Tuesday, July 20, 2010

Homeopathy: Would you trust congress to dictate the validity of your healthcare?

Here in the U.S., we have a great debate about whether congress should control healthcare spending.  In the U.K. the parliment has decided it will dictate what constitutes valid medical practice and is specifically attacking homeopathy.

Apologists may argue that since homeopathy is placebo, it may actually have beneficial effects.  

Meanwhile, it is unlikely that the report was unbiased

But the issue remains, does homeopathy have any effect beyond placebo?  The basis of this belief is a faulty assumption that a consistent placebo effect exists.  It does not.  The largest Cochrane database study of drugs vs. placebo vs. no treatment found no effect of placebo pills beyond a variable effect on subjective pain.  So those using the placebo effect in reference to sugar pills giving any measurable clinical difference in outcomes are basing their opinion on some preliminary information from the 1950's.  In reference to the doctor/patient relationship, which does provide comfort and reduces many illnesses, homeopaths are at the forefront of working to differentiate that effect from the active benefit from homeopathic remedies. A good doctor/patient relationship should not be termed a "placebo" effect because all medical practices encourage a good bedside manner. 

So do homeopathic remedies clearly show significant benefit beyond a good doctor/patient relationship?  Not consistently.  Certainly not when given in the same way drugs are given out.  The best studies consistently show individualized treatments are more effective than a blanket prescription for something like arnica.  But homeopaths have never claimed otherwise.  The equivalent blanket style studies would be giving aspirin for everything and concluding it does not work because it did not provide significant relief for a broken leg or a brain tumor.  That's not how you practice homeopathy. 

I'm attaching below the Cochrane Systemic Review of the Placebo effect and a nice study on homeopathic Crataegus, which was found to be equivalent (non-inferior) to standard drug treatment in every area except blood pressure reduction.  Think about a dilute, low-side-effect compound that can be manufactured for pennies and costs patients next to nothing.  It would be impossible to compete with and allow treatment of chronic conditions even in desperately poor countries with a problematic healthcare infastructure.  Of course the parlimentary witnesses were on the drug company payroll. 

Cochrane Database Syst Rev. 2010 Jan 20;(1):CD003974.
Placebo interventions for all clinical conditions.
Hróbjartsson A, Gøtzsche PC.
The Nordic Cochrane Centre, Rigshospitalet, Blegdamsvej 9, 3343, Copenhagen, Denmark, 2100.
Update of:
Cochrane Database Syst Rev. 2004;(3):CD003974.
BACKGROUND: Placebo interventions are often claimed to substantially improve patient-reported and observer-reported outcomes in many clinical conditions, but most reports on effects of placebos are based on studies that have not randomised patients to placebo or no treatment. Two previous versions of this review from 2001 and 2004 found that placebo interventions in general did not have clinically important effects, but that there were possible beneficial effects on patient-reported outcomes, especially pain. Since then several relevant trials have been published. OBJECTIVES: Our primary aims were to assess the effect of placebo interventions in general across all clinical conditions, and to investigate the effects of placebo interventions on specific clinical conditions. Our secondary aims were to assess whether the effect of placebo treatments differed for patient-reported and observer-reported outcomes, and to explore other reasons for variations in effect. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library Issue 4, 2007), MEDLINE (1966 to March 2008), EMBASE (1980 to March 2008), PsycINFO (1887 to March 2008) and Biological Abstracts (1986 to March 2008). We contacted experts on placebo research, and read references in the included trials. SELECTION CRITERIA: We included randomised placebo trials with a no-treatment control group investigating any health problem. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information. Trials with binary data were summarised using relative risk (a value of less than 1 indicates a beneficial effect of placebo), and trials with continuous outcomes were summarised using standardised mean difference (a negative value indicates a beneficial effect of placebo). MAIN RESULTS: Outcome data were available in 202 out of 234 included trials, investigating 60 clinical conditions. We regarded the risk of bias as low in only 16 trials (8%), five of which had binary outcomes.In 44 studies with binary outcomes (6041 patients), there was moderate heterogeneity (P < 0.001; I(2) 45%) but no clear difference in effects between small and large trials (symmetrical funnel plot). The overall pooled effect of placebo was a relative risk of 0.93 (95% confidence interval (CI) 0.88 to 0.99). The pooled relative risk for patient-reported outcomes was 0.93 (95% CI 0.86 to 1.00) and for observer-reported outcomes 0.93 (95% CI 0.85 to 1.02). We found no statistically significant effect of placebo interventions in four clinical conditions that had been investigated in three trials or more: pain, nausea, smoking, and depression, but confidence intervals were wide. The effect on pain varied considerably, even among trials with low risk of bias.In 158 trials with continuous outcomes (10,525 patients), there was moderate heterogeneity (P < 0.001; I(2) 42%), and considerable variation in effects between small and large trials (asymmetrical funnel plot). It is therefore a questionable procedure to pool all the trials, and we did so mainly as a basis for exploring causes for heterogeneity. We found an overall effect of placebo treatments, standardised mean difference (SMD) -0.23 (95% CI -0.28 to -0.17). The SMD for patient-reported outcomes was -0.26 (95% CI -0.32 to -0.19), and for observer-reported outcomes, SMD -0.13 (95% CI -0.24 to -0.02). We found an effect on pain, SMD -0.28 (95% CI -0.36 to -0.19)); nausea, SMD -0.25 (-0.46 to -0.04)), asthma (-0.35 (-0.70 to -0.01)), and phobia (SMD -0.63 (95% CI -1.17 to -0.08)). The effect on pain was very variable, also among trials with low risk of bias. Four similarly-designed acupuncture trials conducted by an overlapping group of authors reported large effects (SMD -0.68 (-0.85 to -0.50)) whereas three other pain trials reported low or no effect (SMD -0.13 (-0.28 to 0.03)). The pooled effect on nausea was small, but consistent. The effects on phobia and asthma were very uncertain due to high risk of bias. There was no statistically significant effect of placebo interventions in the seven other clinical conditions investigated in three trials or more: smoking, dementia, depression, obesity, hypertension, insomnia and anxiety, but confidence intervals were wide.Meta-regression analyses showed that larger effects of placebo interventions were associated with physical placebo interventions (e.g. sham acupuncture), patient-involved outcomes (patient-reported outcomes and observer-reported outcomes involving patient cooperation), small trials, and trials with the explicit purpose of studying placebo. Larger effects of placebo were also found in trials that did not inform patients about the possible placebo intervention. AUTHORS' CONCLUSIONS: We did not find that placebo interventions have important clinical effects in general. However, in certain settings placebo interventions can influence patient-reported outcomes, especially pain and nausea, though it is difficult to distinguish patient-reported effects of placebo from biased reporting. The effect on pain varied, even among trials with low risk of bias, from negligible to clinically important. Variations in the effect of placebo were partly explained by variations in how trials were conducted and how patients were informed.
PMID: 20091554

