Table 5.
Therapeutic effects for CINV and reports of adverse events in included trials.
| Study | Evaluation of therapeutic effect | Therapeutic effects | Effective rate | Adverse event | ||
|---|---|---|---|---|---|---|
| Markedly effective (number) | Effective (number) | Not effective (number) | ||||
| Sa1 | Not reported | Not reported | Nausea: I = 53 (88.33%), C = 47 (78.33%) Vomiting: I = 55 (91.67%), C = 48 (80.00%) |
Nausea: I = 7 (11.67%), C = 13 (21.67%) Vomiting: I = 5 (8.33%), C = 12 (20.00%) |
Nausea: I = 88.33%, C = 78.33% Vomiting: I = 91.67%, C = 80.00% |
Not reported |
|
| ||||||
| S2 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4)b | Grade 0 I = 3 (7.89%), C = 1 (5.00%) |
Grades 1 I = 34 (89.47%), C = 15 (75.00%) |
Grades 2–4 I = 1 (2.63%), C = 4 (20.00%) |
I = 97.37%, C = 80.00% | Not reported |
|
| ||||||
| S3 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4) | Grades 0-1 I = 11 (68.75%), C = 7 (43.75%) |
Grades 2 1 = 5 (31.25%), C = 6 (37.50%) |
Grades 3-4 I = 0 (0.00%), C = 3 (18.75%) |
I = 100.00%, C = 81.25% | Not reported |
|
| ||||||
| S4 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4) | Grades 0-1 I = 38 (76.00%), C = 12 (24.00%) |
Grades 2-3 I = 7 (14.00%), C = 18 (36.00%) |
Grades 4 I = 5 (10.00%), C = 20 (40.00%) |
I = 90.00%, C = 60.00% | Not reported |
|
| ||||||
| S5 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4) | Grade 0 I = 13 (32.50%), C = 7 (17.50%) |
Grades 1-2 I = 22 (55.00%), C = 11 (27.50%) |
Grades 3-4 I = 5 (12.50%), C = 22 (55.00%) |
I = 87.50%, C = 45.00% | Not reported |
|
| ||||||
| S6 | Morrow assessment of nausea and emeticsc | Real auricular acupressure group showed a better impact on managing CINV compared with usual care group (P < 0.05); no difference in CINV can be found between real acupressure group and sham acupressure group. | Not applicable | Itching of the tapes (n = 3) | ||
|
| ||||||
| S7 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4), Diagnostic standard for TCM differentiation of symptoms and signsd |
Grades 0-1 Day 1: acute CINV I = 12 (24.00%), C = 12 (24.00%) Day 2–7: delayed CINV Day 2: I = 12 (24.00%), C = 8 (16.00%) Day 3: I = 13 (26.00%), C = 10 (20.00%) Day 4: I = 13 (26.00%), C = 10 (20.00%) Day 5: I = 12 (24.00%), C = 8 (16.00%) Day 6: I = 13 (26.00%), C = 10 (20.00%) Day 7: I = 13 (26.00%), C = 10 (20.00%) |
Grade 2 Day 1: acute CINV I = 32 (64.00%), C = 32 (64.00%) Day 2–7: delayed CINV Day 2: I = 34 (68.00%), C = 30 (60.00%) Day 3: I = 33 (66.00%), C = 29 (58.00%) Day 4: I = 33 (66.00%), C = 29 (58.00%) Day 5: I = 33 (66.00%), C = 28 (56.00%) Day 6: I = 34 (68.00%), C = 25 (50.00%) Day 7: I = 34 (68.00%), C = 26 (52.00%) |
Grades 3-4 Day 1: acute CINV I = 6 (12.00%), C = 6 (12.00%) Day 2–7: delayed CINV Day 2: I = 4 (8.00%), C = 12 (24.00%) Day 3: I = 4 (8.00%), C = 11 (22.00%) Day 4: I = 4 (8.00%), C = 11 (22.00%) Day 5: I = 5 (10.00%), C = 14 (28.00%) Day 6: I = 3 (6.00%), C = 15 (30.00%) Day 7: I = 3 (6.00%), C = 14 (28.00%) |
Day 1: acute CINV
I = 88.00%, C = 88.00% Day 2–7: delayed CINV Day 2: I = 92.00%, C = 76.00% Day 3: I = 92.00%, C = 78.00% Day 4: I = 92.00%, C = 78.00% Day 5: I = 90.00%, C = 72.00% Day 6: I = 94.00%, C = 70.00% Day 7: I = 94.00%, C = 72.00% |
Not reported |
|
| ||||||
| S8 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4) | Grade 0 Day 1: acute CINV I = 0 (00.00%), C = 0 (00.00%) Day 2–7: delayed CINV I = 0 (00.00%), C = 0 (00.00%) |
Grades 1-2 Day 1: acute CINV I = 39 (90.70%), C = 29 (69.05%) Day 2–7: delayed CINV I = 43 (100.00%), C=36 (85.71%) |
