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. 

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

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.

• 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

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

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

Randomized, controlled trials at multiple centers

• 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

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.

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.

• 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.

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