Professional kinesiology practice for chronic low back pain: single-blind, randomised controlled pilot study.

BACKGROUND: Chronic low back pain is a highly prevalent condition with no definitive treatment. Professional Kinesiology Practice (PKP) is a little known complementary medicine technique using non-standard muscle testing; no previous effectiveness studies have been performed. METHODS: This is an exploratory, pragmatic single-blind, 3-arm randomised sham-controlled pilot study with waiting list control (WLC) in private practice UK (2007-2009). 70 participants scoring ≥4 on the Roland and Morris Disability Questionnaire (RMDQ) were randomised to real or sham PKP receiving 1 treatment weekly for 5 weeks or a WLC. WLC's were re-randomised to real or sham after 6 weeks. The main outcome was a change in RMDQ from baseline to end of 5 weeks of real or sham PKP. RESULTS: With an effect size of 0.7 real treatment was significantly different to sham (mean difference RMDQ score = -2.9, p = 0.04, 95% CI -5.8 to -0.1). Compared to WLC, real and sham groups had significant RMDQ improvements (real -9.0, p < 0.01, 95% CI -12.1 to -5.8; effect size 2.1; sham -6.1, p < 0.01, 95% CI -9.1 to -3.1; effect size 1.4). Practitioner empathy (CARE) and patient enablement (PEI) did not predict outcome; holistic health beliefs (CAMBI) did, though. The sham treatment appeared credible; patients did not guess treatment allocation. 3 patients reported minor adverse reactions. CONCLUSIONS: Real treatment was significantly different from sham demonstrating a moderate specific effect of PKP; both were better than WLC indicating a substantial non-specific and contextual treatment effect. A larger definitive study would be appropriate with nested qualitative work to help understand the mechanisms involved in PKP.

Complementary medicine use by men with prostate cancer: a systematic review of prevalence studies.

Men with prostate cancer are reported as commonly using complementary and alternative medicine (CAM) but surveys have not recently been subjected to a rigorous systematic review incorporating quality assessment. Six electronic databases were searched using pre-defined terms. Detailed information was extracted systematically from each relevant article. Study reporting quality was assessed using a quality assessment tool, which demonstrated acceptable inter-rater reliability and produces a percentage score. In all, 42 studies are reviewed. All were published in English between 1999 and 2009; 60% were conducted in the United States. The reporting quality was mixed (median score = 66%, range 23-94%). Significant heterogeneity precluded formal meta-analysis. In all, 39 studies covering 11,736 men reported overall prevalence of CAM use; this ranged from 8 to 90% (median=30%). In all, 10 studies reported prevalence of CAM use specifically for cancer care; this ranged from 8 to 50% (median = 30%). Some evidence suggested CAM use is more common in men with higher education/incomes and more severe disease. The prevalence of CAM use among men with prostate cancer varies greatly across studies. Future studies should use standardised and validated data collection techniques to reduce bias and enhance comparability.

Evaluating the efficacy of acupuncture in defined aspects of stroke recovery: a randomised, placebo controlled single blind study.

OBJECTIVE: To investigate the efficacy of acupuncture on stroke recovery compared to an inert placebo. DESIGN: Placebo-controlled, randomised, clinical trial. SETTING: Post-stroke rehabilitation wards in five NHS hospitals in the UK. SUBJECTS: Patients between 4 and 10 days after their first stroke. INTERVENTIONS AND OUTCOME MEASURES: The patients received 12 acupuncture or placebo treatments over four weeks. Acupuncture with electrical stimulation was compared with mock TENS, and assessments continued for 12 months after entry. Primary outcome was the Barthel Index (BI). Secondary outcomes were muscle power, Motricity Index (MI), mood, Nottingham Health Profile (NHP) and treatment credibility. RESULTS: 92 patients completed data sets. Data were analysed using both t tests and a structural equation based on longitudinal analysis of both BI and MI, using generalised estimating equations with an exchangeable correlation structure. While both acupuncture and placebo (mock TENS) appeared to have had an equal effect on stroke recovery, there is no significant difference between the two interventions at 12 (p = 0.737, 95 % CI -2.00 to 2.81) and 52 weeks (p = 0.371, 95 % CI -3.48 to 1.32). An apparently accelerated improvement in the MI scores in the acupuncture group at 3 weeks (p = 0.009, 95 % CI 1.55 to 10.77) is interesting. CONCLUSIONS: Acupuncture did not demonstrate specific efficacy over placebo and both groups did as well as normally expected with this condition.

