Maria Hondras

Systematic reviews of complementary therapies – an annotated bibliography. Part 3: Homeopathy

BackgroundComplementary therapies are widespread but controversial. We aim to provide a comprehensive collection and a summary of systematic reviews of clinical trials in three major complementary therapies (acupuncture, herbal medicine, homeopathy). This article is dealing with homeopathy. Potentially relevant reviews were searched through the register of the Cochrane Complementary Medicine Field, the Cochrane Library, Medline, and bibliographies of articles and books. To be included articles had to review prospective clinical trials of homeopathy; had to describe review methods explicitly; had to be published; and had to focus on treatment effects. Information on conditions, interventions, methods, results and conclusions was extracted using a pretested form and summarized descriptively.ResultsEighteen out of 22 potentially relevant reviews preselected in the screening process met the inclusion criteria. Six reviews addressed the question whether homeopathy is effective across conditions and interventions. The majority of available trials seem to report positive results but the evidence is not convincing. For isopathic nosodes for allergic conditions, oscillococcinum for influenza-like syndromes and galphimia for pollinosis the evidence is promising while in other areas reviewed the results are equivocal.InterpretationReviews on homeopathy often address general questions. While the evidence is promising for some topics the findings of the available reviews are unlikely to end the controversy on this therapy.

Systematic reviews of complementary therapies - an annotated bibliography. Part 1: acupuncture

BackgroundComplementary therapies are widespread but controversial. We aim to provide a comprehensive collection and a summary of systematic reviews of clinical trials in three major complementary therapies (acupuncture, herbal medicine, homeopathy). This article is dealing with acupuncture. Potentially relevant reviews were searched through the register of the Cochrane Complementary Medicine Field, the Cochrane Library, Medline, and bibliographies of articles and books. To be included articles had to review prospective clinical trials of acupuncture; had to describe review methods explicitly; had to be published; and had to focus on treatment effects. Information on conditions, interventions, methods, results and conclusions was extracted using a pretested form and summarized descriptively.ResultsFrom a total of 48 potentially relevant reviews preselected in a screeening process 39 met the inclusion criteria. 22 were on various pain syndromes or rheumatic diseases. Other topics addressed by more than one review were addiction, nausea, asthma and tinnitus. Almost unanimously the reviews state that acupuncture trials include too few patients. Often included trials are heterogeneous regarding patients, interventions and outcome measures, are considered to have insufficient quality and contradictory results. Convincing evidence is available only for postoperative nausea, for which acupuncture appears to be of benefit, and smoking cessation, where acupuncture is no more effective than sham acupuncture.ConclusionsA large number of systematic reviews on acupuncture exists. What is most obvious from these reviews is the need for (the funding of) well-designed, larger clinical trials.

A Randomized Controlled Trial Comparing 2 Types of Spinal Manipulation and Minimal Conservative Medical Care for Adults 55 Years and Older With Subacute or Chronic Low Back Pain

OBJECTIVE Chiropractic care is used by many older patients for low back pain (LBP), but there are no published results of randomized trials examining spinal manipulation (SM) for older adults. The purpose of this study was to compare the effects of 2 biomechanically distinct forms of SM and minimal conservative medical care (MCMC) for participants at least 55 years old with subacute or chronic nonradicular LBP. METHODS Randomized controlled trial. The primary outcome variable was low back-related disability assessed with the 24-item Roland Morris Disability questionnaire at 3, 6, 12, and 24 weeks. Participants were randomly allocated to 6 weeks of care including 12 visits of either high-velocity, low-amplitude (HVLA)-SM, low-velocity, variable-amplitude (LVVA)-SM, or 3 visits of MCMC. RESULTS Two hundred forty participants (105 women and 135 men) ages 63.1 +/- 6.7 years without significant comorbidities. Adjusted mean Roland Morris Disability change scores (95% confidence intervals) from baseline to the end of active care were 2.9 (2.2, 3.6) and 2.7 (2.0, 3.3) in the LVVA-SM and HVLA-SM groups, respectively, and 1.6 (0.5, 2.8) in the MCMC group. There were no significant differences between LVVA-SM and HVLA-SM at any of the end points. The LVVA-SM group had significant improvements in mean functional status ranging from 1.3 to 2.2 points over the MCMC group. There were no serious adverse events associated with any of the interventions. CONCLUSIONS Biomechanically distinct forms of SM did not lead to different outcomes in older LBP patients and both SM procedures were associated with small yet clinically important changes in functional status by the end of treatment for this relatively healthy older population. Participants who received either form of SM had improvements on average in functional status ranging from 1 to 2.2 over those who received MCMC. From an evidence-based care perspective, patient preference and clinical experience should drive how clinicians and patients make the SM procedure decision for this patient population.

