Description
Homeopathy is a system of medicine based on the similia (‘treating like with like’) principle. It usually entails taking highly diluted remedies by mouth. Homeopaths aim to treat the individual patient holistically such that the body is stimulated to heal itself. Homeopathy is thus advocated for all human conditions; in oncology, this is mostly for palliative and supportive care.
A systematic review of eight controlled clinical trials of homeopathy for the prevention or treatment of adverse effects of cancer treatments concluded that the evidence is not convincing. Results from seven more recent trials and a systematic review including 18 trials fail to demonstrate that homeopathy is an effective therapy for cancer.
Efficacy
Supportive and palliative care
Radiation-related dermatitis: Preliminary evidence suggested an effect of Calendula extract ointment on dermatitis (1 RCT, n=254) but the effect is likely to be pharmacological rather than homeopathic due to the concentration of active ingredient. No evidence is available on other remedies (2 RCTs).
Mucositis/stomatitis: Positive effects reported initially (1 RCT) have not been confirmed in subsequent trials (2 CCTs).
Global health status and wellbeing: Some evidence exists for a beneficial effect of individualised homeopathy on global health status and wellbeing but due to a high risk of bias, this evidence is not conclusive (one RCT, n=410).
Fatigue and quality of life: Positive effects have been reported of a beneficial effect of homeopathy added to conventional treatments on fatigue and quality of life (1 RCT and 2 observational studies) but this is preliminary evidence and further confirmation is required.
Chemotherapy-induced nausea and vomiting (CINV): There is currently no evidence of an effect of homeopathic remedies on CINV (2 RCTs).
Venous function: There is currently no evidence of an effect of homeopathic medicines on venous function (1RCT).
Menopausal symptoms: There is currently no evidence of an effect of homeopathy on menopausal symptoms associated with medication in cancer patients (3 RCTs).
Joint pain: There is very low grade evidence of an effect for joint pain related to aromatase inhibitors (1 non-randomized trial).
Recovery after surgery: There is no evidence of an effect of homeopathy on recovery after breast cancer surgery (2 trials)
Anxiety and depression: no differences were seen between homeopathy and placebo in a small trial in breast cancer patients (1 trial) or in a non-randomised prospective study in various cancers.
Antitumour treatment
Survival: The evidence from one study of the effect on survival is not convincing.
Safety
There are no serious direct risks associated with homeopathy but there are indirect risks, if homeopathic preparations are used in place of conventional cancer treatment.
Description
Homeopathy (or homoeopathy) is a system of medicine based on the similia principle. This states that “substances may be used to treat disorders whose manifestations are similar to those which they will themselves induce in a healthy subject (‘let like be cured by like’) (Swayne 2000). It usually entails taking highly diluted remedies by mouth of substances thought to cause similar symptoms to those being treated. Homeopathic remedies are frequently made from natural substances, e.g. plants or minerals, but in principle they can originate from any material.
Homeopathic preparations are produced through a process of serial dilution and succussion/shaking (potentisation) of the “mother tincture”. Preparations are available in a range of dilutions, from low dilutions where concentrations of the original substance are measurable, to extremely high dilutions in which it is unlikely that a single molecule of the original substance remains (Swayne 2000).
Homeopathic potencies are designated by a number and a letter. The number refers to the number of successive serial dilutions to which the starting material has been subjected. The letter refers to the scale used, the decimal (D or X) and centesimal scales (C) being those most widely used. In the decimal method a 1 in 10 dilution is used at each stage while in the centesimal method a 1 in 100 dilution is used in successive stages (Swayne 2000).
Background and prevalence
Homeopathy was developed by the German doctor Samuel Hahnemann (1755-1843) and became popular, first in Europe, then in a wide variety of countries around the world, especially in the US, India, and South America. When more and more effective pharmacological treatments were discovered, its popularity decreased. Recently, it has experienced somewhat of a renaissance in parallel with the growing interest in CAM.
Homeopathy’s prevalence of use depends on the country and the setting. For instance, homeopathy is popular in France (Thomas-Schoemann 2011), Italy (Clerici 2009) and Germany (Längler 2011). Prevalence appears to vary by type of cancer; for example, surveys across a range of European countries suggested higher rates of use in breast cancer (16-24%) compared with gynecological cancers (<5%) (Molassiotis 2006a; Molassiotis 2006b).
Alleged indications
Homeopaths believe that homeopathic remedies stimulate the body’s own healing powers (vis medicatrix naturae), i.e. the inherent ability of an organism to overcome disease and disorder and regain its health (Swayne 2000). Therefore, Hahnemann viewed homeopathy as a “cure all” (Ernst 1998). Today it is mostly advocated as a treatment or prevention of chronic conditions and often administered as an adjunctive treatment (Spence 2005).