Systematic review of the nutritional supplements dimethyl sulfoxide (DMSO) and methylsulfonylmethane (MSM) in the treatment of osteoarthritis.

OBJECTIVE: Conventional treatment of osteoarthritis (OA) with non-steroidal anti-inflammatory drugs is associated with serious gastrointestinal side effects and in view of the recent withdrawal of some cyclo-oxygenase-2 inhibitors, identifying safer alternative treatment options is needed. The objective of this systematic review is to evaluate the existing evidence from randomised controlled trials of two chemically related nutritional supplements, dimethyl sulfoxide (DMSO) and methylsulfonylmethane (MSM) in the treatment of OA to determine their efficacy and safety profile. METHODS: The electronic databases [Cochrane Library, Medline, Embase, Amed, Cinahl and NeLH (1950 to November 2007)] were searched. The search strategy combined terms: osteoarthritis, degenerative joint disorder, dimethyl sulfoxide, DMSO, methylsulfonylmethane, MSM, clinical trial; double-blind, single blind, RCT, placebo, randomized, comparative study, evaluation study, control. Inclusion and exclusion criteria were applied. Data were extracted and quality was assessed using the JADAD scale. RESULTS: Six studies were included [evaluating a total of 681 patients with OA of the knee for DMSO (N=297 on active treatment); 168 patients for MSM (N=52 on active treatment)]. Two of the four DMSO trials, and both MSM trials reported significant improvement in pain outcomes in the treatment group compared to comparator treatments, however, methodological issues and concerns over optimal dosage and treatment period, were highlighted. CONCLUSION: No definitive conclusion can currently be drawn for either supplement. The findings from all the DMSO studies need to be viewed with caution because of poor methodology including; possible unblinding, and questionable treatment duration and dose. The data from the more rigorous MSM trials provide positive but not definitive evidence that MSM is superior to placebo in the treatment of mild to moderate OA of the knee. Further studies are now required to identify both the optimum dosage and longer-term safety of MSM and DMSO, and definitive efficacy trials.

Systematic review of the nutritional supplement Perna Canaliculus (green-lipped mussel) in the treatment of osteoarthritis.

Complementary treatments for osteoarthritis (OA) are sought by patients for symptomatic relief and to avoid the iatrogenic effects of non-steroidal anti-inflammatories. This systematic review evaluates the efficacy of the nutritional supplement Perna Canaliculus (green-lipped mussel, GLM) in the treatment of OA and substantially adds to previous work by focussing solely on GLM use in OA as well providing a re-analysis of the original trial data. Randomized or quasi-randomized controlled trials (comparative, placebo-controlled or crossover) were considered for inclusion from Cochrane Library, Medline, Embase, Amed, Cinahl, Scopus and NeLH databases where adults with OA of any joint were randomized to receive either GLM vs. placebo, no additional intervention (usual care), or an active intervention. The methodological quality of the trials was assessed using the JADAD scale. Four RCTs were included, three placebo controlled, the fourth a comparative trial of GLM lipid extract vs. stabilized powder extract. No RCTs comparing GLM to conventional treatment were identified. All four studies assessed GLM as an adjunctive treatment to conventional medication for a clinically relevant time in mild to moderate OA. All trials reported clinical benefits in the GLM treatment group but the findings from two studies cannot be included in this review because of possible un-blinding and inappropriate statistical analysis. The data from the two more rigorous trials, in conjunction with our re-analysis of original data suggests that GLM may be superior to placebo for the treatment of mild to moderate OA. As a credible biological mechanism exists for this treatment, further rigorous investigations are required to assess efficacy and optimal dosage.

