Homeopathy Detailed Scientific Review

Overview

Background

A major homeopathic principal is that remedies are most effective when they are based on a total set of symptoms and characteristics rather than just those of a disease¹. In classic or individualized homeopathy, choices of remedies are based upon the match of a patient’s particular symptoms with a “remedy picture” rather than a conventional diagnosis².

Prescribing of homeopathic substances is based on its proposed “law of similars” which suggests that “like cures like”. Although roots of this concept may be found among the ancient Greeks, it was the German physician, Samuel Hahnemann (born 1753), who developed the theory as it is known today. The theory occurred to him when he took the remedy for malaria, quinine, and then developed most of the symptoms of malaria³.

In order to test his theory, he then gave hundreds of natural substances to family and friends who were not sick and then gave them to patients. Rather than prescribing doses in concentrations that might bring about extreme symptoms, however, he gave doses that had been diluted in water or alcohol many times^4,5. Although he initially diluted these substances in order to reduce toxicity, he came to believe that the actual process of diluting and shaking imparted additional potency to each solution1. His process of testing natural substances in healthy individuals became known as drug provings and the results continue to be collected into an encyclopedia of homeopathic drug effects known as the Materia Medica^3,5.

Partly because the conventional medicine of Hahnemann’s time still involved such practices as bloodletting, violent purging and lack of either hand washing or vaccination; homeopathy became known as a safer and often more effective system¹. It was widespread in Europe and the United States and provided ideas for the treatment of diseases with drugs such as nitroglycerin³. Clear distinctions between homeopaths and allopaths (a term coined by Hahnemann) became blurred as both types of physicians began to follow the developing laboratory and bacteriological sciences of the late 1800s. In 1903, homeopaths were invited to join the American Medical Association and some attribute this to the decline of homeopathy as a separate practice in the 1900s^1,3.

One of the reasons that homeopathy was not able to compete as a separate practice was because of the discovery of a principle of molecular concentration known as Avogadro’s law. This law established that one mole of any substance contains 6.0 x 10²³ molecular or atomic units. It could then be demonstrated that a dilution of any substance greater than 10²⁴ would have an increasingly remote chance of even a single molecule of the original substance remaining. Homeopathic theorists respond by maintaining that even if a single molecule of a substance no longer exists in a solution, a “memory” of the substance remains. They believe that if a person or animal has chaotic energy because of disease, a solution whose energy has been altered in only a small way can affect a change⁵.

A renaissance in homeopathy occurred in the United States and Europe during the latter part of the 20th century with over $165 million spent on homeopathic remedies in 1994 and sales rising 20% annually³.

Prevalence of use increased from .7% to 3.4% between 1990 and 1997⁶.

Legal Regulations

The Homeopathic Pharmacopoeia of the United States was established in 1897 and is still updated regularly. Homeopathic medicines are currently regulated by the Food and Drug Administration, but less stringently than allopathic medicines. Homeopathic substances may be bought for one’s own use without a prescription for self-limiting diseases that are amenable to self-diagnosis as long as they do not contain toxic substances⁷. Additional information concerning labeling and other issues is available in the FDA Regulations.

Prescribing homeopathic remedies to others is regulated by each state and usually includes those whose degree entitles them to practice medicine in that state such as doctors of medicine (MD), osteopathy (DO) or naturopathy (ND) and sometimes dentists (DDS), veterinarians (DVM) and certain doctors of chiropractic (DC). No diploma or certificate from any homeopathic school or program is recognized as a license to practice homeopathy in the United States, according to the National Center for Homeopathy.

Toxicity

Some homeopathic substances are toxic (e.g., Aristolochia⁸, arsenic⁹). Even though homeopathic preparations are usually highly dilute, those with toxic “mother substances” may only be administered by prescription⁷. Most authorities assume that homeopathic drugs are safe as long as conventional medical care is not delayed; however, adverse effects have been reported in some studies¹.

Proposed Mechanism of Action (Cancer)

This Web site previously noted that homeopathy had not been proposed as a direct treatment for cancer. This was based upon statements by an Italian homeopathic authority, Bellavite, who stated, “Homeopathy cannot be considered as an antitumor therapy in the sense of being able to attack the tumor directly… Furthermore, since the identification of suitable homeopathic remedies is supposed to be based on experiments with such remedies in healthy subjects, it would be unthinkable to cause tumors in healthy people”⁵. However, it has now been learned that some homeopathic physicians are treating with intent to affect cancer itself by using dilute doses of carcinogens and/or human tumors^9-11.

Evidence of Effectiveness (Non-Cancer)

Efficacy of homeopathy for non-cancerous conditions has been assessed in several reviews and meta-analyses. A 1991 review by Kleijinen cited 107 controlled trials of homeopathy. He found methodological problems with all trials, but presented the results of the 23 best trials in which 15 showed a positive effect, “in most cases statistically significant”¹².

A 1997 meta-analysis by Linde of 89 trials concluded that the homeopathy appeared to not be completely limited to placebo effects¹³. He subsequently limited his review to 19 placebo-controlled trials of individualized homeopathic prescriptions and found significant effects compared with placebo. However, when he further limited his analysis to the six methodologically best trials; he found no significant effects². A reanalysis of Linde’s data by Ernst identified only five best trials for different conditions and reached similar conclusions¹⁴. Overviews of the quality and results of these reviews have been provided by Barnes² and Jonas¹.

Methodological considerations in homeopathic research are further examined by Bell¹⁵.

Evidence of Effectiveness (Cancer)

A collaborative systematic review of controlled trials of homeopathy for patients with cancer was published in 2006. Results of this review and additional notes about other reviews and studies are provided in the Summary of Research.

