Effects of diclofenac and misoprostol: A Synthesis of Findings from 28 Studies

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Original Abstract of the Article

Major research findings

Several studies have shown that the combination of diclofenac and misoprostol is effective in reducing the risk of gastrointestinal complications associated with NSAIDs, without compromising the analgesic and anti-inflammatory effects. 3 、 25 、 1 、、 5 、 23 、 28 、 11 The combination has been shown to be as effective as diclofenac alone in treating osteoarthritis and rheumatoid arthritis. 3 、 25 、 1 、、 5 、 23 、 28 、 11 In some studies, the combination even showed a better analgesic effect compared to diclofenac alone. 1 Moreover, the combination of diclofenac and misoprostol may also be more cost-effective than other NSAIDs. 25 、 10 、 27

Benefits and Risks

Benefit Summary

The combination of diclofenac and misoprostol offers potential benefits in reducing the risk of gastrointestinal complications associated with NSAIDs, while maintaining or even enhancing their analgesic and anti-inflammatory effects. 3 、 25 、 1 、、 5 、 23 、 28 、 11 Furthermore, the combination may be more cost-effective than other NSAIDs. 25 、 10 、 27

Risk Summary

While effective, the combination of diclofenac and misoprostol can cause side effects such as abdominal pain, diarrhea, nausea, and dyspepsia. 12 、 13 While these are typically mild, they can be severe in some cases. 12 It is important to be aware of these potential risks and consult a healthcare professional if experiencing any adverse effects. 12

Comparison of Studies

Commonalities of Studies

Many studies have consistently found that the combination of diclofenac and misoprostol reduces the risk of gastrointestinal complications associated with NSAIDs. 3 、 25 、 1 、、 5 、 23 、 28 、 11 Moreover, many studies indicate that the combination is as effective as diclofenac alone in treating osteoarthritis and rheumatoid arthritis. 3 、 25 、 1 、、 5 、 23 、 28 、 11 Additionally, some studies suggest that the combination may be more cost-effective than other NSAIDs. 25 、 10 、 27

Differences in Studies

The incidence and severity of side effects associated with the combination of diclofenac and misoprostol can vary depending on the study. 12 、 13 Some studies have reported a higher analgesic effect with the combination compared to diclofenac alone, while others have not. 1 Furthermore, different study methods and assessment criteria may be employed in evaluating the effectiveness and safety of the combination, making it difficult to compare results across studies. 15

Consistency and Contradictions in Results

While a significant body of evidence indicates that the combination of diclofenac and misoprostol effectively reduces the risk of gastrointestinal complications associated with NSAIDs, 3 、 25 、 1 、、 5 、 23 、 28 、 11 there are some inconsistencies in the findings regarding the analgesic effect of the combination compared to diclofenac alone. 1 Additionally, the incidence and severity of side effects can vary across different studies. 12 、 13

Considerations for Real-World Application

While the combination of diclofenac and misoprostol shows promise in reducing gastrointestinal complications associated with NSAIDs, it is important to remember that it can cause side effects, such as abdominal pain and diarrhea. 12 、 13 Therefore, it is crucial to follow the instructions of your healthcare provider when taking this medication and to report any adverse effects promptly. 12

Limitations of Current Research

Research on the combination of diclofenac and misoprostol is still ongoing, and there is a lack of long-term studies. 15 Additionally, the use of different study methods and assessment criteria makes it difficult to compare results across different studies. 15

Directions for Future Research

Future research should focus on long-term studies of the combination of diclofenac and misoprostol, as well as standardizing study methods and assessment criteria for evaluating the effectiveness and safety of the combination. 15 Comparative studies of the combination with other NSAIDs and COX-2 inhibitors are also warranted. 19

Conclusion

The combination of diclofenac and misoprostol has the potential to reduce gastrointestinal complications associated with NSAIDs while maintaining or enhancing their therapeutic effects. 3 、 25 、 1 、、 5 、 23 、 28 、 11 However, it is important to be aware of potential side effects and to consult a healthcare professional if any adverse effects are experienced. 12 、 13 Further research is needed to fully understand the long-term effects of this combination and to optimize its use for patient benefit. 15

Literature analysis of 28 papers
Positive Content
26
Neutral Content
0
Negative Content
2
Article Type
10
1
0
8
28
1.

