“Get your facts first, and then you can distort them as much as you please.”
Mark Twain
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Many thanks to Dana Ullman. He watches the research and alerts us to new interesting studies. Several of the studies quotes here came from his alerts. Visit his site Homeopathic Educational Services
Quadruple – Blind (Editorial), The Lancet, April 22, 1989, p. 914.4 Complete Text
Can blind discussion remove bias from the reader? Take a trial in which 149 general practitioners entered 487 patients with an influenza-like syndrome into a randomized double-blind comparison of active treatment and matching placebo, both given sublingually. The first dose was supervised, the other four doses were taken on the following mornings and evenings. 478 of the entered patients (98.2%) met the admission criteria (5 out of 242 patients in the active treatment group and 4 out of 245 placebo patients were ineligible). At admission the groups were similar in age and proportion with severe illness. The patients recorded their rectal temperature morning and evening and whether they still had any or all of five cardinal symptoms within forty-eight hours of the start of treatment. The recovery rates were 39/228 (17.1%) in the active treatment group and 24/234 (10.3%) in the placebo group (P=0.03,X2). The relative risk of recovery was 1.67 (95% confidence interval [CI] 1.1-2.7). The difference in the proportion of patients who recovered was 6.8% (95% CI 0.6-13.0%). Logistic regression showed that several potential confounders did not substantially alter the effect of active treatment (odds ratio 1.9, 95% CI 1.1-3.4; P=0.02). Age and severity at admission were significantly associated with recovery: younger patients and those with mild or moderate illness recovered better, as might be expected. All the patients were asked about the effectiveness of their therapy, and more expressed favourable judgments about the active treatment (61% vs 49%, P=0.02). Use of other symptom-relieving drugs for pain, fever, cough, or coryza and use of antibiotics were not confounders; in fact, more patients in the placebo group used compounds to relieve pain or fever. Can the trial be criticized more than the authors do already? There might have been imbalances between the general practitioners in their recruitment of patients: every participating doctor should have entered 4-6 patients, to give a total of at least 596 cases. Also, data on 16 eligible patients were not analyzed for efficacy. There were only four unsupervised doses, but compliance was not reported. Finally side-effects in both groups were not recorded or reported. The authors are restrained in their discussion “The effect was modest … but nevertheless is of interest”. A 7% difference in efficacy as defined would be a respectable proportion in most drug trials. Now let the code be broken–the active treatment was a homeopathic preparation.
Ferley, J.P., A Controlled Evaluation of Homeopathic Preparation in the Treatment of Influenza-like Syndromes, British Journal of Clinical Pharmacology, 1989, 27, pp. 329-335.
- A controlled clinical trial was conducted to assess the effectiveness of a homeopathic preparation in the treatment of influenza-like syndromes.
- 237 cases received the test drug and 241 were assigned to placebo. Patients recorded their rectal temperature twice a day, and the presence or absence of five cardinal symptoms (headache, stiffness, lumbar in articular pain, shivers) along with cough, coryza and fatigue.
- Recovery was defined as a rectal temperature less than 37.5° C and complete resolution of the five cardinal symptoms.
- The proportion of cases who recovered within 48 h of treatment was greater among the active drug group than among the placebo group (17.1% against 10.3%, P=0.03).
- The result cannot be explained given our present state of knowledge, but it calls for further rigorously designed clinical studies.
Reilly, D.T., Is Homeopathy a Placebo Response? Controlled Trail of Homeopathic Potency, with Pollen in Hayfever as a Model, The Lancet, October 18, 1986, pp. 881-886.
The hypothesis that homeopathic potencies are placebos was tested in a randomized, double-blind, placebo-controlled trial. The study model chosen compared the effects of a homeopathic preparation of mixed grass pollens with placebo in 144 patients with active hayfever. The homeopathically treated patients showed a significant reduction in patient and doctor assessed symptom scores. The significance of this response was increased when results were corrected for pollen count and the response was associated with a halving of the need for antihistamines. An initial aggravation of symptoms was noted more often in patients receiving the potency and was followed by an improvement in that group. No evidence emerged to support the idea that placebo action fully explains the clinical responses to homeopathic drugs.