Grades 3-4 Day 1: acute CINV I = 4 (9.30%), C = 13 (30.95%) Day 2–7: delayed CINV I = 0 (00.00%), C = 6 (14.29%) |
Day 1: acute CINV
I = 90.70%, C = 69.05% Day 2–7: delayed CINV I = 100.00%, C = 85.71% |
I: fatigue (n = 1), constipation (n = 11) C: headache (n = 2), constipation (n = 20), fatigue (n = 5)e |
|
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| S9 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4) | Grade 0 I = 44 (46.81%), C = 23 (24.47%) |
Grades 1-2 I = 45 (47.87%), C=58 (61.70%) |
Grades 3-4 I = 5 (5.32%), C = 13 (13.83%) |
I = 94.68%, C = 86.17% | Not reported |
|
| ||||||
| S10 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4) | Complete relief (grade 0) I = 28 (43.75%), C = 4 (6.25%) |
Partial relief (Grade 1-2) I = 32 (50.00%), C=18 (28.13%) |
Minor relief + failure (grades 3-4) I = 4 (6.25%), C = 42 (65.63%) |
I = 93.75%, C = 34.38% | Not reported |
|
| ||||||
| S11 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4) | Grades 0-1 I = 28 (70.00%), C = 23 (57.50%) |
Grade 2 I = 10 (25.00%), C = 9 (22.50%) |
Grades 3-4 I = 2 (5.00%), C = 8 (20.00%) |
I = 95.00%, C = 80.00% | Not reported |
|
| ||||||
| S12 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4) | Grades 0-1 I = 19 (73.08%), C = 12 (46.15%) |
Grade 2 I = 6 (23.08), C = 9 (34.62%) |
Grades 3-4 I = 1 (3.85%), C = 5 (19.23%) |
I = 96.15%, C = 80.77% | Not reported |
|
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| S13 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4) | Grades 0-1 I = 32 (53.33%), C = 7 (11.67%) |
Grade 2 I = 20 (33.33%), C = 24 (40.00%) |
Grades 3-4 I = 8 (13.33%), C = 29 (48.33%) |
I = 86.67%, C = 51.67% | Not reported |
|
| ||||||
| S14 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4) | Grade 0 I = 16 (18.82), C = 5 (11.90%) |
Grade 1 I = 62 (72.94%), C = 27 (64.29%) |
Grades 2–4 I = 7 (8.24%), C = 10 (23.81%) |
I = 91.76%, C = 76.19% | Not reported |
|
| ||||||
| S15 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4) | Grades 0-1 Acute CINV I = 5 (18.52%), C = 1 (5.00%) Delayed CINV I = 11 (40.74%), C = 1 (5.00%) |
Grade 2 Acute CINV I = 7 (25.93%), C = 2 (10.00%) Delayed CINV I = 6 (22.22%), C = 4 (20.00%) |
Grades 3-4 Acute CINV I = 15 (55.56%), C = 17 (85.00%) Delayed CINV I = 10 (37.04%), C = 15 (75.00%) |
Acute CINV
I = 44.44%, C = 15.00% Delayed CINV I = 62.96%, C = 25.00% |
Not reported |
|
| ||||||
| S16 | Use of antiemetic medications (ondansetron), (categories: >20 mg/d, 10–20 mg/d, and <10 mg/d) |
Number of patients using ondansetron at dose of >20 mg/d in intervention group was significantly less than those in control group. Number of patients using ondansetron at dose of <10 mg/d in intervention group was significantly more than those in control group. No statistical difference can be found in the number of patients using ondansetron at dose of 10–20 mg/d between groups. |
Not reported | |||
|
| ||||||
| S17 | National Cancer Institute- (NCI-) Common Toxicity Criteria, Version 2.0 (vomiting, grades 0–4)f | Complete relief (vomiting grade 0) Day 1: acute vomiting I = 18 (75.00%), C = 16 (66.67%) Day 2–7: delayed vomiting Day 2: I = 18 (69.23%), C = 10 (41.67%) Day 3: I = 17 (65.38%), C = 9 (37.50%) Day 4: I = 15 (57.69%), C = 7 (29.17%) Day 5: I = 16 (61.54%), C = 8 (33.33%) Day 6: I = 19 (73.08%), C = 11 (45.83%) Day 7: I = 25 (96.15%), C = 18 (75.00%) |
