Effectiveness Not Established

Herbal Medicine

for Constipation

An herb is a plant or part of a plant that people take for health benefits as dietary supplements or medication. Herbal medicine may also be referred to as phytotherapy or use of botanicals. Herbal medicine interventions include a variety of substances and combinations of substances. Herbal medicine is contraindicated with some chemotherapy agents. 

Systematic Review/Meta-Analysis

Chung, V.C., Wu, X., Lu, P., Hui, E.P., Zhang, Y., Zhang, A.L., . . . Wu, J.C. (2016). Chinese herbal medicine for symptom management in cancer palliative care: Systematic review and meta-analysis. Medicine, 95, e2793. 

Purpose

STUDY PURPOSE: To summarize the results from randomized, controlled trials (RCTs) of the effectiveness of Chinese herbal medicines (CHMs) for managing fatigue, paresthesias, chronic pain, anorexia, edema, and constipation

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: AMED, CENTRAL, MEDLINE, EMBASE, CINAHL, Chinese Biomedical Databases, Wan Feng Digital Journals, Taiwan Periodical Literature Database
 
INCLUSION CRITERIA: RCTs comparing the effect of CHM in combination with other treatments or alone in managing cancer or treatment-related symptoms. RCTs must report the effectiveness of CHM on at least one symptom using validated scales. RCTs must include at least one CHM in the 2010 China Pharmacopeia Chinese herbal medicine index. The control groups included conventional treatment, chemotherapy, radiotherapy, placebo, or no treatment. RCTs reported information on regimens in both treatment and control groups, and the follow-up duration was clearly reported.
 
EXCLUSION CRITERIA: Not identified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 4,767
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two reviewers extracted data on RCT characteristics (author, year, country, eligibility criteria, diagnostic criteria); patient characteristics (CHM, control interventions, outcomes, effect size for each outcome, adverse effects). The data analysis used risk of bias (Cochrane risk of bias tool), relative risk, weighted mean difference, 95% confidence interval, I2 statistic for level of heterogeneity, and funnel plot for publication bias.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 14 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 878
  • SAMPLE RANGE ACROSS STUDIES: 35–124 patients
  • KEY SAMPLE CHARACTERISTICS: Various cancer sites

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Elder care, palliative care

Results

  • Fatigue—four RCTs. In three RCTs, no difference existed between CHM and chemotherapy versus chemotherapy alone. In the other RCT, Fu Zheng decoction plus chemotherapy (ellence [epirubicin]/paclitaxel [taxol]) improved fatigue score compared to chemotherapy alone in breast cancer (MD: –18.62, 95% CI [–24.18, –13.16]).
  • Pain—three RCTs. CHM plus conventional treatment decreased the pain score compared to conventional treatment alone (WMD: –0.9, 95% CI [–1.69, –0.11]).
  • Constipation—seven RCTs. In six RCTs, CHM compared to conventional treatment had a similar effect. In the other RCT, Tong-Tai decoction plus chemotherapy compared to chemotherapy alone showed no difference.
  • Anorexia—two RCTs. No difference existed with CHM plus conventional treatment.

Conclusions

Combining CHM with chemotherapy may improve fatigue in patients with breast cancer. Adding CHM to conventional treatment may improve pain control. CHM alone may improve constipation.

Limitations

  • Mostly low quality/high risk of bias studies
  • High heterogeneity
  • Trials conducted and published in China

Nursing Implications

Further research needs to be performed on CHM treating cancer- and cancer treatment-related symptoms.

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Research Evidence Summaries

Chen, C.M., Lin, L.Z., & Zhang, E.X. (2014). Standardized treatment of Chinese medicine decoction for cancer pain patients with opioid-induced constipation: A multi-center prospective randomized controlled study. Chinese Journal of Integrative Medicine, 20, 496–502. 

Study Purpose

To determine the effect and influence of Chinese medicine (CM) treatment on the quality of life (QOL) of patients with opioid-induced constipation, and to determine any changes in analgesic effect

Intervention Characteristics/Basic Study Process

All patients were treated for 14 days. The control group received 100–200 mg tabs of oral phenolphthalein three times per day with the dose adjusted based on patient condition. The study group received a CM combination consisting of Xiaochengqi decoction (a purgative) and Zengye decoction (also a purgative but less effective). The decoction consisted of several types of plants. The basic formulation was adjusted for one of the four potential syndromes that affected patients.

Sample Characteristics

  • N = 406  
  • AGE = CM 60.66 years (SD = 11.61 years), control 59.32 years (SD = 11.09 years)
  • MALES: 56%, FEMALES: 44%
  • KEY DISEASE CHARACTERISTICS: Patients with cancer pain, who were over 18 years old, who had constipation, who were using ≥ 80 mg controlled release oxycodone per day, who had signed informed consent, and who were able to communicate well
  • OTHER KEY SAMPLE CHARACTERISTICS: No gastrointestinal disorders, acute intestinal obstruction, allergies to study agents, or women who were pregnant or lactating

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Not specified    
  • LOCATION: China

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship
  • APPLICATIONS: Palliative care 

Study Design

Randomized, controlled trials at multiple centers

Measurement Instruments/Methods

  • Cleveland Constipation Score (CCS)
  • The Chinese version of the European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire (EORTC QLQ-C30) version 3
  • Numerical pain rating scale
  • National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3

Results

Both study groups had reduced CCS scores after treatment compared to baseline. CCS scores changed more in the CM group than the control group (93.5% versus 86.4%, p < .05). The CM group had better QOL scores in eight variables including constipation, nausea, and vomiting. Pain management was not affected in either group. Side effects included diarrhea, nausea, and abdominal pain.

Conclusions

Analgesia was not affected in this study. CM was effective in managing constipation in patients receiving opioids. The CM group had a 93.5% efficacy rate and the control group had a 86.4% efficacy rate. QOL was improved and side effects were mild.

Limitations

  • Risk of bias (no blinding)
  • Findings not generalizable
  • Intervention expensive, impractical, or training needs
  • Other limitations/explanation: The study medications used in the intervention arm are not readily available. This lack of availability limits the generalizability of the intervention. Because it is not a readily available product and requires adjustments in formulation based on the assessment of the patient, its use requires special training.

Nursing Implications

The CM intervention was more effective in the management of constipation than the control medication, oral phenolphthalein.

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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. 

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.

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