Systematic reviews of complementary therapies - an annotated bibliography. Part 2: herbal medicine

BackgroundComplementary therapies are widespread but controversial. We aim to provide a comprehensive collection and a summary of systematic reviews of clinical trials in three major complementary therapies (acupuncture, herbal medicine, homeopathy). This article is dealing with herbal medicine. Potentially relevant reviews were searched through the register of the Cochrane Complementary Medicine Field, the Cochrane Library, Medline, and bibliographies of articles and books. To be included articles had to review prospective clinical trials of herbal medicines; had to describe review methods explicitly; had to be published; and had to focus on treatment effects. Information on conditions, interventions, methods, results and conclusions was extracted using a pre-tested form and summarized descriptively.ResultsFrom a total of 79 potentially relevant reviews pre-selected in the screening process 58 met the inclusion criteria. Thirty of the reports reviewed ginkgo (for dementia, intermittent claudication, tinnitus, and macular degeneration), hypericum (for depression) or garlic preparations (for cardiovascular risk factors and lower limb atherosclerosis). The quality of primary studies was criticized in the majority of the reviews. Most reviews judged the available evidence as promising but definitive conclusions were rarely possible.ConclusionsSystematic reviews are available on a broad range of herbal preparations prescribed for defined conditions. There is very little evidence on the effectiveness of herbalism as practised by specialist herbalists who combine herbs and use unconventional diagnosis.

Adding chiropractic manipulative therapy to standard medical care for patients with acute low back pain: results of a pragmatic randomized comparative effectiveness study.

Study Design. Randomized controlled trial. Objective. To assess changes in pain levels and physical functioning in response to standard medical care (SMC) versus SMC plus chiropractic manipulative therapy (CMT) for the treatment of low back pain (LBP) among 18 to 35-year-old active-duty military personnel. Summary of Background Data. LBP is common, costly, and a significant cause of long-term sick leave and work loss. Many different interventions are available, but there exists no consensus on the best approach. One intervention often used is manipulative therapy. Current evidence from randomized controlled trials demonstrates that manipulative therapy may be as effective as other conservative treatments of LBP, but its appropriate role in the healthcare delivery system has not been established. Methods. Prospective, 2-arm randomized controlled trial pilot study comparing SMC plus CMT with only SMC. The primary outcome measures were changes in back-related pain on the numerical rating scale and physical functioning at 4 weeks on the Roland-Morris Disability Questionnaire and back pain functional scale (BPFS). Results. Mean Roland-Morris Disability Questionnaire scores decreased in both groups during the course of the study, but adjusted mean scores were significantly better in the SMC plus CMT group than in the SMC group at both week 2 (P < 0.001) and week 4 (P = 0.004). Mean numerical rating scale pain scores were also significantly better in the group that received CMT. Adjusted mean back pain functional scale scores were significantly higher (improved) in the SMC plus CMT group than in the SMC group at both week 2 (P < 0.001) and week 4 (P = 0.004). Conclusion. The results of this trial suggest that CMT in conjunction with SMC offers a significant advantage for decreasing pain and improving physical functioning when compared with only standard care, for men and women between 18 and 35 years of age with acute LBP.

Consensus on Exercise Reporting Template (CERT): Modified Delphi Study.

Background Exercise interventions are often incompletely described in reports of clinical trials, hampering evaluation of results and replication and implementation into practice. Objective The aim of this study was to develop a standardized method for reporting exercise programs in clinical trials: the Consensus on Exercise Reporting Template (CERT). Design and Methods Using the EQUATOR Networks methodological framework, 137 exercise experts were invited to participate in a Delphi consensus study. A list of 41 items was identified from a meta-epidemiologic study of 73 systematic reviews of exercise. For each item, participants indicated agreement on an 11-point rating scale. Consensus for item inclusion was defined a priori as greater than 70% agreement of respondents rating an item 7 or above. Three sequential rounds of anonymous online questionnaires and a Delphi workshop were used. Results There were 57 (response rate=42%), 54 (response rate=95%), and 49 (response rate=91%) respondents to rounds 1 through 3, respectively, from 11 countries and a range of disciplines. In round 1, 2 items were excluded; 24 items reached consensus for inclusion (8 items accepted in original format), and 16 items were revised in response to participant suggestions. Of 14 items in round 2, 3 were excluded, 11 reached consensus for inclusion (4 items accepted in original format), and 7 were reworded. Sixteen items were included in round 3, and all items reached greater than 70% consensus for inclusion. Limitations The views of included Delphi panelists may differ from those of experts who declined participation and may not fully represent the views of all exercise experts. Conclusions The CERT, a 16-item checklist developed by an international panel of exercise experts, is designed to improve the reporting of exercise programs in all evaluative study designs and contains 7 categories: materials, provider, delivery, location, dosage, tailoring, and compliance. The CERT will encourage transparency, improve trial interpretation and replication, and facilitate implementation of effective exercise interventions into practice.

Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial

BackgroundLow back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults.Methods/designThis pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content analysis of clinical trial notes.DiscussionThis pragmatic, pilot randomized controlled trial uses a mixed method approach to evaluate the clinical effectiveness, feasibility, and participant and provider perceptions of collaborative care between medical doctors and doctors of chiropractic in the treatment of older adults with low back pain.Trial registrationThis trial registered in ClinicalTrials.gov on 04 March 2011 with the ID number of NCT01312233.

Perspectives of older adults on co-management of low back pain by doctors of chiropractic and family medicine physicians: a focus group study.

