Clinical Effectiveness and Tolerability of 2% Menthol in Musculoskeletal Pain : A Pilot Observational Real-world Evidence Study

Objective : To determine the efficacy and safety of 2% menthol in the management of musculoskeletal pain. Materials and Methods : 81 patients above the age of 18 years of either sex with any musculoskeletal pain were included in the study. Subjects were instructed to apply 2% menthol gel twice daily to the affected area for 7 to 10 days. A Visual Analog Scale (VAS) was used to assess the severity of the initial pain. Moreover, the level of muscle soreness on a 7-point Likert scale was also evaluated. The patients were assessed before the treatment and 7 to 10 days after the initiation of the treatment. Results : The VAS scores for pain significantly improved (P< 0.0001) in subjects after completion of the treatment. There was a 70% improvement (7.67 � 1.04 before treatment to 2.30 � 0.56 after treatment) in the VAS scores compared to baseline, and the mean Likert scale of muscle soreness was 2.04 � 0.25 at the end of the treatment. Moreover, no significant adverse events were observed in the patients during the study. Conclusion : The study showed that 2% menthol effectively improves musculoskeletal pain

Coenzyme Q10 in Male and Female Infertility

Infertility is a medical condition that can cause psychological, physical, mental, spiritual, and medical detriments to the patient. Infertility can also be a marker of an underlying chronic disease associated with infertility. It is currently affecting one out of six couples worldwide. The pathophysiology of male and female infertility is multifactorial and still not fully elucidated. Both are related to an imbalance between the production of Reactive Oxygen Species (ROS) and antioxidant defences. Antioxidants are biological and chemical compounds that are synthesized endogenously or exogenously, counteract oxidative stress and act as free radical scavengers. Coenzyme Q10 (CoQ10) is a lipidsoluble quinone acting as an effective antioxidant, which prevents lipid peroxidation and DNA oxidation. It empowers the body’s energy production cycle through Adenosine Triphosphate (ATP) synthesis and has long been used to ameliorate infertility outcomes. Evidence suggests that CoQ10 shows beneficial effects on semen quality, quantity, and mobility in male infertility. Moreover, the potential benefits of oral antioxidants on female infertility treatment are being increasingly investigated, including CoQ10. CoQ10 treatment significantly increases fertilization rate, the number of high-quality embryos, and higher clinical pregnancy and live birth rates. Furthermore, CoQ10 administration enhances ovarian response to stimulation and improves oocyte and embryo quality. Hence, available evidence and clinical studies suggest that CoQ10 supplementation could be considered an inexpensive, safe therapy to enhance infertility treatment in men and women of reproductive age

A Pilot Observational Study of Topical Glucosamine and Chondroitin Sulfate in Patients with Knee Osteoarthritis

Objective : To determine the efficacy and safety of topical glucosamine and chondroitin sulfate in the treatment of knee Osteoarthritis (OA). Materials and Methods : Thirty-three patients diagnosed with knee OA were included in the study. Subjects received topical application of glucosamine and chondroitin sulfate on the affected knee two times a day for four weeks. Pain, joint stiffness, and physical functions were evaluated by the Western Ontario and McMaster Osteoarthritis Index (WOMAC). A Visual Analog Scale (VAS) was used to evaluate the severity of the initial pain. The patients were assessed before the treatment and four weeks after the initiation of the treatment. Results : The WOMAC scores for pain, stiffness, and function, as well as the VAS score, were significantly improved (P<0.01) in subjects at week four compared to the baseline. There was a 44.02% improvement in the total WOMAC scores and a 51.11% improvement in the VAS scores with glucosamine and chondroitin sulfate topical gel after four weeks. Conclusion : Topical glucosamine and chondroitin sulfate are safe and effective in improving knee pain, stiffness, and physical function in knee OA.

Exploring Multi-dimensional Approach for Treating and Preventing Hair Loss with Nutraceuticals

Although hair disorders are not life-threatening, there is no denying that they significantly influence social interactions and patients� psychological well-being. A sufficient and well-balanced nutritional intake is responsible for normal skin and hair function integrity. Dietary imbalance can disturb this equilibrium, whether it takes the form of an overall deficiency, a more specific shortage, or an excess of one component over another. Human skin and hair can be affected by nutritional factors, resulting in excessive hair shedding and hair loss. It is essential to separate those nutritional factors that directly affect the hair cycle and promote hair growth. One of the most emerging areas in dermatology is the role of nutraceuticals in hair loss without any side effects. However, with increasing awareness among patients, there has been a tremendous demand for natural hair care and treatment products. An effective combination of bioactive ingredients derived from natural sources is essential in hair growth stimulation and provides a therapeutic benefit in hair conditioning. When it comes to hair health, dietary supplements and nutraceuticals can be part of a plan to address a visible problem that impacts self-esteem and confidence in men and women.

