Han 2010.
| Methods | Location: China Number of centres: 2 Date of conduct: 1 October 2007 to 31 July 2009 |
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| Participants | Inclusion criteria: quote: "First‐visit patients; diagnosed as mid/moderate to advanced/terminal nasopharyngeal squamous carcinoma through pathological and radiographic examinations; Karnosfsky score ≥ 60; expected survival period > 6 months; without severe complications (e.g. hypertension, coronary heart disease, diabetes, history of mental illness)" Exclusion criteria: see above Age: Jinlong: mean 46.3 (SD 7.4), median 53; control: mean 47.4 (SD 6.8), median 52 Gender: Jinlong: 33 M, 16 F; control: 34 M, 14 F Cancer type: nasopharyngeal squamous carcinoma Radiotherapy: dose 60 to 76 Gy, 2 Gy per day, 5 times a week Chemotherapy: "concurrent chemoradiotherapy" (no further details) Number randomised: 97 (Jinlong: 49, control: 48) Number evaluated: 95 (Jinlong: 48, control: 47) |
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| Interventions |
Jinlong capsules versus no intervention 4 tablets once, 3 tablets every day Duration: 3 months Follow‐up: 12 weeks after treatment Quote: "Jinlong capsule is a modern 'fresh medicine preparation' made of fresh gecko and fresh long‐noded pit vipers, using cryogenic modern biochemical extracting and separation techniques. It maintained to the greatest degree the activity of effective ingredients of organisms, and reasonable compatibility among the ingredients. Basic research has shown that Jinlong can directly damage cancer cells by blocking the mitosis and proliferation of cancer cells, fix the p21 small protein molecule, restore the regulation of cancer cells, and turn cancer cells to normal cells..." |
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| Outcomes | Xerostomia: quote: "observe the patients for toxic and side effects during and after radiotherapy, assess the toxic and side effects according to RTOG's criteria" Salivary flow rates: not reported Adverse effects: leukopenia, nausea, vomiting, 1 participant had dizziness and blood pressure drop, 1 participant had skin rash Survival data: not reported Other oral symptoms: mucositis Other oral signs: not reported Quality of life: not reported Patient satisfaction: not reported Cost data: not reported |
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| Funding | Not reported; conflicts of interest: not reported | |
| Trial registration | Not registered | |
| Sample size calculation presented | No | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomly divided" |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information |
| Blinding (performance bias and detection bias) patients/carers | High risk | Jinlong versus no intervention |
| Blinding (performance bias and detection bias) outcome assessment | High risk | Jinlong versus no intervention |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quotes: "1 patient quit because of myocardial infarction (Tx Group)", "1 patient quit because of mucosa toxicity (control group)" |
| Selective reporting (reporting bias) | Low risk | Xerostomia and adverse events reported |
| Other bias | Low risk | No other sources of bias are apparent |