Sarah Brien

Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled clinical trial

OBJECTIVES To assess whether any benefits from adjunctive homeopathic intervention in patients with RA are due to the homeopathic consultation, homeopathic remedies or both. METHODS Exploratory double-blind, randomized placebo-controlled trial conducted from January 2008 to July 2008, in patients with active stable RA receiving conventional therapy. Eighty-three participants from three secondary care UK outpatient clinics were randomized to 24 weeks of treatment with either homeopathic consultation (further randomized to individualized homeopathy, complex homeopathy or placebo) or non-homeopathic consultation (further randomized to complex homeopathy or placebo). Co-primary outcomes: ACR 20% improvement (ACR20) criteria and patient monthly global assessment (GA). SECONDARY OUTCOMES 28-joint DAS (DAS-28), tender and swollen joint count, disease severity, pain, weekly patient and physician GA and pain, and inflammatory markers. RESULTS Fifty-six completed treatment phase. No significant differences were observed for either primary outcome. There was no clear effect due to remedy type. Receiving a homeopathic consultation significantly improved DAS-28 [mean difference 0.623; 95% CI 0.1860, 1.060; P = 0.005; effect size (ES) 0.70], swollen joint count (mean difference 3.04; 95% CI 1.055, 5.030; P = 0.003; ES 0.83), current pain (mean difference 9.12; 95% CI 0.521, 17.718; P = 0.038; ES 0.48), weekly pain (mean difference 6.017; 95% CI 0.140, 11.894; P = 0.045; ES 0.30), weekly patient GA (mean difference 6.260; 95% CI 0.411, 12.169; P = 0.036; ES 0.31) and negative mood (mean difference - 4.497; 95% CI -8.071, -0.923; P = 0.015; ES 0.90). CONCLUSION Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable RA. TRIAL REGISTRATION Current controlled trials, http://www.controlled-trials.com/, ISRCTN09712705.

Bromelain as a Treatment for Osteoarthritis: a Review of Clinical Studies

Bromelain, an extract from the pineapple plant, has been demonstrated to show anti-inflammatory and analgesic properties and may provide a safer alternative or adjunctive treatment for osteoarthritis. All previous trials, which have been uncontrolled or comparative studies, indicate its potential use for the treatment of osteoarthritis. This paper reviews the mechanism of its putative therapeutic actions, those clinical trials that have assessed its use in osteoarthritis to date, as well as considering the safety implications of this supplement for osteoarthritis and reviewing the evidence to date regarding the dosage for treating this condition. The data available at present indicate the need for trials to establish the efficacy and optimum dosage for bromelain and the need for adequate prospective adverse event monitoring in such chronic conditions as osteoarthritis.

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.

Devil’s Claw (Harpagophytum procumbens): An Anti-Inflammatory Herb with Therapeutic Potential

Extracts of the secondary roots of the southern African plant, Devil’s Claw (Harpagophytum procumbens) provide a herbal drug with a variety of traditional indications. One area of its use that has become very popular in recent years is in the treatment of inflammatory disorders of the musculoskeletal system and of low back pain. There have been several clinical studies recently published that generally support its use in treating osteoarthritis although more studies are required in order to establish this drug as a definite therapeutic option. Here in this review, the pharmacological properties of Devil’s Claw are reviewed in detail and the clinical evidence is briefly summarised. There is good in vitro and in vivo pharmacological evidence of the anti-inflammatory and analgesic properties of this drug, although some negative findings have also been reported. Generally, the pharmacological properties of Devil’s Claw is supportive of its therapeutic potential, but more evidence from clinically relevant models, as well as at the cellular and molecular level, should be sought. Such studies may provide evidence in support of additional indications, both traditional and novel. The clinical data on Devil’s Claw is also very promising.

Meta-Analysis of the Related Nutritional Supplements Dimethyl Sulfoxide and Methylsulfonylmethane in the Treatment of Osteoarthritis of the Knee

Dimethyl sulphoxide and methylsulfonylmethane are two related nutritional supplements used for symptomatic relief of osteoarthritis (OA). We conducted a meta-analysis to evaluate their efficacy in reducing pain associated with OA. Randomized or quasi-randomized controlled trials (RCTs), identified by systematic electronic searches, citation tracking and searches of clinical trial registries, assessing these supplements in osteoarthritis of any joint were considered for inclusion. Meta-analysis, based on difference in mean pain related outcomes between treatment and comparator groups, was carried out based on a random effect model. Seven potential trials were identified of which three RCTs, two DMSO and one MSM (total N = 326 patients) were eligible for inclusion. All three trials were considered high methodological quality. A significant degree of heterogeneity (χ 2 = 6.28, P = .043) was revealed. Two studies demonstrated statistically significant (but not clinically relevant) reduction in pain compared with controls; with one showing no group difference. The meta-analysis confirmed a non significant reduction of pain on visual analogue scale of 6.34 mm (SE = 3.49, 95% CI, −0.49, 13.17). The overall effect size of 1.82 was neither statistically nor clinically significant. Current evidence suggests DMSO and MSM are not clinically effective in the reduction of pain in the treatment of OA. No definitive conclusions can currently be drawn from the data due to the mixed findings and the use of inadequate dosing periods.