Determination of suitable sample sizes for multi-patient based finite element studies.

Finite element analysis is used extensively to assess joint replacements, but the majority of these are single sample studies. Recent investigations have suggested that such studies are unable to account for natural inter-patient variation in bone geometry and material property distribution. Recent developments in computer tomography based analyses make multiple sample studies possible; the question remains how many femurs are required to perform a study which accounts for such variations. This work investigates the factors that should be considered in answering this question. It explores sample sizing techniques when comparing strain distribution in the intact and implanted femur and when comparing two or more implant designs in a group of femurs. An example analysis of the effect of femoral head resurfacing was undertaken. Two sample sizing calculations were utilised, one based on achieving the desired precision in results, the other based on determining if a significant difference exists between two designs. The analysis shows that reasonable statistical precision can be achieved with a group of femurs. The study was also able to determine a suitable sample size for the analysis of a statistically significant difference between two groups of femurs with varying design parameters. The study concluded that while sample sizing is recommended for an accurate analysis, consideration must be made for the practicality of such a task.

Bromelain as an adjunctive treatment for moderate-to-severe osteoarthritis of the knee: a randomized placebo-controlled pilot study.

BACKGROUND: Osteoarthritis (OA) of the knee is the most prevalent joint disorder. Previous studies suggest that bromelain, a pineapple extract, may be a safer alternative/adjunctive treatment for knee OA than current conventional treatment. AIM: To assess the efficacy of bromelain in treating OA of the knee. DESIGN: Randomized, double-blind placebo-controlled trial. METHODS: Subjects (n = 47) with a confirmed diagnosis of moderate to severe knee OA were randomized to 12 weeks of bromelain 800 mg/day or placebo, with a 4-week follow-up. Knee (pain, stiffness and function) and quality-of-life symptoms were reported monthly in the WOMAC and SF36 questionnaires, respectively. Adverse events were also recorded. The primary outcome measure was the change in total WOMAC score from baseline to the end of treatment at week 12. Longitudinal models were used to evaluate outcome. RESULTS: Thirty-one patients completed the trial (14 bromelain, 17 placebo). No statistically significant differences were observed between groups for the primary outcome (coefficient 11.16, p = 0.27, 95%CI -8.86 to 31.18), nor the WOMAC subscales or SF36. Both treatment groups showed clinically relevant improvement in the WOMAC disability subscale only. Adverse events were generally mild in nature. DISCUSSION: This study suggests that bromelain is not efficacious as an adjunctive treatment of moderate to severe OA, but its limitations support the need for a follow-up study.

Corynebacterium striatum: an underappreciated community and nosocomial pathogen.

Corynebacterium striatum (CS) is an underappreciated human pathogen that has been associated with serious infections in both immunocompetent and immunocompromised hosts. CS infections tend to be more frequent in males and major infection sites have included blood stream, lung, and central nervous system. Most are nosocomially acquired and there is a significant association with medical devices ranging from intravascular catheters to central nervous system drainage devices. Empiric therapy with vancomycin is advisable as susceptibility to other agents is variable. Treatment may also include removal of foreign material such as an intravascular catheter. The present review describes the wide spectrum of infections associated with CS and we add a unique case of CS pancreatic abscess where treatment included linezolid.

How do homeopaths make decisions? An exploratory study of inter-rater reliability and intuition in the decision making process.

The validity of clinical decision making in homeopathy is largely unexplored and little is understood about the process or its reliability. This exploratory study investigated, in the context of a questionnaire based re-proving of Belladonna 30c, the extent to which decisions are based on clinical facts or intuition and how reliable decisions are. Three experienced, independent homeopathic clinicians/proving researchers rated the symptom diaries of the 206 subjects taking part. They reported their proving decision (ie positive proving response, no proving response or undecided) based on the total symptom profiles and rated (on a scale of 0-10) their use of clinical facts or intuition. Keynote symptoms and overall confidence scores were also reported. The level of agreement between raters was generally poor (weighted kappa 0.349-0.064). All raters used both facts and intuition. The rater's reliance on the facts was significantly associated with classifying those subjects who had no proving response [rater 1, P<0.001; rater 2, P<0.001]. Raters used significantly higher intuition scores when classifying a prover [rater 2, P= 0.001; rater 3, P= 0.012]. Issues regarding the education and practice of homeopathy are discussed.