Day, C.E.I., Control of Stillbirths in Pigs Using Homeopathy, International Journal for Veterinary Homeopathy, Vol. 1, No. 2, October 1986, pp. 26-28.
The author tested Caulophyllum C30 for its effect against stillbirth in a herd of pigs. Ten sows received Caulophyllum C30 prior to farrowing; ten sows received no treatment (control). Stillbirth rate was over 20, 8% in the control and 10, 3% in the treated group. These results are statistically significant.
Fisher, P., Effect of Homeopathic Treatment on Fibrositis (Primary Fibromyalgia), British Medical Journal, 1989, 229, pp. 365-6.
Fibrositis (primary Fibromyalgia) is a controversial condition but is becoming increasingly accepted. It is difficult to treat. We showed that the homeopathic medicine Rhus toxicondendron 6c was effective for a selected subgroup of patients with fibrositis. The improvement in tenderness, which is the best discriminator of fibositis, was particularly distinct. The improvement experienced by our patients while receiving active treatment was at least as great as that reported for any other treatment that has been assessed double blind.
Gibson, R.G., Homeopathic Therapy in Rheumatoid Arthritis: Evaluation by Double-Blind Clinical Therapeutic Trial, British Journal of Clinical Pharmacology, 1980, 9, pp. 453-459.
- Twenty-three patients with rheumatoid arthritis on orthodox first-line anti-inflammatory treatment plus homeopathy were compared with a similar group of twenty-three patients on orthodox first-line treatment plus an inert preparation.
- There was a significant improvement in subjective pain, articular index, stiffness and grip strength in those patients receiving homeopathic remedies, whereas there was no significant change in the patients who received placebo.
- Two physicians were involved in prescribing for the patients and there were no significant differences in the results which they obtained.
- No side effects were observed with the homeopathic remedies.
Jacobs, J. et al, Treatment of Acute Childhood Diarrhea with Homeopathic Medicine: A Randomized Clinical Trial in Nicaragua, Pediatrics, Vol. 93, No. 5, May 1994, pp. 719-725.
Objective—Acute diarrhea is the leading cause of pediatric morbidity and mortality world-wide. Oral rehydration treatment can prevent death from dehydration, but does not reduce the duration of individual episodes. Homeopathic treatment for acute diarrhea is used in many parts of the world. This study was performed to determine whether homeopathy is useful in the treatment of acute childhood diarrhea.
Methodology—A randomized double-blind clinical trial comparing homeopathic medicine with placebo in the treatment of acute childhood diarrhea was conducted in Leon, Nicaragua, in July 1991. Eighty-one children aged 6 months to 5 years of age were included in the study. An individualized homeopathic medicine was prescribed for each child and daily follow-up was performed for 5 days. Standard treatment with oral rehydration treatment was also given.
Results—The treatment group had a statistically significant (P<.05) decrease in duration of diarrhea, defined as the number of days until there were less than three unformed stools daily for 2 consecutive days. There was also a significant difference (P<.05) in the number of stools per day between the groups after 72 hours of treatment.
Conclusions—The statistically significant decrease in the duration of diarrhea in the treatment group suggests that homeopathic treatment might be useful in acute childhood diarrhea. Further study of this treatment deserves consideration.
Reilly, D., et. al, Is Evidence for Homeopathy Reproducible?, The Lancet, 1994; 344: pp. 1601-06
We tested under independent conditions, the reproducibility of evidence from two previous trials that homeopathy differs from placebo. The test model was again homeopathic immunotherapy.
