Reduced side-effects of adjuvant hormone therapy in breast cancer patients by complementary medicine.
A clinical investigation (representing evidence-based medicine level III) was performed to evaluate the benefit of complementary medicine in breast cancer patients undergoing adjuvant hormone therapy (HT).


METHODS
The patients (n=129) were treated according to international guidelines. All patients suffered from arthralgia and mucosal dryness induced by the adjuvant HT. To reduce these side-effects, the patients were complementarily treated with a combination of sodium selenite, proteolytic plant enzymes (bromelaine and papain) and Lens culinaris lectin. On the basis of case report formulas (CRFs), self assessment of defined side-effects of HT (arthralgia and mucosal dryness) were documented before as well as 4 and 8 weeks after complementary treatment. Validation was carried out by scoring from 1 (no side-effects/optimal tolerability) to 6 (extreme side-effects/extremely bad tolerability).


RESULTS
The severity of side-effects of HT was reduced by complementary treatment with sodium selenite, plant enzymes (bromelaine and papain) and Lens culinaris lectin. The mean score of symptoms declined from 4.2 (before treatment) to 3.2 (after 4 weeks of treatment) to 2.7 (after 8 weeks of treatment) for arthralgia and from 3.2 (before treatment) to 2.9 (after 4 weeks of treatment) to 2.6 (after 8 weeks of treatment) for mucosal dryness, the primary aims of this investigation. The reduction of side-effects of HT was statistically significant (p<0.001 after 4 weeks and p<0.0001 after 8 weeks).


CONCLUSIONS
This investigation demonstrates benefits of indication-based complementary treatment in breast cancer patients, e.g. reduction of side-effects of adjuvant HT. A randomized controlled trial is planned to integrate the complementary treatment with the combination of sodium selenite, proteolytic enzymes and Lens culinaris lectin into evidence-based medicine.
Institute of Immunobiology, University of Cologne, Germany.
G
G
Uhlenbruck
R
R
VAN Leendert
B
B
Schneider
J
J
Beuth
D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects*; D000529:Complementary Therapies; D019317:Evidence-Based Medicine; D005260:Female; D007987:Gonadotropin-Releasing Hormone / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D010447:Peptide Hydrolases / Q000008:administration & dosage / Q000009:adverse effects; D037121:Plant Lectins / Q000008:administration & dosage / Q000009:adverse effects; D018038:Sodium Selenite / Q000008:administration & dosage / Q000009:adverse effects
D018931:Antineoplastic Agents, Hormonal; D037121:Plant Lectins; C033619:lentil lectin; D007987:Gonadotropin-Releasing Hormone; D010447:Peptide Hydrolases; D018038:Sodium Selenite