Does homoeopathy help reduce the side effects of treatment for cancer?

1.         Abstract
2.               Treatment
3.         Background
4.         Objectives
5.         Criteria for including studies
6.         Search strategy
7.         Data collection and evaluation of studies
8.         Description of studies
9.         Methodological quality
10.       Results
11.       Discussion of findings
12.       Conclusions
13.       References
14.      Further Resources

1. Abstract
Radiotherapy and chemotherapy treatments for cancer can have significant side effects. Many people being treated for cancer use alternative and complementary medicines. Homoeopathy is used by some people with cancer to alleviate the symptoms caused by the disease or the treatment.

Homoeopathic treatment involves giving extremely small doses of a substance (called a ‘remedy’) in a very dilute solution. The remedy is selected based on the total picture of the person and their symptoms, not just the symptoms of the illness. Various aspects of the person are considered, including their lifestyle, emotions, mental state and nutrition. (Vickers and Zollman 1999)

There is evidence that homoeopathy may reduce side-effects of radiotherapy, reduce the severity and duration of chemotherapy-induced stomatitis and reduce the total severity of skin reaction to radiotherapy.

There is evidence that homoeopathy does not reduce severity or frequency of menopausal symptoms in breast cancer survivors and may, in women not taking tamoxifen, increase the severity and number of hot flushes. There is also evidence in this group of women that there was an increase in number and severity of hot flushes taking the combination remedy and an increase in the number of headaches. No other side effects were reported in any of the studies.

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2. Treatment
Type of treatment: Homoeopathy

3. Background
Cancer is a common cause of death in developed countries. The non-surgical treatments, including radiotherapy and chemotherapy, can have significant side effects that can limit their use. Side effects from radiotherapy include tiredness, flu-like symptoms, loss of appetite, weight loss, reddened hot sensitive skin, pigmented skin, menopause-like symptoms, and emotional symptoms. Chemotherapy side effects include fatigue, nausea or vomiting, loss of appetite, diarrhoea, constipation, hair loss, mouth ulcers and dry, pigmented or sunlight sensitive skin. http://www.cancerhelp.org.uk/default.asp

A recent survey (Molassiotis, Fernadez-Ortega et al. 2005) has shown that homoeopathy is one of the commonest used complementary therapies for cancer. As a complementary treatment, homoeopathy is used mainly to strengthen the body, improve well-being and to alleviate symptoms caused by the disease or the treatment. (Milazzo, Russell et al. 2006)

Homoeopathy is a system of medicine developed in the late 1700s in Germany by Samuel Hahnemann.

Homoeopathic treatment involves giving extremely small doses of a substance (called a ‘remedy’) that, if given to a healthy person in larger doses, will cause the same or similar symptoms. This is the principle of similars or “like cures like”. Most homoeopathic remedies are derived from natural substances that come from plants, minerals or animals.

These remedies are prepared by a process of successive dilution and vigorous shaking (called ‘succusion’) between dilutions. This process is called ‘potentization’ and the more times the dilution and shaking is done, the more potent the remedy. The final remedy can be so dilute that no molecule of the original substance may be present. Theories of a mechanism of action include electromagnetic interactions, ‘memory of water’ and chaos theory. (Micozzi 2001)

Homoeopathic treatment is selected based on the total picture of the person and their symptoms, not just the symptoms of the illness. Various aspects of the person are considered including their lifestyle, emotions, mental state and nutrition.

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4. Objectives
The aim of this review is to assess the potential benefits and harms of homoeopathy for the treatment of side-effects of cancer treatment and symptoms of cancer.

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5. Criteria for including studies
Types of study: Published systematic reviews, randomised or non-randomised controlled trials of homoeopathy versus no treatment, placebo/sham treatment or other therapeutic interventions, limited to the English language.

Types of participants: People with cancer or a history of cancer.

Types of intervention: Homoeopathic treatment versus no treatment, placebo/sham treatment or other treatments.

Types of outcome measure: Amount and/or intensity of symptoms in cancer patients and cancer survivors including quality of life and general well-being.