Twenty-eight patients with allergic asthma, most of them sensitive to house-dust mite, were randomly allocated to receive either oral homeopathic immunotherapy to their principal alergen or identical placebo. The test treatments were given as a complement to their unaltered conventional care. A daily visual analogue scale of overall symptom intensity was the outcome measure. A difference in visual analogue score in favour of homeopathic immunotherapy appeared within one week of starting treatment and persisted for up to 8 weeks (P=0.003). There were similar trends in respiratory function and bronchial reactivity tests.
A meta-analysis of all three trials strengthened the evidence that homeopathy does more than placebo (P=0.0004). Is the reproducibility of evidence in favour of homeopathy proof of its activity or proof of the clinical trial’s capacity to produce false-positive results?
Randomised controlled trial of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series.
Erratum in
- BMJ 2000 Sep 23;321(7263):733.
Abstract
OBJECTIVE:
To test the hypothesis that homoeopathy is a placebo by examining its effect in patients with allergic rhinitis and so contest the evidence from three previous trials in this series.
DESIGN:
Randomised, double blind, placebo controlled, parallel group, multicentre study.
SETTING:
Four general practices and a hospital ear, nose, and throat outpatient department.
PARTICIPANTS:
51 patients with perennial allergic rhinitis.
INTERVENTION:
Random assignment to an oral 30c homoeopathic preparation of principal inhalant allergen or to placebo.
MAIN OUTCOME MEASURES:
Changes from baseline in nasal inspiratory peak flow and symptom visual analogue scale score over third and fourth weeks after randomisation.
RESULTS:
Fifty patients completed the study. The homoeopathy group had a significant objective improvement in nasal airflow compared with the placebo group (mean difference 19.8 l/min, 95% confidence interval 10.4 to 29.1, P=0.0001). Both groups reported improvement in symptoms, with patients taking homoeopathy reporting more improvement in all but one of the centres, which had more patients with aggravations. On average no significant difference between the groups was seen on visual analogue scale scores. Initial aggravations of rhinitis symptoms were more common with homoeopathy than placebo (7 (30%) v 2 (7%), P=0.04). Addition of these results to those of three previous trials (n=253) showed a mean symptom reduction on visual analogue scores of 28% (10.9 mm) for homoeopathy compared with 3% (1.1 mm) for placebo (95% confidence interval 4.2 to 15.4, P=0.0007).
CONCLUSION:
The objective results reinforce earlier evidence that homoeopathic dilutions differ from placebo.
Frass, M., et. al, Influence of Potassium Dichromate on Tracheal Secretions in Critically Ill Patients, Chest, 2005; 127:936-941
Background—Stringy, tenacious tracheal secretions may prevent extubation in patients weaned from the respirator. This prospective, randomized, double-blind, placebo-controlled study with parallel assignment was performed to assess the influence of sublingually administered potassium dichromate C30 on the amount of tenacious, stringy tracheal secretions in critically ill patients with a history of tobacco use and COPD.
Methods—In this study, 50 patients breathing spontaneously with continuous positive airway pressure were receiving either potassium dichromate C30 globules (group 1) [Deutsche Homoopathic-Union, Pharmaceutical Company; Karlsruhe, Germany] or placebo (group 2). Five globules were administered twice daily at intervals of 12 h. The amount of tracheal secretions on day 2 after the start of the study as well as the time for successful extubation and length of stay in the ICU were recorded.
Results—The amount of tracheal secretions was reduced significantly in group 1 (p <0.0001). Extubation could be performed significantly earlier in group 1 (p <0.0001). Similarly, length of stay was significantly shorter in group 1 (4.20 ± 1.61 days vs. 7.68 ± 3.60 days, p <0.0001 [mean ± SD]).
Conclusion—These data suggest that potentized (diluted and vigorously shaken) potassium dichromate may help to decrease the amount of stringy tracheal secretions in COPD patients.
Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo.
Rheumatology (Oxford). 2004 May;43(5):577-82. Epub 2004 Jan 20.
Abstract
OBJECTIVE:
To assess the efficacy of individualized classical homeopathy in the treatment of fibromyalgia.
