Homeopathic medicines for adverse effects of cancer treatments Edited (no change to conclusions), comment added to review

Abstract

Abstract Background

Homeopathic medicines are used by patients with cancer, often alongside conventional treatment. Cancer treatments can cause considerable morbidity and one of the reasons patients use homeopathic medicines is to help with adverse effects.

Objectives

Evaluate effectiveness and safety of homeopathic medicines used to prevent or treat adverse effects of cancer treatments.

Search methods

The following were searched up to November 2008: Cochrane PaPaS Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; CINAHL; BNI; CancerLIT; AMED; CISCOM; Hom‐Inform; SIGLE; National Research Register; Zetoc; www.controlled‐trials.com; http://clinicaltrials.gov; Liga Medicorum Homeopathica Internationalis (LMHI, Liga) conference proceedings; reference lists of relevant studies were checked; and homeopathic manufacturers, leading researchers and practitioners were contacted.

Selection criteria

Randomised controlled trials (RCTs) of homeopathic medicines in participants with a clinical or histological diagnosis of cancer where the intervention was aimed at preventing or treating symptoms associated with cancer treatments. All age groups, and all stages of disease were included.

Data collection and analysis

Two review authors independently assessed studies for inclusion and two review authors extracted data. Three review authors independently assessed trial quality using the Delphi List and the Cochrane Collaboration's tool for assessing risk of bias. Disagreements were resolved by consensus. Where available, data were extracted for analysis.

Main results

Eight controlled trials (seven placebo controlled and one trial against an active treatment) with a total of 664 participants met the inclusion criteria. Three studied adverse effects of radiotherapy, three studied adverse effects of chemotherapy and two studied menopausal symptoms associated with breast cancer treatment.

Two studies with low risk of bias demonstrated benefit: one with 254 participants demonstrated superiority of topical calendula over trolamine (a topical agent not containing corticosteroids) for prevention of radiotherapy‐induced dermatitis, and another with 32 participants demonstrated superiority of Traumeel S (a proprietary complex homeopathic medicine) over placebo as a mouthwash for chemotherapy‐induced stomatitis. Two other studies reported positive results, although the risk of bias was unclear, and four further studies reported negative results.

No serious adverse effects or interactions were reported attributable to the homeopathic medicines used.

Authors' conclusions

This review found preliminary data in support of the efficacy of topical calendula for prophylaxis of acute dermatitis during radiotherapy and Traumeel S mouthwash in the treatment of chemotherapy‐induced stomatitis. These trials need replicating. There is no convincing evidence for the efficacy of homeopathic medicines for other adverse effects of cancer treatments. Further research is required.

Author(s)

Sosie Kassab, Mike Cummings, Saul Berkovitz, Robbert van Haselen, Peter Fisher

Abstract

Plain language summary

Homeopathic medicines for adverse effects of cancer treatments 

Homeopathic medicines are used by many patients with cancer, usually alongside conventional treatment. Cancer treatments can cause adverse effects, and one of the reasons patients use homeopathic medicines is to help with these symptoms. This review looked at whether these medicines could help patients with problems caused by cancer treatments. Eight studies with a total of 664 participants were included in this review. Three studied adverse effects of radiotherapy, three studied adverse effects of chemotherapy and two studied menopausal symptoms associated with breast cancer treatment. Two studies with low risk of bias demonstrated benefit: one with 254 participants demonstrated benefits from calendula ointment in the prevention of radiotherapy‐induced dermatitis, and another with 32 participants demonstrated benefits from Traumeel S (a complex homeopathic medicine) over placebo as a mouthwash for chemotherapy‐induced stomatitis. These trials need replicating. Two other studies reported positive results, although the risk of bias was unclear, and four further studies reported negative results. The homeopathic medicines used in all eight studies did not seem to cause any serious adverse effects or interact with conventional treatment. No cancer treatments were modified or stopped because of the homeopathic interventions.

Author(s)

Sosie Kassab, Mike Cummings, Saul Berkovitz, Robbert van Haselen, Peter Fisher

Reviewer's Conclusions

Authors' conclusions

Implications for practice

Prophylactic use of calendula ointment may be considered as an option for patients undergoing radiotherapy for breast cancer, although this intervention requires further evaluation. Compared with trolamine, it reduced the incidence of acute dermatitis of grade two or above in women undergoing radiotherapy for breast cancer in one clinical trial involving 254 participants. The calendula ointment used in this study was prepared according to the German Homeopathic Pharmacopoeia and so the results may not apply to topical preparations of calendula extracts prepared by different methods.

There is no convincing evidence for the efficacy of other homeopathic medicines for adverse symptoms and skin reactions related to radiotherapy. Two small studies were positive but both had an unclear risk of bias.

Based on a single trial involving 32 participants, one particular homeopathic combination (Traumeel S ‐ a proprietary complex homeopathic medicine) appears to show promise in the treatment of chemotherapy‐induced stomatitis.

High quality trials to date provide no evidence for the efficacy of homeopathic medicines over placebo in women with breast cancer suffering from menopausal symptoms.

No serious adverse effects that could be attributed to homeopathic medicines or interactions with conventional treatment were reported in the included studies. No cancer treatments were modified or stopped because of the homeopathic interventions.

Implications for research

Further studies are warranted using calendula ointment for acute dermatitis in patients undergoing radiotherapy. It may be worthwhile considering different formulations since 30% of participants reported that the ointment was difficult to apply.

Further independent trials of Traumeel S for cancer treatment associated mucositis are warranted, and one is underway (Sadhev 2004).

Further RCTs of homeopathic medicines for adverse symptoms and skin reactions related to radiotherapy are needed to confirm the results described in this review. Since patients frequently use homeopathic medicines for general supportive care, rather than control of specific symptoms, outcome measures should be broader than those used in some of the included studies, and should differentiate between symptoms as well as using global and quality of life scores. Radiotherapy‐associated fatigue might be considered as a separate outcome, and observation beyond the end of radiotherapy should be included.

In the design of future studies of individualised homeopathy, consideration should be given to the possibility of an interaction between effects attributable to the homeopathic consultation and those of the homeopathic medicine itself.

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