Summary of Research

Collaborative Review of Controlled Studies

Searches of five major scientific literature databases were conducted in June of 2005 by an investigator at the University of Exeter, United Kingdom, in collaboration with an investigator at MD Anderson Cancer Center. The five databases searched included Medline (through PubMed and NHS dialogues), AMED, CINHAL, EMBASE and CAMbase.

Fifty-five potentially relevant studies of homeopathy in patients with cancer were identified: 12 animal or in vitro studies and 42 human studies. Only the six human studies with a control group were selected for review.
The following table depicts the types of controlled studies in humans identified:

The six controlled studies were independently reviewed by investigators at the two institutions who assessed the quality of each study using Jadad Criteria, and the significance of their results based upon the statistical measures reported. Discrepancies between the two reviewers were resolved by a third reviewer from the University of Exeter¹⁶.

One of the six controlled studies was a triple blinded study (Jadad 5) of single and combination homeopathic remedies for women with a history of breast cancer who were experiencing hot flashes. Significant decreases in number of hot flashes and hot flash scores were found for those taking the single homeopathic remedy. However, those taking the combination remedy had increased hot flashes, hot flash scores and headaches. This may have been related to taking the combination daily for a year in contrast to the over-the-counter instructions that specified taking only until symptoms decreased or for seven days if they did not decrease¹⁷. A second trial (Jadad 5) also investigated relief of hot flashes for women undergoing estrogen withdrawal did not report any significant differences, but was underpowered to detect such differences¹⁸. Although these two trials had the highest possible Jadad study design scores, their sample sizes were only large enough to detect large differences in response.

Another randomized double-blind controlled trial (Jadad 4) investigated the effectiveness of homeopathic treatment for skin reactions during radiotherapy for breast cancer. Patients treated with homeopathy appeared to experience two transient benefits: significantly less hyperpigmentation and skin heat during most observations although these differences were no longer significant by eight weeks. These benefits were in contrast to the greater degree of edema that they experienced in most weeks that became statistically significant during the fifth and sixth weeks (41% versus 16%)¹⁹.

A fourth randomized and blinded trial (Jadad 4) evaluated use of a homeopathic remedy, Traumeel S^®, for the relief of stomatitis/mucositis in children with leukemia or lymphoma who were undergoing stem cell transplants. Significant reduction of severity, duration of symptoms and longer time to worsening of symptoms was detected for the children who received Traumeel S^® in addition to standard oral care²⁰.
The fifth randomized trial (Jadad 1) was not blinded. It reported lower index scores of reactions to radiation for patients with different types of cancer who received either of two different types of homeopathic remedies compared to placebo, but no significant differences in tumor reductions²¹.

A sixth controlled trial (Jadad 0) will not be discussed because it was only intended as a small preliminary non-randomized pilot study²² in preparation for the larger randomized controlled trial of Traumeel S^® for stomatitis described above20.

Review and Research by the National Cancer Institute (NCI)

In 2004, investigators at the Office of Cancer Complementary and Alternative Medicine (OCCAM) of the (NCI) published Parts I²³ and II²⁴ of a review of homeopathy for patients with cancer that provides an extensive background on homeopathy. The NCI concluded that published data demonstrating benefit in the treatment of cancer and cancer-related systems was lacking²³; however, their review did not identify the six trials included in the 2006 collaborative review described above.

Based upon the results of the fourth randomized trial that reported relief of stomatitis in children, the U. S. National Cancer Institute initiated its own multi-center randomized and blinded clinical trial of Traumeel S^® for mucositis in pediatric patients.

Conclusions

Conclusions are based upon the 2006 collaborative review of controlled trials16, in which five of the six trials suggested that homeopathic remedies were beneficial. However, only two of these trials reported statistically significant positive results: relief of chemotherapy induced stomatitis in children undergoing stem cell transplantation²⁰ and transient relief of radiation dermatitis¹⁹. These findings need replication in large studies with study designs that minimize bias.

Previous Searches by this Web Site

Previous searches by this web site have been limited to two major databases: Medline and AlthHealth Watch. Between 11/1/1997 and 12/31/2005, these searches had identified 74 references to homeopathy and cancer, and we had retrieved the 53 articles most relevant to the effectiveness or safety of homeopathy. (Not retrieved were 15 surveys of use and two articles reprinted from previous time periods).

Searches of Medline as of 10/31/1997 had identified 59 citations generally applicable to cancer, and we had retrieved the 30 most relevant to its safety or effectiveness.

Combining the results of both sets of searches as of 12/31/2005 yields 53 + 59 = 112 references generally applicable to homeopathy and cancer of which we retrieved 30 + 53 = 83 articles.

The addition of controlled studies in humans identified in the 2006 review that searched five databases, brings this combined total to 87 and we classified these references into the following types of information:

*Includes controlled trials as of June 2004 cited in collaborative review of 2006¹⁶.

Studies in humans that evaluated the efficacy or safety of homeopathy (n=21) were classified into the following types of study designs:

Due to publishing of the 2006 review of controlled studies, we will no longer evaluate and summarize the findings of uncontrolled human studies in our Summaries of Research for Homeopathy.
Brief notes of both controlled and uncontrolled human studies remain in the Table of Human Studies.

Further details for both controlled and uncontrolled human studies are provided in the Annotated Bibliography.

Annotated Bibliography

Human Studies

Randomized and Blinded Controlled Clinical Trials (4)

¹⁷Jacobs J, Herman P, Heron K, Olsen S, Vaughters L. Homeopathy for menopausal symptoms in breast cancer survivors: a preliminary randomized controlled trial. The Journal of Alternative and Complementary Medicine 2005;11(1):21-7.