METHODS:
This study was a double-blind, randomized, parallel-group, placebo-controlled trial of homeopathy. Community-recruited persons (N = 62) with physician-confirmed fibromyalgia (mean age 49 yr, s.d. 10 yr, 94% women) were treated in a homeopathic private practice setting. Participants were randomized to receive oral daily liquid LM (1/50,000) potencies with an individually chosen homeopathic remedy or an indistinguishable placebo. Homeopathic visits involved joint interviews and concurrence on remedy selection by two experienced homeopaths, at baseline, 2 months and 4 months (prior to a subsequent optional crossover phase of the study which is reported elsewhere). Tender point count and tender point pain on examination by a medical assessor uninvolved in providing care, self-rating scales on fibromyalgia-related quality of life, pain, mood and global health at baseline and 3 months, were the primary clinical outcome measures for this report.
RESULTS:
Fifty-three people completed the treatment protocol. Participants on active treatment showed significantly greater improvements in tender point count and tender point pain, quality of life, global health and a trend toward less depression compared with those on placebo.
CONCLUSIONS:
This study replicates and extends a previous 1-month placebo-controlled crossover study in fibromyalgia that pre-screened for only one homeopathic remedy. Using a broad selection of remedies and the flexible LM dose (1/50,000 dilution factor) series, the present study demonstrated that individualized homeopathy is significantly better than placebo in lessening tender point pain and improving the quality of life and global health of persons with fibromyalgia.
Adjunctive homeopathic treatment in patients with severe sepsis: a randomized, double-blind, placebo-controlled trial in an intensive care unit.
Homeopathy. 2005 Apr;94(2):75-80.
Abstract
BACKGROUND:
Mortality in patients with severe sepsis remains high despite the development of several therapeutic strategies. The aim of this randomized, double-blind, placebo-controlled trial was to evaluate whether homeopathy is able to influence long-term outcome in critically ill patients suffering from severe sepsis.
METHODS:
Seventy patients with severe sepsis received homeopathic treatment (n = 35) or placebo (n = 35). Five globules in a potency of 200c were given at 12h interval during the stay at the intensive care unit. Survival after a 30 and 180 days was recorded.
RESULTS:
Three patients (2 homeopathy, 1 placebo) were excluded from the analyses because of incomplete data. All these patients survived. Baseline characteristics including age, sex, BMI, prior conditions, APACHE II score, signs of sepsis, number of organ failures, need for mechanical ventilation, need for vasopressors or veno-venous hemofiltration, and laboratory parameters were not significantly different between groups. On day 30, there was non-statistically significantly trend of survival in favour of homeopathy (verum 81.8%, placebo 67.7%, P= 0.19). On day 180, survival was statistically significantly higher with verum homeopathy (75.8% vs 50.0%, P = 0.043). No adverse effects were observed.
CONCLUSIONS:
Our data suggest that homeopathic treatment may be a useful additional therapeutic measure with a long-term benefit for severely septic patients admitted to the intensive care unit. A constraint to wider application of this method is the limited number of trained homeopaths.
Individualized Homeopathic Treatment and Fluoxetine for Moderate to Severe Depression in Peri- and Postmenopausal Women (HOMDEP-MENOP Study): A Randomized, Double-Dummy, Double-Blind, Placebo-Controlled Trial
- Published: March 13, 2015
- DOI: 10.1371/journal.pone.0118440
Abstract
Background
Perimenopausal period refers to the interval when women’s menstrual cycles become irregular and is characterized by an increased risk of depression. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. The aim of this study was to assess efficacy and safety of individualized homeopathic treatment versus placebo and fluoxetine versus placebo in peri- and postmenopausal women with moderate to severe depression.