Integrated medicine in the management of chronic illness: a qualitative study

BACKGROUND Complementary and alternative medicine (CAM) is popular with patients, yet how patients use CAM in relation to orthodox medicine (OM) is poorly understood. AIM To explore how patients integrate CAM and OM when self-managing chronic illness. DESIGN OF STUDY Qualitative analysis of interviews. METHOD Semi-structured interviews were conducted with individuals attending private CAM practices in the UK, who had had a chronic benign condition for 12 months and were using CAM alongside OM for more than 3 months. Patients were selected to create a maximum variation sample. The interviews were analysed using framework analysis. RESULTS Thirty five patient interviews were conducted and seven categories of use were identified: using CAM to facilitate OM use; using OM to support long-term CAM use; using CAM to reduce OM; using CAM to avoid OM; using CAM to replace OM; maximising relief using both CAM and OM; and returning to OM. Participants described initiating CAM use following a perceived lack of suitable orthodox treatment. Participants rejecting OM for a specific condition never totally rejected OM in favour of CAM. CONCLUSION Patients utilise CAM and OM in identifiably different ways, individualising and integrating both approaches to manage their chronic conditions. To support patients and prevent potential adverse interactions, open dialogue between patients, OM practitioners, and CAM practitioners must be improved.

Why Do Parents Take Their Children to Homeopaths? – An Exploratory Qualitative Study

Background: There has been a threefold increase in the proportion of children among patients visiting homeopaths in Norway from 1985 to 1998. As no study has investigated the reasons for this increase, the aim of the present study was to explore why parents take their children to homeopaths. Participants and Methods: In this qualitative study, parents who had taken their child to a homeopath for the first time during the last 3 months were interviewed in depth using a semi-structured interview guide. The interviews were analysed using thematic analysis based on techniques from grounded theory. Results: 9 parents were interviewed. Parents consulted a medical doctor to clarify how serious their child’s health condition was, and sought treatment from a homeopath if the symptoms were not dangerous. Personal recommendations or personal experience of homeopathy were identified as being a main factor that triggered seeking treatment specifically from a homeopath. The reasons they sought an alternative, or rather complement, to conventional medical treatment were: they did not wish to give their child allopathic medication; they wanted to find an alternative treatment to their child’s currently prescribed allopathic medication; they had ceased conventional medication due to its side effects; to obtain treatment whilst waiting for a problem to be assessed; or they were not offered any treatment by their medical doctor. Conclusion: Parents took their child to a homeopath due to experiences with the medical encounter or treatment and due to recommendations or own personal experience.

A review of the literature in applied and specialised kinesiology

Introduction: Kinesiology is a diagnostic, therapeutic complementary therapy utilising subtle change in manual muscle testing results to evaluate the body’s energetic balance and select healing modalities. Anecdotal evidence suggests kinesiology is helpful, therefore we wished to critically review the literature. Aims: (1) To ascertain if diagnostic accuracy including inter-examiner reliability has been established. (2) To review whether there is evidence for its therapeutic effectiveness. (3) To critically assess the quality of relevant studies. Methods: Electronic databases were searched. Diagnostic accuracy studies were analysed and scored for methodological quality and quality of reporting using the quality assessment tool for studies of diagnostic accuracy included in systematic reviews (QUADAS) and the Standards for Reporting of Diagnostic Studies (STARD). Clinical studies were analysed for methodological quality using the JADAD scale and for quality of reporting using the Consolidated Standards of Reporting Trials (CONSORT). Results: 22 original relevant studies were identified. Their methodology was poor. Items reported on QUADAS scored 1-11 out of a possible 14, STARD scores were between 6-13 out of 25, JADAD scores were all 0 out of 5 and CONSORT 4-6 out of 22. Consequently, we were unable to answer any of our research questions. Conclusion: There is insufficient evidence for diagnostic accuracy within kinesiology, the validity of muscle response and the effectiveness of kinesiology for any condition. The standards of reporting were low. We recommend a pragmatic study of the effectiveness of kinesiology as the most appropriate initial step to determine whether kinesiology has any clinical value.

Are the therapeutic effects of homeopathy attributed to the consultation, the homeopathic remedy, or both? A protocol for a future exploratory feasibility trial in patients with rheumatoid arthritis

Systematic reviews suggest that homeopathy has a greater effect than placebo, however, the mechanisms of its action are unknown. The clinical effects of homeopathy could be attributed to the specific effects of the remedy and/or to the contextual effects of the consultation process; these factors have not been critically evaluated. We have developed a model that attempt to separate the consultation effects from the specific effects because of the remedy. We propose to investigate this design in a chronic condition, rheumatoid arthritis, for which previous research has evaluated both classical and complex homeopathic interventions. The following protocol describes the study design. The aims of this exploratory trial are to assess the feasibility of the study design, identify effect sizes of the consultation, the complex treatment, and the individualized remedy, as well as possibly efficacy, for the two types of homeopathic treatment and the homeopathic consultation. Data collection will take place in 2004.