Purpose: Relief of side effects
Type of Study: Triple-blind controlled clinical trial (Jadad score 5 of 5 possible points)
Methods: (Breast cancer) Women with a history of breast cancer who had completed all surgery, chemotherapy and radiation treatment and who had an average of at least three hot flashes per day for the previous month were eligible for this study; those taking tamoxifen were also eligible. Patients (N=83) were evaluated by an experienced and certified homeopathic practitioner who prescribed an individualized homeopathic medication that best matched their symptoms. The prescription was sent to a homeopathic pharmacist who randomized the subjects to one of three treatment groups:

A placebo combination medicine and a verum single remedy (n=26)

A verum combination medicine (Hyland’s Menopause) and a placebo single remedy (n=30)

Two placebo medications (n=27)

All subsequent prescriptions for patients were filled according to the initial randomization. Patients were stratified by age, breast cancer staging and tamoxifen use. Patients had follow-up visits with the homeopathic practitioner every two months for one year, at which time the individualized homeopathic prescription could be renewed or revised accordingly. Patients were asked to bring remaining medication to each visit to permit an evaluation of compliance. Patients were interviewed by phone at one, two, three, six, nine and 12 months to evaluate outcomes. For the week prior to the interview, patients completed a daily hot flash diary. The patients, homeopathic practitioners, and evaluators were blinded to randomization.
Results: A total of 28 patients withdrew from the study, reporting no relief from hot flashes (n=11), cancer recurrence or other illness (n=7), inconvenience (n=5) and loss to follow-up (n=4). At least six months of the study was completed by 80.5% of randomized patients. There were no significant differences between the three groups at baseline or between those who withdrew from the study and those who completed the study. There were no significant differences in self-reported compliance among the three groups. When adjusted for baseline, time and tamoxifen use, there was no significant difference in the hot flash severity score or total number of hot flashes among the three groups. However, there was a significant positive trend (p=.01) toward a decreased hot flash severity score in the single remedy group overall during the first three months. By sub-group analysis, women in the combination remedy group not receiving tamoxifen had a statistically significant increase in the hot flash severity score and total number of hot flashes compared to placebo (p=.01, p=.006) and to the single homeopathic remedy group (p<.001, p=.002). Women in both the combination and single remedy groups had a significantly increased general health score compared to placebo (p=.03, p=.02). A statistically significant increase in headaches was found in the combination group at six months (p=.04) and 12 months (p=.03).
Note: The authors commented upon the increased hot flashes and headaches in the combination homeopathic group and noted that the dose of three times a day for up to one year was in contrast to the over-the-counter instructions that specified taking only until symptoms subsided or discontinuing after seven days if symptoms worsened.

¹⁸Thompson E, Montgomery A, Douglas D, Reilly D. A pilot, randomized, double-blinded, placebo-controlled trial of individualized homeopathy for symptoms of estrogen withdrawal in breast cancer survivors. Journal of Alternative and Complementary Medicine 2005;11(1):13-20.

Purpose: Relief of side effects
Type of Study: Randomized controlled trial (Jadad score 5)
Methods: (Breast cancer) Women who were experiencing more than three hot flashes per day, had no metastatic disease, were not undergoing or about to receive chemotherapy and were not currently on any other treatment for hot flashes were eligible for the study and recruited through poster advertising. Fifty-three women (out of 77 patients who registered) were randomized to receive either a homeopathic prescription (n=28) or placebo (n=25). Helios Homeopathic Pharmacy prepared the homeopathic medicines and placebos and sent the medicine directly to the patients’ homes. Both patients and investigators were blinded to the randomization. All patients had an initial consultation and then follow-up visits every four weeks for 16 weeks. The same doctor saw all patients and the homeopathic prescription could be modified during follow-up visits. The primary outcomes were the activity score and profile score from the Measure Yourself Medical Outcomes Profile (MYMOP), a validated instrument where a change of 0.8 is considered clinically relevant. Secondary outcomes included the Menopausal Symptom Questionnaire, patient diaries, quality of life, anxiety and depression, Final Assessment Questionnaire and the Homeopathic Hospital Outcome Scale.
Results: Five women withdrew from the homeopathic group because of metastatic disease (2), a change in medication (1), inappropriate allocation to study (1) and no reason given (1). Three women withdrew from the placebo group because of change in medication (1), long distance (1) and no reason given (1). A total of 71 different remedies were prescribed over the study period, with the most common ones including sulfur, sepia, carcinosin, Natrum muriaticum, belladonna and arnica. Clinically relevant within-group improvements were seen for symptoms and mood disturbance, with 75% of women reporting marked or major improvement. There was no statistically significant difference between the two groups for either MYMOP activities of daily living or overall profile score. No significant differences in adverse events were seen.
Note: The authors noted that post hoc power calculations suggested a sample size of 65-175 was needed per group to detect differences.

¹⁹Balzarini A, Felisi E, Martini A, De Conno F. Efficacy of homeopathic treatment of skin reactions during radiotherapy for breast cancer: a randomised, double-blind clinical trial. British Homeopathic Journal 2000 Jan;89(1):8-12`

Purpose: Relief of side effects on skin
Type of Study: Randomized, double-blinded controlled trial (Jadad score 4 – randomization not fully described)
Methods: (Breast cancer) Patients who had received surgery and were undergoing radiotherapy were recruited sequentially and enrolled in this study (32 treatment, 29 controls). Both groups used a topical medication containing fluocortolone. The homeopathic group also received a diluted solution of Belladonna (7cH) plus a water-alcohol solution irradiated up to a concentration of 10-30 and the other group received placebo solutions. Patients were checked weekly during the six-week radiotherapy and at 15 and 30 days after its completion. Evaluation included skin color, heat to the touch, edema and hyperpigmentation. Scales used and statistical evaluation of differences are described in the report.
Results: Five patients dropped out; four due to effects of radiation and one due to increased symptoms with the homeopathic medicines. Edema was more frequent in the homeopathic group in all weeks except the second and it was statistically significant in the fifth and sixth weeks (41% compared with 16%, P = 0.025). Hyperpigmentation was significantly less in the homeopathic group during the fifth week (P = 0.05) and approached significance in the eighth week (P=0.06). Erythema (redness) was of the same frequency and severity in the two groups. Heat of the skin to the touch was significantly less in the homeopathic group in the third, fourth, sixth and seventh observations (all P-values .02 or less), but this significance was lost by the eighth observation, which was 30 days after the end of radiation. Analysis of variance (Anova) of Total Severity Indexes during radiation and during recovery indicated less average severity with homeopathy during both time periods that was significantly less during recovery (homeopathy standard deviation 1.343, placebo s.d. 2.079, P-value = 0.05).