Methods/Design
A randomized, placebo-controlled, double-blind, double-dummy, superiority, three-arm trial with a 6 week follow-up study was conducted. The study was performed in a public research hospital in Mexico City in the outpatient service of homeopathy. One hundred thirty-three peri- and postmenopausal women diagnosed with major depression according to DSM-IV (moderate to severe intensity) were included. The outcomes were: change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression, Beck Depression Inventory and Greene Scale, after 6 weeks of treatment, response and remission rates, and safety. Efficacy data were analyzed in the intention-to-treat population (ANOVA with Bonferroni post-hoc test).
Results
After a 6-week treatment, homeopathic group was more effective than placebo by 5 points in Hamilton Scale. Response rate was 54.5% and remission rate, 15.9%. There was a significant difference among groups in response rate definition only, but not in remission rate. Fluoxetine-placebo difference was 3.2 points. No differences were observed among groups in the Beck Depression Inventory. Homeopathic group was superior to placebo in Greene Climacteric Scale (8.6 points). Fluoxetine was not different from placebo in Greene Climacteric Scale.
Conclusion
Homeopathy and fluoxetine are effective and safe antidepressants for climacteric women. Homeopathy and fluoxetine were significantly different from placebo in response definition only. Homeopathy, but not fluoxetine, improves menopausal symptoms scored by Greene Climacteric Scale.
Potentized estrogen in homeopathic treatment of endometriosis-associated pelvic pain: A 24-week, randomized, double-blind, placebo-controlled study
Marcus Zulian Teixeira, Sérgio Podgaec, Edmund Chada Baracat
European Journal of Obstetrics and Gynecology and Reproductive Biology
Apr. 2017, Volume 211, Pages 48–55
Abstract
Objective
To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP).
Study design
The present was a 24-week, randomized, double-blind, placebo-controlled trial that included 50 women aged 18–45 years old with diagnosis of deeply infiltrating endometriosis based on magnetic resonance imaging or transvaginal ultrasound after bowel preparation, and score ≥ 5 on a visual analogue scale (VAS: range 0 to 10) for endometriosis-associated pelvic pain. Potentized estrogen (12cH, 18cH and 24cH) or placebo was administered twice daily per oral route. The primary outcome measure was change in the severity of EAPP global and partial scores (VAS) from baseline to week 24, determined as the difference in the mean score of five modalities of chronic pelvic pain (dysmenorrhea, deep dyspareunia, non-cyclic pelvic pain, cyclic bowel pain and/or cyclic urinary pain). The secondary outcome measures were mean score difference for quality of life assessed with SF-36 Health Survey Questionnaire, depression symptoms on Beck Depression Inventory (BDI), and anxiety symptoms on Beck Anxiety Inventory (BAI).
Results
The EAPP global score (VAS: range 0 to 50) decreased by 12.82 (P < 0.001) in the group treated with potentized estrogen from baseline to week 24. Group that used potentized estrogen also exhibited partial score (VAS: range 0 to 10) reduction in three EAPP modalities: dysmenorrhea (3.28; P < 0.001), non-cyclic pelvic pain (2.71; P = 0.009), and cyclic bowel pain (3.40; P < 0.001). Placebo group did not show any significant changes in EAPP global or partial scores. In addition, the potentized estrogen group showed significant improvement in three of eight SF-36 domains (bodily pain, vitality and mental health) and depression symptoms (BDI). Placebo group showed no significant improvement in this regard. These results demonstrate superiority of potentized estrogen over placebo. Few adverse events were associated with potentized estrogen.
Conclusions
Potentized estrogen (12cH, 18cH and 24cH) at a dose of 3 drops twice daily for 24 weeks was significantly more effective than placebo for reducing endometriosis-associated pelvic pain.
Systematic Reviews
Personally, I no longer trust published results of systematic reviews in highly controversial areas of science. The results almost always reflect the bias of the group doing this “research”. I put research in quotes, because such work is non-scientific. The only purpose of such work is to promote the agenda of the group doing it. I’ve seen too many instances of this to trust these reviews any longer. Even the prestigious Cochrane Collaboration, which used to be my go-to for reliable systematic research, appears to have fallen in disrepute due to controversy resulting in bad politics. By the way, this issue did not have anything to do with homeopathy. This is actually very sad.