In oncology, homeopathy is mostly but not exclusively used as palliative and supportive care to improve quality of life, to ease or prevent the adverse effects of treatments, or to alleviate or prevent the symptoms of the cancer.
Application and providers
Homeopathic remedies are usually prescribed on a highly individualized basis; ideally, the totality of the patient’s complaints should match the “drug picture” of the remedy which has been defined in so-called “provings”, i.e. homeopathic pathogenetic trials. These are studies which test a substance at a non-toxic level on healthy volunteers to determine the symptoms it provokes and which, according to the similarity principle, it may be used to treat (Ernst 1998).
Today, there are several variations of homeopathy as described above e.g. isopathy (homeopathically diluted remedies derived from the causative agent of the disease itself), or homotoxicology (illness is understood as the body’s inability to effectively cope with its burden of toxins), or complex homeopathy (combination of two or more homeopathic medicines in a standardised mixture), or clinical homeopathy (one or more single remedies for standard clinical situations) (Swayne 2000).
Mechanism of action
No biologically plausible mechanism of action is known. A 2007 systematic review of in-vitro research on high potency effects found that “no positive result was stable enough to be reproduced by all investigators”; however, it also stated that “even experiments with high methodological standard could demonstrate an effect of high potencies” (Witt 2007). The fact that homeopathic preparations “may exhibit specific physiochemical properties” (Baumgartner 2009) does not mean that a mechanism of action has been identified. Several recent pre-clinical investigations have suggested direct anti-cancer effects of homeopathic preparations on tumour cells, such as apoptosis and stimulation of natural killer cell activity (Preethi 2012; Toliopoulos 2013). However, these findings require independent replication.
Legal status
Homeopathy is practised by medical doctors, other health professionals and by lay homeopaths (or “professional homeopaths”). The former two groups are statutorily regulated by their professional bodies, while the latter are often not regulated. In the UK, for example, anyone regardless of background can currently practise as a homeopath. Homeopathic preparations can be prescribed by a homeopath during a consultation but can also be purchased from health food shops, some pharmacies or online suppliers.
Non-medically qualified homeopaths are in many countries not regulated by statute. In some countries, for example the UK, it is illegal for homeopaths to claim they can cure cancer.
A 2009 Cochrane review aimed at evaluating “the effectiveness and safety of homeopathic medicines used to prevent or treat adverse effects of cancer treatments" (Kassab 2009). The authors found eight controlled clinical trials: three studied adverse effects of radiotherapy, three studied the adverse effects of chemotherapy and two investigated menopausal symptoms due to breast cancer therapy. A further seven controlled trials (randomised and non-randomised) were published subsequently and in 2022 a second systematic review was published (Wagenknecht 2022). This review included 18 studies of which 11 trials (9 RCTs and 2 CCTs) assessed effects of treatments and the remaining studies were used to assess safety. The controlled clinical trials of homeopathy in cancer supportive care are described in table 1. The authors concluded that there was no conclusive evidence from clinical studies to support the use of homeopathy in cancer care.
Description of studies
Supportive and palliative care
The systematic review by Kassab (2009) of 8 RCTs concluded that there was preliminary evidence for topical calendula for prophylaxis of acute dermatitis during radiotherapy and Traumeel S mouthwash in the treatment of chemotherapy‐induced stomatitis but that the trials need to be replicated. No convincing evidence was found for homeopathic medicines for other adverse effects of cancer treatments. The subsequent systematic review by Wagenknecht (2022) included 18 studies of various study types, the majority of which were judged to be low quality and concluded that there was no conclusive evidence from clinical studies in cancer care.
Radiotherapy-related dermatitis
The Cochrane review included three RCTs on this adverse effect of radiotherapy. One large, rigorous study of Calendula extract ointment (n=254) suggested benefit for the prevention of radiotherapy-induced dermatitis compared to controls treated with trolamine (Pommier 2004). While the ointment was apparently prepared according to the German homeopathic pharmacopoeia, it contains a concentration of active ingredient Calendula officinalis flowering tops of 20% w/w which may have had pharmacological (rather than homeopathic) activity. One RCT (n=66) compared homeopathic medicines (Belladonna 7c three granules twice daily and X‐ray 15c) with placebo (Balzarini 2000) and another RCT (n=82) compared homeopathic Cobaltum 30, homeopathic Causticum 30 and placebo (Kulkarni 1988). Both studies reported positive results for homeopathy but both were at unclear risk of bias. The Cochrane review concluded that there is no convincing evidence for the efficacy of homeopathic medicines (other than the ointment above) for adverse symptoms and skin reactions related to radiotherapy. A more recent systematic review (Wagenknecht 2022) included only one of the above studies (Balzarini 2000) noting that some of the outcomes were positive while others were negative and the scoring system was not internationally validated.
