Prolotherapy injections and physiotherapy used singly and in combination for lateral epicondylalgia: a single-blinded randomised clinical trial.

BACKGROUND: Lateral epicondylalgia (tennis elbow) is a common, debilitating and often treatment-resistant condition. Two treatments thought to address the pathology of lateral epicondylalgia are hypertonic glucose plus lignocaine injections (prolotherapy) and a physiotherapist guided manual therapy/exercise program (physiotherapy). This trial aimed to compare the short- and long-term clinical effectiveness, cost effectiveness, and safety of prolotherapy used singly and in combination with physiotherapy. METHODS: Using a single-blinded randomised clinical trial design, 120 participants with lateral epicondylalgia of at least 6 weeks' duration were randomly assigned to prolotherapy (4 sessions, monthly intervals), physiotherapy (weekly for 4 sessions) or combined (prolotherapy+physiotherapy). The Patient-Rated Tennis Elbow Evaluation (PRTEE) and participant global impression of change scores were assessed by blinded evaluators at baseline, 6, 12, 26 and 52 weeks. Success rate was defined as the percentage of participants indicating elbow condition was either 'much improved' or 'completely recovered.' Analysis was by intention-to-treat. RESULTS: Eighty-eight percent completed the 12-month assessment. At 52 weeks, there were substantial, significant improvements compared with baseline status for all outcomes and groups, but no significant differences between groups. The physiotherapy group exhibited greater reductions in PRTEE at 12 weeks than the prolotherapy group (p = 0.014). CONCLUSION: There were no significant differences amongst the Physiotherapy, Prolotherapy and Combined groups in PRTEE and global impression of change measures over the course of the 12-month trial. TRIAL REGISTRATION: ACTRN12612000993897 .

Management of Whiplash Associated Disorders in Australian general practice.

BACKGROUND: Whiplash Associated Disorders (WAD) are common and costly, and are usually managed initially by general practitioners (GPs). How GPs manage WAD is largely unstudied, though there are clinical guidelines. Our aim was to ascertain the rate of management (percentage of encounters) of WAD among patients attending Australian general practice, and to review management of these problems, including imaging, medications and other treatments. METHODS: We analysed data from 2013 to 2016 collected by different random samples of approximately 1000 general practitioners (GPs) per year. Each GP collected data about 100 consecutive consultations for BEACH (Bettering the Evaluation and Care of Health), an Australian national study of general practice encounters. Main outcome measures were: the proportion of encounters involving management of WAD; management including imaging, medications and other treatments given; appropriateness of treatment assessed against published clinical guidelines. RESULTS: Of 291,100 encounters from 2919 GP participants (a nationally representative sample), WAD were managed at 137 encounters by 124 GPs (0.047%). Management rates were 0.050% (females) and 0.043% (males). For 63 new cases (46%), 19 imaging tests were ordered, most commonly neck/cervical spine x-ray (52.6% of tests for new cases), and neck/cervical spine CT scan (31.6%). One or more medications were prescribed/supplied for 53.3% of WAD. NSAIDs (11.7 per 100 WAD problems) and compound analgesics containing paracetamol and opioids (10.2 per 100 WAD problems) were the commonest medications used by GPs overall. Paracetamol alone was used in 8 per 100 WAD problems. The most frequent clinical/procedural treatments for WAD were physical medicine/rehabilitation (16.1 per 100 WAD problems), counselling (6.6), and general advice/education (5.8). CONCLUSIONS: GPs refer about 30% of new cases for imaging (possibly overutilising imaging), and prescribe a range of drugs, approximately 22% of which are outside clinical guidelines. These findings suggest a need for further education of GPs, including indications for imaging after whiplash injury, identification of those more likely to develop chronic WAD, and medication management guidelines. WAD carry a large personal and economic burden, so the impact of improvements in GP management is potentially significant.

Psychological interventions for symptomatic management of non-specific chest pain in patients with normal coronary anatomy.