Kleijnen, J., Clinical Trials of Homeopathy, British Medical Journal, 1991, 302, 216-23.
Objective—To establish whether there is evidence of the efficacy of homeopathy from controlled trials in humans.
Design—Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality.
Setting—Controlled trials published world wide.
Main outcome measures—Results of the trials with the best methodological quality. Trials of classical homeopathy and several modern varieties were considered separately.
Results—In 14 trials some form of classical homeopathy was tested and in 58 trials the same single homeopathic treatment was given to patients with comparable conventional diagnoses. Combinations of several homeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homeopathy.
Conclusions—At the moment, the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for future evaluation of homeopathy, but only by means of well performed trials.
Linde, K., et. al, Are the Clinical Effects of Homoeopathy Placebo Effects? A Meta-analysis of Placebo-controlled Trials, The Lancet, 1997; 350: pp.834-43
Background—Homoeopathy seems scientifically implausible but has widespread use. We aimed to assess whether the clinical effect reported in randomized controlled trials of homoeopathic remedies is equivalent to that reported for placebo.
Methods—We sought studies from computerized bibliographies and contacts with researchers, institutions, manufacturers, individual collectors, homoeopathic conference proceedings, and books. We included all languages. Double-blind and/or randomized placebo-controlled trials of clinical conditions were considered. Our review of 186 trials identified 119 that met the inclusion criteria. 89 had adequate data for meta-analysis, and two sets of trial were used to assess reproducibility. Two reviewers assessed study quality with two scales and extracted data for information on clinical condition, homeopathy type, dilution, “remedy”, population, and outcomes.
Findings—The combined odds ratio for the 89 studies entered into the main meta-analysis was 2.45 (95% CI 2.05, 2.93) in favor of homeopathy. The odds ratio for the 26 good-quality studies was 1.66 (1.33, 2.08), and that corrected for publication bias was 1.78 (1.03, 3.10). Four studies on the effects of a single remedy on seasonal allergies had a pooled odds ratio for ocular symptoms at 4 weeks of 2.03 (1.51, 2.74). Five studies on postoperative ileus had a pooled mean effect-size-difference of -0.22 standard deviations (95% Cl -0.36, -0.09) for flatus, and -0.18 SDs (-0.33, -0.03) for stool (both p<0.05)
Interpretation—The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homoeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homoeopathy is clearly efficacious for any single clinical condition. Further research on homeopathy is warranted provided it is rigorous and systematic.
Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy.
Shang A, Huwiler-Müntener K, Nartey L, Jüni P, Dörig S, Sterne JA, Pewsner D, Egger M.
Lancet. 2005 Aug 27-Sep 2;366(9487):726-32.
Note from Dr. Mirman: This is the study you will see quoted most by the denialists of homeopathy. Be sure to read the next entry which discusses the shortcomings of this study.
Abstract
BACKGROUND:
Homoeopathy is widely used, but specific effects of homoeopathic remedies seem implausible. Bias in the conduct and reporting of trials is a possible explanation for positive findings of trials of both homoeopathy and conventional medicine. We analysed trials of homoeopathy and conventional medicine and estimated treatment effects in trials least likely to be affected by bias.
METHODS:
Placebo-controlled trials of homoeopathy were identified by a comprehensive literature search, which covered 19 electronic databases, reference lists of relevant papers, and contacts with experts. Trials in conventional medicine matched to homoeopathy trials for disorder and type of outcome were randomly selected from the Cochrane Controlled Trials Register (issue 1, 2003). Data were extracted in duplicate and outcomes coded so that odds ratios below 1 indicated benefit. Trials described as double-blind, with adequate randomisation, were assumed to be of higher methodological quality. Bias effects were examined in funnel plots and meta-regression models.
