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.
Effectiveness Not Established
Research Evidence Summaries
Bao, Y.J., Hua, B.J., Hou, W., Lin, H.S., Zhang, X.B., & Yang, G.X. (2010). Alleviation of cancerous pain by external compress with Xiaozheng Zhitong Paste. Chinese Journal of Integrative Medicine, 16, 309–314.doi: 10.1007/s11655-010-0501-5
To observe the clinical effectiveness of a topical application of Xiaozheng Zhitong Paste (XZP) in alleviating the cancerous pain of patients with middle/late-stage cancer
Intervention Characteristics/Basic Study Process:
Patients were randomized into either the treatment group (64 patients) or the control group (60 patients). In addition to utilization of three-ladder (3L) analgesia therapy in both groups, topical application of XZP was given to patients in the treatment group for pain alleviation. Analgesic efficacy was recorded in terms of pain intensity, analgesia initiating time and sustaining time, and the optimal analgesic effect revealing time. Quality of life and adverse reactions that occurred in patients were also recorded.
- The study reported on 124 patients.
- Mean patient age in the treatment group was 69 years (range = 58–74 years); mean patient age in the control group was 67 years (range = 56–75 years).
- The treatment group was 56% female and 44% male; the control group was 65% female and 35% male.
- Patients estimated their pain degree by the verbal rating scale (VRS) as greater than 4; had received 3L analgesia without adequate control, and required an increase or change in dosing. The pain was localized, with the number of pain sites being less than four, and suitable for external compression with no skin damage, edema, or heat.
- Patients were older than age 18, had no allergy history, had no psychiatric illness, had normal language expression, and were able to self-report.
- Inpatient oncology
- Department of oncology, Guang’anmen Hospital
Phase of Care and Clinical Applications:
- Patients were undergoing the active treatment phase of care.
- The study has clinical applicability for end-of-life and palliative care.
The extent of pain, the analgesic effect initiating time and sustaining time of medication, and the optimal effect revealing time were recorded before medication and 24 hours after medication. Quality of life was estimated by Karnofsky scoring and the Brief Pain Inventory (BPI).
Intensity of pain was evaluated per standards of the World Health Organization with the numeric rating scale (NRS), expressed as digits from 0–10 (0 for no pain, 10 for extreme pain). Intensity of pain was ranked into four grades: 0 = no pain; grade I = endurable pain, normal daily life, sleep not affected, NRS 1–3; grade II = obvious pain, unendurable, patients asked for analgesia, daily life and sleep affected, NRS 4–6; grade III = severe pain, could hardly endure, analgesia necessary, sleep interfered with, impact on motion, forced posture, painful complexion, and incessant groaning, NRS 7– 10.
Effectiveness on pain treatment was classified into four grades: completely remitted (CR), partially remitted (PR), mildly remitted (MR), and no palliation (NP). Comparison of the total effective rate (sum of CR+PR+MR) between the two groups showed no significant difference (p > 0.05). Analgesic effect initiating time was decreased, and its sustaining time was elongated in both groups after medication (p < 0.01), but the initiating time was shorter in the treatment group than in the control group (p < 0.01). The mean optimal analgesia effect was shorter in the treatment group, demonstrating a significant difference (p < 0.01).
Compared by the effect of pain on patients, the effect was attenuated by both groups after medication, but the mental condition, walking capacity, social acceptability, sleep, and joy of living were all better with those in the control group, showing statistical significance (p < 0.01).
The combination of 3L analgesia and XZP compress demonstrates the similar effects in pain alleviation as compared with 3L analgesia alone.
XZP paste was prepared at the pharmaceutical department of the author’s hospital.
Chinese medicine may prove to be beneficial for patients with cancer-associated pain management issues, as well as in end-of-life and palliative care; however, these findings do not provide support for the intervention tested here. Nursing participation in these evaluations is essential.