²⁰Oberbaum M, Yaniv I, Ben-Gal Y, Stein J, Ben-Zvi N, Freedman L, et al. A randomized, controlled clinical trial of the homeopathic medication TRAUMEEL S in the treatment of chemotherapy induced stomatitis in children undergoing stem cell transplantation. Cancer 2001;92(3):684-90.

Purpose: Relief of chemotherapy induced stomatitis
Type of Study: Randomized controlled trial (Jadad score 4)
Methods: (Lymphoma and leukemia) Patients between the ages of three and 25 with malignant disease who had undergone allogeneic or autologous stem cell transplantation admitted to a medical center were eligible for the study. A total of 32 patients were enrolled in the trial and randomized to receive either a homeopathic medication, TRAUMEEL S (n=16) or a placebo (n=16). Both TRAUMEEL S and the placebo were provided by the HEEL company, and did not differ in color, taste or odor. Treatment began on day 2 after stem cell transplantation. Patients were instructed to take either TRAUMEEL S or placebo (30 second mouth rinse, five times daily), in addition to the standard mouth care (twice-daily mouth washes with chloroheximide, oral amphoterin B and gentle tooth brushing). Stomatitis was evaluated using the World Health Organization grading system for mucositis (Grade 0, no complaints; Grade 4, very severe complaints). Area under the curve (AUC), the sum of the grade on each day from start of treatment, and time to first worsening, were the main treatment outcomes. The trial continued until the patient received a Grade 0 for two consecutive days or for at least 14 days after the start of treatment in patients with no symptoms. Patients were evaluated at least once every two days. Both patients and evaluators were blind to the randomization.
Results: One patient from each study group withdrew from the study, complaining of nausea and these patients are not included in the analysis because they were not subsequently evaluated for stomatitis. Study groups were comparable at baseline with the exception of disease distribution. There were seven versus three patients with acute myelogenous leukemia and zero versus three patients with lymphoma in the TRAUMEEL S and placebo groups, respectively. One placebo patient received TRAUMEEL S, but was analyzed according to the intent-to-treat principle. A statistically significant difference was found in the mean AUC scores between TRAUMEEL S (10.4) and placebo (24.3) (Wilcoxon rank-sum score, 167.5; expected score, 232.5; p<.01), suggesting TRAUMEEL S reduced the severity and/or duration of stomatitis. This remained statistically significant when only patients less than 15 years were analyzed (Wilcoxon rank-sum score, 93; expected score, 126.5; p<.01). Worsening of symptoms occurred in 47% of TRAUMEEL S patients and 93% of placebo patients. The median time to worsening was longer and statistically significant in the TRAUMEEL S group (4.7 days) compared with the placebo group (4.0 days) (p<.001). Patients in the TRAUMEEL S group showed a reduction of severity of dryness of mouth, oral pain, and eating difficulty, compared to the placebo group. There were no significant differences between groups regarding adverse effects or death.

Randomized but Unblinded Controlled Studies (1)

²¹Kulkarni A, Nagarkar BM, Burde GS. Radiation protection by use of homeoopathic medicines. Hahnemann Homoeopath Sand 1988;12:20-3.

Purpose: Relief of side effects of radiation
Type of Study: Randomized controlled trial (Jadad score 1)
Methods: (Various cancers) Patients with different types of cancer were randomized to either placebo, or one of two different types of homeopathic remedies. The two homeopathic remedies (cobaltum 30 or causticum 30) were selected because they mimicked various symptoms of radiation reaction.
Results: The index score for reactions to radiation was lower in both intervention groups compared to placebo, but no significant differences in tumor reductions were seen in the study.
Note: This summary based upon assessment in the 2006 collaborative review¹⁶.
Prospective Controlled Studies (1)

²²Oberbaum M. Experimental treatment of chemotherapy-induced stomatitis using a Homeopathic complex preparation: A preliminary study. BioMedical Therapy 1998 Oct;16(4):261-5.

Purpose: Relief of side effects
Type of Study: Prospective non-randomized controlled trial preliminary to above randomized and blinded controlled trial²⁰
Methods: (Various cancers) Treatment of chemotherapy induced stomatitis (mouth ulcers) with “Traumeel^®”, a popular European homeopathic drug, was evaluated in this study. Traumeel is an oral liquid containing the following ingredients in an isotonic saline solution (arnica, calendula, millefolium, chamomille, symphytum, belladonna, aconitum, Bellis perennis, hypericum, Echinacea angustifolia, Echinacea purpurea, hamamelis, mercurius and Hepar sulfuris. The treatment group included 20 children and teenagers who were compared with seven randomly chosen controls from the same ages with similar stages of cancer and conventional treatment.
Results: Significantly fewer days of symptoms were observed in the homeopathic group (six median days versus 13 days) so a larger and double-blinded trial of this therapy was subsequently begun in two medical centers in Israel²⁰.

