Rose H. Goldman

Sham device v inert pill: randomised controlled trial of two placebo treatments

Abstract Objective To investigate whether a sham device (a validated sham acupuncture needle) has a greater placebo effect than an inert pill in patients with persistent arm pain. Design A single blind randomised controlled trial created from the two week placebo run-in periods for two nested trials that compared acupuncture and amitriptyline with their respective placebo controls. Comparison of participants who remained on placebo continued beyond the run-in period to the end of the study. Setting Academic medical centre. Participants 270 adults with arm pain due to repetitive use that had lasted at least three months despite treatment and who scored ≥3 on a 10 point pain scale. Interventions Acupuncture with sham device twice a week for six weeks or placebo pill once a day for eight weeks. Main outcomemeasures Arm pain measured on a 10 point pain scale. Secondary outcomes were symptoms measured by the Levine symptom severity scale, function measured by Pranskys upper extremity function scale, and grip strength. Results Pain decreased during the two week placebo run-in period in both the sham device and placebo pill groups, but changes were not different between the groups (−0.14, 95% confidence interval −0.52 to 0.25, P = 0.49). Changes in severity scores for arm symptoms and grip strength were similar between groups, but arm function improved more in the placebo pill group (2.0, 0.06 to 3.92, P = 0.04). Longitudinal regression analyses that followed participants throughout the treatment period showed significantly greater downward slopes per week on the 10 point arm pain scale in the sham device group than in the placebo pill group (−0.33 (−0.40 to −0.26) v −0.15 (−0.21 to −0.09), P = 0.0001) and on the symptom severity scale (−0.07 (−0.09 to −0.05) v −0.05 (−0.06 to −0.03), P = 0.02). Differences were not significant, however, on the function scale or for grip strength. Reported adverse effects were different in the two groups. Conclusions The sham device had greater effects than the placebo pill on self reported pain and severity of symptoms over the entire course of treatment but not during the two week placebo run in. Placebo effects seem to be malleable and depend on the behaviours embedded in medical rituals.

Mercury exposure: current concepts, controversies, and a clinic's experience.

In the context of controversies surrounding fish consumption, amalgams, and commercial hair testing, we reviewed all cases from an occupational and environmental medicine clinic that had undergone mercury testing. Sixty-nine of 71 (97%) patients had no known mercury exposures other than diet or amalgams. Of these 69, 48 had blood mercury tested and 58 had urine testing. Regular-to-heavy fish consumption explained 10 of 11 cases with blood mercury concentrations >15 &mgr;g/L (19 to 53 &mgr;g/L). Six of these 10 individuals reported regular swordfish consumption. For the 31 patients with adequate dietary history, there was a significant relationship between fish consumption and blood mercury concentration (P < 0.001). Higher blood mercury concentrations were, however, not associated with specific patterns of health complaints. Ninety-eight percent (57 of 58) of urine values were <10 &mgr;g/L. Fourteen patients were evaluated because they were labeled as mercury toxic by other practitioners after unconventional commercial testing. Using standard tests of blood and urine, we could not document evidence of mercury toxicity in any of these 14 cases. We conclude that consumption of commercially available fish can lead to elevated blood mercury concentrations. A recognized exposure source is a better predictor of significant mercury concentrations in biologic media than any particular symptom constellation. Unconventional commercial panels that test hair or urine for multiple metals have questionable validity. Clinicians should use standard blood and urine tests to evaluate mercury exposure.

Taiwan food scandal: The illegal use of phthalates as a clouding agent and their contribution to maternal exposure

In 2011 the Taiwan Food and Drug Administration reported that plasticizers di(2-ethylhexyl) phthalate (DEHP) and di-iso-nonyl phthalate (DiNP), endocrine disruptors, were illegally added to clouding agents used in foods and beverages. 965 products were found contaminated, of which 206 were exported to 22 countries. This studys purpose was to obtain English names for 28 contaminated products for which DEHP levels were reported, calculate estimated average daily intake (mg/kg/day) for a 50 kg woman consuming one portion, and compare to U.S. and E.U. guidelines for daily intake. We found that drinking just one bottle (500 ml) of sports drinks would result in an average DEHP intake of 0.14 mg/kg bw/day (range 0.091-0.341), which exceeds by several fold government guidelines (0.02-0.06 mg/kg bw/day). One (2 g) serving from 4/14 samples of contaminated dietary supplements exceeds the guideline of 0.02 mg/kg bw/day. In conclusion, consuming even one portion of tainted drinks and some powders would lead to daily intake of DEHP that greatly exceeds established safety guidelines, raising concerns about potential adverse effects, particularly reproductive tract development in the male fetus. Global distribution of DEHP-contaminated and other adulterated products should prompt governments to become proactive in food safety regulations and chemical testing.

Lead Poisoning in Automobile Radiator Mechanics

Exposure to lead occurs during automobile radiator repair when soldered joints are heated, but this relatively common hazard has received little public recognition. We therefore studied lead exposure among automobile radiator mechanics in the Boston area. Twenty-seven shops were surveyed, and most were found to be small and poorly ventilated. Seventy-five workers were interviewed and tested for blood lead and free erythrocyte protoporphyrin levels. Fifty-six of the 75 actually repaired radiators, and they had a mean blood lead level of 37.1 micrograms per deciliter (range, 16 to 73). Thirty-nine percent of these mechanics had levels higher than 40 micrograms per deciliter; hematologic, neurologic, and renal effects are known to develop at or above this blood lead level. Multiple regression analysis showed that the number of radiator repair work stations (an index of exposure) was the variable most significantly associated with increased blood lead levels. We conclude that excessive exposure to lead occurs frequently among radiator repair workers and should be prevented by improved ventilation, engineering controls, and the use of respirators (if indicated) while working.

