Table 3C.
Author | Any side effects of treatment | Null finding interpretation | Important effects overlooked | Comparison with previous literature | Implications for practise |
---|---|---|---|---|---|
Castro et al. 2003 [38] | Pain, Cardiovascular, Gatrointestinal, Haematological symptoms, Neurotoxicity, Hepatoxicity, Occular toxicity, Edema Severe side effects CDDP/epi gel group: 54.8% (34/62), Placebo gel group: 28% (7/25) | Rejected | 2 patients died- supposed to be related to treatment with CDDP/epi gel: 1 CVA, 1 fatal haemorrhage | Conclusions similar to study by Werner et al. | CDDP/epi gel is a good option for recurrence, but demands proper patient selection and skilful use |
Georgiou et al. 2000 [39] | Group A (thoracic catheter) Group B (cervical catheter): nausea and vomiting: A 50% (8/16);B 31% (4/13) urinary retention: A 12.5% (2/16); B 0% constipation: A 62% (10/62); B 38% (5/13) purities: A 31% (5/16); B 15% (2/13) |
Rejected | More side effects in patients who received thoracic epidural morphine | Agrees with the literature on the efficacy of epidural analgesia | In cases of oral analgesia being ineffective epidural morphine is a good option with cervical being superior to thoracic. |
Jovic et al. 2008 [40] | Group A (Ketoprofen) Group B (Metamizole): nausea: A 10% (3/30); B 13.3%(4/30), bleeding from wounds: A 10% (3/30); B 10% (3/30), haematomas: A 10% (3/30); B 6.7% (2/30), infections: A 10% (3/30); B 3.3% (1/30). |
Rejected | None | No prior studies found | Ketoprofen is an alternative to Metamizole for reducing pain postoperatively. More research is needed. |
McNeely et al. 2004 [47] | 10% (1/10) episode of nausea in PRET patient | Rejected | Varying period between surgery and exercise intervention | Concurs with previous studies | Exercise is an option post surgery to reduce pain |
McNeely et al. 2008 [27] | Pain in 3.7% (1/27) patient | Rejected | None | Agrees with McNeely et al. 2004 (pilot study) | Addition of PRET could be considered in Head and Neck cancer survivors, but more research with a less specific group needed |
Pfister et al. 2010 [48] | 27 minor events including: pain, bruising and bleeding | Rejected | None | Comparable results with similar acupuncture trials on cancer pain. | As acupuncture has only a few minor side effects, potential benefit outweighs risk. |
Plantevin et al. 2007 [41] | MNB with ropivacaine blood aspiration: A 26.3% (5/19);
Paraesthesia: A 31.6% (6/19); No complications in GA group |
Rejected | No evaluation of block efficacy to maintain blinding. Patients must understand PCA | First study to be carried out | Beneficial for certain types of oropharyngeal surgery |
Roussier et al. 2006 [42] | Group A (PCA-Epid) Group B (PCA-IV): Nausea: A 5% (1/20); B 0%, Vomiting: A 5% (1/20); B 4.5% (1/22), Pruritus: A 5% (1/20); B 0%, Urinary retention: A 0%; B 9.1% (2/22) |
Rejected | Patients must understand PCA | Concurs with previous studies | Dangers of epidural procedure outweigh benefits of increased pain control |
Saxena et al. 1994 [43] | Piroxicam group: 30% (6/20) experienced dry mouth ASA group: 31.3% (5/16) experienced GI symptoms (e.g. nausea, sour eructations, vomiting) |
Accepted | 4 day follow-up | First study to be carried out | Piroxicam has less severe side effects and once daily dosing |
Singhal et al. 2006 [44] | 6.7% (2/30) patients on IV morphine were lethargic | Rejected | None | First trial of type. Comparable trials on thoracic surgery yield similar results | Implications limited as epidural risks outweigh benefits |
Werner et al. 2002 [45] | Group A (CDDP/epi gel) Group B (Placebo gel): pain: A 33.3% (19/57); B 11.4% (4/35), tachycardia: A 5.3% (3/57); B 0%, local cytotoxic effects, headache: A 5.3% (3/57); B 0%, nausea and vomiting: A 14% (8/57); B 0%, hypomagnesemia: A 5.3% (3/57); B 0%, local cytotoxic effects (erosion erythema, eschar, necrosis, swelling and ulceration): A 127 cases B 34 cases serious adverse event one in each of 8 patients: anaemia, allergic reaction, haemorrhage, pallor, blindness, cardiac arrest (non-fatal), oedema, and swelling. |
Rejected | Subjective pain scoring by patients. (24/29) crossed over to receive active treatment after dropping out. Intention to treat maintained | Concurs with previous studies | Can be done as out patient Useful in palliation and intractable pain |
Wittekindt et al. 2006 [46] | Neck muscle weakness in 20% (2/10) patients in the BtxA high dose group | Rejected | No placebo group | First study to investigate effect of different doses of BtxA. Previously reported that use of BtxA leads to pain reduction after neck dissection surgery. | Low dose BtxA injections are a plausible option to reduce pain after neck dissection, however more studies are needed to determine dosage. |
Yagi et al. 1997 [35] | None mentioned | Rejected | N/A | Agrees with literature on efficacy of Fentanyl and Piroxicam | IV Fentanyl or pre-operative Piroxicam are good alternatives in the management of head and neck cancer pain postoperatively. |
CVA = cerebrovaskular accident; CDDP/epi gel = intratumoral cisplatin/epinephrine injectable gel; PCA = patient controlled analgesia; PRET = progressive resistance exercise training; ASA = acetylsalicylic acid.