at baseline and after treatment (3 months), alongside economic evaluation during a randomized controlled trial (RCT) comparing home and office biofeedback in patients with DD (Rome III). Costs related to both biofeedback programs were estimated from the hospital financial records, study questionnaires, and electronic medical records. A conversion algorithm (Brazier) was used to calculate the patient's quality-adjusted life years (QALYs) from SF-36 responses. Cost-effectiveness was expressed as incremental costs per QALY between the treatment arms. RESULTS: One hundred patients (96 female patients, 50 in each treatment arm) with DD participated. Six of the 8 QOL domains improved (P < 0.05) in office biofeedback, whereas 4 of the 8 domains improved (P < 0.05) in home biofeedback; home biofeedback was noninferior to office biofeedback. The median cost per patient was significantly lower (P < 0.01) for home biofeedback ($1,112.39; interquartile range (IQR), $826-$1,430) than for office biofeedback ($1,943; IQR, $1,622-$2,369), resulting in a cost difference of $830.11 The median QALY gained during the trial was 0.03 for office biofeedback and 0.07 for home biofeedback (P = NS). The incremental cost-effectiveness ratio was $20,752.75 in favor of home biofeedback. DISCUSSION: Biofeedback therapy significantly improves QOL in patients with DD regardless of home or office setting. Home biofeedback is a cost-effective treatment option for DD compared with office biofeedback, and it offers the potential of treating many more patients in the community.

Evaluation and Comparison of Daiokanzoto and Lubiprostone for Constipation: A Retrospective Cohort Study.

Daiokanzoto (DKT) and lubiprostone (LPS) are drugs used for constipation, but few studies have compared them. This study examined the effectiveness, adverse events, and medical economic efficiency of DKT and LPS for constipation. Patients who received DKT (DKT group) and those who received LPS (LPS group) during admission to Ogaki Municipal Hospital between November 2012 and May 2016 were enrolled. Drug efficacy was evaluated based on the median value of bowel movement frequency over 1 week before and after drug administration, and their safety was evaluated by the presence or absence of diarrhea, abdominal pain, nausea, and vomiting. To assess medical economic efficiency, drug costs for constipation per week were calculated. The median values (quartile ranges) of bowel movement frequency at 1 week after drug administration were 8.5 (6.0-12.0) in the DKT group and 5 (3.0-7.0) in the LPS group, which was significantly different (p < 0.01). Diarrhea occurred significantly less often in the DKT group (4 cases) than in the LPS group (17 cases) (p < 0.01). The median cost of drugs administered for constipation for 1 week was significantly lower in the DKT group (631 [quartile range, 513-653] yen) than in the LPS group (1431 [1135-2344] yen) (p < 0.01). DKT had a higher immediate effect on constipation and was associated with more frequent bowel movement and fewer adverse events of diarrhea than LPS, suggesting that it may be effective and safe for treating constipation, and DKT is inexpensive.

Sacral neuromodulation versus personalized conservative treatment in patients with idiopathic slow-transit constipation: study protocol of the No.2-trial, a multicenter open-label randomized controlled trial and cost-effectiveness analysis.

PURPOSE: The evidence regarding the (cost-)effectiveness of sacral neuromodulation (SNM) in patients with therapy-resistant idiopathic slow-transit constipation is of suboptimal quality. The Dutch Ministry of Health, Welfare and Sports has granted conditional reimbursement for SNM treatment. The objective is to assess the effectiveness, cost-effectiveness, and budget impact of SNM compared to personalized conservative treatment (PCT) in patients with idiopathic slow-transit constipation refractory to conservative treatment. METHODS: This study is an open-label, multicenter randomized controlled trial. Patients aged 14 to 80 with slow-transit constipation, a defecation frequency (DF) < 3 per week and meeting at least one other Rome-IV criterion, are eligible. Patients with obstructed outlet, irritable bowel syndrome, bowel pathology, or rectal prolapse are excluded. Patients are randomized to SNM or PCT. The primary outcome is success at 6 months (DF ≥ 3 a week), requiring a sample size of 64 (α = 0.05, ß = 0.80, 30% difference in success). Secondary outcomes are straining, sense of incomplete evacuation, constipation severity, fatigue, constipation specific and generic quality of life, and costs at 6 months. Long-term costs and effectiveness will be estimated by a decision analytic model. The time frame is 57 months, starting October 2016. SNM treatment costs are funded by the Dutch conditional reimbursement program, research costs by Medtronic. CONCLUSIONS: The results of this trial will be used to make a final decision regarding reimbursement of SNM from the Dutch Health Care Package in this patient group. TRIAL REGISTRATION: This trial is registered at clinicaltrials.gov , identifier NCT02961582, on 12 October 2016.

