Soma (Carisoprodol) - Summary

SOMA SUMMARY

Carisoprodol produces muscle relaxation.

Carisoprodol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Carisoprodol does not directly relax tense skeletal muscles in man.

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NEWS HIGHLIGHTS

Media Articles Related to Soma (Carisoprodol)

Higher Levels Of Psychosomatic Symptoms Reported By Physically Abused Children
Source: Body Aches News From Medical News Today [2012.02.13]
Children who display multiple psychosomatic symptoms, such as regular aches and pains and sleep and appetite problems, are more than twice as likely to be experiencing physical abuse at home than children who do not display symptoms, according to a study in the March edition of Acta Paediatrica...

New Ways Of Generating Stem Cells For Patients With Dysfunctional Or Damaged Tissues And Organs
Source: Stem Cell Research News From Medical News Today [2013.05.17]
Somatic cell nuclear transfer (SCNT) is a technique in which the nucleus of a donor cell is transferred to an egg cell whose nucleus has been removed, generating embryos that are almost an identical genetic match to the donor individual. For the first time, a team of scientists has used SCNT to produce human embryonic stem cells (hESCs)...

Surprising Findings On Hypertension In Adolescents
Source: Hypertension News From Medical News Today [2013.05.07]
Teenagers with high blood pressure appear to have better psychological adjustment and enjoy higher quality of life than those with normal blood pressure, suggests a study in the May issue of Psychosomatic Medicine: Journal of Biobehavioral Medicine, the official journal of the American Psychosomatic Society...

Frequently Playing Violent Games May Desensitize Players To Physiological And Emotional Effects
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2013.05.07]
Teenagers who are highly exposed to violent video games - three or more hours per day - show blunted physical and psychological responses to playing a violent game, reports a study in the May issue of Psychosomatic Medicine: Journal of Biobehavioral Medicine, the official journal of the American Psychosomatic Society...

Combined Liver-Kidney Transplantation May Benefit Some Patients With Complicated Childhood Polycystic Kidney Disease
Source: Liver Disease / Hepatitis News From Medical News Today [2013.04.30]
A collaborative team of physician-scientists at the Medical College of Wisconsin (MCW) and Children's Hospital of Wisconsin Research Institute has developed a new evidence-based, clinical algorithm to help physicians treat complex patients with autosomal recessive polycystic kidney disease (ARPKD). Their invited manuscript, written by Grzegorz Telega, M.D...

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Published Studies Related to Soma (Carisoprodol)

Randomized, double-blind trial of carisoprodol 250 mg compared with placebo and carisoprodol 350 mg for the treatment of low back spasm. [2010.01]
CONCLUSIONS: When administered three times daily and at bedtime, carisoprodol 250 mg was as effective as 350 mg three times daily and at bedtime with a lower incidence of adverse events and fewer discontinuations of therapy due to adverse events. Patients improved whether or not they reported sedation as an adverse event.

Randomized, double-blind trial of carisoprodol 250 mg compared with placebo and carisoprodol 350 mg for the treatment of low back spasm. [2010]
CONCLUSIONS: When administered three times daily and at bedtime, carisoprodol 250

Double-blind, placebo-controlled trial of carisoprodol 250-mg tablets in the treatment of acute lower-back spasm. [2008.02]
PURPOSE: The objective of this placebo-controlled trial was to determine the efficacy and safety of carisoprodol (Soma, MedPointe Pharmaceuticals, Somerset, NJ, USA), a centrally acting skeletal muscle relaxant used to treat acute, painful musculoskeletal conditions, at a dosage of 250 mg three times daily and at bedtime in patients with acute, painful muscle spasm of the lower back... CONCLUSIONS: In this study, patients with acute muscle spasm of the lower back had significantly greater and more rapid relief from starting backache, and had improved functional status, as measured by the RMDQ, during treatment with carisoprodol 250-mg tablets compared to placebo. Patients experienced clinical improvement with or without sedation.

Cognitive-behavioural therapy for patients with multiple somatoform symptoms--a randomised controlled trial in tertiary care. [2004.04]
OBJECTIVE: (a) To evaluate the effect of a cognitive-behavioural inpatient treatment and (b) to analyse the differential efficacy of an additional ("soma") group management training of somatisation... CONCLUSION: Considering the subjects' high initial impairment, the outcome results are encouraging. The specific effect on health care use highlights the socioeconomic relevance. Copyright 2004 Elsevier Inc.

Late toxicity results of the GORTEC 94-01 randomized trial comparing radiotherapy with concomitant radiochemotherapy for advanced-stage oropharynx carcinoma: comparison of LENT/SOMA, RTOG/EORTC, and NCI-CTC scoring systems. [2003.01.01]
CONCLUSION: Concomitant radiochemotherapy increased overall survival and locoregional control rates. The difference between the two treatment groups for Grade 3-4 complications was only significant for the teeth. The late toxicity assessment of a treatment may depend on the toxicity scale used. The LENT/SOMA scale seems to be the most accurate scale, but most of the score results were not concordant with those obtained with other scales. The results of this study confirm the necessity of using a common late toxicity scale in clinical trials.