BACKGROUND: Recurrent chest pain in the absence of coronary artery disease is a common problem which sometimes leads to excess use of medical care. Although many studies have examined the causes of pain in these patients, few clinical trials have evaluated treatment. This is an update of a Cochrane review originally published in 2005 and last updated in 2010. The studies reviewed in this paper provide an insight into the effectiveness of psychological interventions for this group of patients. OBJECTIVES: To assess the effects of psychological interventions for chest pain, quality of life and psychological parameters in people with non-specific chest pain. SEARCH METHODS: We searched the Cochrane Library (CENTRAL, Issue 4 of 12, 2014 and DARE Issue 2 of 4, 2014), MEDLINE (OVID, 1966 to April week 4 2014), EMBASE (OVID, 1980 to week 18 2014), CINAHL (EBSCO, 1982 to April 2014), PsycINFO (OVID, 1887 to April week 5 2014) and BIOSIS Previews (Web of Knowledge, 1969 to 2 May 2014). We also searched citation lists and contacted study authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) with standardised outcome methodology that tested any form of psychotherapy for chest pain with normal anatomy. Diagnoses included non-specific chest pain (NSCP), atypical chest pain, syndrome X or chest pain with normal coronary anatomy (as either inpatients or outpatients). DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion, extracted data and assessed quality of studies. We contacted trial authors for further information about the included RCTs. MAIN RESULTS: We included two new papers, one of which was an update of a previously included study. Therefore, a total of 17 RCTs with 1006 randomised participants met the inclusion criteria, with the one new study contributing an additional 113 participants. There was a significant reduction in reports of chest pain in the first three months following the intervention: random-effects relative risk = 0.70 (95% CI 0.53 to 0.92). This was maintained from three to nine months afterwards: relative risk 0.59 (95% CI 0.45 to 0.76). There was also a significant increase in the number of chest pain-free days up to three months following the intervention: mean difference (MD) 3.00 (95% CI 0.23 to 5.77). This was associated with reduced chest pain frequency (random-effects MD -2.26, 95% CI -4.41 to -0.12) but there was no evidence of effect of treatment on chest pain frequency from three to twelve months (random-effects MD -0.81, 95% CI -2.35 to 0.74). There was no effect on severity (random-effects MD -4.64 (95% CI -12.18 to 2.89) up to three months after the intervention. Due to the nature of the main interventions of interest, it was impossible to blind the therapists as to whether the participant was in the intervention or control arm. In addition, in three studies the blinding of participants was expressly forbidden by the local ethics committee because of issues in obtaining fully informed consent . For this reason, all studies had a high risk of performance bias. In addition, three studies were thought to have a high risk of outcome bias. In general, there was a low risk of bias in the other domains. However, there was high heterogeneity and caution is required in interpreting these results. The wide variability in secondary outcome measures made it difficult to integrate findings from studies. AUTHORS' CONCLUSIONS: This Cochrane review suggests a modest to moderate benefit for psychological interventions, particularly those using a cognitive-behavioural framework, which was largely restricted to the first three months after the intervention. Hypnotherapy is also a possible alternative. However, these conclusions are limited by high heterogeneity in many of the results and low numbers of participants in individual studies. The evidence for other brief interventions was less clear. Further RCTs of psychological interventions for NSCP with follow-up periods of at least 12 months are needed.

The challenges and opportunities in medical education for digital 'natives' and 'immigrants' in Scotland and abroad.

Although the digital revolution only started towards the end of the twentieth century, it has already dramatically shifted our world away from traditional industries and ushered in a new age of information. Virtually every aspect of our modern lives has either been transformed or challenged, including medical education. This article describes three of the important factors that are causing seismic changes in medical education in Scotland and abroad. The first is the new generation of 'digital natives' that are arriving in medical schools. In response, faculty members have had to become 'digital immigrants' and adapt their pedagogies. Second, the rise of social media has allowed the creation of virtual learning environments and communities that augment but also compete with traditional brick-and-mortar institutions. Finally, an ever-increasing range of e-learning resources promise freely accessible and up-to-date evidence, but their sheer volume and lack of standardisation will require careful curation.

Best practice care for acute low back pain: A new clinical standard to assist general practitioners.

BACKGROUND: Low back pain is one of the most common presentations in general practice. Although there is excellent evidence regarding best management of the condition, in primary care there is often overuse of less effective and expensive options, whereas effective, inexpensive options are underused. After broad consultation and evidence review, the Australian Commission on Safety and Quality in Health Care has developed a clinical care standard in response to this identified gap between best and actual practice. A clinical care standard focuses only on key areas of care where the need for quality improvement is greatest. OBJECTIVE: We explore the new standard using a typical patient scenario in primary care to highlight evidence-based approaches for challenging aspects of management, such as imaging and pain management. DISCUSSION: General practitioners (GPs) might find the practical GP 'quick guide' resource from the standard useful to support their care of patients with low back pain.