Diclofenac/misoprostol: novel findings and their clinical potential.

Author: ShieldM J

Enhanced analgesia
Improved gastrointestinal safety
Improved mobility
Gastrointestinal damage
Hemoglobin decrease

Diclofenac/misoprostol combination therapy offers improved gastrointestinal safety and enhanced analgesic and anti-inflammatory effects compared to diclofenac alone.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

3.

Cost effectiveness of replacing diclofenac with a fixed combination of misoprostol and diclofenac in patients with rheumatoid arthritis.

Author: KristiansenI S, KvienT K, NordE

Cost-effective treatment
Serious GI events

Replacing diclofenac with a fixed combination of diclofenac and misoprostol is cost-effective in treating rheumatoid arthritis (RA) patients at increased risk of serious gastrointestinal (GI) events.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

A randomized, double-blind, crossover clinical trial of diclofenac plus misoprostol versus acetaminophen in patients with osteoarthritis of the hip or knee.

Author: PincusT, KochG G, SokkaT, LefkowithJ, WolfeF, JordanJ M, LutaG, CallahanL F, WangX, SchwartzT, AbramsonS B, CaldwellJ R, HarrellR A, KremerJ M, LautzenheiserR L, MarkensonJ A, SchnitzerT J, WeaverA, CumminsP, WilsonA, MorantS, FortJ

Improve pain
Adverse effects

Diclofenac + misoprostol was found to be more effective than acetaminophen in improving pain scores in patients with osteoarthritis of the hip or knee. Significantly higher levels of improvement in pain scores were seen with diclofenac + misoprostol, but acetaminophen was associated with fewer adverse events.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

A double-blind comparison of the gastroduodenal safety and efficacy of diclofenac and a fixed dose combination of diclofenac and misoprostol in the treatment of rheumatoid arthritis.

Author: VerdicktW, MoranC, HantzschelH, FragaA M, SteadH, GeisG S

Rheumatoid arthritis treatment
Gastroduodenal damage

Diclofenac sodium and misoprostol combination caused significantly less gastroduodenal damage than diclofenac alone, but was equally effective in treating rheumatoid arthritis. Ulcers were found in 11% of the diclofenac/placebo group and only 4% of the diclofenac/misoprostol group.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Controlled Clinical TrialA clinical trial that evaluates the effectiveness of a treatment by comparing a group that receives the intervention with a group that receives a placebo or standard treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

6.

A framework for evaluating the clinical consequences of initial therapy with NSAIDs, NSAIDs plus gastroprotective agents, or celecoxib in the treatment of arthritis.

Author: BurkeT A, ZabinskiR A, PettittD, ManiadakisN, MaurathC J, GoldsteinJ L

Cost-effective treatment
NSAID toxicity

This study aims to compare the economic efficiency of NSAIDs, gastroprotective agents, and celecoxib for treating osteoarthritis and rheumatoid arthritis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

7.

Diclofenac/misoprostol vs diclofenac/placebo in treating acute episodes of tendinitis/bursitis of the shoulder.

Author: ZuinenC

Gastroprotection
Tendinitis/bursitis relief
Abdominal pain
Nausea
Vomiting

Diclofenac/misoprostol was as effective as diclofenac alone in the short-term treatment of acute tendinitis/bursitis of the shoulder, with similar improvements in patient assessments. Diclofenac/misoprostol had slightly more abdominal pain, nausea, and vomiting, but patient withdrawals due to adverse events were similar.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Controlled Clinical TrialA clinical trial that evaluates the effectiveness of a treatment by comparing a group that receives the intervention with a group that receives a placebo or standard treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

8.

Double-blind comparison of efficacy and gastroduodenal safety of diclofenac/misoprostol, piroxicam, and naproxen in the treatment of osteoarthritis.