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Clinical Trials Related to Soma (Carisoprodol)

Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer [Recruiting]
The purpose of this study is to evaluate the interest of breath holding for the prevention of radiation pneumonitis following conformal radiation therapy.

Eligible patients will be randomly assigned in a 2-arm trial to free breathing or breath holding during conformal radiation.

The primary objective of the study is to establish the efficacy of breath holding, compared to free breathing, in the prevention of early pulmonary toxicity following conformal radiation.

Several departments of radiotherapy, many pneumology units and two basic and applied research laboratories take part in this multicentric study.

The number of patients required to demonstrate a reduction in radiation pneumonitis from 45 % to 22. 5 %, assuming an alpha risk of 5% in a two-sided test and 95% power, is 240 (120 per arm). With a planned accrual of 7 patients per month, it is estimated that the inclusion period should be approximately 3 years.

Interleukin-2 Treatment for Wiskott-Aldrich Syndrome [Recruiting]
Context: Wiskott-Aldrich syndrome (WAS) is a fatal, devastating disease with ill-defined treatment modalities, which affects young boys. Classic WAS is characterized by a clinical triad of thrombocytopenia, eczema and severe, recurrent infections. Despite diagnostic and therapeutic advances most WAS patients die at less than 12 years of age due to infections, hemorrhage, malignancy or complications from treatments. WAS patients suffer from herpesvirus infections as a result of poor Natural Killer (NK) cell function (cytotoxicity). In the laboratory, the investigators have seen correction of WAS Natural Killer Cell (NK) function after treatment with Interleukin-2 (IL-2).

Objectives: Initiate a prospective clinical trial by treating WAS subjects with IL-2 and using safety as the primary endpoint. Restoration of NK cell cytotoxicity and effects on cytoskeletal dynamics are secondary endpoints. The investigators will also observe patient clinical status (eczema, infections, use of treatment dose antibiotics, food allergies, etc).

Study Design/Setting/Participants: This is a prospective clinical trial treating 9 WAS subjects in the Clinical Translational Research Center (CTRC) with IL-2.

Intervention: The investigators propose to subcutaneously administer 0. 5 MU/m2 of IL-2 daily to WAS subjects for 5 days. Research treatment will be repeated 2 and 4 months later. Inter-patient dose escalation will be employed to 1 MU/m2 and/or 2 MU/m2 based on safety as the primary endpoint.

Study Measures: The investigators will observe safety and tolerability measures and perform assays on subject blood samples prior to and after research treatment to observe improvement in NK cell function.

Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia [Active, not recruiting]
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy delivers thin beams of radiation of different strengths directly to the tumor from many angles. This type of radiation therapy may reduce damage to the parotid (salivary) glands, prevent xerostomia (dry mouth), and improve quality of life. It is not yet known whether intensity-modulated radiation therapy is more effective than conventional radiation therapy in preventing xerostomia and improving quality of life in patients who have throat cancer.

PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy to see how well it works compared to conventional radiation therapy in treating patients with oropharyngeal or hypopharyngeal cancer who are at risk of developing xerostomia caused by radiation therapy.

Trial of Combined Pentoxifylline-tocopherol-clodronate vs Placebo in Radiation-induced Brachial Plexopathy [Recruiting]
Radiation-induced brachial plexopathy (RIP) is a rare and severe delayed peripheral nerve complication of radiotherapy, that is spontaneously irreversible with no medical treatment to limit or reduce symptoms. The investigators planed in RIP a randomized double blind clinical trial, using a pentoxifylline (P)- tocopherol (E)- clodronate combination versus placebo, to assess a possible symptomatic regression by a sensory-motor neurological quantifiable and reproducible score (modified Subjective Objective Medical management Analytic, SOMA).

The investigators previously developed a successful PE treatment in symptomatic RI injuries via the antioxidant pathway, in clinical phase II and III trails and experiments obtaining a major significant radiation-induced fibrosis regression, then the PE clodronate combination (PENTOCLO), obtaining a rapid and significant healing of mandible osteoradionecrosis and significant neurological signs regression (- 35% modified SOMA score at 18 months) in 50 partial RIP.

The aim of this phase III randomized clinical trial is to show PENTOCLO efficiency and its tolerance in long survival patients irradiated before for cancer and presenting with partial RIP of upper or lower legs.

The investigators calculated to include 60 patients to show a significant clinical difference between the two groups after 18 months of treatment: PENTOCLO[Pentoxifylline 400 (2x/d) + vitamine E 500 (2x/d) + intermittent Clodronate 800 (2/d, 5d/7)] versus triple placebo, with prednisone 20 (2d/7) for all patients.

