Effectiveness Not Established

MS 20 Soybean Extract

for Fatigue

MS 20 is a fermented soybean extract. Fermented soybean products contain isoflavones that may have chemoprotective effects and increase antioxidant activity. MS 20 use has been examined in patients with cancer for its effects on natural killer cell activity and symptoms of anorexia and fatigue.

Research Evidence Summaries

Chi, K.H., Chiou, T.J., Li, C.P., Chen, S.Y., & Chao, Y. (2014). MS-20, A chemotherapeutical adjuvant, reduces chemo-associated fatigue and appetite loss in cancer patients. Nutrition and Cancer, 66, 1211–1219.

Study Purpose

To examine the effects of MS-20, a fermented soybean extract, on quality of life, fatigue, and appetite for patients with cancer receiving chemotherapy (Immunologic and antioxidant profiles were also examined.)

Intervention Characteristics/Basic Study Process

MS 20 was taken orally on an empty stomach at a dose of 5 mL in the morning and 3 mL in the afternoon diluted in 100 mL of warm water. Patients were randomly assigned to receive MS 20 during either the first or second chemotherapy cycle after a one to two-week washout period. The study duration was eight weeks. Patients were evaluated at weekly office visits.

Sample Characteristics

  • N = 98  
  • MEAN AGE = 56.3 years
  • MALES: 63%, FEMALES: 37%
  • KEY DISEASE CHARACTERISTICS: Multiple tumor types; the most common was gastrointestinal cancer.
  • OTHER KEY SAMPLE CHARACTERISTICS: Greater than 70% of patients had received previous chemotherapy.

Setting

  • SITE: Single-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Taiwan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, unblended, crossover trial

Measurement Instruments/Methods

  • European Organization for Research and Treatment of Cancer (EORTC) Quality of Life–C30 questionnaire
  • Visual Analog Scale (VAS) for fatigue and appetite loss

Results

Physical functioning scores were significantly better during treatment with MS 20 (p = .023). VAS scores for fatigue and appetite loss improved significantly while taking MS 20 (p < .001); however, fatigue and appetite loss scales on the EORTC questionnaire showed no significant difference between study conditions. There were no measurable effects on immunological parameters examined in the study.

Conclusions

Findings were mixed regarding the effect of MS 20 on fatigue and appetite loss.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Key sample group differences that could influence results
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: There was a greater than 40% loss to follow-up in the study for a variety of reasons; the most common were patient refusal and noncompliance. How noncompliance was determined is not clear. There is no intent to treat analysis. Patients were on a variety of chemotherapy regimens, making it difficult to evaluate efficacy well, given potential effects of different agents and dosages. The authors focus the discussion on the VAS scores showing improvement in fatigue and appetite and do not address that fact that other measurements of these symptoms showed no effect.

Nursing Implications

This study provides some mixed findings regarding the effect of MS 20, a fermented soybean extract, on fatigue and anorexia in patients during chemotherapy.

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