Using aggregated single patient (N-of-1) trials to determine the effectiveness of psychostimulants to reduce fatigue in advanced cancer patients: a rationale and protocol.

BACKGROUND: It is estimated that 29% of deaths in Australia are caused by malignant disease each year and can be expected to increase with population ageing. In advanced cancer, the prevalence of fatigue is high at 70-90%, and can be related to the disease and/or the treatment. The negative impact of fatigue on function (physical, mental, social and spiritual) and quality of life is substantial for many palliative patients as well as their families/carers. METHOD/DESIGN: This paper describes the design of single patient trials (n-of-1 s or SPTs) of a psychostimulant, methylphenidate hydrochloride (MPH) (5 mg bd), compared to placebo as a treatment for fatigue, with a population estimate of the benefit by the aggregation of multiple SPTs. Forty patients who have advanced cancer will be enrolled through specialist palliative care services in Australia. Patients will complete up to 3 cycles of treatment. Each cycle is 6 days long and has 3 days treatment and 3 days placebo. The order of treatment and placebo is randomly allocated for each cycle. The primary outcome is a reduction in fatigue severity as measured by the Functional Assessment of Cancer Therapy-fatigue subscale (FACIT-F). Secondary outcomes include adverse events, quality of life, additional fatigue assessments, depression and Australian Karnovsky Performance Scale. DISCUSSION: This study will provide high-level evidence using a novel methodological approach about the effectiveness of psychostimulants for cancer-related fatigue. If effective, the findings will guide clinical practice in reducing this prevalent condition to improve function and quality of life. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12609000794202.

Psychological interventions for symptomatic management of non-specific chest pain in patients with normal coronary anatomy.

BACKGROUND: Recurrent chest pain in the absence of coronary artery disease is a common problem that sometimes leads to excess use of medical care. Although many studies examine the causes of pain in these patients, few clinical trials have evaluated treatment. The studies reviewed in this paper provide an insight into the effectiveness of psychological interventions for this group of patients. OBJECTIVES: To update the previously published systematic review. SEARCH METHODS: We searched the Cochrane LIbrary (CENTRAL and DARE) (Issue 3 of 4 2011), MEDLINE (1966 to August Week 5, 2011), CINAHL (1982 to Sept 2011) EMBASE (1980 to Week 35 2011), PsycINFO (1887 to Sept Week 1, 2011), and Biological Abstracts (January 1980 to Sept 2011). We also searched citation lists and approached authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) with standardised outcome methodology that tested any form of psychotherapy for chest pain with normal anatomy. Diagnoses included non-specific chest pain (NSCP), atypical chest pain, syndrome X, or chest pain with normal coronary anatomy (as either inpatients or outpatients). DATA COLLECTION AND ANALYSIS: Two authors independently selected studies for inclusion, extracted data and assessed quality of studies. The authors contacted trial authors for further information about the RCTs included. MAIN RESULTS: Six new RCTs were located and added to the existing trials, therefore, a total of 15 RCTs (803 participants) were included. There was a significant reduction in reports of chest pain in the first three months following the intervention; fixed-effect relative risk = 0.68 (95% CI 0.57 to 0.81). This was maintained from three to nine months afterwards; relative risk = 0.59 (95% CI 0.45 to 0.76). There was also a significant increase in the number of chest pain free days up to three months following the intervention; mean difference = 2.81 (95% CI 1.28 to 4.34). This was associated with reduced chest pain frequency (random-effects mean difference = -2.26 95% CI -4.41 to -0.12) but there was no evidence of effect of treatment on chest pain frequency from three to twelve months (random-effects mean difference -0.81 95% CI -2.35, 0.74). There was no effect on severity (random-effects mean difference = -4.64 (95% CI -12.18 to 2.89) up to three months after the intervention. Overall there was generally a low risk of bias, however, there was high heterogeneity and caution is required in interpreting these results. Wide variability in outcome measures made integration of studies for secondary outcome measures difficult to report on. AUTHORS' CONCLUSIONS: This review suggests a modest to moderate benefit for psychological interventions, particularly those using a cognitive-behavioural framework, which was largely restricted to the first three months after the intervention. Hypnotherapy is also a possible alternative. The evidence for brief interventions was less clear. Further RCTs of psychological interventions for NSCP with follow-up periods of at least 12 months are needed.

