Nancy Carnide, Sheilah Hogg-Johnson, Mieke Koehoorn, Andrea D Furlan1, Pierre Côté
Institute for Work and Health,
Toronto, Ontario, Canada.
OBJECTIVES: To examine and compare whether dispensing of prescription opioids, non-steroidal anti-inflammatory drugs (NSAIDs) and skeletal muscle relaxants (SMRs) within 8 weeks after a work-related low back pain (LBP) injury is associated with work disability.
METHODS: A historical cohort study of 55 571 workers’ compensation claimants with LBP claims in British Columbia from 1998 to 2009 was conducted using linked compensation, dispensing and healthcare data. Four exposures were constructed to estimate the effect on receipt of benefits and days on benefits 1 year after injury: drug class(es) dispensed, days’ supply, strength of opioids dispensed and average daily morphine-equivalent dose.
RESULTS: Compared with claimants receiving NSAIDs and/or SMRs, the incidence rate ratio (IRR) of days on benefits was 1.09 (95% CI 1.04 to 1.14) for claimants dispensed opioids only and 1.26 (95% CI 1.22 to 1.30) for claimants dispensed opioids with NSAIDs and/or SMRs. Compared with weak opioids only, the IRR for claimants dispensed strong opioids only or strong and weak opioids combined was 1.21 (95% CI 1.12 to 1.30) and 1.29 (95% CI 1.20 to 1.39), respectively. The incident rate of days on benefits associated with each 7-day increase in days supplied of opioids, NSAIDs and SMRs was 10%, 4% and 3%, respectively. Similar results were seen for receipt of benefits, though effect sizes were larger.
Health Economics and Economic Evaluation Research Group,
Medical Management Centre,
BACKGROUND: Chiropractic care is a common but not often investigated treatment option for back pain in Sweden. The aim of this study was to explore patient-reported outcomes (PRO) for patients with back pain seeking chiropractic care in Sweden.
METHODS: Prospective observational study. Patients 18 years and older, with non-specific back pain of any duration, seeking care at 23 chiropractic clinics throughout Sweden were invited to answer PRO questionnaires at baseline with the main follow-up after four weeks targeting the following outcomes: Numerical Rating Scale for back pain intensity (NRS), Oswestry Disability Index for back pain disability (ODI), health-related quality of life (EQ-5D index) and a visual analogue scale for self-rated health (EQ VAS).
RESULTS: 246 back pain patients answered baseline questionnaires and 138 (56%) completed follow-up after four weeks. Statistically significant improvements over the four weeks were reported for all PRO by acute back pain patients (n = 81), mean change scores: NRS -2.98 (p < 0.001), ODI -13.58 (p < 0.001), EQ VAS 9.63 (p < 0.001), EQ-5D index 0.22 (p < 0.001); and for three out of four PRO for patients with chronic back pain (n = 57), mean change scores: NRS -0.90 (p = 0.002), ODI -2.88 (p = 0.010), EQ VAS 3.77 (p = 0.164), EQ-5D index 0.04 (p = 0.022).
Harvard Medical School,
Boston, Massachusetts, USA.
In alternative medicine, the main question regarding placebo has been whether a given therapy has more than a placebo effect. Just as mainstream medicine ignores the clinical significance of its own placebo effect, the placebo effect of unconventional medicine is disregarded except for polemics.
This essay looks at the placebo effect of alternative medicine as a distinct entity. This is done by reviewing current knowledge about the placebo effect and how it may pertain to alternative medicine. The term placebo effect is taken to mean not only the narrow effect of a dummy intervention but also the broad array of nonspecific effects in the patient-physician relationship, including attention; compassionate care; and the modulation of expectations, anxiety, and self-awareness.
Five components of the placebo effect — patient, practitioner, patient-practitioner interaction, nature of the illness, and treatment and setting — are examined. Therapeutic patterns that heighten placebo effects are especially prominent in unconventional healing, and it seems possible that the unique drama of this realm may have “enhanced” placebo effects in particular conditions. Ultimately, only prospective trials directly comparing the placebo effects of unconventional and mainstream medicine can provide reliable evidence to support such claims.