Cost-effectiveness of sacral neuromodulation for chronic refractory constipation in children and adolescents: a Markov model analysis.

AIM: This study aimed to assess the cost-effectiveness of sacral neuromodulation (SNM) compared with conservative treatment in children and adolescents with constipation refractory to conservative management. METHOD: A Markov probabilistic model was used, comparing costs and effectiveness of SNM and conservative treatment in children and adolescents aged 10-18 years with constipation refractory to conservative management. Input for the model regarding transition probabilities, utilities and healthcare costs was based on data from a cohort of patients treated in our centre. This cohort consisted of 30 female patients (mean age 16 years) with functional constipation refractory to conservative management. The mean duration of laxative use in this group was 5.9 years. All patients had a test SNM, followed by a permanent SNM in 27/30. Median follow-up was 22.1 months (range 12.2-36.8). The model was run to simulate a follow-up period of 3 years. RESULTS: The mean cumulative costs for the SNM group and the conservative treatment group were €17 789 (SD €2492) and €7574 (SD €4332) per patient, respectively. The mean quality adjusted life years (QALYs) in the SNM group was 1.74 (SD 0.19), compared with 0.86 (SD 0.14) in the conservatively managed group. The mean incremental cost-effectiveness ratio was €12 328 per QALY (SD €4788). Sensitivity analysis showed that the outcomes were robust to a wide range of model assumptions. CONCLUSION: Chronic constipation seriously affects the quality of life of children and adolescents. Preliminary evidence suggests that SNM can improve symptoms and quality of life at a reasonable cost.

Complementary and alternative medicine use for constipation: a critical review focusing upon prevalence, type, cost, and users' profile, perception and motivations.

OBJECTIVES: Complementary and alternative medicine (CAM) is increasingly used by those suffering from constipation. This paper reports the first critical integrative review of CAM use for people with constipation focusing upon the prevalence, type and cost of CAM use, as well as CAM users' profile, perception and motivations. METHODS: A comprehensive search of international literature was conducted in MEDLINE, Academic Search Complete (EBSCO), and Allied and Complementary Medicine Database (AMED). The search was limited to original research peer-reviewed English language articles concerning CAM use for constipation published with an abstract and full text between 2005 and 2015. RESULTS: A total of 35 papers met the inclusion criteria and were included in the review. The review shows approximately one in every three people suffering from constipation use CAM with herbal medicine the most commonly used CAM treatment for constipation and a large proportion of CAM use occurring concurrent with or in addition to conventional medical treatments. While early investigation suggests the cost of herbal medicine use in constipation care may be lower than that associated with the use other CAM modalities and conventional medications, this issue requires further research. CONCLUSIONS: Although a high percentage of people with constipation using CAM consider these treatments effective, there remains a need for further in-depth examination of both patient and provider perspectives as well as communication and decision-making around CAM use for constipation to inform safe, effective and coordinated care for patients with constipation.

In-hospital costs associated with chronic constipation in Belgium: a retrospective database study.

