Abstract
Background/Aim: The present clinical investigation was performed to confirm the benefit of complementary medicine in patients with breast cancer undergoing adjuvant hormone therapy (HT). Patients and Methods: The patients (n=1561) were treated according to international guidelines. All patients suffered from arthralgia and mucosal dryness induced by the adjuvant HT. In order to reduce the side-effects, the patients were complementarily treated with a combination of sodium selenite, proteolytic plant enzymes (bromelaine and papain) and Lens culinaris lectin. On case report formulas, self assessment arthralgia and mucosal dryness were documented before and four weeks after complementary treatment. Validation was carried-out by scoring from 1 (no side-effects/optimal tolerability) to 6 (extreme side-effects/extremely poor tolerability). A total of 1,165 patients suffering from severe side-effects (symptom scores >3) were enrolled in this investigation. Results: Overall, 62.6% of patients (729 out of 1,165) suffering from severe arthralgia and 71.7% of patients (520 out of 725) with severe mucosal dryness significantly benefited from complementary medicine. Mean scores of symptoms declined from 4.83 before treatment to 3.23 after four weeks of treatment for arthralgia and from 4.72 before treatment to 2.99 after four weeks of treatment for mucosal dryness, the primary aims of the present investigation. The reduction of side-effects of HT was statistically significant (p<0.001) after four weeks. Conclusion: This investigation confirms studies suggesting a benefit of complementary treatment with the combination of sodium selenite, proteolytic enzymes and L. culinaris lectin in patients with breast cancer.
Breast cancer is the most common cause of cancer death in women worldwide (1). Evidence-based treatment of breast cancer follows recommendations of international expert panels (2, 3). The standard adjuvant endocrine therapy for women with hormone receptor-positive breast cancer is often restricted by severe side-effects such as mucosal dryness, arthralgia and vascular events (4, 5).
Hormone therapy (HT) for breast cancer treatment exerts anti-estrogenic effects within the breast and in the mucosal tissue. Recently a clinical investigation demonstrated an enhanced tolerability to chemotherapy, radiotherapy and HT of patients with breast cancer that were complimentarily treated with a combination of sodium selenite, plant enzymes and Lens culinaris lectin due to side-effects such as mucosal dryness and arthralgia (6, 7). Since reduced function of mucosal linings and correlating symptoms such as arthalgia and mucosal dryness result from cytotoxic effects of chemotherapy or radiotherapy and from hormone depletion (5-8), these distinct side-effects were chosen as the primary aims of the investigation.
Patients and Methods
Patients. Women (n=1561) with histologically-verified breast cancer undergoing adjuvant HT (according to the actual recommendations) were enrolled into this investigation. A total of 1,165 patients suffering from severe side-effects of their HT (arthralgia and mucosal dryness) were validated and documented.
Complementary treatment. The patients were complementarily treated with an oral medication (Equizym MCA; Kyberg Pharma GmbH, Oberhaching, Germany) containing sodium selenite (300 μg/day), proteolytic enzymes (bromelaine 400 mg/day and papain 400 mg/day) and L. culinaris lectin (20 mg/day). Complementary treatment was continued for four weeks. Safety and efficacy of sodium selenite and proteolytic enzymes were extensively investigated in randomized controlled trials (9, 10). No other complementary remedies, in particular antioxidant vitamins, trace elements and immunostimulants, were taken by the patients throughout this investigation.
Side-effects of HT. Case report formulas were used to document self-assessed safety and efficacy of the complementary treatment. Patients were assessed routinely before onset and four weeks after terminating the complementary therapy. The efficacy of the complementary treatment was verified by questioning the severity of the side-effects mucosal dryness and arthralgia (as primary aims of this investigation). Severity of symptoms was quantified by scoring from 1 (no side-effects) to 6 (extreme side-effects). An average score was calculated for symptoms of the adjuvant therapy to investigate the value of this complementary treatment.
Statistics. Student's paired t-test was performed to calculate statistical significance between mean values of scores for side-effects of HT after four weeks of complementary treatment.
Results
A total of 1,561 evaluable patients with breast cancer were enrolled into this clinical investigation. Patients investigated (n=1165; mean age 58 years) suffered from severe mucosal dryness and arthralgia induced by HT.
Tolerability to adjuvant HT along with complementary administration of sodium selenite, proteolytic enzymes and L. culinaris lectin was investigated by self- assessment. Overall, 62.6% of patients (729 out of 1165) suffering from arthralgia and 71.7% of patients (520 out of 725) with mucosal dryness significantly benefited from complementary medicine. Furthermore, the severity of both side-effects were significantly reduced (Figure 1; p<0.001) after four weeks of complementary treatment. These results demonstrate that an efficient management of adverse reactions to adjuvant HT in patients with breast cancer is possible by well-defined complementary medicine.
No severe adverse reactions (e.g. nausea, or bloating) to the complementary medication (sodium selenite, proteolytic enzymes and L. culinaris lectin) were documented. These findings confirm recent trials on the safety of this complementary therapy (11, 12).
Discussion
This clinical investigation was performed to further evaluate and confirm the safety and efficacy of a complementary medication composed of sodium selenite, proteolytic enzymes and L. culinaris lectin. Sodium selenite and proteolytic enzymes have proven clinical safety and efficacy in controlled trials (9, 10); L. culinaris lectin was added to the medication because of its stabilizing effects on mucosal surfaces (11, 12, 13). The scientific rationale for this complementary treatment is enhancement of the tolerability to HT by reduction of defined adverse reactions to optimize this guideline-based therapy. This investigation shows that complementarily administered sodium selenite, proteolytic enzymes and L. culinaris lectin significantly reduced defined side-effects (e.g. arthralgia, mucosal dryness) of adjuvant HT in patients with breast cancer.
Since the tolerability to adjuvant HT determines its optimal administration, complementary treatment with sodium selenite, proteolytic enzymes and L. culinaris lectin may enhance the chance of curing this disease.
- Received September 16, 2015.
- Revision received October 20, 2015.
- Accepted October 23, 2015.
- Copyright © 2016 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved