How Herb Clinical Trials Are Designed and Why Results Differ
How controlled herb trials are built, why herbs are harder to test than a single-compound drug, and why two trials of the same herb can reach different results.
Content last updated . This page has not been medically reviewed.
Safety first. Natural products can cause side effects and interact with medicines. Read herb safety and interactions before you use anything on this page.
A good herb trial compares a defined herbal product with an inactive look-alike in people who do not know which one they are getting. Herbs are harder to test than drugs made of one compound, because the product itself can vary. That is one reason trials of the same herb often disagree. This page explains the design and the herb-specific problems. It does not recommend any herb.
The basic design
- Control group. NCCIH describes a controlled trial as one that compares groups of participants who are as identical as possible in other respects. One group receives the treatment and the other receives standard care or an inactive substance. [1]
- Blinding. In a double-blind study neither the participants nor the researchers know who is in which group. [1] NCCIH says it can be surprisingly difficult to avoid bias in clinical trials. [2]
- Size. Small sample sizes are more likely to produce results due to chance. [3]
- Meaning of the result. Differences can be statistically significant but so small that they are not clinically significant for patients. [4]
- Where trials sit. NCCIH says clinical trials give the clearest information about whether a treatment is effective and safe in humans. [5] Studies in cells or animals are preclinical and cannot show this.
Where herb trials get harder
The product has to be described. A review of 206 randomized trials of ten herbal medicines found that 45% of the reporting checklist items were reported across all trials, and that key herbal details such as the percentage of active constituents and the type or form of the preparation may be missing. [6] The reporting guideline CONSORT applies to herbal products, [7] and a version specific to herbal medicine trials was written for authors. [6]
The placebo is hard to make. A 2026 survey of 136 trials of Chinese herbal medicine found that deficiencies persist in how placebos were designed and reported. In 33 of the trials the placebos contained traditional Chinese medicine ingredients, which the authors say challenges the principle that a placebo is pharmacologically inert. [8] (The paper has been corrected by an erratum, so check the journal version for the figures.)
Many different products carry one name. The Cochrane review of echinacea for colds found 24 double-blind trials that used different species and parts of the plant. Because of strong clinical heterogeneity (the studies were too different), the authors did not pool them for the main analysis. [9]
The product in the trial may not be the product on the shelf. NCCIH says supplements you buy may differ in important ways from products tested in studies. [10]
What the trials found, as examples
| Question | What the source found | Evidence label |
|---|---|---|
| Does ginkgo prevent dementia? | The NIH-funded GEM study enrolled more than 3,000 people aged 75 or older, who were randomly assigned to ginkgo or placebo for a median of 6 years. There was no difference between the groups in the rates of dementia of any type or Alzheimer's disease. [11] | No good evidence of benefit |
| Does saw palmetto help prostate-related urinary symptoms? | A 2023 review found that saw palmetto alone provides little or no benefit for these symptoms. It included two NIH-funded trials of saw palmetto alone, and in both the herb did not improve symptoms. [12] | No good evidence of benefit (for that use) |
| Does the way the extract is made matter? | Because it had been suggested that hexane-extracted saw palmetto might work better, the reviewers compared them. No difference was found between those and other products. [12] | Mixed picture; limited to that use |
| Do echinacea products shorten colds? | The Cochrane review concluded that the products have not been shown to benefit treatment of colds. [9] | Mixed |
Limits
Proper evidence not found for a single rule that explains all herb trial differences. We searched the NCCIH, Cochrane and PubMed sources cited here. Product variation, placebo design, trial size and funding each play a part and none alone explains the pattern.
Frequently asked questions
Why are herb trials harder than drug trials?
Herbal products can vary by plant species, plant part and extract, and their makeup is not always reported. [6][9]
What is a placebo in an herb trial?
An inactive look-alike used for comparison. NCCIH describes the comparison group as receiving standard care or an inactive substance. [1] Making a convincing look-alike for a herb can be difficult. [8]
What is blinding?
It means participants and researchers do not know who receives which treatment, so expectations cannot sway the results. [1][2]
Can I trust one trial?
Treat a single study with care. NCCIH says a single study rarely provides a final, definitive answer. [4]
Where can I see registered trials?
The Research Library explains registered trials and protocols and why a registration is not a result.
More details: evidence, limits and cautions
The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.
Safety and who should ask first
A trial result applies to the people and the product studied. Whether it applies to you is a question for a pharmacist or clinician, especially if you take prescription medicines, are pregnant or breastfeeding, have liver or kidney disease, or face surgery. See the medicine interactions guide.
For more, read why herb studies disagree, how to read a herb study and the Research Library's evidence types and study designs.
References
- National Center for Complementary and Integrative Health (NCCIH). Know the Science: Design of the Study. Read 2026-10-22.
- National Center for Complementary and Integrative Health (NCCIH). Know the Science: Minimizing Bias. Read 2026-10-22.
- National Center for Complementary and Integrative Health (NCCIH). Know the Science: Size of the Study. Read 2026-10-22.
- National Center for Complementary and Integrative Health (NCCIH). Know the Science: Results. Read 2026-10-22.
- National Center for Complementary and Integrative Health (NCCIH). Know the Science: Types of Research. Read 2026-10-22.
- Gagnier JJ, DeMelo J, Boon H, Rochon P, Bombardier C. Quality of reporting of randomized controlled trials of herbal medicine interventions. Am J Med. 2006. PMID 16945616. Read 2026-10-22.
- Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C; CONSORT Group. Recommendations for reporting randomized controlled trials of herbal interventions: Explanation and elaboration. J Clin Epidemiol. 2006. PMID 17027423. Read 2026-10-22.
- Yu J, et al. Placebo design, reporting compliance, and methodological problems in randomized, placebo-controlled trials of Chinese herbal medicine: a cross-sectional study. Pharmacol Res. 2026;229:108244 (an erratum, 108272, has been published). PMID 42128211. Read 2026-10-22.
- Karsch-Völk M, Barrett B, Kiefer D, Bauer R, Ardjomand-Woelkart K, Linde K. Echinacea for preventing and treating the common cold. Cochrane Database Syst Rev. 2014. PMID 24554461. Read 2026-10-22.
- National Center for Complementary and Integrative Health (NCCIH). Using Dietary Supplements Wisely. Read 2026-10-22.
- National Center for Complementary and Integrative Health (NCCIH). Ginkgo. Last updated February 2025. Read 2026-10-22.
- National Center for Complementary and Integrative Health (NCCIH). Saw Palmetto. Last updated April 2025. Read 2026-10-22.