Table 3A.
RCT of Kampo medicine for FD and GERD.
| References | Study design | Subjects (n) | Age, years (mean ± SD or range) | Disease/symptom | Kampo formulation | Comparator | Outcome | Adverse reaction |
|---|---|---|---|---|---|---|---|---|
| Tominaga et al. (37) | DB-RCT | 125 | 50.4 ± 13.7 (23–76)/50.4 ± 14.9 (23–83) | Functional dyspepsia | RKT | Placebo | RKT increased overall treatment efficacy. RKT improved upper gastrointestinal symptoms, especially postprandial fullness/early satiety and bloating. Improvement of the Hospital Anxiety and Depression Scale correlated with those of the Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index, the Global Overall Symptom scale, and the modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease, postprandial fullness/early satiety, dyspepsia, and postprandial distress syndrome. RKT may be beneficial for patients with FD to simultaneously treat gastrointestinal and psychological symptoms. | None |
| Tominaga et al. (38) | DB-RCT | 242 | 62.1 (25–85)/59.4 (22–83) | Patients with PPI-refractory non-erosive reflux disease | RKT with PPI | Placebo with PPI | The mental component summary scores improved more in RKT administration, especially more effective in patients with a low body mass index and significantly improved the acid-related dysmotility symptoms in female and elderly patients. | Nausea, mild cough, dizziness, diarrhea, etc. (low level) |
| Sakata et al. (39) | DB-RCT | 95 | 72.1 (65–85)/73.4 (65–83) | Patients with PPI-refractory non-erosive reflux disease | RKT with PPI | Placebo with PPI | The degree of improvement of total and acid-related dysmotility symptoms scores was significantly greater in the RKT group. Combination therapy with RKT showed significant improvement in abdominal bloating, heavy feeling in stomach, sick feeling after meals, and heartburn after meals. | N/A |
| Suzuki et al. (41) | DB- RCT | 247 | 54.5 ± 16.2 (22–85)/53.6 ± 16.0 (21–85) | Functional dyspepsia | RKT | Placebo | Administration of RKT reduced dyspepsia, particularly symptoms of epigastric pain and postprandial fullness. Among Helicobacter pylori-positive individuals, RKT improved acyl ghrelin levels. | None |
| Hayakawa et al. (42) | DB- RCT | 23 | 75 ± 11/70 ± 13 | Patients who were projected to require intragastric tube feeding | RKT | Metoclopramide | RKT group reached 50% of the target amount of enteral feeding significantly earlier than the metoclopramide group. RKT increased the plasma level of active ghrelin. | N/A |
| Tokashiki et al. (43) | RCT | 22 | 55.9 (39–76)/56.6 (25–76) | PPI-refractory laryngopharyngeal reflux | RKT | RKT with PPI | RKT significantly decreased the globus sensation. It also improved delayed gastric emptying. A significant positive correlation between improvements in globus sensation and in gastric emptying were shown. | N/A |
| Tominaga et al. (44) | DB-RCT | 101 | 63.6 (25–86)/64.5 (25–90) | Refractory GERD with PPI | RKT with a standard dose of PPI | Double dose of PPI | RKT addition significantly decreased the frequency scale of the GERD symptom score similar to treatment with a double dose of PPI. | None |
| Arai et al. (45) | RCT | 27 | 56.5 ± 15.0/59.0 ± 14.0 | FD | RKT | Domperidone | A significant improvement was shown in dyspeptic symptoms treated with either RKT or domperidone. RCT increased acylated ghrelin. The symptom improvement of reflex and ingestion were well correlated with the increase of acylated ghrelin. | N/A |
| Kato et al. (40) | RCT | 19 | 74.1 ± 6.4/71.7 ± 5.2 | GERD with cough, sputum, pharyngolaryngeal discomfort, or mild dyspnea | HKT | no HKT | HKT significantly improved respiratory symptoms related with GERD. | N/A |
| Harasawa et al. (46) | DB-RCT | 235 | 53.5 (23–79)/52.3 (21–78) | Dysmotility-like dyspepsia | Regular dose of RKT | Low dose of RKT | Regular dose of RKT improved dysmotility-like dyspepsia. | Gastrointestinal symptom, liver dysfunction, or pseudo aldosteronism were shown, the frequency and severity were low |
| Tatsuta et al. (47) | RCT | 42 | Chronic dyspepsia | RKT | Placebo | Gastric emptying was significantly accelerated and gastrointestinal symptoms were significantly reduced in patients treated with RKT. | N/A | |
| Miyoshi et al. (48) | RCT | 246 | Under 20 to over 80 years | Non-ulcer dyspepsia | RKT | Cisapride | RKT significantly improved symptom of appetite loss, epigastric pain, abdominal discomfort, cold feeling of limb, dazzling compared with cisapride. In subanalysis, RKT was more effective in patients over 60 years old, thin, and with water retention. | N/A |
HKT, hangekobokuto; PPI, proton-pump inhibitor; RKT, rikkunshito; N/A, not assigned.