Table 3. Short descriptions including disease name, Kampo diagnosis, intervention (Kampo formula), and control for each use category.
| Randomi zation | Disease | Kampo diagnosis | intervention | control | Author (year) | |
| 1 | 1 Inclusion criteria (n = 10) | Polycystic ovary syndrome | Sixty-four patients were randomly assigned to one of 2 groups using the diagnostic criteria “yin and yang, excess or deficiency, interior and exterior, cold and heat”, to receive 8-week preliminary administration of either keishibukuryogan or tokishakuyakusan. Then, 54 non-responder patients were further assigned to receive either a continuation of the same treatment (n = 27) or unkeito (n = 27) for 8 weeks. | Unkeito (n = 27) | Keishibukuryogan or Tokishakuyakusan (n = 27) | Ushiroyama T, et al. (2006) |
| 2 | 1 Inclusion criteria (n = 10) | Sleep disorders | Of 20 normal healthy men receiving yokukansankachimpihange before the start of the study, 7 with sleep disorders favorably affected were selected for the study. | Yokukansankachimpi hange (n = 7) | Anchusan (n = 7) | Aizawa R, et al. (2002) |
| 3 | 1 Inclusion criteria (n = 10) | Essential hypertension. | Excess pattern | Daisaikoto (n = 14) | No administration (n = 15) | Sasaki J, et al. (1993) |
| Deficiency pattern | Chotosan (n = 24) | No administration (n = 30) | ||||
| 4 | 1 Inclusion criteria (n = 10) | Common cold | Subject selection was made on the basis of persistent symptoms and discomfort in the mouth, which indicate “shosaikoto-sho” | Shosaikoto (n = 131) | Placebo (n = 119) | Kaji M, et al. (2001) |
| 5 | 1 Inclusion criteria (n = 10) | Atopic dermatitis | Qi-deficiency was one of the inclusion criteria for enrollment in this trial. | Hochuekkito (n = 37) | Placebo (n = 40) | Kobayashi H, et al. (2010) |
| 6 | 1 Inclusion criteria (n = 10) | Senile pruritus | intermediate pattern to excess pattern | Orengedokuto (n = 16) | Antihistamine (n = 16) | Ohkawara A, et al. (1991) |
| deficiency pattern | Goshajinkigan (n = 25) | Antihistamine (n = 29) | ||||
| 7 | 1 Inclusion criteria (n = 10) | Gonarthro sis | The sho concept was an inclusion criterion. Although “gonarthrosis complying with the sho for boiogitokabushi” was used as a criterion, the sho concept was not defined. | Boiogitoka shuchibushimatsu (n = 110) | Loxoprofen (n = 101) | Nishizawa Y, et al. (2007) |
| 8 | 1 Inclusion criteria (n = 10) | Dysmeno rrhea | Forty females suffering from dysmenorrhea for at least 1 year, with all qi deficiency, yin, and static blood scores of 30 or more, without orthopedic disorders, and not receiving oral low-dose medications or prescribed anxiolytics. | Tokishakuyakusan (n = 20) | Placebo (n = 20) | Kotani N, et al. (1997) |
| 9 | 1 Inclusion criteria (n = 10) | Climacteric complaints | Table 1, which shows the 7 target symptoms of climacteric disorder, was referred for selection of keishibukuryogan*. | Keishibukuryogan (n = 21) | Keishibukuryogan and tofisopam (n = 22) | Tanaka E, et al. (1997) |
| 10 | 1 Inclusion criteria (n = 10) | Chronic headache | patients with chronic headache that responded to goshuyuto | Goshuyuto (n = 28) | Placebo(n = 25) | Odaguchi H, et al. (2005, 2006) |
| 11 | 2 Exclusion criteria (n = 9) | Chronic hepatitis C | Patients with yin pattern and deficiency pattern were excluded before the allocation. | Shosaikoto (n = 49) | One of the commonly used liver protectors (n = 50) | Nakajima O et al. (1999) |
| 12 | 2 Exclusion criteria (n = 9) | Interferon-resistant chronic hepatitis C | One patient with yin pattern and deficiency pattern was excluded before the allocation, and the study was actually conducted in 99 patients. | Shosaikoto (n = 39) | Squalene (n = 33) Cepharanthine (n = 40) | Nakajima O, et al. (2003) |
| 13 | 2 Exclusion criteria (n = 9) | Spring nasal allergy (pollinosis) | Deficiency pattern patients were excluded. | Ryokankyomishingeninto (n = 15) | Shoseiryuto (n = 15) | Mori H, et al. (1996) |
| 14 | 2 Exclusion criteria (n = 9) | Spring allergic rhinitis (pollinosis) | Since shoseiryuto is used in intermediate or excess pattern patients, and eppikajutsuto is used in physically strong patients, physically weak patients were excluded. | Eppikajutsuto (n = 49) | Shoseiryuto (n = 45) | Mori H, et al. (1997) |
| 15 | 2 Exclusion criteria (n = 9) | Spring allergic rhinitis (pollinosis). | Since shoseiryuto is used in intermediate pattern to excess pattern patients, physically weak patients were excluded. | Daiseiryuto (Keishito + Makyokansekito) (n = 24) | Shoseiryuto (n = 45) | Mori H et al. (1998) |