BACKGROUND: Real-life data on the economic burden of chronic idiopathic constipation are scarce. The objectives of this study were to assess hospitalization resource use and costs associated with chronic constipation and its complications in Belgium. METHODS: This was a single country, retrospective study using the IMS Hospital Disease Database (2008), which comprises data on 34% of acute hospital beds in Belgium and contains information on patient demographics, length of stay (LOS), billed costs, drug use, diagnoses, and procedures. Stays with a primary diagnosis of constipation, or a secondary diagnosis of constipation and a concomitant diagnosis of a constipation-related complication, were selected. Patients with diagnoses of colorectal cancer, ulcerative colitis or Crohn's disease, or who had stays involving potentially constipation-inducing procedures, were excluded as having secondary constipation. Patients receiving opioids, calcium-antagonists, antipsychotics or antidepressants were excluded as having drug-induced constipation. KEY RESULTS: In total, 1541 eligible patients were identified. The average unadjusted cost per day in hospital for idiopathic constipation was €441 (€311 ± 1.4 in day clinic visits without overnight stays; €711 ± 14.0 in full hospitalizations with complications). The average LOS in a full hospitalization setting was 7.0 and 4.0 days in stays with and without complications, respectively. The most frequent drug and procedural treatments were osmotically acting laxatives (with complications: 42.61%; without complications: 35.69%), and transanal enema (2.32% and 2.03%), respectively. CONCLUSIONS & INFERENCES: The burden of constipation is often underestimated; it is a condition reflected by hospital-related costs comparable to such indications as migraine, which increase when associated with complications.

Abdominal massage in the management of chronic constipation for children with disability.

A service development initiative was conducted to assess the impact of abdominal massage on chronic constipation in children with physical disabilities and learning needs. Twenty-five parents engaged in an abdominal massage training programme led by a specialist health visiting team (children's disability). Participants were asked to carry out abdominal massage for a total of 20 minutes per day. Quality of life indicators, descriptions of bowel movements, use of laxative medication and contact with health care services were recorded by parents. Costs and professional contact time with families was calculated. Results reported a wide range of quality of Life improvements including relief in symptoms of constipation (87.5%), reduction in laxative medication (58%) and improved dietary intake (41%). Qualitative data indicated positive experiences described by parents which included enhanced parent-child relationships.

Abdominal massage for people with constipation: a cost utility analysis.

AIM: This paper is a report of a study conducted to evaluate change in health-related quality of life for people with constipation receiving abdominal massage and to estimate the cost-effectiveness of two alternative scenarios developed from the original trial. BACKGROUND: Constipation is a common problem and is associated with decrease in quality of life. Abdominal massage appears to decrease the severity of gastrointestinal symptoms, but its impact on health-related quality of life has not been assessed. METHODS: A randomized controlled trial including 60 participants was conducted in Sweden between 2005 and 2007. The control group continued using laxatives as before and the intervention group received additional abdominal massage. Health-related quality of life was assessed using the EQ-5D and analyzed with linear regression. Two scenarios were outlined to conduct a cost utility analysis. In the self-massage scenario patients learned to give self-massage, and in the professional massage scenario patients in hospital received abdominal massage from an Enrolled Nurse. RESULTS: Linear regression analysis showed that health-related quality of life was statistically significantly increased after 8 weeks of abdominal massage. About 40% were estimated to receive good effect. For 'self-massage', the cost per quality adjusted life year was euro75,000 for the first 16 weeks. For every additional week of abdominal massage, the average dropped and eventually approached euro8300. For 'professional massage', the cost per quality adjusted life year was euro60,000 and eventually dropped to euro28,000. CONCLUSION: Abdominal massage may be cost-effective in the long-term and it is relevant to consider it when managing constipation. A crucial aspect will be to identify those who will benefit.

Complementary and alternative medicine use and cost in functional bowel disorders: a six month prospective study in a large HMO.

BACKGROUND: Functional Bowel Disorders (FBD) are chronic disorders that are difficult to treat and manage. Many patients and doctors are dissatisfied with the level of improvement in symptoms that can be achieved with standard medical care which may lead them to seek alternatives for care. There are currently no data on the types of Complementary and Alternative Medicine (CAM) used for FBDs other than Irritable Bowel Syndrome (IBS), or on the economic costs of CAM treatments. The aim of this study is to determine prevalence, types and costs of CAM in IBS, functional diarrhea, functional constipation, and functional abdominal pain. METHODS: 1012 Patients with FBD were recruited through a health care maintenance organization and followed for 6 months. Questionnaires were used to ascertain: Utilization and expenditures on CAM, symptom severity (IBS-SS), quality of life (IBS-QoL), psychological distress (BSI) and perceived treatment effectiveness. Costs for conventional medical care were extracted from administrative claims. RESULTS: CAM was used by 35% of patients, at a median yearly cost of $200. The most common CAM types were ginger, massage therapy and yoga. CAM use was associated with female gender, higher education, and anxiety. Satisfaction with physician care and perceived effectiveness of prescription medication were not associated with CAM use. Physician referral to a CAM provider was uncommon but the majority of patients receiving this recommendation followed their physician's advice. CONCLUSION: CAM is used by one-third of FBD patients. CAM use does not seem to be driven by dissatisfaction with conventional care. Physicians should discuss CAM use and effectiveness with their patients and refer patients if appropriate.