Wang, C., Tan, W., Huang, X., Fu, T., Lin, J., Bu, J., . . . Du, Y. (2013). Curative effect of Dingqi analgesic patch on cancer pain: A single-blind randomized controlled trail. Journal of Traditional Chinese Medicine, 33, 176–180.doi: 10.1016/S0254-6272(13)60121-1
To observe the curative effect of an acupoint application with a Dingqi analgesic patch on moderate-to-severe pain caused by liver cancer
Intervention Characteristics/Basic Study Process:
Patients were randomized to a control or a treatment group. Patients with visual analog scale (VAS) scores of 4–6 were given 100 mg sustained-release tramadol daily. Those with VAS scores of 7–10 were given 4.2 mg fentanyl transdermal every three days. The treatment group was given the acupoint patch consisting of a mixture of traditional Chinese herbs on one to two pain points. The control group was given the same size patch without medication. The VAS scores were assessed at intervals throughout the 12 days of treatment.
- N = 40
- AGE = 18–80 years
- MALES, FEMALES: Not available
- KEY DISEASE CHARACTERISTICS: Liver cancer with pain
- SITE: Single site
- SETTING TYPE: Not specified
- LOCATION: China
Phase of Care and Clinical Applications:
- PHASE OF CARE: Transition phase after active treatment
- APPLICATIONS: Elder care
- Single-blind, randomized, controlled study
- Karnofsky Performance Scale
Findings suggest that the Dingqi patch might be helpful in pain management; however, this study provides very limited support for this approach.
- Small sample (less than 100)
- Risk of bias (no appropriate attentional control condition)
- Unintended interventions or applicable interventions not described that would influence results
- Key sample group differences that could influence results
- Other limitations/explanation: This study shows a decrease in pain over the 12-day period, almost equivocal in the treatment and control group. The patients scored their pain on the VAS scale and were given either controlled-release tramadol or Duragesic® patches at the start of the study, in addition to the Dingqi patch, or the control patch. Additionally, during the 12 days, if a patient scored a 4–6 on the VAS, they were given a 50 mg tramadol injection; if they scored a 7–10 on the VAS, they were given a 5 mg morphine injection. The report was very limited with no information on patient demographics. Actual data are not reported.
This study does not provide evidence in support of the use of this analgesic patch for pain.
Wu, T.H., Chiu, T.Y., Tsai, J.S., Chen, C.Y., Chen, L.C., & Yang, L.L. (2008). Effectiveness of Taiwanese traditional herbal diet for pain management in terminal cancer patients. Asia Pacific Journal of Clinical Nutrition, 17, 17–22.http://apjcn.nhri.org.tw/server/APJCN/17/1/17.pdf
To evaluate the effects of a Taiwanese traditional diet including paeony and licorice components on pain in patients with terminal cancer
Intervention Characteristics/Basic Study Process:
Patients were randomly assigned to one of three groups: (a) Taiwanese traditional herbal diet (TTHD) group, consisting of analgesic herbs (paeony root and licorice root) and tonic vegetable soup (lilli bulbus, nelumbo seed, and jujube fruit), (b) reference group, receiving the regular hospital diet, (c) and control group, receiving the tonic soup without addition of analgesic herbs. All patients remained on the assigned diet for one week. Pain was assessed via patient self-report questionnaire on days 3 and 10.
- The study reported on a sample of 2,466 patients.
- Patient age ranged from 9 to 89 years; 87% were between 40–79 years old.
- The sample was 50.7% male and 49.3% female.
- A variety of cancer sites were included, with the most common being lung, liver, colorectal, and stomach.
- An estimated 90% of patients had pain that was from medical conditions other than cancer. Most patients had neuropathic pain.
- Patients on any analgesics were excluded from the study.
- Single site
- Inpatient setting
- Taiwan University Palliative Medicine Ward
The study was a randomized, parallel group trial.
- Numeric rating scale using a 100-point scale: without pain, minimal pain, mild but tolerable pain, moderately uncomfortable pain, and extreme pain
- Previous tool validation identified
- No information on reliability
All groups reported significant reduction in mean pain scores on days 3 and 10. Patients in the TTHD group reported a three-point improvement in pain (from 53 to 50), which was significantly greater than that in the reference and control groups (p < 0.01).