Key findings on ECGs - level of agreement between GPs and cardiologists.

BACKGROUND: Previous research has demonstrated accuracies of 70% for the detection of electrocardiogram (ECG) abnormalities by general practitioners. This study aimed to retrospectively assess the level of agreement between GPs and cardiologists of key findings on ECGs. METHODS: A retrospective study of all patient referrals from GPs sent to a cardiology clinic at a medium sized public hospital over a 3 year period. The ECG diagnosis of the GP and the interpretive function of the ECG was compared with the ECG diagnosis of the cardiologist. Results A total of 2143 referrals were received from 292 GPs from 111 different practices. The level of agreement between the GPs and the cardiologists key findings was 58.9%. In comparison, the level of agreement between the key findings of the interpretive function on the GPs' ECG machines and of the cardiologists was 44.4%. DISCUSSION: The GPs' ability to accurately diagnose key findings on the ECG was modest, however, the GPs' ability to appropriately refer based on clinical presentation was exceptional. Based on our findings, the interpretive function on ECG machines should be viewed with extreme caution, particularly when using this to diagnose key findings.

Predictive ability of a modified Örebro Musculoskeletal Pain Questionnaire in an acute/subacute low back pain working population.

The original 'Örebro Musculoskeletal Pain Questionnaire' (original-ÖMPQ) has been shown to have limitations in practicality, factor structure, face and content validity. This study addressed these concerns by modifying its content producing the 'Örebro Musculoskeletal Screening Questionnaire' (ÖMSQ). The ÖMSQ and original-ÖMPQ were tested concurrently in acute/subacute low back pain working populations (pilot n = 44, main n = 106). The ÖMSQ showed improved face and content validity, which broadened potential application, and improved practicality with two-thirds less missing responses. High reliability (0.975, p < 0.05, ICC: 2.1), criterion validity (Spearman's r = 0.97) and internal consistency (α = 0.84) were achieved, as were predictive ability cut-off scores from ROC curves (112-120 ÖMSQ-points), statistically different ÖMSQ scores (p < 0.001) for each outcome trait, and a strong correlation with recovery time (Spearman's, r = 0.71). The six-component factor structure reflected the constructs originally proposed. The ÖMSQ can be substituted for the original-ÖMPQ in this population. Further research will assess its applicability in broader populations.

Prolotherapy injections and eccentric loading exercises for painful Achilles tendinosis: a randomised trial.

OBJECTIVE: To compare the effectiveness and cost-effectiveness of eccentric loading exercises (ELE) with prolotherapy injections used singly and in combination for painful Achilles tendinosis. DESIGN: A single-blinded randomised clinical trial. The primary outcome measure was the VISA-A questionnaire with a minimum clinically important change (MCIC) of 20 points. SETTING: Five Australian primary care centres. PARTICIPANTS: 43 patients with painful mid-portion Achilles tendinosis commenced and 40 completed treatment protocols. INTERVENTIONS: Participants were randomised to a 12-week program of ELE (n=15), or prolotherapy injections of hypertonic glucose with lignocaine alongside the affected tendon (n=14) or combined treatment (n=14). MAIN OUTCOME MEASUREMENTS: VISA-A, pain, stiffness and limitation of activity scores; treatment costs. RESULTS: At 12 months, proportions achieving the MCIC for VISA-A were 73% for ELE, 79% for prolotherapy and 86% for combined treatment. Mean (95% CI) increases in VISA-A scores at 12 months were 23.7 (15.6 to 31.9) for ELE, 27.5 (12.8 to 42.2) for prolotherapy and 41.1 (29.3 to 52.9) for combined treatment. At 6 weeks and 12 months, these increases were significantly less for ELE than for combined treatment. Compared with ELE, reductions in stiffness and limitation of activity occurred earlier with prolotherapy and reductions in pain, stiffness and limitation of activity occurred earlier with combined treatment. Combined treatment had the lowest incremental cost per additional responder ($A1539) compared with ELE. CONCLUSIONS: For Achilles tendinosis, prolotherapy and particularly ELE combined with prolotherapy give more rapid improvements in symptoms than ELE alone but long-term VISA-A scores are similar. TRIAL REGISTRATION NUMBER: ACTRN: 12606000179538.

Moving with the times - familiarity versus formality in Australian general practice.