Exclusions: No exclusions

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6. Search strategy
We searched the following databases in May 2006: AMED, The Cochrane Library, MEDLINE, and CINAHL. We also checked the reference lists of publications retrieved by the search for further relevant studies. We also searched the World Wide Web for any other relevant studies.

7. Data collection, analysis and development of recommendations
We used the above search strategy to obtain titles and abstracts of studies that were potentially relevant to this review. Where studies met the criteria for inclusion, they were assessed in full text. The quality of each study was evaluated using the GATE criteria (http://www.health.auckland.ac.nz/population-health/epidemiology-biostats/epiq/) for the evaluation of RCTs and systematic reviews.

Only one systematic review was found and its quality was assessed to be fair. The studies were highly heterogeneous in all aspects and no meta-analysis was done. Therefore each study included in this systematic review was looked at separately.

The overall quality of the body of evidence (including all the included studies) was graded according to the NZGG CAM levels of evidence system (reference).

Relevant data were extracted from the studies selected for inclusion.

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8. Description of studies

Summary details of the systematic review:

Study details

Participants/studies

Intervention and comparison(s)

Outcomes measured

Comment

Millazzo

2006

Included studies: 5 RCTs and 1 CCT

N (range)=27–83

Patients with cancer or past experience with cancer

Single or combined homoeopathic treatment as sole treatment or adjuvant treatment

vs no treatment, placebo or other treatments

Improvement of symptoms

Tumour response

Quality of life

The methodological quality of two of the included studies was poor.

No meta-analysis because of high heterogeneity

Poor reporting

Summary details of the studies included in the systematic review:

Study details

Participants/studies

Intervention and comparison(s)

Outcomes measured

Comment

Kulkarni

1988

82 patients with cancer undergoing radiation therapy

Two single homoeopathic remedies (Cobaltum or Causticum)

vs placebo

Follow-up not specified

Degree of radiation reaction

RCT with three parallel arms

Results of statistical analysis not reported

Randomization method not described

No adverse events reported

Incomplete information regarding patients

Oberbaum

1998

27 children and teenagers with leukaemia and chemotherapy-induced stomatitis

Mean age 12.3yrs (treated group) and 11.29 yrs (untreated group)

Age range 6-18 years

Homoeopathic treatment (Traumeel S®)

vs no treatment

Follow-up not specified

Opiates for pain

Duration of symptoms

Quality of life

Non-randomised CCT

No statistical analysis given for differences in duration between the groups

No adverse events reported

Balzarini

2000

66 women with breast cancer and undergoing radiotherapy

Mean age 52.7 years (range 28.3–70.0yrs)

Homoeopathic remedies Belladonna 7cH and X-ray 15cH

vs placebo

Follow-up 10 weeks

Skin heat

Hyper-pigmentation

Erythema

Oedema

Total severity of symptoms

Double-blind RCT

Randomisation method not described

Allocation concealment not described

Good methodological quality (4/5 on the Jadad score)

Adverse events reported

Oberbaum

2001

32 patients with various cancers and undergone bone marrow transplantation

Mean age 10.1 yrs (treatment group) and 9.7 yrs (placebo group)

Age range 3–25 years

17 male; 15 female

Homoeopathic treatment (Traumeel S®)

vs no treatment

Follow-up 44 weeks

Occurrence of stomatitis

Time to worsening of symptoms

Oral pain

Double-blind RCT

Randomisation method not described

Allocation concealment described

Drop-outs: one in each group (6%) -not included in analysis

ITT analysis

Good methodological quality (4/5 on the Jadad score)

Adverse events reported in both groups

Jacobs

2005

83 women with breast cancer who had completed all surgical, chemotherapy and radiotherapy treatments with a history of hot flushes for 1 month with an average ≥3 hot flushes per day for at least one week

Mean age 55.4, 56.8 and 54.5 years (combination remedy, single remedy and placebo respectively)

Combination homoeopathic remedy (‘Hyland’s menopause’)

Single homoeopathic remedy (selected from 35 different remedies)

vs placebo

Follow-up 1 year

Severity and frequency of hot flushes

Quality of life

Triple-blind RCT

Randomisation method described

Allocation concealment described

Drop-out/withdrawal rate 39% (32/83)