Pharmacological basis of Evening Primrose Oil in Premenstrual Syndrome — An evidenced based approach

Premenstrual Syndrome (PMS) is a recurrent luteal-phase condition associated with somatic emotional and behavioral symptoms. Frequently reported symptoms include breast discomfort, mood swings, fluid retention and food cravings. The exact etiology of PMS is unknown; however, the underlying mechanism is a complex interaction between fluctuations in ovarian steroids and central neurotransmitters as well as peripheral effects of hormones. Therefore, surprisingly a wide range of treatments are not available with satisfactory outcomes. Evening Primrose Oil (EPO) is one of the most popular for the management of PMS. EPO is a valuable fixed oil extracted from the Oenothera biennis seeds. It comprises essential fatty acids, including linoleic acid, Gamma-Linolenic Acid (GLA), and Vitamin E, which have been used in various treatments. It has been clinically shown to improve psychological (mood and sleep disturbances) and physical symptoms (breast pain/tenderness, bloating, fatigue) in women suffering from PMS. The rationale put forward for investigating the use of EPO in PMS is thataffected women appear to have abnormal levels of essential fatty acids; hence administrating linoleic acid and GLA in the form of EPO could potentially alleviate the symptoms of PMS.

Clinical Efficacy of Pancreatin Minimicrospheres Supplementation in Patients with Exocrine Pancreatic Insufficiency (EPI) : Real-world Evidence

Background : Exocrine pancreatic insufficiency (EPI), characterized by reduced secretion or activity of pancreatic enzymes, causes improper absorption of food, excessive fat excretion in the stool, and malnourishment. Methods : In this observational, real-world evidence study, patients with one or more of the following condition were enrolled: abdominal pain, acidity, diarrhea, nausea, or dyspepsia (as per ROME III criteria). Patients had either been diagnosed with gallstones, hypertriglyceridemia, alcohol consumption or undergone abdominal surgery. Patients were prescribed capsule EnzigestTM10000 (pancreatin minimicrospheres) for one month.The severity and frequency of various gastric symptoms was measured at day 0 and day 30. Results : 540 patients were enrolled with a mean age of 51.6 years. Enzigest significantly reduced the severity of functional dyspepsia by 88.67% (p<0.001) as per Rome III Criteria. There is significant improvement in frequency of symptoms (83.80%), abdominal pain severit(81.58%), epigastric pain (83.09%), nausea (84.35%) and vomiting by 89.62% (all P<0.001). The overall improvement in symptoms was significant (p<0.001). Enzigest was well tolerated.Conclusion : Enzigest improved abdominal pain, dyspepsia, and acidity in patients with exocrine pancreatic insufficiency due to alcohol consumption, gallstones, hypertriglyceridemia, diuretic (Furosemide or Thiazide) or abdominal surgery. Enzigest containing pancreatin minimicrospheres can be an easy therapeutic option to counteract EPI.

Long COVID : New Treatment Perspective Using Nutraceuticals

Coronavirus disease (COVID-19) is an ongoing worldwide pandemic affecting a large population regardless of gender, age, and ethnicity. The persistence of the COVID-19 symptoms has become a significant health issue and is collectively called “Long COVID.” It can be described as the presence of symptoms of COVID even after the recovery from the viral infection. The prolonged symptoms in the patients could be due to various reasons and factors. Prolonged fatigue is a common symptom of Long COVID in patients even after they have recovered from the viral infection. Currently, only rehabilitation has shown promising results in managing the symptoms of Long COVID. Although pharmaceutical drugs have shown potential in treating the symptoms of Long COVID, more clinical evidence is required to confirm its treatment with less to no side effects; since it’s a new disease, the in-depth knowledge of the same is still evolving. Another healthier approach to treating the symptoms of Long COVID could be dietary supplements or “Nutraceuticals,” identified as an alternative to pharmaceuticals, including nutritional supplements, derived nutrients, and dietary and herbal products that display physiological advantages. Nutritional strategies can also play a role in treating hospitalized patients as maintaining the immune system is critical to combat viral infection.Nutraceuticals may be a practical and healthier approach to managing the symptoms of Long COVID or COVID-19. Although ample clinical evidence is present for the treatment of symptoms of COVID-19, further studies in treating Long COVID or its symptoms are required

Medical devices in India: a perspective of guidelines and the way forward.