BACKGROUND: Forms of address between patients and general practitioners is an underexplored area which may influence productive dialogue within a consultation. This article aims to describe how Australian patients prefer to be addressed by their GP, how patients prefer to address their GP, and the factors influencing these preferences. METHODS: Twenty consecutive patients of 13 randomly selected GPs (n=260) were surveyed on preferences for use of names in consultations and the factors influencing these preferences. RESULTS: Ninety percent of patients prefer to be addressed by their first name. Thirty-five percent of patients prefer to call the GP by first name, 27% by title and last name, 21% by title only, and 10% by title and first name. A range of influencing factors was identified. DISCUSSION: These findings allow GPs to feel confident in addressing their patients informally. They indicate the diversity of patient preferences for addressing their GP and the factors influencing these choices.

Childhood obesity: how do Australian general practitioners feel about managing this growing health problem?

General practitioners (GPs) are ideally placed to identify and treat childhood obesity, but its prevalence continues to rise and evidence for effective GP interventions is lacking. Further analysis of the barriers to effective identification and management of childhood obesity is warranted. This survey aimed to explore how Queensland GPs feel about managing the growing problem of childhood obesity. A cross-sectional survey was sent to a random sample of 573 Queensland GPs about perceptions of diagnosis and management of childhood obesity. A total of 30% of GPs responded (n=170). The main perceived obstacles to identification of childhood obesity were uncertainty about definition criteria and how to calculate body mass index, and lack of access to body mass index percentile charts. The main perceived obstacles in managing childhood obesity were lack of financial incentive, time constraints, lack of health system support and parental resistance. Only 22% of respondents indicated awareness of the National Health and Medical Research Council guidelines for management of obese children and 92% had never used any formal clinical guidelines in assessment or management of childhood obesity. Addressing these barriers to identification of childhood obesity by GPs may facilitate more effective management. Strategies include greater emphasis on this issue in general practice training, financial incentives for diagnosis and management, incorporating clinical management guidelines into medical software, and increasing allied and community health support.

Using N-of-1 trials to improve patient management and save costs.

BACKGROUND: N-of-1 trials test treatment effectiveness within an individual patient. OBJECTIVE: To assess (i) the impact of three different N-of-1 trials on both clinical and economic outcomes over 12 months and (ii) whether the use of N-of-1 trials to target patients' access to high-cost drugs might be cost-effective in Australia. DESIGN: Descriptive study of management change, persistence, and costs summarizing three N-of-1 trials. PARTICIPANTS: Volunteer patients with osteoarthritis, chronic neuropathic pain or ADHD whose optimal choice of treatment was uncertain. INTERVENTIONS: Double-blind cyclical alternative medications for the three conditions. MEASURES: Detailed resource use, treatment and health outcomes (response) data collected by postal and telephone surveys immediately before and after the trial and at 3, 6 and 12 months. Estimated costs to the Australian healthcare system for the pre-trial vs. 12 months post-trial. RESULTS: Participants persisting with the joint patient-doctor decision 12 months after trial completion were 32% for osteoarthritis, 45% for chronic neuropathic pain and 70% for the ADHD trials. Cost-offsets were obtained from reduced usage of non-optimal drugs, and reduced medical consultations. Drug costs increased for the chronic neuropathic pain and ADHD trials due to many patients being on either low-cost or no pharmaceuticals before the trial. CONCLUSIONS: N-of-1 trials are an effective method to identify optimal treatment in patients in whom disease management is uncertain. Using this evidence-based approach, patients and doctors tend to persist with optimal treatment resulting in cost-savings. N-of-1 trials are clinically acceptable and may be an effective way of rationally prescribing some expensive long-term medicines.

Psychological interventions for symptomatic management of non-specific chest pain in patients with normal coronary anatomy.

