Sun, D.Z., Jiao, J.P., Zhang, X., Xu, J.Y., Ye, M., Xiu, L.J., . . . Wei, P.K. (2014). Therapeutic effect of Jinlongshe Granule on quality of life of stage IV gastric cancer patients using EORTC QLQ-C30: A double-blind placebo-controlled clinical trial. Chinese Journal of Integrative Medicine, 2014(Nov.), 1–8. 

DOI Link

Study Purpose

To observe functional and symptomatic changes related to quality of life in patients with advanced gastric cancer with administration of Jinlongshe granule (JLSG, a Chinese herbal medicine)

Intervention Characteristics/Basic Study Process

Patients were randomized into a JLSG group or a placebo group. All patients received Chinese medicinal herbs prescribed individually. The intervention arm additionally received JLSG, and the other arm received a placebo three times daily. Patients were followed biweekly in clinic visits. Study measures were obtained at enrollment and at 3, 6, 9, 12, and 15 months after treatment.

Sample Characteristics

  • N = 39  
  • AGE: Mean and range not determinable
  • MALES: 66.7%, FEMALES: 33.3%
  • KEY DISEASE CHARACTERISTICS: All patients had advanced gastric cancer and most had liver metastasis.
  • OTHER KEY SAMPLE CHARACTERISTICS: Inclusion criteria included expected three-month survival.

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care 

Study Design

Double-blind, placebo-controlled, randomized clinical trial

Measurement Instruments/Methods

  • European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ–C30)

Results

There were statistically significant group-by-time effects for multiple symptoms including cognitive function, fatigue, pain, dyspnea, insomnia, appetite loss, constipation, and and general quality of life (p < .05). For some symptoms, differences were due to increased symptoms in the placebo group. No information regarding any adverse effects is reported. The direction of change in symptom scores is not always clear in this manuscript.

Conclusions

This study has several limitations that make it difficult to assess the potential efficacy of JLSG for symptom management.

Limitations

  • Small sample (< 100)
  • Unintended interventions or applicable interventions not described that would influence results
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: All patients received a variety of Chinese herbal medications that were not described and were not standardized; therefore, it is not possible to determine the actual effect of the JLSG. No other interventions aimed at symptoms are described. Repeated measures of the same instrument may produce testing effect.
 

 

Nursing Implications

This study provides minimal evidence in support of a specific Chinese herbal medicine in patients with advanced gastric cancer. Further well-designed studies are needed for clinically meaningful evaluation of efficacy.