Prospective Uncontrolled Studies (4)

²⁵Clover A, Ratsey D. Homeopathic treatment of hot flushes: a pilot study. Homeopathy: the Journal of the Faculty of Homeopathy 2002 Apr;91(2):75-9.

Purpose: Relief of side effects
Type of Study: Prospective uncontrolled trial
Methods: (Breast cancer) All new patients referred to a homeopathic hospital during a one-year period with a principal complaint of hot “flushes” (flashes) were included in the study. Three groups were enrolled
Women with no history of carcinoma of the breast
Those with breast carcinoma who had taken Tamoxifen
Those with breast carcinoma who had not taken Tamoxifen
Follow-up consultations included review of conventional medication likely to influence hot flashes particularly changes in Tamoxifen prescriptions. Assessments included baseline and – questionnaires concerning severity and frequency of hot flashes.
Results: The majority of women in each of the groups (73%, 86% and 77%) reported improvement in severity and frequency of hot flashes during the one-year trial period. However, this was a small pilot study (n=31) and no measures of statistical significance were reported²⁵.

²⁶Thompson EA and Reilly D. The homeopathic approach to symptom control in the cancer patient: a prospective observational study. Palliative Medicine 2002 May;16(3):227-33.

Purpose: Relief of side effects
Type of Study: Prospective uncontrolled trial
Methods: (Various cancers) One hundred consecutive patients at the Glasgow Homeopathic Hospital were invited to join this study. Ages were from 41 to 55 and most were women (81) whose most common diagnosis was breast cancer. Thirty-nine had metastatic disease and nine patients were refusing conventional treatment. They were seen for a one-hour consultation during which an individualized homeopathic medicine was prescribed. They were asked to identify a maximum of three symptoms that they rated as a problem and to complete the Hospital Anxiety and Depression Scale and the European Organisation for Research and Treatment in Cancer-Quality of life Questionnaire at the initial consultation and at four to six consultations during the next three years (March 1996 to August 1999). The most common symptoms were pain (including joint pain), fatigue and hot flashes.
Results: Fifty-six patients completed the study, 26 died during the study and 18 dropped out after two to three visits. For the 69 patients who had at least two follow-ups significant improvements occurred in mean scores for hot flashes, fatigue, “other” symptoms, anxiety and depression, but not pain. For the 67 patients who had at least two follow-ups, significant improvements occurred in hot flashes, fatigue and “other” symptoms. However, 30% of those experiencing improvement felt that other factors may have contributed such as exercise and weight loss, change in conventional medication, surgery, chemotherapy and time. Quality of life scores (EORTC scale) improved for 59%, remained the same for the 11% with initially high scores and deteriorated for the remaining 30% of the patients completing at least two follow-ups. (Mean scores, mean changes, standard deviations and P-values for t-tests are all reported in the article.)²⁶

²⁷Thompson EA, Reilly D. The homeopathic approach to the treatment of symptoms of oestrogen withdrawal in breast cancer patients. A prospective observational study. Homeopathy: the Journal of the Faculty of Homeopathy 2003 Jul;92(3):131-4.

Purpose: Relief of side effects
Type of Study: Prospective uncontrolled trial
Methods: (Breast cancer) Forty-five consecutive patients (ages 34-71) with metastatic cancer were enrolled and none of them had refused conventional treatment. They were asked to identify a maximum of three symptoms that they rated as a problem and to complete the Hospital Anxiety and Depression Scale and the European Organisation for Research and Treatment in Cancer-Quality of life Questionnaire at the initial consultation and at three to five consultations during the next three years (June 1997 – June 2000). The most common symptoms were hot flashes, mood disturbances, joint pains and fatigue.
Results: Forty women completed the study. Mean scores for hot flashes and symptoms other than joint pain and stiffness decreased significantly while quality of life and well-being scores increased significantly. (Mean scores, mean changes, standard deviations and P-values for t-tests are all reported in the article.)
Note: This study is described as a follow-up to the previous study by the same author in which “recruitment continued”; however, this study is limited to patients with breast cancer and the study period dates overlap.

²⁸Schlappack O. Homeopathic - itching

Purpose: Relief of side effects
Type of Study: Prospective uncontrolled trial
Methods: (Breast cancer) Between January 2002 and May 2003, 140 patients were treated with radiation and had a homeopathic consultation at a hospital in Austria. Patients were asked to record a visual analogue scale, where 0 was no problem and 100 was severe problems before taking the homeopathic medication and at evaluation. Ninety of the patients had breast cancer, 25 of whom complained of radiation-induced itching. Visual analogue scales of itching for this subset were analyzed from one to 27 days (median 3) after taking the homeopathic medicine. Twelve different homeopathic medicines were prescribed with Fluoric acid given most often.
Results: Patients’ age ranged from 39 to 72 years (median 61 years), and the majority had either stage 0 or stage 1 disease. Reddening and dryness of the skin with tiny pustules were the most common local signs of itching. Nine of 13 who received the Fluoric acid responded. In total, 14 out of 25 responded to the first medicine, and of the remaining, seven out of nine responded to the second medicine. Overall, 84% of patients had relief of itching after being treated with homeopathic medicine. Half were relieved after the first medicine, but the rest after the second medicine. The difference in the visual analogue scale before (median 64 mm, range 20-100 mm) and after (median 34 mm, range 0-84 mm) homeopathic treatment was statistically significant (p=0.000). Case reports of three of the women treated are provided in the article.
Best Case Series (1)

⁹Ramakrishnan AU, Coulter. A Homoeopathic Approach to Cancer. St. Louis, Missouri, U.S.: Quality Medical Publishing, Inc., 2001.