Author: Melo GomesJ A, RothS H, ZeehJ, BruynG A, WoodsE M, GeisG S

Comparable efficacy
Ulcer reduction
Abdominal pain
Diarrhea

Diclofenac/misoprostol at twice daily dosing is associated with significantly fewer gastroduodenal ulcers than either piroxicam or naproxen. The efficacy of diclofenac/misoprostol in treating the signs and symptoms of osteoarthritis is at least comparable to that of piroxicam and naproxen.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

9.

Improving medication adherence through patient education distinguishing between appropriate and inappropriate utilization. Patient Education Study Group.

Author: EdworthyS M, DevinsG M

Beneficial clinical outcomes
Improved knowledge
Improved stiffness
Increased self-efficacy

Computer-assisted education for patients with osteoarthritis (OA) improved knowledge, realistic expectations of medication benefits, perceived ease of adherence, and self-efficacy, resulting in more frequent appropriate medication utilization. This intervention also led to greater improvement in stiffness.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Management of NSAID-induced gastropathy: an economic decision analysis.

Author: GoldsteinJ L, LarsonL R, YamashitaB D, BoydM S

Cost-effective treatment
Gastrointestinal complications

This study evaluated the economic impact of different strategies for preventing and managing NSAID-induced gastropathy. The combined diclofenac/misoprostol regimens were more cost-effective than NSAIDs alone or in combination with other drugs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Diclofenac/misoprostol compared with diclofenac in the treatment of osteoarthritis of the knee or hip: a randomized, placebo controlled trial. Arthrotec Osteoarthritis Study Group.

Author: BocanegraT S, WeaverA L, TindallE A, SikesD H, BallJ A, WallemarkC B, GeisG S, FortJ G

Ulcer prevention
GI symptoms

Misoprostol, when combined with diclofenac, reduced the incidence of NSAID-induced ulcers in patients with osteoarthritis.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Overall safety of Arthrotec.

Author: GeisG S

Effective treatment
Gastrointestinal issues
Serious side effects

Diclofenac/misoprostol was found to be associated with a higher incidence of gastrointestinal side effects than diclofenac alone. The most common adverse events were abdominal pain, diarrhea, nausea, dyspepsia, and flatulence.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

13.

Efficacy of diclofenac/misoprostol vs diclofenac in the treatment of ankylosing spondylitis.

Author: McKennaF

Ankylosing spondylitis relief
Gastroprotection
Abdominal pain
Diarrhea

Diclofenac/misoprostol was as effective as diclofenac in treating ankylosing spondylitis, with no significant difference in efficacy between the two groups. However, diclofenac/misoprostol had a higher incidence of abdominal pain and diarrhea (18.1% and 17.2%, respectively) compared to diclofenac (12.4% each).

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

14.

Drug treatment of rheumatic diseases in the 1990s. Achievements and future developments.

Author: ChoyE H, ScottD L

Arthritis treatment

There have been several advances in the therapy of arthritis, based on better understanding of the pathogenesis of rheumatic diseases, re-evaluation of previous therapeutic concepts, and developments within biotechnology. These advances include the development of new anti-inflammatory drugs, slow-acting antirheumatic drugs, and cytokine immunotherapy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

15.

Prevention of nonsteroidal anti-inflammatory drug-induced gastropathy: clinical and economic implications of a single-tablet formulation of diclofenac/misoprostol.

Author: GoldsteinJ L, LarsonL R, YamashitaB D

Economic benefits
Improved medical outcomes
Gastroduodenal injury
Hemorrhage
Perforation
Ulceration

NSAID use is associated with gastroduodenal injury and a 2%-4% annual risk for symptomatic gastroduodenal ulceration, hemorrhage, and perforation. Diclofenac/misoprostol is effective in treating signs and symptoms of arthritis and in reducing the incidence of NSAID-induced gastroenteropathy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

Oral misoprostol does not protect the kidneys from diclofenac induced toxicity: data from an unilateral ureteral obstructive rat model.

Author: BuyukserbetciM, DadaliM, AydogmusY, HuriE, HascicekA M, OzerE, OgusE, KilincA S, ErogluM

NAC protects against contrast agent toxicity

N-acetylcysteine (NAC) was protective against radiographic contrast agent toxicity in obstructed kidneys, but misoprostol did not have any protective effect against diclofenac.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

18.

