Ahmedzai, S.H., & Boland, J. (2010, April). Constipation in people prescribed opioids. Clinical Evidence, 2407.
To answer the following questions: What are the effects of oral laxatives, rectal preparations, and opioid antagonists for constipation in people prescribed opioids?
Databases searched were MEDLINE, Embase, Cochrane Central Register of Controlled Trials and Library, NHS Centre for Reviews and Dissemination (CRD), Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment, TRIP, and the National Institute for Health and Clinical Excellence (NICE) up to August 2009. Alerts from the U.S. Food and Drug Administration and the U.K. Medicines and Healthcare Products Regulatory Agency were included to identify any adverse effects.
Search keyword were constipation and opioids, Lactulose, macrogols, senna, bisacodyl, co-danthrusate/co-danthramer, docusate, ispaghula husk, liquid paraffin, magnesium salts, methylcellulose, arachis oil enema, glycerol suppository, phosphate enema, sodium citrate enema, and opioid antagonists.
Studies were included in the review if they
The GRADE System was used to evaluate study quality. Full information is available online with a subscription.
The final sample comprised 23 systematic reviews, RCTs, or observational studies. This was an update of a previous review that added 1 systematic review and 5 RCTs, with no change in overall recommendations provided.
Oral Laxatives
Rectal Preparations
Opioid Antagonists
Nurses should be aware of potential implications related to the use of opioid antagonists in controlling constipation for opioid interactions and changes in pain control. In addition, nurses should routinely assess for pain relief, as well as symptoms of constipation, in this patient population.
Ahmedzai, S.H., Nauck, F., Bar-Sela, G., Bosse, B., Leyendecker, P., & Hopp, M. (2012). A randomized, double-blind, active-controlled, double-dummy, parallel-group study to determine the safety and efficacy of oxycodone/naloxone prolonged-release tablets in patients with moderate/severe, chronic cancer pain. Palliative Medicine, 26, 50–60.
To determine whether oxycodone/naloxone prolonged-release tablets (OXN PR) can improve constipation and maintain analgesia, compared with oxycodone prolonged-release tablets (OxyPR) in patients with moderate to severe cancer pain
This was a randomized, double-blind, active-controlled, double-dummy, parallel-group study in which 185 patients were randomized to receive up to 120 mg per day of OXN PR or OxyPR over four weeks. Efficacy assessments included Bowel Function Index (BFI), Brief Pain Inventory Short-Form (BPI-SF), and laxative and rescue medication use. Quality-of-life and safety assessments also were conducted.
Overall, 133 of 184 patients (72.3%) completed the study. Rates of discontinuation were similar for OXN PR (28.3%) and OxyPR (27.2%). In both groups, the primary reason for discontinuation was adverse events. At randomization, mean BFI values were high and comparable in the OXN PR and OxyPR groups (63.97 [SD = 17.42] versus 62.40 [SD = 23.56], respectively), and similar to baseline assessments in previous phase III trials. The difference in change from baseline in BFI score between groups was statistically significant. A statistically significant difference between treatments in favor of OXN PR was observed at week 1.
At randomization, mean BPI-SF scores were comparable for OXN PR and OxyPR treatment groups (4.16 [SD = 1.87] versus 4.18 [SD = 1.87]). After four weeks of treatment, mean BPI-SF scores remained comparable between the two groups (3.50 [SD = 1.88] and 3.52 [SD = 1.80]). Results of the primary analysis confirmed non-inferiority of OXN PR to OxyPR.
Patients who were switched directly from other opioids to OXN PR experienced a similar analgesic effect as well as a statistically significant and clinically relevant improvement in bowel function, compared with those switched to OxyPR.
Opioid-induced bowel dysfunction is common and adds to the burden of living with chronic pain. Current oral and rectal laxatives often are ineffective and do not have a good evidence base. The new targeted approach of administering peripherally acting opioid antagonists is effective and supported by extensive clinical trial data. The present trial demonstrates that oral OXN PR tablets are well tolerated and can effectively and conveniently provide targeted treatment of opioid-induced constipation.
