Cost-effectiveness of acupuncture for irritable bowel syndrome: findings from an economic evaluation conducted alongside a pragmatic randomised controlled trial in primary care.

BACKGROUND: There is insufficient evidence to determine whether acupuncture is a cost-effective treatment for irritable bowel syndrome. The objective of this study is to assess the cost-effectiveness of acupuncture as an adjunct to usual care versus usual care alone for the treatment of Irritable Bowel Syndrome (IBS). METHODS: Cost-utility analysis conducted alongside a pragmatic, multicentre, randomised controlled trial. 233 patients with irritable bowel syndrome were randomly allocated to either acupuncture plus usual care, or usual care alone. Cost-effectiveness outcomes are expressed in terms of incremental cost per quality adjusted life year (QALY) at one year after randomisation. Costs were estimated from the UK National Health Service perspective for a time horizon of one year. Cost-utility ratios were estimated based on complete case analysis for the base case analysis, where only patients with available EQ-5D and cost data were included. Sensitivity analyses comprised a multiple imputation approach for missing data and a subgroup analysis for the more severe cases of IBS. RESULTS: The base case analysis showed acupuncture to be marginally more effective than usual care (gain of 0.0035 QALYs, 95% CI: -0.00395 to 0.0465) and more expensive (incremental cost of £218 per patient (95% CI: 55.87 to 492.87) resulting in an incremental cost-effectiveness ratio of approximately £62,500. Sensitivity analysis using multiple imputation for missing data resulted in acupuncture appearing less effective and more costly than usual care, so usual care is dominant. Subgroup analysis selecting the most severe cases of IBS (Symptom Severity Score of over 300) suggested that acupuncture may be a cost-effective treatment option for this group, with a cost-per-QALY of £6,500. CONCLUSIONS: Acupuncture as an adjunct to usual care is not a cost-effective option for the whole IBS population; however it may be cost-effective for those with more severe irritable bowel syndrome. TRIAL REGISTRATION: Current Controlled Trials ISRCTN08827905.

Acupuncture for irritable bowel syndrome: primary care based pragmatic randomised controlled trial.

BACKGROUND: Acupuncture is used by patients as a treatment for irritable bowel syndrome (IBS) but the evidence on effectiveness is limited. The purpose of the study was to evaluate the effectiveness of acupuncture for irritable bowel syndrome in primary care when provided as an adjunct to usual care. DESIGN: A two-arm pragmatic randomised controlled trial. SETTING: Primary care in the United Kingdom. PATIENTS: 233 patients had irritable bowel syndrome with average duration of 13 years and score of at least 100 on the IBS Symptom Severity Score (SSS). INTERVENTIONS: 116 patients were offered 10 weekly individualised acupuncture sessions plus usual care, 117 patients continued with usual care alone. MEASUREMENTS: Primary outcome was the IBS SSS at three months, with outcome data collected every three months to 12 months. RESULTS: There was a statistically significant difference between groups at three months favouring acupuncture with a reduction in IBS Symptom Severity Score of -27.43 (95% CI: -48.66 to -6.21, p=0.012). The number needed to treat for successful treatment (≥50 point reduction in the IBS SSS) was six (95% CI: 3 to 17), based on 49% success in the acupuncture group vs. 31% in the control group, a difference between groups of 18% (95% CI: 6% to 31%). This benefit largely persisted at 6, 9 and 12 months. CONCLUSIONS: Acupuncture for irritable bowel syndrome provided an additional benefit over usual care alone. The magnitude of the effect was sustained over the longer term. Acupuncture should be considered as a treatment option to be offered in primary care alongside other evidenced based treatments. TRIAL REGISTRATION: Current Controlled Trials ISRCTN08827905.

Acupuncture for irritable bowel syndrome: diagnosis and treatment of patients in a pragmatic trial.

OBJECTIVE: The aim of this study was to evaluate the treatments delivered during a pragmatic effectiveness study of acupuncture for irritable bowel syndrome (IBS) and to explore the roles of Traditional Chinese Medicine (TCM) diagnoses and preferences of the acupuncturists in treatment design. METHODS: Patients allocated to an acupuncture arm of a study were offered up to ten sessions of acupuncture over 3 months. Acupuncturists followed a flexible treatment protocol that allowed for treatment individualization, use of additional therapies such as moxa, and provision of lifestyle advice. All treatments were recorded in logbooks and analyzed by content analysis. RESULTS: Seven primary and eight secondary TCM patterns were identified among the 113 patients with IBS, and were combined in various ways to produce unique diagnoses for 84% patients. Liver Qi Stagnation and Damp Heat were the most commonly reported patterns. Of the 126 acupuncture points used, a distinct core and supporting group of points was associated with each primary pattern. Each practitioner also utilized a distinct core and supporting group of points that reflected his/her preferences. Use of additional therapies (e.g., moxa) and provision of lifestyle advice (e.g., diet) were generally consistent with a particular practitioner. CONCLUSIONS: Data suggest that a patient's TCM diagnosis, the practitioner's preferences, and a patient's individual characteristics beyond his/her diagnosis influence treatment delivery. In particular, TCM diagnoses appear to influence the acupuncture (i.e., point selection) aspect of treatment more than the selection of additional therapies and lifestyle advice. From another perspective, the treatments incorporated pragmatic, individualized, and disease-specific approaches with combinations that produced both treatment commonalities and diversities.

Database recruitment: a solution to poor recruitment in randomized trials?

BACKGROUND: Achieving sample size is imperative to obtaining sufficient power to detect potential effects in health care research, yet many research studies are prone to under-recruitment. Not only does this create problems with power but also it contributes to research extensions, additional costs and delayed results. To combat this problem, one increasingly used technique is database recruitment, a method of searching the electronic medical records system for potential research participants. OBJECTIVE: We discuss the advantages and disadvantages of identifying potential research participants using database recruitment with particular reference to primary care. CONCLUSION: Database recruitment is a relatively simple and affordable means to recruit large numbers of patients in a timely manner; however, it is not without limitations.