Key Words: Chinese herbal medicine; endometriosis; gestrinone; danazol
What is the effectiveness and safety of Chinese herbal medicine (CHM), compared with conventional treatment, on endometriosis-related pain and infertility in women with endometriosis?
Endometriosis is a disease characterized by the presence of tissue that is morphologically and biologically similar to normal endometrium in locations outside the uterine cavity. Primary symptoms of endometriosis are endometriosis-related pain and infertility. The conventional treatment of endometriosis involves surgery and hormonal drugs, with short term benefits and high rates of rates of symptom recurrence (or return).
In China, treatment of endometriosis using CHM is routine. CHM is thought to act via improvement of blood circulation and anti-inflammatory activity. There is considerable anecdotal evidence supporting the use of CHM as a potential treatment for endometriosis. Analyzing the evidence on the effectiveness and safety of CHM in the treatment of endometriosis can promote the development of treatment strategies for endometriosis which may reduce the suffering of patients and improve their quality of life.
The review included two small, Chinese randomized controlled trials (RCTs), with a total of 158 women aged 23 to 45 years and an average age of 30 years. All participants had a laparoscopically confirmed diagnosis of endometriosis.
The two trials, conducted by the same researchers, took place in a hospital outpatient department in China. One trial compared CHM endometriosis pills plus CHM enema (24 participants) and CHM endometriosis pills only (16 participants) with danazol (18 participants), and the other compared CHM endometriosis pills plus a herbal enema (48 participants) with gestrinone (52 participants).
Treatment durations were for 3 months. One trial followed up for 1-24 months, while the other one did not follow up. The primary outcome was relief of endometriosis-related pain (both in the long term and short term) while secondary outcomes included improvement in fertility rates (live birth or pregnancy); reduction in the size and extent of endometrial cysts; improvement in quality of life scores; improvement of endometriosis-related symptoms apart from pain (e.g. fatigue); adverse effects resulting from the CHM intervention and rates of reoccurrenceand adverse effects.
Both trials described adequate randomization and allocation concealment methods. The trials also reported single blinding for participants, and assessor blinding. Few or no participants were excluded from the analysis. Both studies were evaluated as a moderate risk of bias.
The results were presented in a narrative synthesis.
Summary of Key Evidence:
In total, 100% of women in both trials showed some improvement in their symptoms, in both experimental and control groups.
The comparison of CHM with gestrinone groups showed no evidence of a significant difference between the two groups in the rates of symptomatic relief and pregnancy over a 24 month period.
CHM administered orally and in conjunction with a herbal enema resulted in a greater proportion of women obtaining symptomatic relief than with danazol (Risk Ratio [RR] 5.06, 95% Confidence Interval [CI] 1.28 to 20.05; RR 5.63, 95% CI 1.47 to 21.54, respectively). Oral plus enema administration of CHM resulted in a greater reduction in average dysmenorrhoea pain scores than treatment with danazol (mean difference [MD] -2.90, 95% CI -4.55 to -1.25). It also showed a greater improvement measured as the disappearance or shrinkage of adnexal masses than treatment with danazol (RR 1.70, 95% CI 1.04 to 2.78). For lumbosacral pain, rectal discomfort, or vaginal nodules tenderness, there was no significant difference between CHM and danazol groups.
Best Practice Recommendations:
The evidence from this review suggests that following laparoscopic surgery, combined oral and enema administration of CHM has a comparable beneficial effect to gestrinone but with fewer adverse effects. Oral and enema administration of CHM may be more effective than danazol in providing extended relief of endometriosis symptoms and in shrinking adnexal masses, with fewer adverse effects. However, the two trials included in this review were small and of limited quality so these findings must be interpreted cautiously. Better quality RCTs are needed.
A member of the Cochrane Nursing Care Field (CNCF)
Flower, A., Liu, J. P., Lewith, G., Little, P. & Qing, L. (2012). Chinese herbal medicine for endometriosis. Cochrane Database of Systematic Reviews 2012, 8. Art. No. CD006568. DOI:10.1002/14651858.CD006568.pub3. The full review report, including references, can be accessed at http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006568.pub3/pdf