The Difference between the Two Representative Kampo Formulas for Treating Dysmenorrhea: An Observational Study

Abstract

In Kampo medicine, two different formulas are effective for treating dysmenorrhea—tokishakuyakusan and keishibukuryogan; however, the criteria by which specialists select the appropriate formula for each patient are not clear. We compared patients treated with tokishakuyakusan and those with keishibukuryogan and proposed a predictive model. The study included 168 primary and secondary dysmenorrhea patients who visited the Kampo Clinic at Keio University Hospital. We collected clinical data from 128 dysmenorrhea patients, compared the two patient groups and selected significantly different factors as potential predictors, and used logistic regression to establish a model. An external validation was performed using 40 dysmenorrhea patients. Lightheadedness, BMI < 18.5, and a weak abdomen were significantly more frequent in the tokishakuyakusan group; tendency to sweat, heat intolerance, leg numbness, a cold sensation in the lower back, a strong abdomen, and paraumbilical tenderness and resistance were more frequent in the keishibukuryogan group. The final model fitted the data well. Internally estimated accuracy was 81.2%, and a leave-one-out cross-validation estimate of accuracy was 80.5%. External validation accuracy was 85.0%. We proposed a model for predicting the use of two Kampo formulas for dysmenorrhea, which should be validated in prospective trials.

Effectiveness of Japanese Kampo treatment in dysmenorrhea: Single‐center observational study

“…Higher efficacy rates are expected with longer treatment periods. Studies conducted on ibuprofen (Brufen) and naproxen (Naixan) have reported almost the same efficacy rates . We also observed a high efficacy rate with respect to other symptoms within the Kampo treatment term.…”

“…We also showed that Kampo treatment caused some adverse reactions, but the reactions were mild and resolved after stopping or even continuing the Kampo formulas. In the aforementioned studies on ibuprofen (Brufen) and naproxen (Naixan), side‐effect rates of 3.04% and 3.50%, respectively, were noted . Studies on the safety of OC have reported overall adverse outcome rates of 96.6–100% for drospirenon/ethinylestradiol betadex (Yaz) and 25–41.9% for norethisterone/ethinylestradiol (Lunabell), with some patients experiencing moderate or severe adverse reactions .…”

“…We encourage non‐specialist physicians to select appropriate Kampo formulas: a standardized and reproducible intervention will be the most beneficial. We have already proposed a statistical model that predicts the most appropriate of two representative Kampo formulas using subjective symptoms and objective findings . This model will be applied in standardized comparative effectiveness research .…”

Gyejigachulbutang (Gui‐Zhi‐Jia‐Shu‐Fu‐Tang, Keishikajutsubuto, TJ‐18) in Degenerative Knee Osteoarthritis Patients: Lessons and Responders from a Multicenter Randomized Placebo‐Controlled Double‐Blind Clinical Trial

“…Pattern diagnosis, which not only considers symptoms of a patient but also the complexion and physique, is important when administering herbal medicine. In TEAM, various diagnostic methods have been used to administer herbal formulas, including a “cold-heat/deficiency-excess pattern” diagnosis [ 34 – 36 ]. GCB is a traditionally used herbal medicine for patients with pain and has been primarily prescribed for patients with poor nutrition and a skinny, cold intolerance tendency [ 37 ].…”

Efficacy of Tokishakuyakusan add‐on therapy with low‐dose oral contraceptive pills on endometriosis patients with dysmenorrhea

“…TSS has been mainly used for women who have dysmenorrhea or ovarian dysfunction, which can be used for pain alleviation or estrogen-secreting qualities. 3,4 In addition, accumulated evidence of its neuroactive and neuroprotective effects was verified. [5][6][7] Currently, the mechanisms of TSS have been reported to involve immunological effects on murine endometriosis and pregnancy loss model.…”