| 16 | 2 Exclusion criteria (n = 9) | Springtime nasal allergy and allergic conjuncti vitis | Patients with deficiency pattern were excluded*. | Keimakakuhanto (Keishito + Maoto) (n = 33) | Shoseiryuto (n = 32) | Mori, et al. (1999) |
| 17 | 2 Exclusion criteria (n = 9) | Nasal allergy and allergic conjunctivi tis in spring | Subjects with deficiency pattern were excluded because shoseiryuto and gokoto are used to treat subjects with excess or intermediate patterns. | Gokoto (n = 58) | Shoseiryuto (n = 58) | Shimazaki Y, et al. (2001) |
| 18 | 2 Exclusion criteria (n = 9) | Springtime nasal allergy and allergic conjunctivi tis | Patients with deficiency pattern were excluded*. | Maobushisaishinto (n = 32) | Shoseiryuto (n = 34) | Yoshimoto T, et al. (2002) |
| 19 | 2 Exclusion criteria (n = 9) | Antibody production after influenza vaccination | Subjects not intending to use hochuekkito, as well as subjects with easy fatigability, a high susceptibility to colds, slow recovery from colds, a high susceptibility to other infections like herpes and wound infection, poor appetite, loose bowels, and somnolence especially after meals | Hochuekkito (n = 18) | Placebo (n = 18) | Hamazaki K, et al. (2007) |
| 20 | 3 Inclusion & exclusion criteria (n = 2) | Hyper tension symptoms | The inclusion criteria were high blood pressure and presence of hypertension symptoms. Patients with cold/yin pattern or deficiency pattern were excluded. Patients with thin physique were also excluded. | Orengedokuto (n = 103) | Placebo (n = 101) | Arakawa K, et al. (2003, 2003) |
| 21 | 3 Inclusion & exclusion criteria (n = 2) | Dyspepsia caused by dysfunction of the upper gastro intestinal tract | In this study, the inclusion criteria were deficiency pattern symptoms (i.e., decreased tone of abdominal wall, subjective/objective splashing sound, gastroptosis tendency, and mental/physical weakness) and the exclusion criteria were excess pattern symptoms (i.e., mental and physical strength, massive and muscular body, and reddish face). | Rikkunshito (n = 147) | low-dose (1:4 dilution) Rikkunshito (n = 133) | Harasawa S, et al. (1998, 1999) |
| 22 | 4 Selection of Kampo formula according to Kampo criteria (n = 6) | Aqueous flare elevation after small-incision cataract surgery | Evaluation of sho and selection of Kampo formulations for each patient were conducted at the Kampo medicine clinic (now Department of Japanese Oriental Medicine) in the above-mentioned university hospital. | Orengedokuto (n = 14) Kakkonto (n = 10) Saireito (n = 10) | no medication (n = 20) | Ikeda N, et al. (2001) |
| 23 | 4 Selection of Kampo formula according to Kampo criteria (n = 6) | Aqueous flare elevation after complicated cataract surgery | Evaluation of sho and selection of Kampo formulations for each patient were conducted at the Kampo medicine clinic(now Department of Japanese Oriental Medicine)in the above-mentioned university hospital. | Kakkonto (n = 12) | Saireito (n = 10) | Ikeda N, et al. (2002) |
| 24 | 4 Selection of Kampo formula according to Kampo criteria (n = 6) | Common cold syndrome associated with fever | Kampo prescriptions were administered according to sho in patients with fever associated with common cold. | Kakkonto, Maoto, Keimakakuhanto, Chikujountanto, Shoseiryuto, Keishikashakuyakuto or Kososan (n = 35) | Fenoprofen (n = 45) | Homma Y, et al. (1995) |
| 25 | 4 Selection of Kampo formula according to Kampo criteria (n = 6) | Peptic ulcer | Based on the endoscopic findings, patients with marked redness and irregularity of gastric antral mucosa were assigned to the shigyakusan treatment, and patients with less evident findings to the saikokeishito treatment. | Shigyakusan or Saikokeishito (n = 7) | Sucralfate (n = 6) | Watanabe H, et al. (1995) |
| 26 | 4 Selection of Kampo formula according to Kampo criteria (n = 6) | Sjögren's syndrome | Arm 1 used Kampo diagnosis to allocate patients, specifically jinkyo (kidney deficiency). Kampo formulations for Arm 1 were selected based on the status of jinkyo: 1) bakumondoto alone for jinkyo-negative; 2) bakumondoto plus rokumigan for jinkyo without chills; and 3) bakumondoto plus hachimijiogan for jinkyo with chills. | Hochuekkito (n = 28) | Bakumondoto, Bakumondoto + Rokumigan or Bakumondoto + Hachimijiogan (n = 30) | Ohno S, et al. (2006) |
| 27 | 4 Selection of Kampo formula according to Kampo criteria (n = 6) | Osteopenia in women during menopause | Keishibukuryogan for 6 patients with excess pattern, and tokishakuyakusan for 6 patients with deficiency pattern*. | Keishibukuryogan (n = 6) Tokishakuyakusan (n = 6) | no administration of Kampo drug (n = 6) | Ohta H, et al. (1990) |
* described in the original article, not in SA.