In recent times, emerging countries including India have become favored destination for medical device companies to leverage the growth opportunities. However, the Indian regulatory system is not ready to meet the challenges that may come up with growing medical device business. It needs major amendments to current Drugs and Cosmetic Act 1940, to include medical device as a separate entity. Like in developed world, the challenges could be addressed by defining medical devices, risk based classification of devices, guidelines for device safety surveillance, and clinical trials for medical devices. Drugs and Cosmetic (Amendment) Bill 2013, which is yet to be released has addressed the concerns to some extent. However, it needs a major revamp to establish effective regulatory framework for medical devices.

Medication adherence: the critical step towards better patient outcome.

Medication adherence is defined as patient’s adherence to take their medications as prescribed and continue to take the prescribed medication for stipulated time frame. Medication non-adherence is a growing concern to physicians, healthcare systems, and other stakeholders (e.g., payers) and there is an increasing evidence of its prevalence and is associated with adverse clinical outcomes eventually resulting into higher costs of care. The cost of non-adherence has been estimated at $100 billion to $300 billion annually, including costs from avoidable hospitalizations, nursing home admissions, and premature deaths. Improving adherence to medication is critical to improve the quality of health care, to encourage better chronic care management, and promote better health outcomes. Reasons for non-adherence are multiple and complex. Studies have reported that poor adherence to drug dosage is due to patient perception that the disease is non-significant, adverse drug effects, lack of treatment effectiveness, and the patient’s poor or incomplete knowledge of the disease and (cost). A multifactorial approach is required to tackle this complex problem as a single approach will be ineffective for all patients. The most effective intervention is to use a combination of approaches and address literacy, behavior, and organizational issues. There are challenges as well as opportunities in addressing the public health issue of medication adherence. Changing healthcare reforms, advances in digital health media, social media and modern technologies can now provide alternatives to tackle this issue.

Levofloxacin in enteric fever--a study.

Typhoid fever is an important cause of morbidity and mortality in patients especially in developing country. Therapy with conventional drugs is associated with increasing resistance, non-compliance to therapy and toxicity. Oral fluoroquinolones have been shown to be effective compared to parenteral broad-spectrum cephalosporins in the treatment of uncomplicated typhoid. However, there is no data available regarding the use of levofloxacin in the treatment of typhoid fever in spite of the susceptibility of Salmonella species to levofloxacin. The present study was undertaken to evaluate the efficacy, safety and tolerability of oral levofloxacin 750 mg once daily in the treatment of typhoid fever. Results indicated that levofloxacin 750 mg administered orally once daily was an effective, safe, well-tolerated and cost-effective option in the treatment of typhoid fever in adult Indian males and non-pregnant females.

Comparative assessment of the bioavailability, efficacy and safety of a modified-release (MR) carbonyl iron tablet and oral conventional iron preparation in adult Indian patients with nutritional iron deficiency anaemia.

The objective of the study is to evaluate the bioavailability, efficacy and safety of a new modified-release (MR) formulation of carbonyl iron (45 mg) relative to a commercially available conventional formulation of ferrous fumarate (300 mg) in adult Indian patients with clinical and laboratory diagnosis of nutritional iron deficiency anaemia. This prospective, comparative, randomised, double-blind study was carried out among 60 patients received a single daily dose of either MR carbonyl iron or ferrous fumarate for 12 weeks. The effect of therapy on haematological parameters and iron status and estimation of bioavailability were the main efficacy outcomes. There was a significant (p<0.05) increase in mean haemoglobin levels, reticulocyte counts, haematocrit and mean corpuscular volume in MR carbonyl iron group compared to ferrous fumarate group. There was also an increase in mean serum iron and ferritin levels and a corresponding decrease in total iron binding capacity in MR carbonyl iron group compared to ferrous fumarate group at the end of 12 weeks therapy. The estimated overall bioavailability of MR carbonyl iron was about 147% that of ferrous fumarate. Both the formulations were equally well-tolerated and adverse events were mainly gastrointestinal in nature. The prevalence of adverse events was slightly more in the ferrous fumarate group. It can be concluded that the MR formulation of carbonyl iron was more efficacious than ferrous fumarate in correcting haematologic abnormalities and improving iron status in patients with nutritional iron deficiency anaemia. In conditions where efficacy is an important consideration, the higher bioavailability of MR carbonyl iron may make it the treatment of choice for nutritional iron deficiency anaemia.