FINDINGS:
110 homoeopathy trials and 110 matched conventional-medicine trials were analysed. The median study size was 65 participants (range ten to 1573). 21 homoeopathy trials (19%) and nine (8%) conventional-medicine trials were of higher quality. In both groups, smaller trials and those of lower quality showed more beneficial treatment effects than larger and higher-quality trials. When the analysis was restricted to large trials of higher quality, the odds ratio was 0.88 (95% CI 0.65-1.19) for homoeopathy (eight trials) and 0.58 (0.39-0.85) for conventional medicine (six trials).
INTERPRETATION:
Biases are present in placebo-controlled trials of both homoeopathy and conventional medicine. When account was taken for these biases in the analysis, there was weak evidence for a specific effect of homoeopathic remedies, but strong evidence for specific effects of conventional interventions. This finding is compatible with the notion that the clinical effects of homoeopathy are placebo effects.
Homeopathy: Meta-Analyses of Pooled Clinical Data
Hahn R.G.
Research Unit, Södertälje Hospital, Södertälje, b Department of Anesthesiology, Linköping University, Linköping, Sweden
Forsch Komplementmed 2013;20:376–381
Note from Dr. Mirman: This is the article explaining the shortcomings of the Lancet study (see above). Make sure to read the entire article, and more than once. The author explains how so-called scientists manipulate data to prove their own point of view. Unless you are a statistician, this is not easy to grasp, but it is very important to understand.
Abstract
In the first decade of the evidence-based era, which began in the mid-1990s, meta-analyses were used to scrutinize homeopathy for evidence of beneficial effects in medical conditions. In this review, meta-analyses including pooled data from placebo-controlled clinical trials of homeopathy and the aftermath in the form of debate articles were analyzed. In 1997 Klaus Linde and co-workers identified 89 clinical trials that showed an overall odds ratio of 2.45 in favor of homeopathy over placebo. There was a trend toward smaller benefit from studies of the highest quality, but the 10 trials with the highest Jadad score still showed homeopathy had a statistically significant effect. These results challenged academics to perform alternative analyses that, to demonstrate the lack of effect, relied on extensive exclusion of studies, often to the degree that conclusions were based on only 5-10% of the material, or on virtual data. The ultimate argument against homeopathy is the ‘funnel plot’ published by Aijing Shang’s research group in 2005. However, the funnel plot is flawed when applied to a mixture of diseases, because studies with expected strong treatments effects are, for ethical reasons, powered lower than studies with expected weak or unclear treatment effects. To conclude that homeopathy lacks clinical effect, more than 90% of the available clinical trials had to be disregarded. Alternatively, flawed statistical methods had to be applied. Future meta-analyses should focus on the use of homeopathy in specific diseases or groups of diseases instead of pooling data from all clinical trials.
The Lancet paper by Shang et al.
This is a page on Homeopathy Research Institute website, providing further critique of the Lancet study claiming that homeopathy has no effect beyond placebo. As with any meta-analysis, garbage in – garbage out. Summary:
- Although 110 homoeopathy trials and 110 matched conventional medicine trials were included in the study, the conclusions were based on only 8 homeopathy trials and 6 conventional medicine trials described as ‘larger higher quality trials’.
- If all 21 homeopathy trials they identified as higher quality had been analysed, they would have got the opposite result – that homeopathy has an effect beyond placebo.10 No justification has been given for discounting the other 13 high quality trials just because they were smaller.
- The study fails sensitivity analysis i.e. if just one of the 8 homeopathy trials they chose from the 110 is changed, you get the opposite result, that homeopathy works better than placebo.4
- All 8 trials tested non-individualised homeopathy i.e. the same remedy given to all patients. The conclusions of this study therefore have no relevance to usual homeopathic clinical practice involving individually prescribed medicines, given after an in-depth consultation.
- The study does not state which 8 homeopathy trials and which 6 conventional trials they used. Such lack of reporting transparency is typically not tolerated in studies of conventional medicine.6 Following an outcry, the authors eventually provided this information.