ITT analysis

Good methodological quality (5/5 on the Jadad score)

Adverse events reported in combination group

Small sample size

Thompson

2005

53 women with breast cancer experiencing >3 hot flushes per day, not on treatment for the hot flushes, with no severe concurrent illnesses and not (or going to be) undergoing chemotherapy

Mean age 53.6 and 51.6 years (treatment vs placebo)

Individualised homoeopathic treatment

vs placebo

Follow-up 16 weeks

MYMOP scores (measures symptoms, activities of daily living and general well-being)

Frequency and severity of hot flushes

Quality of life

Double-blind RCT

Randomisation method described

Allocation concealment described

Drop-out/withdrawal rate 15% (8/53)

ITT analysis

Good methodological quality (5/5 on the Jadad score)

Adverse events not specified

9. Methodological quality
The systematic review was assessed to be of fair quality. The studies where highly heterogeneous in almost every aspect therefore no meta-analysis was performed. Consequently we looked at each individual study. The methodological quality of the first two (Kulkarni, Nagarkar et al. 1988; Oberbaum 1998) was poor and the other four (Balzarini, Felisi et al. 2000; Oberbaum, Yaniv et al. 2001; Jacobs, Herman et al. 2005; Thompson, Montgomery et al. 2005) was good.

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10. Results

Radiotherapy side-effects

Kulkarni (Kulkarni, Nagarkar et al. 1988) conducted a study to assess the effectiveness of homoeopathy on radiotherapy side effects. The reaction to radiation was evaluated once a week using an 18-point scale. The reaction index was lower in both intervention groups compared to placebo (5 or ‘minimal reaction’ vs 8.5 or ‘moderate but tolerable reaction’ respectively). The statistical analysis was not reported. Information regarding patients, remedies and randomisation was incomplete.

Chemotherapy-induced stomatitis

The effect of a homoeopathic remedy (Traumeel S®) on chemotherapy-induced stomatitis (mouth sores) was tested in a case-control study (Oberbaum 1998) of 20 children and teenagers. In all patients, the homoeopathic treatment immediately reduced pain. Symptom duration was reduced in the treatment group (6 vs 13 days in the control group). No statistical analysis was given.

The authors of this study carried out a larger RCT (Oberbaum, Yaniv et al. 2001) to test the effectiveness of Traumeel S® for chemotherapy-induced stomatitis in children undergoing bone marrow transplant. There was a significant reduction in severity and/or duration of stomatitis in the treatment group compared to the placebo group (p<0.01). Also a significant difference was found in the time it took for symptoms to worsen; it took longer for the symptoms to worsen in the treatment group. Five patients in the treatment group did not develop stomatitis compared to one from the placebo group. Seven patients in the treatment group had worsening of symptoms compared to 14 in the placebo group.

Skin reactions as a result of radiotherapy

Balzarini (Balzarini, Felisi et al. 2000) investigated the effect of homoeopathy on skin reactions as a result of radiotherapy treatment for breast cancer. Significantly less hyperpigmentation at week 5 and significantly less heat at week 8 were observed. However, these were not significant at the end of week 10 follow-up. Total severity score was significantly less during the recovery period. A significantly high frequency of oedema was seen in the treatment group at week 5 and 6 but this became non-significant at weeks 7 and 8.

Menopausal symptoms in breast cancer survivors

Jacobs (Jacobs, Herman et al. 2005) investigated the effect of homoeopathy on menopausal symptoms in breast cancer survivors. A wide range of homoeopathic remedies (35) were used for the single remedies. No significant difference was found for severity and frequency of hot flushes. A significant improvement in general health score was found in each homoeopathic group. In a subgroup analysis of those women not taking tamoxifen, there was a significant increase in both severity and total number of hot flushes in the combination homoeopathy group compared to the placebo and single remedy groups. A significant increase in headaches was noted in the combination group as well.

Another study (Thompson, Montgomery et al. 2005) investigated the effect of homoeopathy on oestrogen withdrawal symptoms in women who have survived breast cancer. They found no significant differences between the treatment and placebo group in any outcome measure. About one quarter of participants experienced adverse events in both groups but no significant difference was found between each group.