A pilot study for evaluation of the efficacy and safety of telmisartan in reducing microalbuminuria in hypertensive patients with type 2 diabetes mellitus.

To evaluate efficacy and tolerability of telmisartan, an angiotensim II receptor blocker, in reducing microalbuminuria in adult Indian hypertensive patients with type 2 diabetes mellitus, a prospective, open-label, non-comparative, assessor-blind, multicentric, pilot study was conducted in 60 eligible hypertensive patients with type 2 diabetes mellitus and microalbuminuria after obtaining their informed consent. The study was approved by the respective institutional review boards. Each patient received telmisartan 40 mg initially once daily for first 4 weeks which was titrated upwards to 80 mg once daily for the next 8 weeks. Blood pressure was assessed at the end of every 2 weeks and urinary albumin excretion and creatinine clearance were measured at baseline and after 12 weeks of therapy. Safety outcome measures included monitoring of physical examination, laboratory parameters and monitoring treatment-emergent adverse events. Fifty-five patients completed the study while 5 cases were lost to follow-up. The mean age of the patients was 48.27 years. Of the total patients 63.6% were males and 46.4% were females. At baseline the mean urinary albumin excretion rate was 131.81 +/- 38.82 mg/minute. A statistically significant (p < 0.05) reduction (32.96%) in urinary albumin excretion rate occurred after 12 weeks of therapy (118.36 +/- 37.22). The mean pre-study systolic blood pressure was 165.05 +/- 15.24 mmHg which was significantly (p < 0.05) reduced to 123.72 +/- 5.88 mmHg at the end of 12 weeks. At baseline the mean diastolic blood pressure was 103.55 +/- 9.84 mmHg which was significantly (p < 0.05) reduced to 84.71 +/- 8.54 mmHg. The JNC-VII goal of blood pressure below 130/80 was achieved in 34 (61.8%)of the 55 patients at the end of 12 weeks. Both fasting and postprandial blood sugar levels were well-controlled at the end of the study. Telmisartan was well tolerated with only 9.09% of the patients reported mild and transient adverse events like fatigue, dizziness, nausea and diarrhoea. No abnormalities were detected in the laboratory parameters. The results of this pilot study indicate that telmisartan is effective, safe and well tolerated while reducing microalbuminuria in adult Indian hypertensive patients with type 2 diabetes mellitus.

Assessment of efficacy, safety and tolerability of fixed dose combination of telmisartan 40mg and hydrochlorothiazide 12.5mg in adult Indian patients with mild to moderate hypertension.

The objective of the study was to assess the efficacy, safety and tolerability of a fixed dose combination of telmisartan 40 mg and hydrochlorothiazide 12.5 mg in adult Indian patients with mild to moderate hypertension. A prospective, multicentric, open-label, non-comparative, phase IV study was conducted. A total of 353 patients of either sex, between 18- 65 years of age with supine blood pressure (BP) levels of systolic BP (SBP) of 140-200 mmHg and diastolic BP (DBP) of 95-114 mmHg were included. After a placebo run-in period of 2 weeks, each patient received a fixed dose combination of telmisartan/hydrochlorothiazide (40mg/12.5mg) once daily, for 8 weeks. Supine BP was assessed at the end of every 2 weeks. Tolerability and safety were assessed by physical examination, laboratory parameters and evaluation of adverse events. A total of 339 patients completed the study with 14 drop-out cases because of loss to follow-up. There was a significant fall (p<0.05) in both the SBP and DBP starting from the second week as compared to the baseline. Mean SBP had a significant reduction of 23.55 mmHg (15.0%) and 27.79 mmHg (18%) at the end of 6th and 8th week respectively, compared to baseline values. Mean DBP had also had a significant reduction of 12.51 mmHg (12.6%) and 15.17 mmHg (15.3%) at the end of 6th and 8th week respectively, compared to baseline values. This combination was well tolerated with only 3.9% of the total cases reporting mild adverse events like fatigue, dizziness, nausea, diarrhoea etc. The laboratory values were within normal limits. Fixed dose combination of telmisartan/hydrochlorothiazide (40 mg/12.5 mg) once daily has a significant therapeutic effect and a good tolerability profile in adult Indian patients with mild to moderate hypertension.

