A Randomised Placebo-Controlled Trial of a Traditional Chinese Herbal Formula in the Treatment of Primary Dysmenorrhoea
2007

Trial of Chinese Herb Medicine for Menstrual Pain

Sample size: 78 publication 10 minutes Evidence: moderate

Author Information

Author(s): Yeh Lan Lan Liang, Liu Jah-Yao, Lin Kao-Si, Liu Yu-Shen, Chiou Jeng-Min, Liang Kung-Yee, Tsai Te-Feng, Wang Li-Hsiang, Chen Chiung-Tong, Huang Ching-Yi

Primary Institution: National Health Research Institutes, Taiwan

Hypothesis

Four-Agents-Decoction (Si Wu Tang) has a beneficial effect to treat primary dysmenorrhoea.

Conclusion

The study found no statistically significant difference in reducing menstrual pain intensity at the end of treatment, but some pain reduction was observed in follow-up cycles.

Supporting Evidence

  • Participants reported a decrease in peak-pain intensity after treatment.
  • The study used a rigorous methodology to assess the herbal formula's effectiveness.
  • Adverse reactions were not significantly different between the treatment and placebo groups.
  • Pain intensity was measured using a validated visual analog scale.
  • Follow-up cycles showed some unexpected pain reduction.
  • Participants were monitored for compliance and adverse effects throughout the trial.
  • The herbal formula has a long history of use in traditional Chinese medicine.
  • Statistical analysis indicated a significant treatment effect in follow-up cycles.

Takeaway

This study tested a traditional Chinese herbal medicine for menstrual pain, but it didn't show clear benefits compared to a placebo.

Methodology

A randomized, double-blind, placebo-controlled pilot clinical trial was conducted with 78 participants who reported primary dysmenorrhoea.

Potential Biases

Participants were aware of the treatment they received, which may have influenced their reporting of pain.

Limitations

The study had a small sample size and was not powered to assess the outcome of work or school absence.

Participant Demographics

Young women with primary dysmenorrhoea, aged around 23 years.

Statistical Information

P-Value

0.020

Statistical Significance

p=0.020

Digital Object Identifier (DOI)

10.1371/journal.pone.0000719

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