BackgroundWhile older adults may seek care for low back pain (LBP) from both medical doctors (MDs) and doctors of chiropractic (DCs), co-management between these providers is uncommon. The purposes of this study were to describe the preferences of older adults for LBP co-management by MDs and DCs and to identify their concerns for receiving care under such a treatment model.MethodsWe conducted 10 focus groups with 48 older adults who received LBP care in the past year. Interviews explored participants’ care seeking experiences, co-management preferences, and perceived challenges to successful implementation of a MD-DC co-management model. We analyzed the qualitative data using thematic content analysis.ResultsOlder adults considered LBP co-management by MDs and DCs a positive approach as the professions have complementary strengths. Participants wanted providers who worked in a co-management model to talk openly and honestly about LBP, offer clear and consistent recommendations about treatment, and provide individualized care. Facilitators of MD-DC co-management included collegial relationships between providers, arrangements between doctors to support interdisciplinary referral, computer systems that allowed exchange of health information between clinics, and practice settings where providers worked in one location. Perceived barriers to the co-management of LBP included the financial costs associated with receiving care from multiple providers concurrently, duplication of tests or imaging, scheduling and transportation problems, and potential side effects of medication and chiropractic care. A few participants expressed concern that some providers would not support a patient-preferred co-managed care model.ConclusionsOlder adults are interested in receiving LBP treatment co-managed by MDs and DCs. Older adults considered patient-centered communication, collegial interdisciplinary interactions between these providers, and administrative supports such as scheduling systems and health record sharing as key components for successful LBP co-management.

International web survey of chiropractic students about evidence-based practice: a pilot study

BackgroundPositive attitude toward evidence-based practice (EBP) principles in healthcare education may be one of the first steps for motivating a healthcare professional student to later apply EBP principles in clinical decision-making. The objectives for this project were to pilot an international web-based survey of chiropractic students and to describe student attitudes, behaviors, and knowledge about EBP principles.MethodsWe used SurveyMonkey™ to develop our survey based on an existing questionnaire used to measure basic knowledge, skills and beliefs about EBP among allied healthcare professionals and CAM practitioners. We invited 26 chiropractic educational institutions teaching in English and accredited by official organizations to participate. Academic officials and registrars at participating institutions forwarded an invitation email and two reminders to students between July and September 2010. The invitation contained a link to the 38-item web-based questionnaire. Descriptive statistics were performed for analysis.ResultsFourteen institutions from Australia, Canada, US, Denmark and New Zealand participated. Among an estimated 7,142 student recipients of invitation letters, 674 participated in the survey for an estimated response rate of 9.4%. Most respondents reported having access to medical/healthcare literature through the internet, but only 11% read literature every week and 21% did not read literature at all. Respondents generally agreed that the use of research evidence in chiropractic was important. Although 76% of respondents found it easy to understand research evidence and 81% had some level of confidence assessing the general worth of research articles, 71% felt they needed more training in EBP to be able to apply evidence in chiropractic care. Respondents without previous training in research methods had lower confidence in assessing published papers. While more than 60% marked the correct answer for two knowledge items, the mean number of correct answers to the five knowledge questions was 1.3 (SD 0.9).ConclusionsAlthough it is feasible to conduct an international web survey of chiropractic students, significant stakeholder participation is important to improve response rates. Students had relatively positive attitudes toward EBP. However, participants felt they needed more training in EBP and based on the knowledge questions they may need further training about basic research concepts.

A feasibility study assessing manual therapies to different regions of the spine for patients with subacute or chronic neck pain

OBJECTIVE The purpose of this project was to develop and test protocols for a randomized clinical trial of a combined therapeutic approach (thoracic spine and sacroiliac joint high-velocity, low-amplitude spinal manipulation [HVLA SM] + cervical spine postisometric relaxation) and cervical spine HVLA SM for patients with subacute or chronic neck pain. METHODS Patients were recruited in the Quad Cities in Iowa and Illinois. After a baseline assessment visit, eligible patients were randomly assigned to cervical spine HVLA SM or to the combined therapeutic approach for 4 treatment visits over 2 weeks. Outcome assessments included the Neck Disability Index, visual analog scale, and posttreatment response questionnaire. Patient outcomes were not aggregated or compared by treatment group. RESULTS It took approximately 8 months of planning, which included the development of forms and protocols, pretesting the forms, and training staff and clinicians in the standardized protocols. Twelve participants were screened, and 6 patients were enrolled and randomly allocated to care over a 6-week period. All patients completed 5 visits. Five of 6 patients had an improvement on the Neck Disability Index. On the visual analog scale, 2 patients improved at 2 weeks, whereas the other 4 got worse. Five patients completed the posttreatment response questionnaire; 2 of the 5 indicated they experienced discomfort or an unpleasant reaction from the study treatments. CONCLUSIONS Designing a successful feasibility randomized clinical trial requires considerable planning, development and pretesting of the forms and protocols, and training clinicians and staff for standardized protocols. Patients were willing to be randomized, follow treatment protocols, complete baseline and outcome assessments, and return 83% of the follow-up questionnaires.