Ahmedzai, S.H., Laude, E., Robertson, A., Troy, G., & Vora, V. (2004). A double blind, randomized, controlled phase II trial of heliox28 gas mixture in lung cancer patients with dyspnoea on exertion. British Journal of Cancer, 90(2), 366–371.
The study is a double-blind, randomized, controlled phase ll trial of heliox 28 gas mixture in patients with lung cancer with dyspnea on exertion.
The study compared the effects of heliox 28 (72% helium and 28% oxygen) to oxygen-enriched air (72% nitrogen and 28% oxygen) or medical air (78.9% nitrogen and 21.1% oxygen) on dyspnea and exercise capacity in patients with lung cancer.
The study reported on a sample of 12 patients with lung cancer; patients had to be able to do a six-minute walk prior to screening evaluation and at defined time points throughout the study.
The study was a double-blind, randomized, controlled phase ll trial.
Patients’ symptoms were evaluated with a VAS and modified Borg scale (0–10). Pulse oximetry (SaO2) monitoring was done continuously before, after, and then for five minutes after patients breathed the gas mixture.
Dyspnea assessments and VAS scores indicated a significant decrease in breathlessness following heliox 28 compared to medical air. No significant difference was found between heliox and oxygen-enriched air. Borg assessments showed no significant differences across treatments. Patients receiving heliox 28 walked farther than patients receiving oxygen-enriched air or medical air (p < 0.001). No significant difference was found in oxygen saturation percentage measured before the walk. Oxygen saturation was significantly higher during the walk and at rest after breathing heliox 28 than with the other two gas mixtures (p < 0.0001). No significant difference was found between oxygen-enriched air and medical air. No adverse events were reported.
The study had a small sample size of 12.
A promising beneficial role may exist for heliox therapy to improve exercise tolerance in dyspneic patients with cancer.
Ahmedzai, S., & Brooks, D. (1997). Transdermal fentanyl versus sustained-release oral morphine in cancer pain: Preference, efficacy, and quality of life. The TTS-Fentanyl Comparative Trial Group. Journal of Pain and Symptom Management, 13, 254–261.
To compare transdermal fentanyl and sustained-released morphine in palliative care patients with cancer by measuring efficacy, tolerance, and quality of life (QOL).
Patients received one treatment for 15 days, then the other for 15 days to compare which provided the greatest efficacy and QOL, and the fewest side effects. The null hypothesis was 50% of patients would prefer fentanyl and 50% would prefer morphine.
38 different palliative care centers in the United Kingdom
This was a randomized, open, two-period, crossover study.
Ahmed, R.L., Thomas, W., Yee, D., & Schmitz, K.H. (2006). Randomized controlled trial of weight training and lymphedema in breast cancer survivors. Journal of Clinical Oncology, 24(18), 2765–2772.
To examine associations between exercise and lymphedema in breast cancer survivors
The study and all protocols were approved by the University of Minnesota.
The study took place in the Minneapolis-Saint Paul greater metropolitan area in Minnesota.
The study used a randomized controlled trial design.
After dropouts and loss to follow-up, 78 women completed baseline and six-month measurements of arm circumference. A twice-a-week weight training for a period of six months did not increase arm-circumference measurements or exacerbate symptoms of lymphedema in survivors of breast cancer compared with nonintervention controls.
Ahmed, R.L., Thomas, W., Yee, D., & Schmitz, K.H. (2006). Randomized controlled trial of weight training and lymphedema in breast cancer survivors. Journal of Clinical Oncology, 24(18), 2765–2772.
To examine associations between exercise and lymphedema in breast cancer survivors
The study and all protocols were approved by the University of Minnesota.
The study was conducted in the great Minneapolis-St. Paul, MN, metropolitan area.
A randomized controlled trial
Lymphedema was measured three ways: arm circumference measurements, self-reported symptoms, and symptoms of lymphedema.