Mucositis/stomatitis
One small (n=32) yet rigorous study found that Traumeel S mouthwash (a proprietary complex homeopathic remedy) was better than placebo for chemotherapy-induced stomatitis. (Oberbaum 2001) The Cochrane review concluded that, based on this trial, Traumeel S appears to show promise in the treatment of chemotherapy‐induced stomatitis. One trial was ongoing (see Sencer et al. below). The Oberbaum study was not included in the more recent systematic review but the reason was not given (Wagenknecht 2022)
Subsequently, two further trials of Traumeel S were published. In 2012, Sencer et al published a multi-centre, double-blind, randomized trial comparing Traumeel with placebo in paediatric cancer patients suffering from mucositis. Traumeel or placebo was administered 5 times daily as a mouth rinse. The efficacy of the treatments was assessed using the modified Walsh scale for mucositis, scored daily from Day -1 to 20 days. The main outcome was the sum of Walsh scale scores over this period. Other outcomes included narcotic use, days of total parenteral feeding, days of nasogastric feeding and adverse events. In 181 evaluable patients, there was no significant inter-group difference in any outcome measure. This study was not included in a more recent systematic review (Wagenknecht 2022), possibly because only 87% of patients were cancer patients.
These findings from the Sencer study seem to tie in with those from a non-randomised, controlled clinical trial with patients suffering from radiation-induced mucositis. (Steinmann 2012) The participants were 20 patients who were receiving radiotherapy or radiochemotherapy for head and neck tumours. Five times per day during the observational period, participants self-administered daily mouth rinses with either sage tea (Salvia officinalis, control group) or Traumeel S solution (intervention group). Two independent physicians determined the grade of oral mucositis at least once per week, and the research team derived the degree of oral pain from diaries that participants kept. Both groups were comparable in terms of tumour and treatment characteristics. The research team could not confirm any appreciable specific effect of Traumeel S on the primary endpoints. The lack of effect was noted in the recent systematic review by Wagenknecht (2022).
Global health status and wellbeing
A large, pragmatic RCT involved 410 patients with various types of cancer who were randomised to receive classical homeopathy in addition to standard anti-cancer treatment or standard treatment alone. (Frass 2011). Homeopathy treatment was individually tailored to each patient. The main outcome measures were global health status and subjective wellbeing. Improvements in both were recorded in the homeopathy group based on questionnaires completed at baseline and the two follow-up visits at intervals of two months. At least one outcome measurement was obtained for 373 patients. The improvement in global health status between visits 1 and 3 was significantly greater in the homeopathy group by 7.7 (95%CI 2.3—13.0, p = 0.005) when compared with the control group. A significant difference was also reported for subjective wellbeing (14.7 95% CI 8.5—21.0, p < 0.001). This was a well-designed, rigorous study with adequate randomisation and allocation concealment, and procedures for dealing with missing data. However, the lack of a control intervention and consequent lack of blinding combined with patient-reported subjective outcome measures, mean that the risk of bias is high.
Fatigue and quality of life
A 2011 prospective controlled cohort study compared cancer patients who had opted for homeopathic treatments as an adjunct to conventional cancer therapies with patients who had chosen to have conventional care only. (Rostock 2011). Matched pairs were formed of patients with the same cancer type and prognosis. Encouraging effects in terms of fatigue and quality of life were noted after three months. It is unclear, however, whether the outcome was a result of the treatment or due to selection bias as this was an observational study.
The recent systematic review discussed 7 studies under the heading quality of life, quality of recovery, global health and subjective well‑being (Wagenknecht 2022). The conclusions were that the evidence was not conclusive.
Chemotherapy-induced nausea and vomiting (CINV)
The Cochrane review included one RCT that assessed effects of homeopathy on nausea and vomiting due to chemotherapy (Daub 2005). Sixty-five women with primary or recurrent breast cancer undergoing chemotherapy were randomised to receive either Vomitusheel S suppository and Gastricumeel oral tablets (each intervention being a combination of six homeopathic medicines) or Sambucus Nigra D3 oral tablets (a homeopathic medicine used as the placebo). There was no significant difference between the two groups which may have been due to a true lack of difference between the two arms or lack of power.
Subsequently, another complex homeopathic medicine, Cocculine (main homeopathic ingredient = nux vomica) was also tested in an RCT for the control of CINV in non-metastatic breast cancer patients treated by standard chemotherapy regimens. (Perol 2012). The primary endpoint was nausea score measured after the first chemotherapy course using the FLIE questionnaire (Functional Living Index for Emesis) with 5-day recall. Secondary endpoints were: vomiting measured by the FLIE score, nausea and vomiting measured by patient self-evaluation (EVA) and investigator recording (NCI-CTC AE V3.0) and treatment compliance. In total, 431 patients were randomized: 214 to Cocculine (C) and 217 to placebo (P). There was no difference between the 2 arms when primary endpoint analysis was performed by chemotherapy stratum; or in the subgroup of patients with susceptibility to nausea and vomiting before inclusion. In addition, nausea, vomiting and global emesis FLIE scores were not statistically different at any time between the two study arms.
