Table 3C.
RCT of Kampo medicine for the perioperative period.
| References | Study design | Subjects (n) | Age, years (mean ± SD or range) | Disease/symptom | Kampo formulation | Comparator | Outcome | Adverse event related with Kampo |
|---|---|---|---|---|---|---|---|---|
| Kaido et al. (66) | DB-RCT | 104 | 56 (22–69)/57 (30–67) | Patients undergoing liver transplantation | DKT | Placebo | Postoperative total oral/enteral caloric intake was significantly accelerated in the DKT group. Portal venous flow volume and velocity were significantly higher in the DKT. | None |
| Nishino et al. (53) | RCT | 39 | 68.0 (61.0–74.0)/60.5 (55.0–67.0) | Patients planned of subtotal esophageal resection for esophageal cancer | DKT | Non-DKT | The rate of body weight decreased at postoperative day 21 was significantly suppressed in the DKT group. Postoperative bowel symptoms tended to be rare in the DKT group. The serum CRP level at postoperative day 3 showing a tendency of a suppressed serum CRP level in the DKT group. | N/A |
| Katsuno et al. (54) | DB-RCT | 71 | 67.7 (39–88)/68.2 (51–85) | Patients who were scheduled to undergo open surgery for sigmoid or rectosigmoid cancer | DKT | Placebo | The number of radiopaque markers in the anal side of the small intestine at 6 h was significantly greater in the DKT group. | None |
| Okada et al. (55) | DB-RCT | 207 | 68.9 ± 8.4/64.9 ± 11.3 | Patients who were scheduled to undergo pancreaticoduodenectomy for periampullary tumors and tumors of the head of the pancreas | DKT | Placebo | Perioperative treatment with DKT neither decreased the incidence of clinically relevant postoperative paralytic ileus nor shortened the time to first postoperative flatus. | N/A |
| Shimada et al. (67) | RCT | 209 | 68(36–87)/69(31–84) | Primary and metastatic liver cancer patients who underwent hepatic resection | DKT | Placebo | DKT improve gastrointestinal dysmotility and reduce serum CRP levels in patients with grade B liver damage after hepatectomy. | None |
| Akamaru et al. (56) | RCT | 81 | 63.4 ± 8.9 (32–77)/63.7 ± 9.2 (40–78) | Patients with gastric cancer scheduled for a total gastrectomy | DKT | Non-DKT | DKT significantly improved the number of stools per day, stool consistencies, and gas volume scores. | None |
| Katsuno et al. (57) | DB-RCT | 336 | 68 (28–88)/69 (35–91) | Patients scheduled to undergo colectomy for colon cancer | DKT | Placebo | The frequency of bowel movement in the DKT group at postoperative day 8 was significantly lower than that in the placebo group. The moderate effects of DKT were observed early days after the operation. | None |
| Yoshikawa et al. (58) | DB-RCT | 195 | 68 (33–83)/67 (28–84) | Gastric cancer patients who underwent total gastrectomy | DKT | Placebo | DKT shorter median time to first bowel movement and made fewer gastrointestinal dysfunction on postoperative day 12. | None |
| Yaegashi et al. (59) | RCT | 51 | 69 (51–83)/68 (43–89) | Colon cancer patients who underwent colectomy | DKT | Lactobacillus preparation | DKT group had significantly faster time until first flatus and bowel movement and colonic transit time. DKT accelerated colonic motility in patients undergoing laparoscopy-assisted colectomy for colon cancer. | None |
| Nishi M et al. (68) | RCT | 32 | 68.8 ± 8.7/64.3 ± 7.3 | Patients who underwent hepatic resection | DKT | No DKT | DKT significantly decreased the levels of c-reactive protein and beta-(1–3)-d-glucan on postoperative day 3. DKT significantly shortened postoperative periods for the first flatus, bowel movement, and full recovery of oral intake. | None |
| Yoshikawa et al. (60) | RCT | 30 | 62 ± 12 (41–80)/70 ± 5 (61–86) | Patients who underwent laparoscopic colectomy for colorectal carcinoma | DKT | Non-DKT | Postoperative DKT administration significantly suppressed CRP level and shortened the time until first flatus. | N/A |
| Takahashi et al. (61) | Crossover RCT | 11 | 60 (46–70) | Pylorus-preserving gastrectomy for early gastric cancer | Rikkunshito | No rikkunshito administration | Rikkunshito significantly reduced gastric stasis-related symptoms and improved emptying of solid meals from the remnant stomach. | N/A |
| Endo et al. (62) | Crossover RCT | 17 | 62 ± 10 | Patients who underwent total gastrectomy with jejunal pouch interposition for gastric cancer | DKT | Non-DKT | DKT significantly reduced stasis-related symptoms. In the emptying test, DKT significantly accelerated emptying of both liquid and solid meals from the pouch. The pouch showed bursts of contractions, which were increased significantly by oral intake of DKT. | N/A |
| Kaiho et al. (69) | RCT | 43 | 61.6 ± 8.1/62.4 ± 19.3/63.8 ± 10.0 | Patients with liver resection | DKT | Lactulose or no administration of DKT/lactulose | DKT significantly lower postoperative serum ammonia levels with low occurrence of diarrhea. | N/A |
| Itoh et al. (63) | RCT | 24 | 58 ± 10/60 ± 11 | Postoperative ileus after abdominal surgery | DKT | Placebo | The need for further surgery was significantly lower in patients receiving DKT. DKT also showed a lower tendency in recurrent ileus than those receiving placebo. | N/A |
| Takagi et al. (64) | RCT | 21 | 72 ± 5 | Patients who underwent an aortic replacement for intrarenal abdominal aortic aneurysm with transperitoneal approach | DKT from nasogastric tube | Panthenol and/or lukewarm water from nasogastric tube | DKT significantly improved the timing and disappearance of intestinal gas. | No |
| Kubo et al. (65) | RCT | 30 | 56.1 ± 22.6/53.3 ± 21.5 | Simple adhesive ileus | DKT from ileus tube | Lukewarm water from ileus tube | The duration to defecation, exhaust gas, and ileus tube removal were not significantly different between DKT administration and control. However, DKT reduced abdominal bloating, nausea, and vomiting. | N/A |
DKT, daikenchuto; RCT, randomized controlled trial; N/A, not assigned.