Sham acupuncture devices – practical advice for researchers

Several validated sham acupuncture devices have recently become available. While some debate exists on whether such needles are the best placebo control for an RCT of acupuncture, practical advice based on research experience is missing from the literature. This paper shares our concrete experience using the most commonly used such sham needle (the ‘Streitberger needle’ and its paired verum needle) in a large RCT (n=135) which included a two-week run-in period. The placebo run-in gave us an opportunity to use the sham device on all participants, who were then re-randomised to receive genuine acupuncture or to continue treatment with the device. The blinding was successful both at the end of the run-in and at the conclusion of the trial despite the re-randomisation. We also report our experience with the sham needle in neuroimaging experiments where the magnetic machinery poses considerable challenges for acupuncture research.

Acupuncture for Treatment of Persistent Arm Pain Due to Repetitive Use: A Randomized Controlled Clinical Trial

ObjectiveTo compare true and sham acupuncture in their abilities to relieve arm pain and improve arm function in individuals with arm pain due to repetitive use. MethodsParticipants with persistent arm pain (N=123) were randomly assigned to true or sham acupuncture groups and received 8 treatments over 4 weeks. The primary outcome was intensity of pain (10-point scale) and secondary outcomes were arm symptoms, arm function, and grip strength. Outcomes were measured during treatment (at 2 and 4 wk) and 1 month after treatment ended. ResultsArm pain scores improved in both groups during the treatment period, but improvements were significantly greater in the sham group than in the true acupuncture group. This difference disappeared by 1 month after treatment ended. The true acupuncture group experienced more side effects, predominately mild pain at time of treatments. DiscussionSham acupuncture reduced arm pain more than true acupuncture during treatment, but the difference did not persist after 1 month. Mild side effects from true acupuncture may have blunted any positive treatment effects. Overall, this study did not find evidence to support the effectiveness of true acupuncture in treatment of persistent arm pain due to repetitive use.

Injuries Caused by Hazardous Materials Accidents

STUDY OBJECTIVE To describe exposures that prehospital and ED personnel may encounter as a result of hazardous material incidents. METHODS Retrospective analysis of hazardous material incident reports from six district hazardous material teams in Massachusetts from their inception through May 1996. RESULTS The chemicals most frequently involved were various hydrocarbons and corrosive materials. Chlorine derivatives were involved in 18% of all incidents and 23% of all incidents resulting in victims. Victims were produced by 47 of 162 (29%) incidents. Respiratory exposures were the most frequent type of exposure and resulted in the largest number of victims transported to a hospital. Overall 24 of 26 (92%) incidents with chemical exposures resulted in symptomatic victims and 33 of 35 (94%) incidents produced victims requiring hospital transport. Respiratory symptoms were the most frequent, both in the number of incidents where they were observed and the total number of victims with symptoms. CONCLUSION Multiple victim transport to EDs from a single hazardous material incident is most likely to result from an inhalation exposure to a respiratory irritant. Information from descriptive studies should allow improved preparation for potential hazardous material victims.

Physiotherapy, Steroid Injections, or Rest for Lateral Epicondylosis? What the Evidence Suggests

Objective:  To identify effective lateral epicondylosis interventions and assess the quality of research over time.

Use of a job-exposure matrix to assess occupational exposures in relation to birth defects.

Accurate exposure assessment remains a challenge in occupational epidemiology. We evaluated one approach, use of a job-exposure matrix (JEM), by applying the National Institute for Occupational Safety and Health (NIOSH) JEM to a large case-control birth defects study that included parental occupation information. We investigated the JEM exposure predictions in several ways and found that for a substantial proportion of the parents in the birth defects study, the JEM yielded either no exposure data or nonsense predictions. Among exposure predictions that were plausible, most were of low probability. The high probability exposure predictions were statistically unstable, and neither low nor high probability exposure predictions were reliable. There was considerable discrepancy between the JEM predictions and expert assessments for five exposures of interest. Application of the NIOSH JEM to the birth defects study database (and probably other databases as well) does not provide a useful means of assessing occupational exposures.

The impact of psychological factors on placebo responses in a randomized controlled trial comparing sham device to dummy pill

OBJECTIVES To explore to what extent psychological factors such as expectation, depression, anxiety and belief in alternative medicine impact placebo response and differential responses to separate placebo interventions. METHODS We analysed data from a randomized controlled trial designed to compare the clinical response of two distinct placebo treatments (sham acupuncture device and placebo pill) in 119 participants with persistent distal upper arm pain due to repetitive stress injury. We used a multivariable linear regression model to identify potential correlates of self-reported upper extremity pain at the end of treatment in both placebo arms of the study combined. We also performed stratified analyses by placebo treatment. RESULTS We did not find any of the psychological factors of interest to be associated with pain at the end of treatment in our combined analysis. We found higher baseline pain score and pain for longer than 1 years duration to be significantly associated with higher pain scores at the end of treatment for the placebo treatments combined. In stratified analyses, for the sham acupuncture group, we found higher baseline depression score, higher baseline pain score and younger age to be independently correlated with higher pain score at the end of treatment. For the placebo pill group, only baseline pain was significantly correlated to pain score at the end of treatment. CONCLUSION In this trial, neither expectancy nor psychological states were associated with response to placebo, with the exception of baseline depression score for the sham acupuncture arm.