Risperidone in chronic schizophrenia: a detailed audit, open switch study and two-year follow-up of patients on depot medication.

Little information exists on the medium- to long-term outcome of switching patients with schizophrenia from traditional depot to atypical oral antipsychotic agents. By detailed clinical audit, we identified a representative group of 102 patients of an Irish psychiatric service with DSM-IV chronic schizophrenia and on depot neuroleptics for a mean of 15 years. Of 69 eligible to participate, 33 entered a 6-month switch study of risperidone, with limited follow-up of consenters and non-consenters at 1 and 2 years. At 6 months, 23 of 33 were still on risperidone and had small significant improvements in clinical and extrapyramidal side effects, QOL and adjunct medication measures over baseline. At 12 months, 19 of 33 were still on risperidone, reducing to 13 of 33 at 2 years. At 2 years, of 32 surviving consenters to switch, 19 had suffered clinically detrimental events and were no longer on risperidone, compared to none of the 33 surviving non-consenters, who were all still on depot. These findings suggest that switching from depot to risperidone may encounter high rates of refusal and attrition subsequent to switch. While a majority of switched patients may improve to least 6 months, audit plus switch may have clinically unfavourable effects on others over a 2-year follow-up period [corrected].

Complementary cancer care in Southampton: a survey of staff and patients.

BACKGROUND: Complementary and alternative medicine (CAM) is used by one in ten of the UK population yearly and 47% during their lifetime. One-third of cancer patients seek some form of CAM treatment during their illness. AIM: To evaluate the use of and attitudes to CAM among patients and all healthcare staff in the Southampton Cancer Care Directorate (UK). SETTING: The Royal South Hants Hospital, Countess Mountbatten and Oakhaven Hospices. METHOD: A questionnaire-based survey performed between January 2001 and March 2001. RESULTS: Two hundred and seventy questionnaires were distributed to patients and 162 responses received. The distribution of cancers within this population was generally typical of those in the community. Thirty-two percent (n = 52) were receiving some form of CAM, half of those receiving CAM were in hospice care. Forty-nine percent of those not receiving CAM would like to, and 76% of all patients would be prepared to pay for this treatment. The five most popular treatments were massage, nutrition, aromatherapy, relaxation and reflexology. While most patients expected CAM to palliate their symptoms (n = 149, 92%), some had unrealistic expectations that CAM would cure their cancer (n = 13, 8%). Four hundred and forty-eight staff questionnaires were distributed and 196 responses were received: 148 (75.5%) from nurses. Twenty-one percent of staff responding had CAM training and two-thirds would like to receive training. The most popular therapies used by staff were the same as those identified by the patients. Ninety-nine percent of staff and 98.5% of patients wished to see CAM treatments introduced into service provision within the Cancer Care Directorate. CONCLUSIONS: The use of CAM for cancer care in Southampton is widespread and consistent with its use nationally. There is a clearly expressed need for CAM treatments by patients and a willingness to pay. Two-thirds of the cancer care staff responding wished to receive training in and provide these therapies. There are some misconceptions among patients about the role of CAM in cancer care which need to be discussed and resolved. We believe that all cancer care units should have clear policies on the use of CAM for cancer patients.

Chronic intermittent intravenous insulin therapy: a new frontier in diabetes therapy.