Diclofenac/misoprostol during early pregnancy and the risk of miscarriage: a Danish nationwide cohort study.

Author: AndersenJon T, MastrogiannisDimitrios, AndersenNadia L, PetersenMorten, BroedbaekKasper, CejvanovicVanja, NielsenTorben K, PoulsenHenrik E, Jimenez-SolemEspen

Miscarriage

The study aimed to investigate whether early pregnancy exposure to oral diclofenac/misoprostol was associated with miscarriage.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

19.

[Prevention of NSAID gastropathy: the difference between a coxibs and the addition of a PPI].

Author: LemsWillem F, KuipersErnst J

Gastroprotection
Anaemia

This analysis discusses the CONDOR study, a randomized trial that compared celecoxib with omeprazole for preventing NSAID gastropathy in high-risk patients. Results suggest that celecoxib has different gastro-protective effects compared to diclofenac plus misoprostol.

English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : Dutch

20.

[Comparison of the protective effects of roxatidine and misoprostol on diclofenac gastroduodenal pathology. An endoscopic, controlled study of volunteers].

Author: MüllerP, JackischP, SimonB

Effective for gastroduodenal lesions

The study compared the effectiveness of acid-lowering and mucosa-protective drugs in preventing gastroduodenal lesions caused by non-steroidal anti-inflammatory drugs (NSAIDs). Roxatidine, an acid-lowering drug, significantly reduced lesions compared to placebo, while misoprostol, a mucosa-protective drug, showed similar effectiveness to roxatidine. These findings suggest that both drug types can be used for prophylaxis and highlight the complex mechanisms by which NSAIDs damage the gastrointestinal tract.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : German

21.

An economic model for determining the costs and consequences of using various treatment alternatives for the management of arthritis in Canada.

Author: ZabinskiR A, BurkeT A, JohnsonJ, LavoieF, FitzsimonC, TretiakR, ChancellorJ V

Cost-effective treatment
GI complications

This study compared the costs and clinical consequences of treating patients with celecoxib or various NSAID/GI co-therapy regimens.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

22.

The gastroduodenal safety and efficacy of the fixed combination of diclofenac and misoprostol in the treatment of osteoarthritis.

Author: BoltenW, GomesJ A, SteadH, GeisG S

Effective treatment
Reduced gastroduodenal damage

Diclofenac/misoprostol was associated with significantly less gastroduodenal damage than diclofenac alone, while being as effective in treating osteoarthritis.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

25.

Diclofenac/misoprostol. Pharmacoeconomic implications of therapy.

Author: PloskerG L, LambH M

Cost-effective
Pain and inflammation relief
Reduced ulcer risk
None mentioned

The combined formulation of diclofenac/misoprostol is effective for pain and inflammation, with a lower incidence of ulcers compared to diclofenac alone. This combination appears to be most beneficial for patients at high risk of developing ulcers.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

26.

Gastrointestinal-related healthcare resource usage associated with a fixed combination of diclofenac and misoprostol versus other NSAIDs.

Author: RahmeE, JosephL, KongS X, WatsonD J, PellissierJ M, LeLorierJ

GI problems

Diclofenac/misoprostol and other NSAIDs have similar rates of gastrointestinal events, with no significant differences in healthcare resource use and associated costs.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

27.

The economic consequences of NSAID-induced gastropathy in the United Kingdom and commentary on the article by G. de Pouvourville.

Author: Knill-JonesR P

Increased cost

The iatrogenic cost factor for nonsteroidal anti-inflammatory drugs (NSAIDs) in the United Kingdom was found to be similar to that in France. The cost factor, which represents the ratio of the shadow price of the NSAID to the NHS price, ranged from 1.08 for diclofenac/misoprostol to 2.38 for ibuprofen.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
CommentA short article/note that provides an opinion/perspective/interpretation on a published paper/topic.

Language : English

28.

Arthrotec: the evidence speaks for itself.

Author: MorganD

Arthritis treatment
NSAID risks

The article examines recent literature on arthritis therapy options and mucosal-protective agents, focusing on the risks of NSAID therapy and options for reducing them. A recent meta-analysis on NSAID-associated upper gastrointestinal complications is reviewed.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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