Efficacy and safety of oral Nigella sativa oil for symptomatic treatment of knee osteoarthritis: A double-blind, randomized, placebo-controlled clinical trial

Huseini, H Fallah; Mohtashami, Reza; Sadeghzadeh, Elaheh; Shadmanfar, Soraya; Hashem-Dabaghian, Fataneh; Kianbakht, S

doi:10.1016/j.ctcp.2022.101666

Cited by 5 publications

(18 citation statements)

References 29 publications

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“…Three of the six studies reported adverse events related to the study treatment 21,22,24 . Overall, either topical or oral administration of Nigella sativa was well tolerated, and no serious adverse events were reported.…”

Section: Resultsmentioning

confidence: 99%

“…Five studies used oral/topical Nigella sativa oil 20‐23,25 and one trial used oral capsules 24 . Three studies also allowed the use of NSAIDs for participants if needed 21,22,24 . The control medications included: corn starch, 24 acetaminophen, 23 placebo syrup, 22 mineral oil, 21 diclofenac sodium gel, 20 and patients' routine prescriptions 25 .…”

Section: Resultsmentioning

confidence: 99%

“…Three of the six studies reported adverse events related to the study treatment. 21,22,24 Overall, either topical or oral administration of Nigella sativa was well tolerated, and no serious adverse events were reported. One study documented contact dermatitis in 7.1% and 13.4% of OA patients who were administrated topical and oral Nigella sativa oil, respectively.…”

Section: Safety Of Nigella Sativamentioning

confidence: 91%

“…Furthermore, patients in the Nigella sativa group used fewer acetaminophen tablets (p = 0.001) and reported higher satisfaction with their treatment (p < 0.001) during the trial compared to the placebo group. 22 The oral capsule format of Nigella sativa (2 g/day, four times a day) was compared with corn starch placebo capsules in the study performed by Salimzadeh and colleagues. After a 12-week follow-up period, the KOOS pain (p < 0.05), activities of daily living (p < 0.05), and function in sport and recreation (p < 0.05) were significantly decreased relative to the baseline scores.…”

Section: Efficacy Of Nigella Sativa On Pain Managementmentioning

confidence: 99%

“…24 In addition, there were no substantial changes in the complete blood count and serum biochemical parameters across the study. 22,24 3.5 | Quality assessment Overall, the methodological quality across the parallel group trials was low in one study, 22 had some concerns in two studies, 20,21 and was high in two studies. 24,25 In addition, the crossover trial was rated as a high-risk study.…”

Section: Safety Of Nigella Sativamentioning

confidence: 99%

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The efficacy and safety of Nigella sativa in the management of osteoarthritis: A systematic review

Mousavi,

Noori,

Marandi

et al. 2024

Health Science Reports

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Background and AimsOsteoarthritis (OA) is one of the most common debilitating diseases among the aging population. Nigella sativa is one potential treatment for OA. Here, we sought to evaluate the efficacy and safety of Nigella sativa for treating patients with OA.MethodsPubMed, Scopus, Embase, and Web of Science were searched up to October 20, 2022. The primary outcome was changes in the pain score after receiving Nigella sativa or control agents based on the results of randomized controlled trials (RCTs). The secondary outcome was set as the frequency of adverse events reported during the follow‐up period.ResultsSix RCTs involving a total of 370 patients with knee OA were included in the present systematic review. Among the four screened studies, the topical administration of Nigella sativa oil was found to be more effective than the placebo in relieving pain in three trials. Additionally, the oral use of Nigella sativa oil was assessed in two trials, and an improvement in pain score relative to placebo was documented in only one of the studies. Also, the trial that evaluated the effectiveness of Nigella sativa oral capsules did not demonstrate any difference in pain reduction between the intervention and placebo groups. Overall, either topical or oral administration of Nigella sativa was well tolerated, and no serious adverse events were reported.ConclusionNigella sativa is generally safe, but conflicting findings from low‐quality studies hinder the ability to make clinical recommendations for or against treating OA. Robust trials are needed for informed decisions.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Safety Of Nigella Sativamentioning

confidence: 91%

Section: Efficacy Of Nigella Sativa On Pain Managementmentioning

confidence: 99%

Section: Safety Of Nigella Sativamentioning

confidence: 99%

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The efficacy and safety of Nigella sativa in the management of osteoarthritis: A systematic review

Mousavi,

Noori,

Marandi

et al. 2024

Health Science Reports

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Randomized Controlled Trials Studying Nonoperative Treatments of Osteoarthritis Often Use Misleading and Uninformative Control Groups: A Systematic Review