Purpose: Anti-cancer effects
Type of Study: Best case series
Methods: A series of 117 cases are described by the British physician who were treated them for cancer with homeopathic prescriptions. Patient histories, rationales for the physician’s choice of homeopathic substances and outcomes are provided.
Results: It is not possible to reliably summarize the results of this series of cases due to the lack of adequate documentation and an independent peer-reviewed process. Such a peer-reviewed process would have required more details concerning the timing and extent of conventional treatment, methods of diagnostic verification of tumor regressions, and status of the patients’ disease as of established dates of latest follow-up. The Office of Cancer Complementary and Alternative Medicine of the U. S. National Cancer Institute now provides assistance with the preparation and requirements for such reviews.
Case Reports (12)

²⁹Masiello DJ. Melanoma. American Journal of Holistic Medicine Winter 2003-4 Apr; 96(4):318-20.

Purpose: Anti-cancer effects
Type of Study: Case reports
Methods/Results: This case is described by a homeopathic physician with a friend who did not believe in homeopathy. His friend was a young man who had been diagnosed with melanoma on his arm in January of 1999. It was surgically excised, but metastasized to one of 32 lymph nodes. He was given homeopathic treatments limited to supportive measures for wound healing and edema. Subsequently, he was enrolled in a clinical trial for a vaccine, but the trial was ended due to canceling of federal funds and he had a local recurrence of the melanoma. Local injections of chemotherapy failed to stop its growth so he then had infusions of chemotherapy into his arm that also failed to control the disease. Reluctantly, he began daily use of the homeopathic remedy, Fowler’s Solution (potassium arsenic) to which carcinosin (cancer of the breast and sometimes other cancers) was subsequently added.
Results: In a month or two, the tumor had shrunk by 25%. Carcinosin and Kali arsenicosum. Four months later, the satellite nodules disappeared as confirmed by biopsy. By the following year, no tumors were visible and he had a negative PET/CT scan. As of May 2003, he was continuing to do well.
Note: The homeopathic remedies used were borrowed in modified form from those of Dr. Ramakrishnan’s protocol described in the best cases series above9.
Comment: This interesting case calls for a full-scale review of both conventional and homeopathic treatment records by an independent reviewing organization such as The Office of Cancer Complementary and Alternative Medicine of the U. S. National Cancer Institute.

¹⁰Montfort H. A new homeopathic approach to neoplastic diseases: from cell destruction to carcinogen-induced apoptosis. British Homeopathic Journal 2000 Apr;89(2):78-83.

Purpose: Anti-cancer effects
Type of Study: Case reports
Methods/Results: (Lung, brain, uterus) This doctor provides a thorough description of his rationale and ethics for treating patients with “ultra-low doses” of chemical carcinogens (benzopyrene, nitrated guanine, nitrated xanthine, arsenicum album, nitrated guanidine, methyl cholantrene). His rational includes references to the paradoxical role of such substances in both promoting and controlling malignant cells in the conventional treatment of cancer. He describes three cases:
A man with lung cancer received chemo/radiotherapy and homeopathic medicines. Surgical excision of the primary revealed only fibrous tissue, but multiple metastases developed five months later.
A young boy with an astrocytoma had 60% of his tumor surgically removed, but subsequent chemo/radiation failed to stop tumor regrowth so his parents decided to try homeopathic treatment. After six months, tumor growth stopped according to NMR. Forty-five months later (almost four years) he was completely asymptomatic, but subsequently developed a recurrent brainstem tumor that was inoperable. Chemotherapy and radiotherapy were again given and the tumor was reduced in size.
A woman had metastasis to the lung from a leiomyosarcoma of the uterus that affected 80% of her lungs. Six months of chemotherapy reduced the number of metastases, but she had to stop due to thrombocytopenia. She then began homeopathy and subsequent chest X-rays showed improvement finally reducing the number of shadows to 10-15% of the original count.
Comment: It is not possible to separate the effects of homeopathy from conventional treatment in these individual cases.

³⁰Thompson E, Hicks F. Intrathecal balclofen and homeopathy for the treatment of painful muscle spasms associated with malignant spinal cord compression. Palliative Medicine 1998 Mar;12(2):119-21.

Purpose: Relief of side effects
Type of Study: Case report
Methods: In this case report, homeopathy was used to complement the conventional treatment of 70-year old man had painful muscle spasms associated with spinal cord compression due to bone metastases from a carcinoma of the kidney. He was finally admitted to a hospice where conventional treatment consisted of muscle relaxants and anesthetics both orally and through venous catheter, but side effects of sedation, confusion and infection limited effectiveness. Homeopathy was finally initiated with a consultation session during which the patient was encourage to speak of what was uppermost in his mind in order to select an appropriate therapy. Issues of violent attacks by others similar to his violent muscle spasms let to the prescribing of diluted copper.
Results: After 48 hours, his spasms were worse, but then improved over a 10-day period. One muscle relaxant was gradually stopped and his catheter removed as his general well-being improved. He was even discharged from the hospice; however, a few months later had to be readmitted with similar problems that were managed by restarting other medications along with the homeopathic medicine. As of the writing of the article it had been over five years since his admission for terminal care and his cancer had remained stable.

¹¹Bianchi I. Carcinoma of the Choledochus, of the ovaries and of the liver. Biological Therapy Jan92;10(1):212-18.

Purpose: Anti-cancer effects
Type of Study: Case reports
Methods/Results: Rationale and protocol for treating cancer are described and three cases are presented:
A 58-year old woman had a large tumor with satellite lesions in her liver apparently diagnosed by x-ray. After three months of homeopathic treatment, the biggest neoplasm had shrunk by 45 mm and the appetite and general health of the patient had improved so that she was free of pain.
This 78-year old woman apparently had some sort of lymph node enlargements in her liver and blockage of her bile duct that was relieved with homeopathy. Again, no definitive diagnosis of cancer was provided.
A 56-year old woman had multiple lung metastases one year after a hysterectomy due to an adenocarcinoma of the ovary. After an “intensive” three months of treatment the biggest node was “markedly reduced” and the nodes in one node disappeared. No statement is made as to how long afterwards this occurred and for how long it lasted.