Eur J Heart Fail. 2003 Jun;5(3):319-26.
Efficacy of a homeopathic Crataegus preparation compared with usual therapy for mild (NYHA II) cardiac insufficiency: results of an observational cohort study.
Schröder D, Weiser M, Klein P.
Börsenstrasse 17, Frankfurt/Main, Germany.
Comment in:
Eur J Heart Fail. 2004 Jun;6(4):511; discussion 517-8; author reply 519.
Eur J Heart Fail. 2004 Jun;6(4):509; discussion 517-8; author reply 519.
Eur J Heart Fail. 2004 Jun;6(4):513; discussion 517-8; author reply 519.
Eur J Heart Fail. 2004 Jun;6(4):515; discussion 517-8; author reply 519.
OBJECTIVES: To compare the efficacy of the homeopathic Crataegus preparation Cralonin for non-inferiority to standard treatment for mild cardiac insufficiency. METHODS: Multicentre non-randomised cohort study in patients aged 50-75 years in New York Heart Association class II. Patients received Cralonin (n=110) or ACE inhibitor/diuretics (n=102) for 8 weeks. To adjust for confounding by baseline factors, populations were stratified according to propensity score. After adjusting, there were no statistically significant differences between treatment groups. Treatment efficacy was assessed on 15 variables. A stringent non-inferiority criterion for the upper limit of the 97.5% one-sided confidence interval of the treatment difference was set to 0.2x the standard deviation (S.D.). RESULTS: Both treatment regimens improved scores on most variables studied, with the greatest effect on double product after exercise (average score reduction 15.4% with Cralonin vs. 16.0% for the control group). Stringent non-inferiority of Cralonin was demonstrated on 7 variables. Medium-stringent (0.5xS.D.) non-inferiority was indicated by 13 variables (exceptions: systolic blood pressure (BP) during exercise and diastolic BP at rest; for these, differences between treatments were not significant). Both treatments were well tolerated. CONCLUSION: The Crataegus-based preparation Cralonin is non-inferior to usual ACE inhibitor/diuretics treatment for mild cardiac insufficiency on all parameters except BP reduction.
PMID: 12798830

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