In this study, use of traditional Taiwanese analgesic herbs was effective for pain reduction, compared to control and reference groups, in palliative care patients who were not receiving other analgesic medications.
Patients on analgesics were excluded from this study, and authors stated that in 90% of cases, pain was not cancer-related. Application of findings to other groups with cancer-related pain who require substantial analgesic therapy is questionable. Though statistically significant, the clinical relevance of the change in average pain scores is questionable, with a change of 3 points on a 100-point scale. The pain scale is not clearly explained, and it appears its scoring is not a continuous variable, though the statistical analysis and summary data provided treats the data as continuous data.
Findings here suggest that traditional Taiwanese analgesic herbs may be helpful in managing pain in terminally ill patients. There are a number of study report issues that make these findings very limited, so applicability to other patients with cancer-related pain is questionable. Future research in this area should examine use of this approach as adjunctive therapy in concert with other analgesia in patients with pain that is truly cancer-related. Applicability in other cultures is needed.
Bardia, A., Barton, D.L., Prokop, L.J., Bauer, B.A., & Moynihan, T.J. (2006). Efficacy of complementary and alternative medicine therapies in relieving cancer pain: A systematic review. Journal of Clinical Oncology, 24, 5457–5464.doi: 10.1200/JCO.2006.08.3725
To evaluate the efficacy of various complementary and alternative medicine (CAM) therapies to reduce cancer pain
The type of article is systematic review.
- Databases searched were MEDLINE, EMBASE, CINAHL, Allied and Complementary Medicine (AMED), and the Cochrane Library up to August 2005. Investigators also searched reference lists from articles to identify relevant studies.
- Search keywords were cancer, pain and alternative medicine, and neoplasm, as well as terms for major individual CAM therapies.
- Studies were included in the review if they were randomized clinical trials (RCTs) that had a CAM intervention for cancer pain.
- Exclusion criteria were not cited.
The initial search identified 101 articles, of which investigators excluded 85. Investigators included an additional two articles, which were found through manual scans of reference lists. Investigators appraised articles by using the Jadad scale.
- The final sample included 18 studies reporting on 1,499 patients.
- The average sample included less than 100 patients; median sample size was 54 patients.
- Acupuncture: Investigators evaluated three trials, of which one was a high-quality study that used auricular acupuncture to treat 90 patients. Compared to the placebo group, the treatment group had a significant decrease in pain intensity that lasted two months.
- Mind-body interventions: Investigators assessed five trials. Two of these were trials of intermediate quality in which support groups were effective in decreasing pain. Interventions included group supportive psychotherapy, hypnosis, and support groups. Two trials concluded that relaxation and imagery were effective in reducing pain. Researchers obtained no greater relief by adding cognitive behavioral therapy to relaxation or imagery.
- Music: Assessment revealed that the three trials were of poor quality. Results were mixed. Effects measured were of very short duration.
- Herbal mixtures: Two trials examined different herbal supplements. Both trials were of poor quality, and one did not report actual statistical results. Authors could draw no meaningful conclusions from this information.
- Massage therapy: The four trials involving massage therapy had mixed results in terms of efficacy. Most of these trials had very small sample sizes, and none found intervention effects that lasted longer than four weeks.
- Healing touch or Reiki: Two trials involved these interventions. Results did not warrant conclusions about effectiveness.
The result of this systematic review was that none of these interventions can be recommended as effective. The most promising therapies appear to be mind-body interventions. In particular, hypnosis and relaxation might have some effect in decreasing cancer pain. Effect may be limited by cognitive impairment caused by cancer or cancer treatment. Support groups may have some positive effects. Whether these benefits are due to increased patient awareness, with more frequent visits to care providers, better compliance with medication regimens, or as a result of group interaction and social or emotional support is unclear. One study found that benefit occurred only in those patients who were more distressed at baseline. It is possible that effect sizes of therapies may be more discernible among patients with higher pain ratings, demonstrating a floor effect related to the symptom of pain.