Management of constipation in residents with dementia: sorbitol effectiveness and cost.

OBJECTIVE: The objective of this report is to describe a cost-effective strategy for management of constipation in nursing home residents with dementia. DESIGN: We conducted a prospective observational quality improvement study of 41 residents with chronic constipation and receiving an osmotic laxative. Sorbitol was substituted for lactulose. SETTING: The study was conducted at a dementia special care unit at a Veterans Administration hospital. MEASUREMENT: We measured the number and amount of laxative use over a period of 4 weeks that were required to maintain regular bowel function. RESULTS: There was no difference in efficacy of lactulose and sorbitol. Use of additional laxatives was infrequent: Milk of Magnesia on approximately 10% of days/patient, bisacodyl suppository on 2% to 4% of days/patient, and Fleet enema only on 3 occasions. The cost of constipation management using routine administration of sorbitol and as-needed use of other laxatives was 27% to 55% lower than the cost of other constipation management strategies reported in the literature. CONCLUSION: Substitution of sorbitol for lactulose does not change efficacy of the treatment and decreases cost. Regular use of an osmotic laxative avoids the costs and discomforts of rectal laxatives.

Epidemiology of constipation in elderly patients. Drug utilisation and cost-containment strategies.

Constipation is a common complaint among elderly people, resulting in large amounts of money being spent on laxatives. Strategies for improving patient care while reducing this expenditure include: (a) counselling patients that daily bowel movements and purging are not essential to good health, (b) greater use of nonpharmacological measures such as hydration, exercise and dietary fibre, and (c) considering safety, effectiveness and cost in the selection of a laxative. Generic preparations of psyllium and sorbitol can be recommended in this regard. The widespread use of stool softeners, magnesium hydroxide ('milk of magnesia') and stimulant laxatives is difficult to justify from the available data.

Chronic constipation in long stay elderly patients: a comparison of lactulose and a senna-fibre combination.

OBJECTIVES: To compare the efficacy and cost effectiveness of a senna-fibre combination and lactulose in treating constipation in long stay elderly patients. DESIGN: Randomised, double blind, cross over study. SETTING: Four hospitals in Northern Ireland, one hospital in England, and two nursing homes in England. SUBJECTS: 77 elderly patients with a history of chronic constipation in long term hospital or nursing home care. INTERVENTION: A senna-fibre combination (10 ml daily) or lactulose (15 ml twice daily) with matching placebo for two 14 day periods, with 3-5 days before and between treatments. MAIN OUTCOME MEASURES: Stool frequency, stool consistency, and ease of evacuation; deviation from recommended dose; daily dose and cost per stool; adverse effects. RESULTS: Mean daily bowel frequency was greater with the senna-fibre combination (0.8, 95% confidence interval 0.7 to 0.9) than lactulose (0.6, 0.5 to 0.7; t = 3.51 p < or = 0.001). Scores for stool consistency and ease of evacuation were significantly higher for the senna-fibre combination than for lactulose. The recommended dose was exceeded more frequently with lactulose than the senna-fibre combination (chi 2 = 8.38, p or = 0.01). As an index of the standard daily dose, the dose per stool was 1.52 for lactulose and 0.97 for the senna-fibre combination, at a cost per stool of 39.7p for lactulose and 10.3p for senna-fibre. Adverse effects were no different for the two treatments. CONCLUSIONS: Both treatments were effective and well tolerated for chronic constipation in long stay elderly patients. The senna-fibre combination was significantly more effective than lactulose at a lower cost.