The limited success achieved in controlling diabetes and its complications with conventional insulin therapy suggests the need for reevaluation of the appropriateness of insulin administration protocols. Indeed, conventional subcutaneous insulin administration produces slowly changing blood insulin levels and suboptimal hepatocyte insulinization resulting in impaired hepatic capacity for processing incoming dietary glucose. The novel approach to insulin administration known as chronic intermittent intravenous insulin therapy (CIIIT) delivers insulin in a pulsatile fashion and achieves physiological insulin concentration in the portal vein. Done as a weekly outpatient procedure combined with daily intensive subcutaneous insulin therapy, this procedure has been shown to (1) significantly improve glycemic control while decreasing the incidence of hypoglycemic events, (2) improve hypertension control, (3) slow the progression of overt diabetic nephropathy, and (4) reverse some manifestations of diabetic autonomic neuropathy (e.g., abnormal circadian blood pressure pattern, severe postural hypotension, and hypoglycemia unawareness).

Is electrodermal testing as effective as skin prick tests for diagnosing allergies? A double blind, randomised block design study.

OBJECTIVE: To evaluate whether electrodermal testing for environmental allergies can distinguish between volunteers who had previously reacted positively on skin prick tests for allergy to house dust mite or cat dander and volunteers who had reacted negatively to both allergens. DESIGN: Double blind, randomised block design. SETTING: A general practice in southern England. PARTICIPANTS: 15 volunteers who had a positive result and 15 volunteers who had a negative result on a previous skin prick test for allergy to house dust mite or cat dander. INTERVENTION: Each participant was tested with 6 items by each of 3 operators of the Vegatest electrodermal testing device in 3 separate sessions (a total of 54 tests per participant). For each participant the 54 items comprised 18 samples each of house dust mite, cat dander, and distilled water, though these were randomly allocated among the operators in each session. A research nurse sat with the participant and operator in all sessions to ensure blinding and adherence to the protocol and to record the outcome of each test. OUTCOME: The presence or absence of an allergy according to the standard protocol for electrodermal testing. RESULTS: All the non-atopic participants completed all 3 testing sessions (810 individual tests); 774 (95.5%) of the individual tests conducted on the atopic participants complied with the testing protocol. The results of the electrodermal tests did not correlate with those of the skin prick tests. Electrodermal testing could not distinguish between atopic and non-atopic participants. No operator of the Vegatest device was better than any other, and no single participant's atopic status was consistently correctly diagnosed. CONCLUSION: Electrodermal testing cannot be used to diagnose environmental allergies.

A pilot project to assess the methodological issues involved in evaluating acupuncture as a treatment for disabling breathlessness.

OBJECTIVES: This pilot study explores the methodological implications of evaluating the use of acupuncture in the treatment of disabling breathlessness. DESIGN: A randomized, controlled trial involving three treatments that were used on one occasion, each in random order. SETTINGS: The study was designed to evaluate the feasibility of providing acupuncture treatment on a domiciliary basis, in Southampton (United Kingdom) to patients with disabling breathlessness. SUBJECTS: Sixteen (16) subjects with disabling breathlessness caused by chronic lung disease (primarily chronic obstructive pulmonary disease [COPD]) were recruited from the respiratory medicine clinics of Southampton University Hospitals Trust. INTERVENTIONS: The treatments were real acupuncture, dummy acupuncture, and mock transelectrical nerve stimulation (TENS). OUTCOMES: To evaluate the respiratory outcome measures, to look at the credibility of the three treatments (using a previously validated Borkovec and Nau scale), and to calculate the sample size for a larger, more definitive study. RESULTS: Twelve (12) subjects completed the study. The acupuncture was a predefined point prescription that had been found previously to be of value in this condition, an approach that could be taught to health professionals and provided on a domiciliary basis. The treatment was provided only on one occasion, therefore, we did not expect a clear therapeutic benefit to emerge, but some nonsignificant benefit was noted as a consequence of acupuncture treatment. The shuttle test that we used as an objective measure of breathlessness was impractical in a domiciliary environment and will not be used in further studies. Each of the three treatments was equally credible at the outset, although real and dummy acupuncture were considered by the patients to be preferable choices after the completion of treatment. CONCLUSIONS: It was possible to carry out this study on a domiciliary basis. The information obtained will allow us to design a much clearer definitive study and the small, but statistically insignificant, response to acupuncture has allowed us to estimate sample size.