- Most trials were of low quality, with missing data and incomplete reporting. This fact made extracting sufficient usable information difficult.
- Few studies in the analysis examined a specific intervention.
Current evidence does not support the efficacy of the cited CAM interventions in the management of pain of patients with cancer. Methodologically strong research that incorporates appropriate attentional and sham controls, sufficient sample sizes, and longer duration of follow-up is needed.
Lee, J.W., Lee, W.B., Kim, W., Min, B.I., Lee, H., & Cho, S.H. (2015). Traditional herbal medicine for cancer pain: A systematic review and meta-analysis. Complementary Therapies in Medicine, 23, 265–274.doi: 10.1016/j.ctim.2015.02.003
STUDY PURPOSE: To evaluate the effects of herbal medicine as adjunctive treatment for cancer-related pain
- FINAL NUMBER STUDIES INCLUDED = 24 (four included in the meta-analysis)
- TOTAL PATIENTS INCLUDED IN REVIEW = 4,045
- AVERAGE SAMPLE SIZE: 70 patients (One Chinese study included 2,466 patients.)
- KEY SAMPLE CHARACTERISTICS: Various tumor types
The results of this meta-analysis showed an overall standard mean difference in favor of the herbal intervention across four studies (SMD = -0.51, p < 0.05). In a second meta-analysis, the risk ratio reported was 1.6. The direction of this risk ratio was not clear in the results reported. A meta-analysis was done for studies using herbal interventions in combination with traditional cancer therapy versus only traditional cancer therapy rather than treatment aimed specifically at pain control. Types of in interventions included botanicals, processed animal products, and processed minerals. In some studies, herbal interventions were compared to chemotherapy, aspirin, NSAIDs, Tylenol, diets, placebos, or unnamed analgesic drugs. Most studies showed a high risk of bias according to a study evaluation. A single study that was of high quality across all aspects showed no effect for the intervention.
Although the quantitative analysis showed a statistic significance, the comparisons studied for pain relief did not appear to be appropriate. Although herbal medicine may have better results on pain than no intervention or low-level analgesics, the efficacy of herbal medicine for pain should compare results with those obtained from other interventions shown to be effective for cancer-related pain.
Most studies were of low quality. Many study comparison groups were not adequate because well-recognized, effective interventions for pain were not used in the controls. The results reported in the meta-analysis of risk ratios were unclear. The methods described the use of an odds ratio analysis, but a risk ratio was reported, and it was not clear which study group was considered at-risk.
The findings of this analysis suggested that traditional herbal medicine may have a role in cancer-related pain control. However, the included studies did not provide strong evidence. The potential effects of herbal medicine for pain management remain unclear. Additional well-designed research, including comparisons to pain interventions with strong supportive evidence, are needed to determine any benefits of herbal medicine.
Xu, L., Lao, L.X., Ge, A., Yu, S., Li, J., & Mansky, P.J. (2007). Chinese herbal medicine for cancer pain. Integrative Cancer Therapies, 6, 208–234.doi: 10.1177/1534735407305705
To summarize and evaluate the state of clinical research on the use of Chinese herbal medicine in the treatment of cancer-related pain
The type of article is systematic review.
Databases searched were Chinese Biomedical Literature, Chinese Medical Current Content, Wanfang, and Weipu databases in Chinese, and PubMed and EMBASE in English.
Search keywords were Chinese herb, Chinese medicine and neoplasms and pain. Specific search terms in English and Chinese are displayed in this report.
Studies were included in the review if they were reports of original work on cancer-related pain.
Reviews, commentary, abstracts, and reports on pain associated with cancer therapies were excluded.
An initial search provided 212 Chinese articles and 161 articles from English literature.
Study quality was evaluated using the National Cancer Institute’s Levels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine guidelines.
- A final sample of 115 articles, 106 of which were retrieved from Chinese databases, was included in the report.
- Studies included 3,878 patients. Study sample sizes reported ranged from to 46 to 250 patients.
