Clinical Application Guideline For The Treatment Of Menopausal Syndrome With Traditional Chinese Medicine Ⅲ

4 Clinical Question 2

In what cases is it necessary to use Chinese patent medicines in combination with Western medicines to treat CLS? Can Chinese patent medicines reduce the adverse reactions of Western medicines? A total of 2 Chinese patent medicines were finally recommended. These 2 Chinese patent medicines are mainly for kidney yin deficiency syndrome, and the symptoms are the same as those in Clinical Question 1.

4.1 Kuntai Capsule

4.1. 1 Recommendation Kuntai Capsule combined with hormone drugs has a synergistic effect.

It is recommended for patients with moderate to severe CLS, with hot flashes, irritability, insomnia, palpitations, dizziness, tinnitus, vaginal dryness, and sexual intercourse difficulties as the main symptoms, and those with kidney yin deficiency syndrome (1C). Usage and safety: See 3.1 for details.

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4.1.2 Evidence description

4.1.2. 1 Evidence of the use of Kuntai capsule combined with hormones

Eight randomized controlled studies (760 cases) [4653] reported the changes in Kupperman scores after 3 months of treatment with Kuntai capsule combined with hormones (including estradiol valerate, conjugated estrogens, clemenide, tibolone, nylestriol, etc.) and the same hormone drugs. The results showed that Kuntai capsule combined with hormone therapy had better efficacy [MD= -4. 6 1, 9 5% C/ (-5. 4 5, -3. 7 7), P < 0. 0 0 0 0 1,/2= 6 6%] 〇 4. 1. 2． 2. Evidence of the safety of Kuntai capsule combined with hormones versus hormones

Five randomized controlled studies [444 M8 ＇ 51] compared the incidence of vaginal bleeding after 3 months of treatment with Kuntai capsule combined with hormones and the same hormone drugs (480 cases), indicating that the incidence of vaginal bleeding in the Kuntai capsule group was lower than that in the hormone group [ 尺尺＝０．３９,９５％ Ｃ／(０．１７,０．９０),Ｐ＝０．０３,／２＝０％ ]. Four randomized controlled studies [454M8'51] reported the incidence of breast tenderness after 3 months of treatment with Kuntai capsule combined with hormones and the same hormone drugs (370 cases), indicating that there was no statistically significant difference between the two groups [RR = 0.88, 95%C/ (0.32, 2.36), P = 0. ７ ９ , ０ ％ ／２＝ ０ ％ ］ ; 5 randomized controlled studies [ ４ ４ ４ Ｍ８ ＇ ５ １ ] reported the comparison of Kuntai capsule combined with hormone and the same hormone drugs ( 4 80 cases ) . The incidence of gastrointestinal reactions after 3 months of treatment showed that there was no statistically significant difference between the two groups [ ＲＲ ＝ ０ ． ５ １ , ９ ５ ％ Ｃ／ ( ０ ． ２ ６ , １ ． ０ １ ) , P＝ ０ ． ０ ５ , ０ ％ ／２＝ ０ ％ ]. It is suggested that Kuntai capsule combined with hormone drugs can reduce the incidence of hormone-induced vaginal bleeding.

4.1.2.3 Evidence for the selection of Kuntai capsule combined with hormone drugs

Eight randomized controlled studies (760 cases) [4653] reported that the baseline Kupperman score before treatment was (31.39 &plusmn; 9.39) points. According to the Kupperman score, CL S is mild if it is less than 20 points, moderate if it is 20-35 points, and severe if it is greater than 35 points, suggesting that Kuntai capsule combined with hormone therapy is suitable for patients with moderate or above CL S.

4.1.2.4 Delphi voting results

24 votes for strong recommendation, 6 votes for weak recommendation, and 0 votes for non-recommendation. After questionnaire survey and expert consensus, the final recommendation level was determined to be "strong recommendation".

4.2 Kunbao Pills

4.2.11 Recommended Xiangyanyan

Kunbao Pills have a synergistic effect when combined with hormone drugs. It is recommended for patients with moderate to severe CLS, with insomnia as the main symptom, accompanied by hot flashes and other major symptoms, and with kidney yin deficiency syndrome (2D). Usage and safety: see 3.3.1 for details. 4.2.2 Description of the evidence

４．２．２ ． 1 Evidence of the effectiveness of Kunbao Pills combined with hormone therapy for CLS

Two randomized controlled trials [S7 ' S8] (142 cases) reported the effectiveness of Kunbao Pills combined with estradiol valerate compared with estradiol valerate alone in terms of Kupp erman score after 3 months of treatment, suggesting that Kunbao Pills combined with estradiol valerate had better efficacy [RR = 1.18, 95% C/(1.03, 1.34), P = 0.75, /2 = 0%] ０４.2.2. 2. The voting results of the Delphi method were 13 strong recommendations, 14 weak recommendations, and 2 non-recommendations. After questionnaire surveys and expert consensus, the recommendation level was finally determined to be "weak recommendation".

5. Judgment of effectiveness and safety

During the research process of this guideline, literature evidence suggests that the guideline recommends that Chinese patent medicine has significant efficacy in the treatment of CLS, and some Chinese patent medicine literature evidence further proves that Chinese patent medicine is superior to traditional hormone therapy in terms of drug safety. The research results were affirmed by the consensus experts and unanimously passed the consensus opinion of recommendation.
However, the experts of the research team considered that using only one Chinese patent medicine to treat diseases for a long time is not in line with the Chinese medicine syndrome differentiation and treatment, thus affecting the clinical efficacy. It is recommended that clinical physicians should pay attention to the patient's clinical symptoms and changes in Chinese medicine syndromes when using drugs, weigh the pros and cons, and timely modify the medication according to the patient's specific situation.

６ Limitations and shortcomings of this guideline

６． 1. Literature survey results show that the quality of literature is generally not high.

A total of 23,500 articles were retrieved in this study, and 61 valid articles were finally found to be relevant to the recommendation. Among them, the only articles with good quality were those on Kuntai Capsules and Linglianhua Granules. According to the current literature survey results, most Chinese patent medicines meet the inclusion criteria, but the number of literature and the number of cases included in the study are insufficient, and the blinding and randomization methods of the literature are missing, resulting in the GRADE evidence evaluation of most included literature being low or very low quality. If the inclusion is carried out according to the high-quality literature method, there will be very few documents that can be included, or even no documents can be analyzed. Therefore, the current solution is to analyze and evaluate all the documents that can be included, but the quality of the evidence evaluation obtained in the end is not high, which affects the quality of the guidelines.

In addition, this study also searched for clinical research literature related to the treatment of CLS that was not mentioned in the indications in the drug instructions. However, due to the poor quality of the literature, it cannot become evidence-based evidence for the treatment of CLS, and this type of Chinese patent medicine was not included in this guideline.

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