³¹Benmeir P, Neuman A, Weinberg A, Sucher E, Weshler Z, Lusthaus S, et al. Giant melanoma of the inner thigh: a homeopathic life-threatening negligence Annals of Plastic Surgery 1991 Dec;27(6):583-5.

Type of Study: Case report
Methods/Results: A 37-year-old woman had a Clark 2 nodular melanoma on the calf of her leg that was surgically excised. Two months later she developed a swollen mass on her the inguinal area of the same leg. Instead of returning for her scheduled follow-up at the hospital where the original surgery had been performed, she sought out homeopathic treatment from a practitioner who was not a physician. Eight months later (10 months after the original surgery), the mass had become so large that she was unable to walk so she returned to the hospital. The mass was diagnosed as a probable metastasis of the inguinal node and most of the mass was surgically removed. She then received radium implants and the mass necrosed. The wound healed well and seven months later she was free of symptoms and metastases.
Note: A letter in response to this case described the next case.

³²Escudero Nafs FJ, Guinot Madridejos A, Solano Carreira I, Beltran de Heredia I. Re: Giant melanoma of the inner thigh: a homeopathic life-threatening negligence (letter; comment). Annals of Plastic Surgery 1992 Nov;29(5):478.

Type of Study: Case report
Methods/Results: A 42-year-old woman had an excisional biopsy for a Clark 4 nodular melanoma on her neck. She did not return for follow-up and a huge mass developed in the same area. She sought homeopathic treatment that apparently had no effect. Subsequently (amount of time not stated) she went to another hospital where she received surgery and radiation for a Clark 5 nodular melanoma. She was negative for metastasis, but died four months later (no further details provided).

³³Ehring F. Regression of over 150 skin metastases of malignant melanoma with complex homeopathic therapy. Hautarzt 1989 Jan;40(1):23-7.

Type of Study: Case report
Methods/Results: A woman (age not reported) had over 150 cutaneous metastases that developed near a melanoma on the calf of her leg. Conventional treatment was not specified. Over a period of eight years, all but one metastasis disappeared, but she died a year later after melanoma had metastasized to her lungs and brain.
Note: It has been estimated that 5% to 8% of melanoma primaries may regress in the absence of destructive treatment possibly due to immune responses. However, some malignant cells may escape immune destruction and simply spread at deeper levels where they later become evident in nodal metastases34,35.

³⁶Bradley GW, Clover A. Apparent response of small cell lung cancer to an extract of mistletoe and homoeopathic treatment. Thorax 1989 Dec;44(12):1047-8.

Type of Study: Case report
Methods: In February of 1983, a 59-year-old man had small cell carcinoma of the lung diagnosed in 1983 by bronchoscopy. He refused chemotherapy and began treatment with homeopathy and mistletoe, which he continued until April of 1986 when he was lost to homeopathic follow-up.
Results: The tumor was advanced by August 1983 according to a chest x-ray, but by April of 1984 he had a normal chest x-ray. His chest x-ray remained normal, but by October of 1984 he had developed cancer in the lymph nodes of his supraclavicular fossa. In May of 1985 he accepted radiation and by February of 1987 he had a chest x-ray that was “virtually normal”. In February of 1988 a chest x-ray indicated recurrence of the tumor. He resumed treatment with homeopathy, but had to be admitted to hospital in September of 1988 where he gradually declined until his death in October of 1988.

³⁷Tsur M. Inadvertent child health neglect by preference of homeopathy to conventional medicine. Harefuah 1992 Feb;122(3):137-42.

Purpose: Disease response.
Type of Study: Case report.
Methods: (Acute lymphocytic leukemia) Of four children whose parents refused conventional treatment and opted for homeopathic treatment because of religious beliefs, only this one case was cancer.
Results: The child had severe and unusual, but preventable, complications. This case was considered by the authors to be an example of inadvertent child health neglect because of false beliefs or lack of knowledge.

³⁸Rosenbaum P, Waisse-Priven S, Schunemann C. Elaps in advanced pathology - a case study. Homeopathy 2004;93:51-3.

Type of Study: Case report
Methods: (Rectal adenocarcinoma) A 70-year-old female, five years after surgery for rectal adenocarcinoma, presented with a variety of physical and psychological symptoms. Homeopathic treatment was selected on the basis of individualization of symptoms, where treating the minimum syndrome produces maximum value. Minimum symptoms were dreams of falling, desire/aversion of oranges and fear of snakes. One drop daily of Elaps corallinus was prescribed. The patient was followed for one year.
Results: At one year, the patient had better disposition, a more active life, less anxiety, improved sleep and appetite, harder stools, improved urinary pain and improved pain in hands and feet. Prior to homeopathic treatment, she was diagnosed with pulmonary tuberculosis, and the symptoms remarkably improved over the course of homeopathic treatment.

³⁹Rajendran E. Homeopathy as a supportive therapy in cancer. Homeopathy 2004;93:99-102.