Partial relief (vomiting grade 1) Day 1: acute Vomiting I = 3 (12.50%), C = 4 (16.67%) Day 2–7: delayed Vomiting Day 2: I = 5 (19.23%), C = 8 (33.33%) Day 3: I = 5 (19.23%), C = 10 (41.67%) Day 4: I = 8 (30.77%), C = 15 (62.50%) Day 5: I = 8 (30.77%), C = 15 (62.50%) Day 6: I = 6 (23.08%), C = 13 (54.17%) Day 7: I = 1 (3.85%), C = 6 (25.00%) |
Minor relief + failure (vomiting grades 2–4) Day 1: acute Vomiting I = 3 (12.50%), C = 4 (16.67%) Day 2–7: delayed Vomiting Day 2: I = 3 (11.54%), C = 6 (25.00%) Day 3: I = 4 (15.38%), C = 5 (20.83%) Day 4: I = 3 (11.54%), C = 2 (8.33%) Day 5: I = 2 (7.69%), C = 1 (4.17%) Day 6: I = 1 (3.85%), C = 0 (00.00%) Day 7: I = 0 (00.00%), C = 0 (00.00%) |
Day 1: acute vomiting
I = 87.50%, C = 83.33% Day 2–7: delayed vomiting Day 2: I = 88.46%, C = 75.00% Day 3: I = 84.62%, C = 79.17% Day 4: I = 88.46%, C = 91.67% Day 5: I = 92.31%, C = 95.83% Day 6: I = 96.15%, C = 100.00% Day 7: I = 100.00%, C = 100.00% |
No adverse events |
|
| ||||||
| S18 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0-4)g | Grade 0 Acute CINV I = 19 (63.33%), C = 14 (58.33%) Delayed CINV I = 18 (60.00%), C = 8 (33.33%) |
Grade 1 Acute CINV I = 9 (30.00%), C = 8 (33.33%) Delayed CINV I = 9 (30.00%), C = 6 (25.00%) |
Grades 2–4 (Minor relief + no effect) Acute CINV I = 2 (6.67%), C = 2 (8.33%) Delayed CINV I = 3 (10.00%), C = 10 (41.67%) |
Acute CINV
I = 93.33%, C = 91.67 Delayed CINV I = 90.00%, C = 58.33% |
Not reported |
|
| ||||||
| S19 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4) | Grades 0-1 I = 32 (88.89%), C = 11 (35.48%) |
Grade 2 I = 3 (8.33%), C = 12 (38.71%) |
Grades 3-4 I = 1 (2.78%), C = 8 (25.81%) |
I = 97.22%, C = 74.19% | Not reported |
|
| ||||||
| S20 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4)h | Grades 0-1 I = 46 (65.71%), C1 = 33 (66.00%), C2 = 15 (28.30%) |
Grade 2 I = 14 (20.00%), C1 = 11 (22.00%), C2 = 18 (33.96%) |
Grade 3 I = 10 (14.29%), C1 = 6 (12.00%), C2 = 20 (37.74%) |
I = 85.71%, C1 = 88.00%, C2 = 62.26% | Not reported |
|
| ||||||
| S21 | WHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4)h | Grades 0-1 I = 16 (40.00%), C = 7 (17.50%) |
Grade 2 I = 18 (45.00%), C = 10 (25.00%) |
Grade 3 I = 6 (15.00%), C = 23 (57.50%) |
I = 85.00%, C = 42.50% | Not reported |
I: intervention group, C: control group, CINV: chemotherapy-induced nausea and vomiting, WHO: World Health Organization, and NA: not applicable.
aStudy.
bWHO Recommendations for Grading of Acute and Subacute Toxicity (nausea/vomiting, grades 0–4)*, Grade 0: none, Grade 1: nausea, Grade 2: transient vomiting, Grade 3: vomiting requiring therapy, and Grade 4: intractable vomiting [45].
cMorrow Assessment of Nausea and Emetics: A 17-item self-rated questionnaire used for assessing the occurrence, duration, and severity of nausea and vomiting.
dDiagnostic Standard for TCM Differentiation of Symptoms and Signs, A standardized diagnostic criteria developed by State Administration of TCM of People's Republic of China.
eTherapeutic effects of auricular therapy on adverse events caused By antiemetic medications.
fNational Cancer Institute-Common Toxicity Criteria, Version 2.0: vomiting, grade 0: none, grade 1: 1 episode in 24 hours over pretreatment, grade 2: 2–5 episodes in 24 hours over pretreatment, grade 3: ≥6 episodes in 24 hours over pretreatment or need for IV fluids, grade 4: requiring parenteral nutrition, or physiologic consequences requiring intensive care, hemodynamic collapse [46].
gUsed the WHO Recommendations to judge the incidence and severity of nausea and vomiting but did not specify the source of the criteria.
hOnly applied the first four grades (grades 0–3) to evaluate the incidence and severity of nausea and vomiting.