- The Shang paper, containing studies published up to 2003, is now out of date and superseded by more recent and robust systematic reviews.13
Open the above HRI link to see the references.
Homeoprophylaxis
Homeoprophylaxis: use of homeopathic remedies to prevent illness. It is superficially somewhat similar to vaccinations in that it is given to healthy people hoping to prevent or reduce the impact of the disease. There are two types of this approach:
- Nosodes: remedies made from disease products of the actual disease we are trying to prevent, as well as similar diseases. Example: For prevention of Covid-19 some homeopaths recommend taking a combination of remedies made from a variety of influenza viruses, as well as from SARS 2 virus.
- Regular remedies whose symptom pictures are thought to be similar to the symptoms of the disease. Example: Gelsemium, Bryonia, Eupatorium Perfoliatum, etc.
Some homeopaths suggest a combination of both approaches above in large population work.
Significant number of recent research studies of this methodology exists. This is the largest and most quoted study:
Large-scale application of highly-diluted bacteria for Leptospirosis epidemic control
Gustavo Bracho1,*, Enrique Varela2, Rolando Fernández3, Barbara Ordaz3, Natalia Marzoa3, Jorge Mene´ndez4, Luis Garcı´a5, Esperanza Gilling6, Richard Leyva7, Reynaldo Rufı´n8, Rube´n de la Torre9, Rosa L Solis10, Niurka Batista5, Reinier Borrero5 and Concepción Campa1
1Finlay Institute, Ave. 27, La Lisa, Havana City, Cuba
2Agromin Enterprise Group, Havana City, Cuba
3Homeopathy Department, Finlay Institute, Ave. 7ma, Playa, Havana City, Cuba
4Clinical Trials and Medical Managing Department, Finlay Institute, Ave. 27, La Lisa, Havana City, Cuba
5Bacterial Vaccine Department, Finlay Institute, Ave. 17, Playa, Havana City, Cuba
6Provincial Centre for Homeopathy, Holguı´n, Cuba
7Provincial Centre for Homeopathy, Granma, Cuba
8Provincial Centre for Epidemiology and Hygiene, Holguı´n, Cuba
9National Medical Services, Havana City, Cuba
10Research Vice-presidency Finlay Institute, Ave. 17, Playa, Havana City, Cuba
Background: Leptospirosis is a zoonotic disease of major importance in the tropics where the incidence peaks in rainy seasons. Natural disasters represent a big challenge to Leptospirosis prevention strategies especially in endemic regions. Vaccination is an effective option but of reduced effectiveness in emergency situations. Homeoprophylac-tic interventions might help to control epidemics by using highly-diluted pathogens to induce protection in a short time scale. We report the results of a very large-scale home-oprophylaxis (HP) intervention against Leptospirosis in a dangerous epidemic situation in three provinces of Cuba in 2007.
Methods: Forecast models were used to estimate possible trends of disease incidence. A homeoprophylactic formulation was prepared from dilutions of four circulating strains of Leptospirosis (200C). This formulation was administered orally to 2.3 million persons at high risk in an epidemic in a region affected by natural disasters. The data from surveillance were used to measure the impact of the intervention by comparing with historical trends and non-intervention regions.
Results: After the homeoprophylactic intervention a significant decrease of the disease incidence was observed in the intervention regions (84% decrease in disease incidence). No such modifications were observed in non-intervention regions. In the intervention region the incidence of Leptospirosis fell below the historic median. This observation was independent of rainfall. The cost of “homeopathic immunization” =1/15th of conventional vaccine.
Conclusions: The homeoprophylactic approach was associated with a large reduction of disease incidence and control of the epidemic. The results suggest the use of HP as a feasible tool for epidemic control, further research is warranted. Homeopathy (2010) 99, 156-166.
Keywords: Homeoprophylaxis; Prevention; Leptospirosis; Epidemics; Cuba