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Record W3217451261 · doi:10.21203/rs.3.rs-1075897/v1

Skin‐patch Of Ding Zi Gao on Relieving Local and Systemic Symptoms in Patients with Moderate to Severe Periodic Mastalgia: A Randomized, Double‐Blind Trial

2021· preprint· en· W3217451261 on OpenAlexaboutno aff
Huan Liang, Qiao Huang, Yujian Sun, Na Fu, Wenjie Zhao, Dongxiao Zhang

Bibliographic record

VenueResearch Square · 2021
Typepreprint
Languageen
FieldMedicine
TopicBreast Lesions and Carcinomas
Canadian institutionsnot available
FundersNational Natural Science Foundation of China
KeywordsDouble blindMedicineDermatologyRandomized controlled trialInternal medicineAlternative medicinePathologyPlacebo

Abstract

fetched live from OpenAlex

Abstract Background and purpose: The use of hormone receptor agent drugs such as androgens (tamoxifen) for the treatment of moderate and severe breast pain has limitations such as cardiac, hepatic, and nephrotoxicity and gastrointestinal side effects. Therefore, there is a need to prescribe a new safe and effective topical treatment method to reduce the use of anti-inflammatory and hormonal agent drugs, the incidence of adverse effects and the financial burden on patients. This randomized controlled clinical trial investigates the clinical efficiency and safety of Skin‐patch of Ding Zi Gao (DZG) acupoint-application therapy for the treatment of moderate to severe Periodic mastalgia ( MSPM ), and provides a basis for the design of an optimized, safe and effective comprehensive treatment plan for MSPM. Methods: Sixty patients with moderate to severe Periodic mastalgia (MSPM) who met the inclusion criteria were selected from the breast clinic of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University and randomly divided into 30 cases in the treatment group and 30 cases in the control group. The treatment group was treated by Skin‐patch of Ding Zi Gao (DZG) acupoint-application therapy, which was applied from the 3rd day after the end of menstruation, once a day, for 6-8 h each time, 14 times as a course of treatment, and the treatment was completed within 1 month, and the application was stopped during menstruation. The control group was treated with skin patches of placebo acupoint application , and the duration and course of treatment were the same as that of the treatment group. During the 14 day course of treatment and 2-month follow-up after the experiment, the main outcome indicators (including Breast pain improvement onset time, change in breast pain VAS score, change in patient's mood, sleep, Fullness in both flank, (McGill Pain Questionnaire) MPQ and secondary outcome indicators ( Including changes in breast nodule size and gland thickness guided by breast ultrasound, VAS pain score in the 2-month follow-up at the end of treatment, and adverse reactions), At the same time, the safety of the scheme was evaluated. RESULTS: There were no differences between the two groups in terms of age, body mass index, history of breastfeeding, family history of breast disease, history of allergies, history of breast surgery, or duration of breast pain (months) before recruitment. The comparison between pre-treatment and post-treatment showed that the time to onset of breast pain improvement, visual analogue score (VAS) of breast pain, improvement in mood, sleep, fullness in both flank and the MPQ were significantly lower in both groups after treatment, and the improvement was more significant in the treatment group than in the placebo control group (P < 0.05). Both groups showed significant reductions in improving patient mammography outcomes and VAS pain scores at two months of follow-up, but there were no significant differences between the groups. In terms of safety evaluation, no significant differences in the incidence of adverse events were found. CONCLUSION: point-application treatment with skin patches of Ding Zi Gao (DZG) therapy in patients with MSPM improved breast pain and swelling, reduced breast gland thickness, and decreased breast visual analogue pain score (VAS) and MPQ score. Its efficacy was significantly better than skin patches of placebo acupoint application therapy alone. This study provides a basis for the clinical application of DZG for MSPM .

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.003
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.041
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0030.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0020.000
Bibliometrics0.0010.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.001
Research integrity0.0000.002
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.036
GPT teacher head0.331
Teacher spread0.296 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designRandomized trial
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations0
Published2021
Admission routes1
Has abstractyes

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