Results are organized according to route of administration: oral, IV, and other methods of application, such as inhalation.
External application: This is the most common use. This area included 41 studies
- Analgesic effect was equivalent to positive control treatment across studies.
- In numerous studies, the comparison positive control was nonsteroidal anti-inflammatory drugs (NSAIDs) or palliative chemotherapy or radiation therapy. Few studies were in comparison to opioids.
Oral administration: 48 studies were in this category. Comparison positive controls in this group tended to also be palliative chemotherapy or radiation therapy, NSAIDs, and opioids. Dosage ranges of comparison medications were not discussed.
IV infusions: 23 studies were reported; however, authors included studies of intramuscular administration, and samples being actively treated with chemotherapy or radiotherapy for pain. Overall positive results compared to placebo or no active controls were reported.
Other administration methods: One study involving inhalation and one involving per rectum administration are discussed.
Adverse Reactions: Adverse events were slight and brief, and in most cases patients did not require further intervention. Adverse effects were reported to be higher in conventional medicine control groups.
The authors conclude that Chinese herbal medicine may be useful for managing cancer pain. However, there is no discussion of the fact that control comparisons used were no specific pain treatment, or low-level interventions such as NSAIDs. In this regard, controls used in the research summarized here were insufficient to provide realistic scientific comparisons. Methods of pain measurement reported here show mostly use of a single pain measure such as various verbal reporting scales, which can be expected to influence reliability and validity of individual study results. The authors point out that the quality of studies, design and methods, and study reporting was low. The authors suggest specific approaches in study design for improvement of research in this area.
Well-designed research in the use of Chinese herbal medicine is needed to enable firm conclusions about efficacy. Research regarding the role of this type of treatment as adjunctive pain management would also be useful. Findings here provide only minimal support for the use of Chinese herbal medicine to effectively manage cancer-related pain.
Yanju, B., Yang, L., Hua, B., Hou, W., Shi, Z., Li, W., . . . Lv, W. (2014). A systematic review and meta-analysis on the use of traditional Chinese medicine compound kushen injection for bone cancer pain. Supportive Care in Cancer, 22, 825–836.doi: 10.1007/s00520-013-2063-5
STUDY PURPOSE: To assess the efficacy of compound kushen injection (CKI) for bone pain in cancer
TYPE OF STUDY: Meta-analysis and systematic review
DATABASES USED: MEDLINE, Cochrane Collaboration, four Chinese databases, two Korean databases, and one Japanese medical database
KEYWORDS: kushen, yanshu, matrine, and various terms for bone cancer pain
INCLUSION CRITERIA: RCT, adult patients with cancer-related bone pain; patients in the control group were given radiotherapy, opioids, non-steroidal anti-inflammatory drugs, or bisphosphonates
EXCLUSION CRITERIA: Nonrandomized trials
TOTAL REFERENCES RETRIEVED = 170
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Used the GRADES system for quality evaluation
- FINAL NUMBER STUDIES INCLUDED = 7
- SAMPLE RANGE ACROSS STUDIES, TOTAL PATIENTS INCLUDED IN REVIEW: 521 total patients; sample size per study not reported
- KEY SAMPLE CHARACTERISTICS: Variety of tumor types
Phase of Care and Clinical Applications:
- PHASE OF CARE: Late effects and survivorship
- APPLICATIONS: Palliative care
All studies were done in China at a single center. Analysis showed that CKI relieved pain when compared to bisphosphonates or radiotherapy (RR 1.25, p < .0001). The quality of all studies included was low, and risk of bias was high. Not all studies examined adverse effects. In four studies, patients who received CKI had less nausea and leukopenia. Analysis showed positive results, indicating publication bias.
CKI may have beneficial effects and reduce cancer-related bone pain. However, the small number of trials and low quality of the evidence is insufficient to show efficacy.
- Small number of studies
- Low quality of studies
- All studies done at the same institution
Evidence is insufficient to determine efficacy of the Chinese herbal medicine kushen.