Nonetheless, the possibility of enhanced placebo effects raises complex conundrums. Can an alternative ritual with only nonspecific psychosocial effects have more positive health outcomes than a proven, specific conventional treatment? What makes therapy legitimate, positive clinical outcomes or culturally acceptable methods of attainment? Who decides?
Craig Schulz, Roni Evans, Michele Maiers, Karen Schulz, Brent Leininger and Gert Bronfort
University of Minnesota,
Mayo Building C504,
420 Delaware Street SE,
Minneapolis, MN 55455, USA
Background Low back pain (LBP) is a common disabling condition in older adults which often limits physical function and diminishes quality of life. Two clinical trials in older adults have shown spinal manipulative therapy (SMT) results in similar or small improvements relative to medical care; however, the effectiveness of adding SMT or rehabilitative exercise to home exercise is unclear.
Methods We conducted a randomized clinical trial assessing the comparative effectiveness of adding SMT or supervised rehabilitative exercise to home exercise in adults 65 or older with sub-acute or chronic LBP. Treatments were provided over 12–weeks and self-report outcomes were collected at 4, 12, 26, and 52 weeks. The primary outcome was pain severity. Secondary outcomes included back disability, health status, medication use, satisfaction with care, and global improvement. Linear mixed models were used to analyze outcomes. The primary analysis included longitudinal outcomes in the short (week 4–12) and long-term (week 4–52). An omnibus test assessing differences across all groups over the year was used to control for multiplicity. Secondary analyses included outcomes at each time point and responder analyses. This study was funded by the US Department of Health and Human Services, Health Resources and Services Administration.
Results 241 participants were randomized and 230 (95%) provided complete primary outcome data. The primary analysis showed group differences in pain over the one-year were small and not statistically significant. Pain severity was reduced by 30 to 40% after treatment in all 3 groups with the largest difference (eight percentage points) favoring SMT and home exercise over home exercise alone. Group differences at other time points ranged from 0 to 6 percentage points with no consistent pattern favoring one treatment. One-year post-treatment pain reductions diminished in all three groups. Secondary self-report outcomes followed a similar pattern with no important group differences, except satisfaction with care, where the two combination groups were consistently superior to home exercise alone.
University of Turin Medical School,
I have been fascinated with placebo-controlled trials since the 90s. In those days, virtually all the placebo-controlled manipulative trials claimed that SMT was *no better than placebo*. And in those days, medicine looked down their long noses, considering placebo as worthless, a mild side-effect of trickery and quackery.
“A patient finally went to a chiropractor for her back pain after finding no relief with the orthopedist. After three adjustments and a week of no symptoms, she had a follow-up visit with her M.D.
Upon learning about the success of the D.C., the orthopedist stated, “That was just the placebo effect.”
The patient responded, “If it works so well, why didn’t you use it?”
–– Attributed to Robert Mootz, D.C.
Finally, I got around to copying several of those early SMT/placebo studies, and was pleasantly shocked to discover that, compared to pre-study findings, BOTH groups improved significantly. This did NOT mean SMT didn’t help patients, it just means that it didn’t help them MORE than the pacebo did. It also strongly suggested that the plazcebo(s) were probably NOT inert.
At any rate, now you know why I started collecrting articles on placebo, and they eventually coalesced (2002) into our topical Problem with Placebos/Shams Page. This is how many of our other topical pages evolved from their humble beginnings.
Clinical trials use placebos with the assumption that they are inert, thus all placebos are considered to be equal. Here we show that this assumption is wrong and that different placebo procedures are associated to different therapeutic rituals which, in turn, trigger different mechanisms and produce different therapeutic outcomes. We studied high altitude, or hypobaric hypoxia, headache, in which two different placebos were administered. The first was placebo oxygen inhaled through a mask, whereas the second was placebo aspirin swallowed with a pill.