ArticleBMC complementary medicine and therapies2025
Chinese medicine (Tiao-Chang Ke-Min granules) placebo and nocebo effects for diarrhea-predominant irritable bowel syndrome: a study protocol for a randomized controlled trial based on a balanced experimental design.
Article in BMC complementary medicine and therapies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundIrritable bowel syndrome (IBS) is a common gut-brain interaction disorder, prevalent in the general population. Current medication treatments often leave patients undertreated. Therefore, more and more IBS patients are choosing complementary and alternative medicines for treatment, especially Chinese medicine (CM). However, the therapeutic benefits of CM for IBS have not been well-accepted, and some scholars have attributed the effects of CM to a "placebo effect". It is generally recognized that different placebos could lead to different effects, and that the CM placebo effect is especially high. We think CM treatment responses may be obscured by high, non-specific placebo responses in clinical trials, and thus it is difficult to demonstrate successful treatment effects in a research setting. Thus, ascertaining the magnitude of the CM placebo effect will provide valuable support for accurately understanding CM therapeutic benefits. This study aims to evaluate the placebo and nocebo effects of CM (Tiao-Chang Ke-Min granules, TCKM) in diarrhea-predominant IBS (IBS-D) treatment.
methodsWe plan to use a balanced experimental design embedded in a randomized controlled trial to investigate CM placebo and nocebo effects. This design involves two essential factors: participants' expectations regarding their treatment and the treatment that they actually receive. This balanced design enables the researchers to control the factor of participants' treatment expectations. We use a semi-scripted description of group assignment to elicit participants' expectations regarding IBS-D treatment. Eligible participants will be randomized into 4 groups at a ratio of 1:1:1:1, and receive either TCKM granules or placebo granules. The treatment duration will be 4 weeks. The primary outcome is the proportion of IBS Severity Scoring System responders at the end-of-treatment. The secondary outcomes include individual symptoms, adequate relief, quality of life, and anxiety and depression. This trial has been reviewed and approved by the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (BF2021-082-01). DISCUSSION: To our knowledge, this will be the first trial to investigate CM placebo and nocebo effects in the IBS population. Therefore, this trial may have a real impact on clinical studies and routine practice in the relevant fields.
trial registrationChinese Clinical Trial Registry (ChiCTR2300067549), registered on 11 January 2023.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.