Comparative evaluation of the efficacy, safety, and tolerability of rosuvastatin 10 mg with atorvastatin 10 mg in adult patients with hypercholesterolaemia: the first Indian study.

To compare the efficacy, safety and tolerability of rosuvastatin 10mg with atorvastatin 10 mg in adult Indian patients with hypercholesterolaemia, a prospective, open-label, comparative, phase III study was conducted. A total of 45 patients of either sex, between 18 and 80 years of age with hypercholesterolaemia, having LDL cholesterol (LDL-C) of 160 and < 250 mg/dl and triglyceride < 400 mg/dl, were included in this trial. After a dietary run-in period of 2 weeks, patients received either rosuvastatin 10 mg once daily or atorvastatin 10 mg once daily, for 6 weeks. The fall in the mean LDL-C levels after 6 weeks of treatment in rosuvastatin group (40.1%) was significantly more as compared to the fall in atorvastatin group (29.8%). Other secondary lipid parameters like total cholesterol (TC), HDL cholesterol (HDL-C), triglycerides, apo-B, apo-AI, and TC/HDL-C ratio also showed more beneficial changes from the baseline in rosuvastatin group than in atorvastatin group. Rosuvastatin 10 mg shows significantly better efficacy than atorvastatin 10 mg in reducing LDL-C levels and produces greater improvements in other elements of the lipid profile.

Evaluation of the efficacy, safety and tolerability of valdecoxib gel (1%) in adult patients with painful inflammatory joint disease.

Valdecoxib, a COX-2 inhibitor, has recently been introduced as a gel formulation. The present study was conducted to evaluate the efficacy, safety and tolerability of valdecoxib gel in adult patients with painful inflammatory joint conditions. The present study was a 10-day prospective, open, multicentric (6 centres) trial. Patients with clinical and radiological diagnosis of painful inflammatory joint conditions were treated with valdecoxib gel (1%). Efficacy was assessed by visual analogue scale (VAS), patient's and physician's global assessment of pain relief. Grading of associated clinical manifestations such as stiffness, swelling, tenderness and restriction of mobility was done. Tolerability and safety was assessed by physical examination, laboratory parameters and evaluation of adverse events. There was a statistically significant decrease in the mean pain visual analogue score (p<0.05). Onset of pain relief was within 15 minutes. There was a reduction of 58.8%, 57.2%, 65.4% and 60.2% in mean scores of stiffness, swelling, tenderness and mobility respectively from the baseline which was statistically significant. The laboratory values were within normal limits. The drug was well tolerated. There was no report of any hypersensitivity reaction. This study confirms that valdecoxib gel (1%) is an effective and safe option for the management of painful inflammatory joint conditions.

Efficacy and safety of cilostazol, a novel phosphodiesterase inhibitor in patients with intermittent claudication.

Pharmacotherapy is limited for the relief of intermittent claudication (IC), a common manifestation of peripheral arterial disease (PAD). Pentoxyfylline, the only current pharmacological therapy for IC, has been shown to have similar efficacy as placebo. Cilostazol, a new phosphodiesterase III (PDE III) inhibitor, is a potent inhibitor of platelet aggregation with vasodilatory, antithrombotic, antiproliferative and positive lipid-altering effects. To evaluate the efficacy and safety of cilostazol for the treatment of IC in Indian patients, 123 patients were selected from 6 centres in India. The patients, aged 58-73 years, with the diagnosis of stable moderate-to-severe IC received cilostazol 100/50 mg twice daily for a period of 12 weeks. Primary efficacy measures included initial claudication distance (ICD) and absolute walking distance (ACD) by treadmill testing and ankle-brachial index (ABI) using Doppler ultrasonography-measured systolic pressures. Secondary efficacy outcomes included subjective assessment of symptom improvement by patient and investigator and estimation of lipid values. Adverse events were monitored throughout the study. Laboratory investigations were carried out at baseline and end of study. At the end of week 12 of cilostazol therapy, there was a significant improvement in the raw walking distances (ICD and ACD). Percentage change in ICD and ACD was 46.77% and 64.5%, respectively, at the end of study. There was a significant increase (32.7%) in the ABI by the end of study period. According to patient and investigator assessment of symptoms, 58-60% of the subjects showed significant improvement to complete resolution of claudication symptoms by the end of 12 weeks of therapy. In addition, there was a significant increase of 20.24% in the mean plasma HDL-cholesterol levels and a decrease of 29.55% in the mean plasma triglyceride concentrations by the end of study period. Headache, diarrhoea, palpitation and dizziness were the commonly reported adverse effects during the study. No adverse effect led to discontinuation of therapy. The present study suggests that cilostazol is an effective therapeutic option with an acceptable tolerability profile for the treatment of IC in patients with PAD.

