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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.
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.
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.
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?
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.
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.
Bell, I.R., Lewis, D.A., II, Brooks, A. J., Schwartz, G. E., Lewis, S. E., Walsh, B.T., Baldwin, C. M. (2004)
Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo. Rheumatology 43, 577-582
Frass, M., Linkesch, M., Banjya, S., Resch, G., Dielacher, C., Lobl, T., Endler, C., Haidvogl, M., Muchitsch, I., Schuster, E. (2005)
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
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.
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).
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.
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.
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.
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.
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.
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).
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
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.
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.
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
To evaluate the efficacy and safety of potentized estrogen compared to placebo in homeopathic treatment of endometriosis-associated pelvic pain (EAPP).
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).
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.
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.