Adu,

Ring,

Teunis

2024

Clin Orthop Relat Res

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Background Because there are no known treatments that alter the natural course of the pathophysiology of osteoarthritis, nonoperative treatment needs to be compared with known effective treatments that seek to mitigate symptoms or with similarly invasive inert (placebo) treatments to determine effectiveness. Comparing a treatment to an uninformative control group may inappropriately legitimize and support the use of potentially ineffective treatments. We therefore investigated the prevalence of inappropriate control groups in musculoskeletal research and asked whether these are associated with reporting a positive treatment effect. Questions/purposes We systematically reviewed randomized trials of nonoperative treatments of osteoarthritis and asked: (1) What proportion of randomized trials use uninformative control groups (defined as a treatment less invasive than the tested treatment, or a treatment that might possibly not outperform placebo but is not acknowledged as such)? (2) Is the use of uninformative control groups independently associated with reporting a positive treatment effect (defined as p < 0.05 in favor of the intervention, or as making a recommendation favoring the intervention over the control treatment)? Methods In a systematic review following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched PubMed, Cochrane, and Embase up to September 2023 for randomized controlled trials published between 2020 to 2022 that compared one or more nonoperative treatments for the symptoms of osteoarthritis. We excluded studies that contained a surgical treatment group. We identified 103 trials that met eligibility criteria, with a total of 15,491 patients. The risk of bias was high in 60% (n = 62) of trials using the Cochrane Risk of Bias Tool, version 2. Although the high risk of bias in the included studies is concerning, it does not invalidate our design; instead, it highlights that some studies may use flawed methods to recommend treatments with unproven effectiveness beyond nonspecific effects because the kinds of bias observed would tend to increase the apparent benefit of the treatment(s) being evaluated. We used logistic regression to test the association of uninformative control groups with a positive treatment effect, accounting for potential confounders such as conflict of interest and study bias using the Cochrane Risk of Bias score. Results The use of uninformative control groups (treatments less invasive than the tested treatment, or treatments that might not outperform placebo but are not acknowledged as such) was found in 46% (47 of 103) of included studies. After accounting for potential confounding, there was no association between reporting positive treatment effects and the use of an uninformative control group. Studies with a low risk of bias had a lower likelihood of reporting a positive treatment effect (OR 0.2 [95% confidence interval 0.05 to 0.9]; p = 0.04, model pseudo R2 = 0.21). Conclusion The finding that recent studies that mimic high-level evidence often use uninformative control groups that do not adequately account for nonspecific effects (perceived treatment benefits unrelated to a treatment’s direct physiological effects) points to a high risk of legitimizing ineffective treatments. This raises the ethical imperative for patients, clinicians, journal peer reviewers, and journal editors to hold researchers to the standard of an adequate, informative control group. Awareness and risk of bias checklists might help patients and clinicians forgo new treatments based on seemingly high-level evidence that may carry only iatrogenic, financial, and psychological harm (false hope, in particular). Level of Evidence Level I, therapeutic study.

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Aromatic Plants as Potential Resources to Combat Osteoarthritis

Maring,

C.,

et al. 2024

CCHTS

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Osteoarthritis, which affects an estimated 10% of men and 18% of women over the age of 60 and is increasing in genetic prevalence and incidence, is acknowledged as the condition that degrades the quality of life for older adults in the world. There is currently no known treatment for osteoarthritis. The majority of therapeutic methods slow the progression of arthritis or treat its symptoms, making effective treatment to end the degenerative process of arthritis elusive. When non-pharmacological therapy is ineffective, various pharmacological therapies may be used to treat osteoarthritis. Pharmacological therapy, however, can have major adverse effects and be very expensive. As a result, alternative remedies have been researched. The promise for the safe and efficient management of osteoarthritis has been demonstrated by herbal remedies. Experimental research suggests that herbal extracts and compounds can reduce inflammation, inhibit catabolic processes, and promote anabolic processes that are important for treating osteoarthritis. Due to their therapeutic and innate pharmacological qualities, aromatic herbs are frequently employed as herbal remedies. Recent research has shown that aromatic plants have the potency to treat osteoarthritis. Additionally, complex mixtures of essential oils and their bioactive ingredients, which have anti-inflammatory and antioxidant properties and are obtained from aromatic plants, are frequently utilized as complementary therapies for osteoarthritis. To establish new study avenues, the advantageous anti-osteoarthritic effects of aromatic herbal medicines, including plants, essential oils, and their bioactive components, are extensively discussed.

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Efficacy and safety of oral Nigella sativa oil for symptomatic treatment of knee osteoarthritis: A double-blind, randomized, placebo-controlled clinical trial

Cited by 5 publications

References 29 publications

The efficacy and safety of Nigella sativa in the management of osteoarthritis: A systematic review

The efficacy and safety of Nigella sativa in the management of osteoarthritis: A systematic review

Randomized Controlled Trials Studying Nonoperative Treatments of Osteoarthritis Often Use Misleading and Uninformative Control Groups: A Systematic Review

Aromatic Plants as Potential Resources to Combat Osteoarthritis

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