Author	Main results
Kulkarni	Radiation reaction lower in both treatment groups
Oberbaum	Decrease in duration of symptoms in treatment group
Oberbaum	Reduction in the severity and/or duration of stomatitis
Balzarini	Total severity during recovery was less
Jacobs	No significant difference was found for severity and frequency of hot flushes. Improvement in general health score after 1 year In the combination homoeopathy group of women not taking tamoxifen: increase in severity of hot flushes increase in total number of hot flushes increase in headaches
Thompson	No significant difference was found in any outcome measure

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11. Discussion of findings
There were only 6 studies included in this review of varying quality. The evidence is limited and there is the possibility of publication bias.

In the treatment of side-effects of radiotherapy, one study found that the reaction to radiotherapy was less in the homoeopathy treatment group. However this study was judged to be of poor quality so its conclusions must be interpreted with caution.

For the treatment of chemotherapy-induced stomatitis, the results from two studies suggest some benefit of homoeopathy in reducing the severity and duration of mouth ulcers.

Another study found that homoeopathic treatment for skin reactions to radiotherapy reduced the total severity of skin reactions during recovery. There was also a suggestion of some lessening of heat and hyperpigmentation at times during the radiotherapy treatment.

Two studies of homoeopathic treatment of menopausal symptoms in breast cancer survivors found no effect on severity or frequency of hot flushes. One of these studies found an improvement in general health after one year. In a subgroup of this study, there was an increase in number and severity of hot flushes taking the combination remedy and an increase in the number of headaches.

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12. Conclusion
There is level 4 evidence that homoeopathy may reduce side-effects of radiotherapy.

There is level 3 evidence that a particular homoeopathic treatment (Traumeel S®) may reduce the severity and duration of chemotherapy-induced stomatitis.

There is level 3 evidence that homoeopathy may reduce the total severity of skin reaction to radiotherapy.

There is level 2 evidence that homoeopathy does not reduce severity or frequency of menopausal symptoms in breast cancer survivors.

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13. References

Balzarini, A., E. Felisi, et al. (2000). "Efficacy of homeopathic treatment of skin reactions during radiotherapy for breast cancer: a randomised, double-blind clinical trial." British Homoeopathic Journal 89(1): 8-12.

Jacobs, J., P. Herman, et al. (2005). "Homeopathy for menopausal symptoms in breast cancer survivors: a preliminary randomized controlled trial.[see comment]." Journal of Alternative & Complementary Medicine 11(1): 21-7.

Kulkarni, A., B. M. Nagarkar, et al. (1988). "Radiation protection by use of homoeopathic medicines." Hahnemann Homoeopath Sand 12(1): 20-3.

Micozzi, M. S. (2001). Fundamentals of Complementary and Alternative Medicine. Philadelphia, Churchill Livingston.

Milazzo, S., N. Russell, et al. (2006). "Efficacy of homeopathic therapy in cancer treatment. [Review] [26 refs]." European Journal of Cancer 42(3): 282-9.

Molassiotis, A., P. Fernadez-Ortega, et al. (2005). "Use of complementary and alternative medicine in cancer patients: a European survey." Annals of Oncology 16(4): 655-63.

Oberbaum, M. (1998). "Experimental treatment of chemotherapy-induced stomatitis using a homeopathic complex preparation: a preliminary study." Biomed Ther 16(4): 261-5.

Oberbaum, M., I. Yaniv, et al. (2001). "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 92(3): 684-90.

Thompson, E. A., A. Montgomery, et al. (2005). "A pilot, randomized, double-blinded, placebo-controlled trial of individualized homeopathy for symptoms of estrogen withdrawal in breast-cancer survivors.[see comment]." Journal of Alternative & Complementary Medicine 11(1): 13-20.

Vickers, A. and C. Zollman (1999). "ABC of complementary medicine. Homoeopathy.[see comment]. [Review] [0 refs]." Bmj 319(7217): 1115-8.

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Date prepared: 20 June 2006