Arm circumference
Self-reported symptoms
Symptoms of lymphedema
Ahmed Omar, M.T., Abd-El-Gayed Ebid, A., & El Morsy, A.M. (2011). Treatment of post-mastectomy lymphedema with laser therapy: Double blind placebo control randomized study. The Journal of Surgical Research, 165(1), 82–90.
To evaluate the effect of low-level laser therapy (LLLT) on limb volume, shoulder mobility, and grip strength
Patients were randomized to treatment and placebo control groups. The treatment group received LLLT at an average dose of 1.5 J/cm2 for 20 minutes three times per week for 36 sessions. In the placebo group, the patients were set up with the same parameters of therapy but the machine was not turned on. All patients were advised to perform the same arm and shoulder exercises daily. Patients were evaluated every 4 weeks for 12 weeks.
The study took place in an outpatient setting in Egypt.
The study has clinical applicability for late effects and survivorship.
The study used a randomized double-blind placebo-controlled design.
The laser group had greater reduction in limb volume than controls. The difference was significant at 8 and 12 weeks (p < 0.01). At 16 weeks, total limb circumference was 31 in the laser group and 23 in the control group. Shoulder mobility was better in the laser group and significantly better than controls at 12 weeks (p < 0.01). Grip strength improved in both groups. At 8 and 12 weeks, grip strength improvement was significantly higher in the laser treatment group (p < 0.01).
LLLT reduces lymphedema arm volume and increased shoulder mobility and grip strength in women after mastectomy.
Low-level laser therapy can reduce lymphedema volume and improve extremity strength and mobility. The study showed that 14% of patients did not adhere to receiving all treatments, which has also been shown in other studies of LLLT. The need for patients to make multiple visits for treatments may limit the practicality of the approach. Effects over the longer term are unclear.
Ahles, T. A., Tope, D. M., Pinkson, B., Walch, S., Hann, D., Whedon, M., . . . Silberfarb, P. M. (1999). Massage therapy for patients undergoing autologous bone marrow transplantation. Journal of Pain and Symptom Management, 18, 157–163.
The intervention was a Swedish/Esalen massage of shoulders, neck, and scalp lasting 20 minutes up to three times per week. Prior to hospitalization, patients were randomly assigned to massage or standard medical care conditions.
All participants were inpatients in the bone marrow transplantation unit of a cancer center.
Patients were undergoing the active treatment phase of care.
The study was a randomized trial comparing massage (n = 16) with a quiet time control condition (n = 18).
Fatigue was measured by a zero to 10 Numerical Rating Scale.
Ahles, T.A., Tope, D.M., Pinkson, B., Walch, S., Hann, D., Whedon, M., … Silberfarb, P.M. (1999). Massage therapy for patients undergoing autologous bone marrow transplantation. Journal of Pain and Symptom Management, 18, 157-163.
Patients scheduled to undergo bone marrow transplant were randomly assigned to receive either massage therapy or standard treatment. Patients in the massage therapy group received three 20-minute sessions of shoulder, neck, head, and facial massage per week. The average length of stay was three weeks, so as many as nine sessions were reported during patients’ hospital stays. Massages were performed by a trained, healing arts specialist with more than 10 years of experience.
Participants were inpatients and were scheduled for bone marrow transplant at Dartmouth-Hitchcock Medical Center in New Hampshire.
The study design was a randomized, controlled clinical trial.
Patients in the massage group experienced significantly larger reductions in nausea than the standard group at day 7. The strongest effects were seen immediately after massage when patients experienced a reduction in diastolic blood pressure, nausea, distress, and anxiety. How long the positive effects were maintained is difficult to evaluate.
Agteresch, H. J., Dagnelie, P. C., van der Gaast, A., Stijnen, T., & Wilson, J. H. (2000). Randomized clinical trial of adenosine 5’-triphosphate in patients with advanced non-small-cell lung cancer. Journal of the National Cancer Institute, 92, 321–328.
A 30-hour infusion of adenosine 5’-triphosphate (ATP) was given every two to four weeks for 10 to 20 μg/kg/minute escalated to 75 μg/kg/minute. Regulation of biologic processes may be altered by ATP infusion to inhibit weight loss and deterioration of quality of life.