RIP is assessed before treatment and every 6 months by a standardized sensory-motor neurological (SOMA 95 modified by NCI-CTC 99) score used for main criteria at M18, and various neurological scales of assessment (Visual Analog Scale for pain / VAS for paresthesia, Neuropathic Pain Symptom Inventory [NPSI], Overall Disability Sum Score [ODSS], muscle testing, Nine hole peg test / Timed 25-Foot Walk), quality of life (SF36, Patient Global Impression of Change and Clinical Global impression of Change [PGIC/ CGIC]) and electrophysiology.

Trial of Safety Nets In Hospitalized Patients [Completed]
This study compared standard hospital restraints to a newer safety net restraint system to compare them for acceptability, tolerance, duration of restrain, length of stay in the hospital, and satisfaction of MD, nurse, and relatives of patients.

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Reports of Suspected Soma (Carisoprodol) Side Effects

Anxiety (17),  Pain (15),  Tremor (11),  Drug Ineffective (9),  Fatigue (9),  Insomnia (9),  Aggression (8),  Blood Cholesterol Increased (7),  Unevaluable Event (7),  Muscle Spasms (7), more >>

PATIENT REVIEWS / RATINGS / COMMENTS

Soma review by 44 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		back pain
Dosage & duration:		350mg taken every 6 hrs for the period of 3 days
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		The pain in my back and neck caused stress and spasms. The medication relived the pain , nearly completlly, and allowed the spasms to subside. I tried anti inflamatories before for this re occuring problem and found them to be nearly useless. Strong pain killers like darvocet and vicadin are affective but do not allow me to maintain any normal activity during the drug use.
Side effects:		I found that after two to three doses ther seems to be a cumulative affect of the drug on my sense of balance. This is very mild, and only leaves me feeling a bit light headed at times. I am still able to engage in most of my normal neccessary activities around my home. I do refrain from driving or any other possibly risky activity when on this medication. Also , when I have prolonged pain and require several days of medication, I have noticed slight constipation. This is no where near as bad as the constipation caused by vicoden or darvocet.
Comments:		I suffered form damage to soft tissues on my neck and back from an accedent. i crashed on a mountain bike and after the inisial recovery period, I found that certain activited can cause a sharp pain in my back at the base of my neck. This, if not medicated, will grow in the course of a hours, into spasms and tense pain. It will cause me to contort my neck and everything I do brings more pain and discomfort. The medication when taken at the onset of the pain, cause the muscles to relax and the pain to subside in a day. If the pain becomes severe and medication is postponed, it may take several doses of medication over the next day or two to make the muscles relax.

Soma review by 52 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		migraines/upper back pain
Dosage & duration:		350 mg. taken several times a day for the period of at least a year
Other conditions:		none
Other drugs taken:		vicodin
		Reported Results
Benefits:		None really. At the beginning it did relieve the pain and helped me to sleep.
Side effects:		It wasn't long until I became physically and psychologically dependant on the drug and the treatment became much worse than the problem for which it was prescribed. Soma is listed as a muscle relaxant which is quite misleading. Because it has been cleverly marketed, it is readily prescribed (or was) and very accessible. I think many pain management physicians prescribe soma for their patients without much thought as to the risks. The major adverse affects is the rapid tolerance developement and short term memory loss. There were a number of times that I'd forgotten if /or how much I had taken, which on one occasion precipitated an emergency room visit. It should be classified as a schedule 2 drug at least because of the potential for abuse and overdose. I think this drug should be taken off of the market.
Comments:		There aren't any treatment details. The pain management physician prescribed the medication each monthly visit and increased the dosage not long after introducing the drug as treatment. These kinds of physicians are really drug dealers cloaked in an DEA approved office.

Soma review by 52 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		migraines/upper back pain
Dosage & duration:		350 mg. taken several times a day for the period of at least a year
Other conditions:		none
Other drugs taken:		vicodin
		Reported Results
Benefits:		None really. At the beginning it did relieve the pain and helped me to sleep.
Side effects:		It wasn't long until I became physically and psychologically dependant on the drug and the treatment became much worse than the problem for which it was prescribed. Soma is listed as a muscle relaxant which is quite misleading. Because it has been cleverly marketed, it is readily prescribed (or was) and very accessible. I think many pain management physicians prescribe soma for their patients without much thought as to the risks. The major adverse affects is the rapid tolerance developement and short term memory loss. There were a number of times that I'd forgotten if /or how much I had taken, which on one occasion precipitated an emergency room visit. It should be classified as a schedule 2 drug at least because of the potential for abuse and overdose. I think this drug should be taken off of the market.
Comments:		There aren't any treatment details. The pain management physician prescribed the medication each monthly visit and increased the dosage not long after introducing the drug as treatment. These kinds of physicians are really drug dealers cloaked in an DEA approved office.