Prevalence of osteoporosis in women: variation with skeletal site of measurement of bone mineral density.

OBJECTIVE: To determine retrospectively the prevalence of osteoporosis in a referral population of female patients and to compare the sensitivity for diagnosing osteoporosis by dual-energy x-ray absorptiometry (DXA) measurements of bone mineral density (BMD) at multiple skeletal sites. METHODS: We studied the data from 625 consecutive women (mean age, 57.3 +/- 13.9 years), who had been referred to our center for lumbar spine (anteroposterior [AP] and lateral region) and hip (femoral neck [FN], Ward's triangle [WT], trochanter, intertrochanteric region, and total hip) BMD measurements with use of DXA (Hologic QDR-2000) between June 1994 and July 1998. RESULTS: Osteoporosis (based on the World Health Organization definition--T-score of -2.5 or lower for BMD) was diagnosed by DXA at the following sites: AP spine in 21.7%, lateral spine in 43.2%, FN in 33.6%, WT in 49.1%, trochanter in 26.1%, intertrochanteric region in 25.9%, and total hip in 28.4% of study patients. Significant site differences were found in the prevalence of osteoporosis between the lateral and AP spine (P < 0.001), as well as between WT and the FN, trochanter, intertrochanteric region, and total hip (P < 0.001). In a subgroup of 71 women, forearm (ultradistal radius and radius 1/3 region) BMD results indicated low sensitivity for diagnosing osteoporosis, similar to that seen at the AP spine, trochanter, and intertrochanteric region. Not surprisingly, the prevalence of osteoporosis increased with advancing age (15.5% in patients younger than 50 years, in comparison with 59.6% in those older than 69 years of age). The frequency of misclassification of patients (osteoporosis at one site and normal BMD at another) with use of the seven measurement sites was 16.6% (104 of the 625 patients). CONCLUSIONS: For diagnosis of osteoporosis, DXA BMD measurements are significantly more sensitive at the lateral spine than at the AP spine, as well as at WT than at the FN, trochanter, intertrochanteric region, and total hip sites.

Construction of uniform-balanced cross-over designs for any odd number of treatments.

Cross-over designs balanced for simple carry-over effects are commonly applied in clinical studies for the comparison of treatments for chronic conditions such as hypertension or asthma. Uniform-balanced cross-over designs have the desirable property that the treatment sequences are arranged so that, in the full design, each treatment is followed by every other treatment equally often. Such designs for an even number of treatments and the same number of sequences and periods are readily constructed using suitable cyclic Latin squares. For an odd number of treatments, pairs of squares may be combined to give uniform-balanced designs. Recently, computer search techniques have been used to find nearly-balanced Latin squares which may be combined in pairs or in sets of three to produce designs with the overall properties of uniformity and balance. In this paper, simple generating formulae are described which will give, for any odd number of treatments t > 3, uniform-balanced cross-over designs with p = t periods and n = kt treatment sequences for any k > or = 2. Tables of cross-over designs obtained from these simple formulae are presented for t < or = 15.

Pathogenesis of fibrosing colonopathy: the role of methacrylic acid copolymer.

Fibrosing colonopathy is a serious bowel disorder which was first seen in 1991 in patients with cystic fibrosis treated with high doses of pancreatic enzyme supplements. Epidemiological evidence from two case-control studies, temporal data and direct experimental evidence support the conclusion that there is a causal relationship between the disease and intake of high doses of the excipient, methacrylic acid copolymer, which is used to coat certain brands of pancreatic enzyme. A high intake of lipase, the active ingredient in pancreatic enzymes, is not a risk factor for fibrosing colonopathy in the absence of methacrylic acid copolymer. Excipients may be toxic if used in new patient populations such as children and in doses exceeding the safe levels predicted by animal toxicology.