Efficacy and safety of the first parenteral selective COX-2 inhibitor, parecoxib sodium, in adult patients with postoperative pain.

Parecoxib, a prodrug of valdecoxib, a selective COX-2 inhibitor, has been recently introduced for the treatment of moderate to severe postoperative pain. This prospective, open, multicentric study enrolled 260 patients undergoing orthopaedic, gynaecological, dental and general surgery. Postoperatively, patients were treated with parecoxib, 40 mg IM/IV. There was a statistically significant decrease in the mean pain intensity score (p<0.05). At the end of 24 hours, 89.6% of total cases had a very good to total relief of pain. The mean duration of analgesia was 19.26 hours and mean time of onset of analgesia was 16.25 minutes ranging from 11-20 minutes. The laboratory values were within normal limits. The drug was well tolerated. There was no report of any hypersensitivity reaction. This study suggests that parecoxib, in a dose of 40 mg IM/IV, is an effective and safe option for the management of postoperative pain.

Comparison of the efficacy, safety and tolerability of telmisartan with losartan in Indian patients with mild to moderate hypertension: a pilot study.

A prospective, randomised, double-blind, parallel group study was carried out to compare the efficacy, safety and tolerability of telmisartan 40 mg once daily with losartan 50 mg once daily in Indian patients with mild to moderate hypertension. It had a placebo run-in period of 2 weeks followed by drug treatment (telmisartan 40 mg, once daily or losartan 50 mg once daily) for 8 weeks. Supine BP was assessed at the end of every 2 weeks. Tolerability and safety was assessed by physical examination, laboratory parameters and evaluation of adverse events. Treatment with telmisartan resulted in a significant reduction of SBP of 10.3% and 13.7% as compared to 6.6% and 10.6% in losartan group at the end of 6th and 8th weeks respectively. At the end of 6th and 8th weeks, the reduction was 14.3% and 18.1% among telmisartan which was significantly more as compared to 8.8% and 14.3% in losartan group respectively. The laboratory values were within normal limits. Both drugs were well tolerated. Telmisartan monotherapy in a dose of 40 mg once daily has a clinically better therapeutic effect as compared to losartan 50 mg and a good tolerability profile in patients with mild to moderate hypertension.

Efficacy and safety of a combination of metformin and rosiglitaone in patients with type 2 diabetes mellitus--a postmarketing study.

The efficacy and safety of combined metformin and rosiglitazone therapy in type 2 diabetes has been evaluated in an open-label, phase IV, prospective, multicentre study conducted in India over a period of 3 months in accordance with the principles of Good Clinical Practice and the Declaration of Helsinki. The superiority of the combination therapy in its effects on glycaemic parameters and lipid profile has been observed. A discussion of the same with brief review of literature has been presented here.

Evaluation of efficacy, safety and tolerability of valdecoxib in osteo-arthritis patients--an Indian study.

Valdecoxib, a COX-2 inhibitor, has been introduced as a new treatment for osteo-arthritis (OA). The present study was conducted to evaluate the efficacy, safety and tolerability of valdecoxib, in OA patients in an Indian setting. The present 4-week study was a prospective, non-comparative, assessor blind, single group, multicentric trial with OA patients treated with valdecoxib, 10 mg once a day. Efficacy was assessed by analysing the changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analogue scale (VAS), patient's and physician's global assessment of arthritis. The incidence of adverse events was monitored throughout the study. There was a clinical and statistical significant improvement in the mean pain score, stiffness score, physical function, composite WOMAC index score and VAS (p<0.05). Patient's and physician's global evaluation of valdecoxib treatment was very good to good in 84.1% and 83.6% of cases respectively. The present study has shown that valdecoxib, in a dose of 10 mg/day given over 4 weeks, is an effective and safe treatment for the signs and symptoms of OA of hip and knee joints.