BACKGROUND: Recurrent chest pain in the absence of coronary artery disease is a common problem that sometimes leads to excess use of medical care. Although many studies examine the causes of pain in these patients, few clinical trials have evaluated treatment. The studies reviewed in this paper provide an insight into the effectiveness of psychological interventions for this group of patients. OBJECTIVES: To investigate psychological treatments for non-specific chest pain (NSCP) with normal coronary anatomy. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2008, Issue 4), MEDLINE (1966 to December 2008), CINAHL (1982 to December 2008) EMBASE (1980 to December 2008), PsycINFO (1887 to December 2008), the Database of Abstracts of Reviews of Effectiveness (DARE) and Biological Abstracts (January 1980 to December 2008). We also searched citation lists and approached authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) with standardised outcome methodology that tested any form of psychotherapy for chest pain with normal anatomy. Diagnoses included non-specific chest pain, atypical chest pain, syndrome X, or chest pain with normal coronary anatomy (as either inpatients or outpatients). DATA COLLECTION AND ANALYSIS: Two authors independently selected studies for inclusion, extracted data and assessed quality of studies. The authors contacted trial authors for further information about the RCTs included. MAIN RESULTS: Ten RCTs (484 participants) were included. There was a significant reduction in reports of chest pain in the first three months following the intervention; fixed effects relative risk = 0.68 (95% CI 0.57 to 0.81). This was maintained from 3 to 9 months afterwards; relative risk = 0.59 (95% CI 0.45 to 0.76). There was also a significant increase in the number of chest pain free days up to three months following the intervention; mean difference = 2.81 (95% CI 1.28 to 4.34). This was associated with reduced chest pain frequency (mean difference = -1.73 (95% CI -2.21 to -1.26)) and severity (mean difference = -6.86 (95% CI -10.74 to -2.97)). However, there was high heterogeneity and caution is required in interpreting these results. Wide variability in outcome measures made integration of studies for secondary outcome measures difficult to report on. AUTHORS' CONCLUSIONS: This review suggests a modest to moderate benefit for psychological interventions, particularly those using a cognitive-behavioural framework, which was largely restricted to the first three months after the intervention. Hypnotherapy is also a possible alternative. The evidence for brief interventions was less clear. Further RCTs of psychological interventions for NSCP with follow-up periods of at least 12 months are needed.

Stakeholders' views on the routine use of n-of-1 trials to improve clinical care and to make resource allocation decisions for drug use.

N-of-1 trials are empirical formal tests using a within-patient randomised, double-blind, cross-over comparison of drug and placebo (or another drug), which we adapted to study individual patients' responses as a clinical tool to guide clinical management. We administered semi-structured interviews to gauge stakeholder perspectives on the possibility of using routine n-of-1 trials for this purpose. Stakeholders included government and non-government health care sector, and patient, clinician and consumer, organisations. Stakeholders supported more widespread implementation of n-of-1 trials, in a targeted fashion, with some caveats. Barriers to their widespread implementation included constraints on doctors' time, doctors' acceptance, drug company acceptance, patient willingness, and cost. Strategies for overcoming barriers included conditional Pharmaceutical Benefits Scheme listing if cost-effective. There was little consensus on which model of n-of-1 trial implementation would be most effective. We discuss different approaches to addressing the several concerns raised to enable widespread introduction of n-of-1 trials into routine clinical practice as a decision tool.

N-of-1 randomized trials to assess the efficacy of gabapentin for chronic neuropathic pain.

OBJECTIVE: The objective of this study was to compare the efficacy of gabapentin with placebo for neuropathic pain at the individual and population levels. DESIGN: This study used an n-of-1 trial methodology with three double-blind, randomized, crossover comparisons of gabapentin with placebo. SETTING: This study was carried out at specialist outpatient clinics at two Australian hospitals. Patients. The patients are adults with chronic neuropathic pain. INTERVENTIONS: Following a dose-finding period, participants underwent three comparisons of 2-week periods on gabapentin (600-1,800 mg per day) and placebo. The dose-finding period was commenced by 112 patients, of whom 39 had no response so they did not enroll, leaving 73 trial participants. Of these, 48 completed and 7 partially completed their trials, and 18 withdrew. OUTCOME MEASURES: The five outcome measures were the visual analog scale (0-10) of pain, sleep interference and functional limitation; frequency of adverse events and medication preference. The aggregate response was determined by weighting the response to each measure equally. RESULTS: Of the 55 participants who completed at least one cycle, the aggregate response to gabapentin was better than placebo in 16 (29%), of whom 15 continued gabapentin posttrial. No difference was shown in 38 (69%), and 1 (2%) showed a better response to placebo. Fifteen of these 39 continued gabapentin posttrial. Meta-analysis of the mean scores showed lower mean (standard deviation) scores for gabapentin by 0.8 (0.2) for pain, 0.6 (0.2) for sleep interference, and 0.6 (0.2) for functional limitation. CONCLUSIONS: The response rate and mean reduction in symptoms with gabapentin were small. Gabapentin prescribing posttrial was significantly influenced by the trial results.