Opera supplement for chemotherapy-induced peripheral neuropathy

This paper is part of nmj ’s oncology special edition 2017. Read the newspaper or download the full edition here.

reference

Desideri I., Francolini G., Becerini C., et al. Use of alpha lipoic acid, methylsulfonylmethane and Bromelain as a dietary supplement (Opera®) for the management of chemotherapy-induced peripheral neuropathy, a prospective study. med. Onk . 2017; 34 (3): 46.

objective

Determination of the effectiveness and safety of the Opera® supplement (240 mg alpha-liponic acid, 40 mg Boswellia Serrata, 20 mg Bromelain and 200 mg methylsulfonylmethane [MSM]) in a series of patients with chemotherapy-induced peripheral neuropathy (CIPN).

draft

prospective intervention study

participant

twenty -five Caucasian adults with cipn during or after chemotherapy with potentially neurotoxic ingredients; Patients were included in the study in the first clinical manifestation of neuropathy. The diagnosis of CIPN was based on the National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI-CTCAE) V4.0 degree of ≥1 for sensory neuropathy, with at least one report on paraesthesia of the fingers or toes (a criterion for degrees 1).

inclusion criteria were as follows: 18 years or older; Karnofsky performance score> 70; Treatment with one of the following active ingredients: paclitaxel, docetaxel, nab-paclitaxel, oxaplatin, cisplatin, carboplatin, vinorelbin, vincristin, etoposide, eribulinmesylate; CIPN, which has developed after or during standard chemotherapy. 23 patients (92 %) received chemotherapy with a neurotoxic active ingredient in the admission, while 2 patients (8 %) had completed chemotherapy with a neurotoxic active ingredient.

Intervention

All patients had to take an Opera® capsule once a day regardless of food intake.

study parameters evaluated

chemotherapy-induced peripheral neuropathy was evaluated on the admission vision and repeated every 3 weeks to 12 weeks, the following was used: National Cancer Institute Common Toxicity Criteria (NCI-CTC) V3.0, score for sensory and motor neuropathy; The clinical version of the Total Neuropathy Score (TNSC); and the sensory overall core (Miss) of the modified inflammatory neuropathy bare and treatment (incat) group. The visual analog scale (VAS) was used for pain to assess the pain intensity.

primary result dimensions

The primary end point was the evaluation of the changes in the measured values ​​after 12 weeks therapy compared to the Baseline rating. Secondary endpoints were the evaluation of the reduction in neuropathy 12 weeks after the start of therapy with Opera®.

important knowledge

The Naternity supplement Opera® was able to improve the CIPN symptoms in a prospective case series of patients treated with neurotoxic chemotherapy without significant toxicity or interaction. In addition, no deterioration of pain or cipn symptoms was reported when using Opera®. No statistical analysis was carried out for this study.

practice implications

chemotherapy-induced peripheral neuropathy describes damage to the peripheral nervous system that arises in a patient who has received a neurotoxic chemotherapy. This is a frequent dose-limiting side effect in cancer patients that are treated with platinum derived from platinum, vinca alkaloids, taxanes and the proteasoma inhibitors. ^{1 The incidence of neurotoxicity varies depending on the active ingredient and cumulative dose, which are included in patients who are included in patients are treated between 19 % and more than 85 %. 2 A recently carried out meta-analysis showed a cipn prevalence of 68.1 % (95 % KI: 57.7–78.4) within the first month after chemotherapy, 60.0 % after 3 months and 30.0 % after 6 months or later.}

no reliable treatment for the prevention or treatment of CIPN symptoms has been established. Duloxetine has only brought a modest benefit and is associated with side effects and a high demolition rate. The CIPN guideline of the American Society of Clinical Oncology from 2014 gives a moderate recommendation for treatment with duloxetine and recommends further research in this area.

The increased interest in CIPN has included the examination of several non-pharmaceutical interventions. This study evaluates the Opera® nutritional supplement for the treatment of CIPN. While the authors have found the effectiveness and security of Opera® for CIPN, there are several restrictive variables. There are limited and contradictory evidence of the components of Opera®. It has been shown that alpha lipoic acid increases the glutathione level and supports a healthy nerve tissue and a healthy blood sugar level. ^{5 Boswellia Serrata is a strong anti-inflammatory herb and helps to compensate for the activity of the 5-lipoxygenase (LOX) and to compensate for a healthy inflammation reaction Support. 6 It has been shown that methylsulfonylmethane reduces the C fiber nerve nerve line, 7 which is essential for effective pain control. It also has chemical prevention properties and anti -inflammatory activities.}

no reliable treatment for the prevention or treatment of CIPN symptoms was established.

The components of Opera® can have a synergist manner to improve the symptoms of CIPN, since they have anti -inflammatory effects, strong antioxidant properties and potential benefits for diabetic neuropathy (nerve health and blood sugar control); However, there is no evidence of the effectiveness of these components individually for the use of CIPN. A clear restriction of this study is its small sample size and inhomogeneous patient population. Despite these restrictions, the authors claim that Opera® reduced the patient's pain perception, improved motor and sensory impairments and was well tolerated, without treatment -related toxicities. Unfortunately, the authors failed to statistically evaluate their results. The lack of statistical significance makes it impossible to interpret these apparently positive results.

Although the authors of this study report that Opera® was safe and effective, these results are not significant given the lack of statistical analysis. The activity of this nutritional supplement can benefit patients with CIPN, but future well -designed, prospective, randomized, controlled studies are justified to support their use in these patients.