Purpose: Disease response and relief of side effects
Type of Study: Case reports
Case 1: A 64-year-old male was diagnosed with metastatic adenocarcinoma of the rectum and refused surgery. He was treated with Lycopidium, unmedicated lactose tablets, and Ruta MT. Patient survived approximately 2.5 years with no further hospitalizations and only minor complications.
Case 2: A 77-year-old female with squamous cell carcinoma of the face who had previously undergone radiation nine months previously with good response, but six months after surgery ulceration had spread and patient was in severe pain not relieved by analgesics. She was treated with Calc Carb, which provided pain relief before her subsequent death.
Case 3: A 70-year-old male was diagnosed with carcinoma of the larynx and took homeopathic medicines on his own for four months. He then consulted a homeopathic physician who refused to give homeopathic treatment and advised immediate surgery. The patient had surgery followed by radiation and chemotherapy. He then began prescribed homeopathic treatment with Ferrum-phos for the relief of side effects and other various symptoms. At three-year follow-up, he was symptom-free.

⁴⁰Schumacher H, Huang S. A 20-year-old basal cell carcinoma. Plastic and Reconstructive Surgery 2005;115(2):668-9.

Purpose: Disease response
Type of Study: Case report
Methods: (Basal cell carcinoma) A 74-year-old woman with xeroderma pigmentation had a basal cell lesion on her face treated with an injection of mistletoe by a homeopathic physician. She was also receiving concurrent treatment from a dermatologist which included Roaccutane.
Results: The lesion remained stagnant for 20 years until it was surgically removed.

Animal Studies

Five animal studies from the same laboratory of the homeopathic remedies Chelidonium^41,42, Arnica-30⁴³ and Arsenicum Album-30^44,45 and one animal study on Canova⁴⁶ are not included in this review, but links to abstracts provided by their authors are provided through PubMed.

⁴¹Biswas SJ, Khuda-Bukhsh AR. Effect of a homeopathic drug, Chelidonium, in amelioration of p-DAB induced hepatocarcinogenesis in mice. BMC Complementary & Alternative Medicine 2002 Apr 10;2(1):4.

⁴³Chakrabarti J, Biswas SJ, Khuda-Bukhsh AR. Cytogenetical effects of sonication in mice and their modulations by actinomycin D and a homeopathic drug, Arnica 30. Indian Journal of Experimental Biology 2001 Dec;39(12):1235-42.

⁴⁴Datta S, Mallick P, Bukhsh AR. Efficacy of a potentized homoeopathic drug (Arsenicum Album-30) in reducing genotoxic effects produced by arsenic trioxide in mice: comparative studies of pre-, post- and combined pre- and post-oral administration and comparative efficacy of two microdoses. Complementary Therapies in Medicine. 1999 Jun;7(2):62-75.

⁴⁵Datta S, Mallick P, Bukhsh AR. Efficacy of a potentized homoeopathic drug (Arsenicum Album-30) in reducing genotoxic effects produced by arsenic trioxide in mice: II. Comparative efficacy of an antibiotic, actinomycin D alone and in combination with either of two microdoses. Complementary Therapies in Medicine. 1999 Sep;7(3):156-63.

⁴⁶Sato D, de Oliveira C, Cattaneo R, Malvezzi M, Gabardo J, Buchi Dde F. Histopathological and immunophenotyping studies on normal and sarcoma 180-bearing mice treated with a complex homeopathic medication. Homeopathy: the Journal of the Faculty of Homeopathy 2005;94(1):26-32. PubMed Abstract

⁴²Biswas S, Khuda-Bukhsh A. Evaluation of protective potentials of a potentized homeopathic drug, Chelidonium majus, during azo dye induced hepatocarcinogensis in mice. Indian Journal of Experimental Biology 2004;42(7):698-714. PubMed Abstract

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37. Tsur M. Inadvertent child health neglect by preference of homeopathy to conventional medicine. Harefuah 1992 Feb;122(3):137-42.
38. Rosenbaum P, Waisse-Priven S, Schunemann C. Elaps in advanced pathology - a case study. Homeopathy 2004;93:51-3.
39. Rajendran E. Homeopathy as a supportive therapy in cancer. Homeopathy 2004;93:99-102.
40. Schumacher H, Huang S. A 20-year-old basal cell carcinoma. Plastic and Reconstructive Surgery 2005;115(2):668-9.
41. Biswas SJ, Khuda-Bukhsh AR. Effect of a homeopathic drug, Chelidonium, in amelioration of p-DAB induced hepatocarcinogenesis in mice. BMC Complementary & Alternative Medicine 2002 Apr 10;2(1):4.
42. Biswas S, Khuda-Bukhsh A. Evaluation of protective potentials of a potentized homeopathic drug, Chelidonium majus, during azo dye induced hepatocarcinogensis in mice. Indian Journal of Experimental Biology 2004;42(7):698-714.
43. Chakrabarti J, Biswas SJ, Khuda-Bukhsh AR. Cytogenetical effects of sonication in mice and their modulations by actinomycin D and a homeopathic drug, Arnica 30. Indian Journal of Experimental Biology 2001 Dec;39(12):1235-42.
44. Datta S, Mallick P, Bukhsh AR. Efficacy of a potentized homoeopathic drug (Arsenicum Album-30) in reducing genotoxic effects produced by arsenic trioxide in mice: comparative studies of pre-, post- and combined pre- and post-oral administration and comparative efficacy of two microdoses. Complementary Therapies in Medicine. 1999 Jun;7(2):62-75.
45. Datta S, Mallick P, Bukhsh AR. Efficacy of a potentized homoeopathic drug (Arsenicum Album-30) in reducing genotoxic effects produced by arsenic trioxide in mice: II. Comparative efficacy of an antibiotic, actinomycin D alone and in combination with either of two microdoses. Complementary Therapies in Medicine. 1999 Sep;7(3):156-63.
46. Sato D, de Oliveira C, Cattaneo R, Malvezzi M, Gabardo J, Buchi Dde F. Histopathological and immunophenotyping studies on normal and sarcoma 180-bearing mice treated with a complex homeopathic medication. Homeopathy: the Journal of the Faculty of Homeopathy 2005;94(1):26-32.