A more recent systematic review (Wagenknecht 2022) included only the study by Perol and noted a difference in patient-reported vomiting in the third chemotherapy course that was not maintained in subsequent courses.
Venous function
One RCT included in the Cochrane review assessed whether homeopathic medicines could be used to protect venous function in women undergoing intravenous chemotherapy for breast cancer (Bourgois 1984). Twenty-nine women were randomised to receive either Arnica 5c or placebo for three days before and three days after intravenous chemotherapy for two cycles. No statistically significant differences between active and placebo groups and the study was assessed to be at high risk of bias. This thesis published in French was not included in the more recent systematic review (Wagenknecht 2022).
Menopausal symptoms
The Cochrane review in included two studies with a total of 136 participants that tested homeopathic medicines for the treatment of menopausal symptoms associated with breast cancer treatments. In the first trial, 83 women were randomised to receive individualised single homeopathic medicine, Hyland's Menopause (a proprietary complex homeopathic medicine or placebo. No significant differences in hot flush severity were observed. The second trial involved 53 women who were randomised to receive either individualised homeopathic medicines or placebo. Again, there were no statistically significant differences between groups and the review concluded that both high quality trials that provided no evidence for the efficacy of homeopathic medicines over placebo in women with breast cancer suffering from menopausal symptoms.
Subsequently, another complex proprietary preparation was tested against placebo for hot flushes due to endocrine therapy. (Heudel 2019) This was a larger (n=138), multicentre RCT but similar results were reported with no statistically significant differences between the preparation and placebo. All 3 studies were included in a more recent systematic review which also concluded that there was no convincing evidence of a beneficial effect (Wagenknecht 2022)
Joint pain
Homeopathic remedies have been tested in the treatment of joint pain related to aromatase inhibitors. (Karp 2016) Ruta graveolens 5CH and Rhus toxicodendron 9CH (5 granules, twice a day) in addition to standard treatment was compared to standard treatment alone in 40 women. A significant difference in pain score, sleep and analgesic consumption was reported but the trial was not randomised or blinded and the main outcome was self-assessed so there is a high risk of bias. This study was included in the recent systematic review and the weaknesses in the design were also highlighted (Wagenknecht 2022).
Recovery after surgery
A trial in Italy assessed Arnica Montana 1000 Korsakovian dilution (1000 K) or placebo in 53 women undergoing mastectomy. (Sorrentino 2017) Lower blood and serum volumes were reported but the p value reported suggests that differences were non-significant and there were no differences in other outcomes. The more recent systematic review (Wagenknecht 2022) also included a study in 55 patients undergoing mastectomy (Lotan 2020). Treatments were Arnica montana C30 and Bellis perennis C30 or a placebo. Some differences were found in time to drain removal but the groups differed in key baseline characteristics, the intervention involved two agents and no differences were found in pain, haemoglobin, opioid intake and cortisol levels.
Anxiety and depression
No significant differences were seen between homeopathy and placebo in a small trial in breast cancer patients according to Wagenknecht (2022) or in a prospective observational study comparing complementary homeopathic treatment or conventional cancer treatment (Rostock 2011).
Antitumour treatment
Survival
The recent review (Wagenknecht 2022) identified one RCT (n=150) that measured survival in patients with stage IV non‐small cell lung cancer who were treated with individualised homeopathy or placebo. Significant differences in median-, 2-year- mortality and estimated survival time were found but there were some baseline differences, uneven drop out and an unexplained high early death rate in the placebo group.
Adverse effects
Highly diluted remedies are unlikely to cause serious adverse effects. Less dilute remedies, that may still be described as ‘homeopathic, are likely to have a pharmacologic effect of the main active ingredient.
Contraindications
None known.
Other safety issues
The most serious risk of homeopathy is indirect: if homeopathic remedies replace conventional cancer treatment, this can cause adverse outcomes including premature deaths. In this context, it is important to realise that, according to one German survey (Rostock 2011), cancer patients seek homeopathic treatments much more frequently from providers who are not physicians than from physicians.
Homeopathy/homeopathic remedies should not be used as a replacement for conventional cancer treatment.
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Citation
Karen Pilkington and the CAM Cancer Consortium. Homeopathy [online document]. Dec 13, 2022.
Document history
Latest update: December 2022
Next update due: December 2025
